Biotech Buzz, October 2013

BIOTECH BUZZ

October, 2013

 Time to Renew Your Biotech Membership and Select Your Voting Status……………………………………… 2

Sign up for Biotech’s “Lyris List” to Receive Committee Communications and to Send Emails to Other Members           3

Join Biotech’s LinkedIn Group……………………………………………………………………………………………………….. 3

Biotech Wins First AIPLA Committee of the Year Award!………………………………………………………………. 3

Changing of the Guard…………………………………………………………………………………………………………………… 3

Biotech Work Plan for 2013-14 Submitted to AIPLA Leadership…………………………………………………… 4

Case Law Review……………………………………………………………………………………………………………………………. 4

Bayer CropScience AG v. Dow AgroSciences LLC., Case No. 2013-1002 (Fed. Cir. Sept. 3, 2013).. 4

Aria Diagnostics, Inc. v. Sequenom, Inc., Case No. 2012-1531 (Fed. Cir. 2013)………………………….. 4

 

Time to Renew Your Biotech Membership and Select Your Voting Status

Your present voting status is NON-VOTING.  If you want to vote on Biotech Committee resolutions, you must go into your AIPLA Profile and elect “VOTING” for the Biotech Committee by about December 18, 2013

Instructions for renewing your membership on Biotech and selecting a voting status.

 

Background

In order to be able to vote on things like resolutions, recommendations, amicus positions, and communications from AIPLA about Biotech IP issues to Congress or to the USPTO, you must be a Voting Member of the Biotech Committee.  Over the last few years, we have conducted 1-2 votes annually.  You can only vote if you are a “Voting Member.”

About half of the Biotech Committee’s ~900 members had “Voting” status at some time in the past.  The other half had the status of “Information Only.”  Despite having so many members “with the vote,” when it came to actual voting, our committee, like most others, never received enough votes on any matter to meet quorum requirements.  A quorum is 50% of members with votes.  A vote that does not meet these standards can still be submitted to the Board, but the Board would be justified in giving little weight to it.

Over the last few years, we have conducted 1-2 votes annually.  You can only vote if you are a “Voting Member.”

AIPLA recently implemented new rules relating to voting status:

  1. You must to re-establish committee membership and Voting vs. Non-Voting status each year.
  2. You may be a “Non-Voting” member of as many committees as you like.
  3. You may elect to be a Voting member of up to 3 substantive committees.  Biotech is a substantive committee.
  4. You may be a Voting member of up to 2 other committees.
  5. Each year, during the Annual Meeting, your voting status on all committees will be reset to “Non-Voting.”
  6. Each year, you will have 60 days from the Annual Meeting to go onto your AIPLA profile and select your membership and voting status on the Biotech Committee. 
  7. If you do not select Voting status on the Biotech Committee by the deadline, you will not be able to vote until October 2014. 

So, if you want to be able to vote on anything that the Biotech Committee puts up for a vote between now and next October, please select “Voting” in your profile before about December 18, 2013.

 

Sign up for Biotech’s “Lyris List” to Receive Committee Communications and to Send Emails to Other Members

The Lyris List is the Biotech Committee’s list of the email addresses of those members who have opted to be included on the committee’s email communications.  Each Biotech member who has joins the Lyris List may use the list to send communications to all other list members.

If you join the Lyris List, you will get all of the committee’s email communications.  Over the last year, we had ~18 Lyris List communications.  The Biotech Buzz, for example, is sent via the Lyris List.  Notices about votes are sent via the Lyris List.  Surveys are sent via the Lyris List.  We expect that the Lyris List will be used more in the future, but not to the point of being annoying.

If you do not join the Lyris List, you will not get any of the committee’s email communications. 

Instructions for joining Biotech’s Lyris List.

 

Join Biotech’s LinkedIn Group

The Biotech Committee has a LinkedIn group that also helps members communicate with each other. 

Instructions for joining Biotech’s LinkedIn group.

 

Biotech Wins First AIPLA Committee of the Year Award!

AIPLA instituted a new award this year – Committee of the Year – and the Biotech Committee won the award at the Annual Meeting last week!  A picture of the award and acknowledgements of contributions this last year are in a slide show presented during Biotech’s business meeting last week in Washington.  Many thanks to the many committee members who worked on projects during the last year and delivered on commitments to get things done. 

 

Changing of the Guard

By Jim Kelley, Out-Going Chair

As of November 1, I will no longer be Chair of the Biotech Committee, but I intend to remain involved as Biotech’s liaison with the Corporate Practice Committee, as a partner with in-coming Chair Suzannah Sundby in liaising with a number of other IP associations on biotech IP issues, and as a strong supporter of our in-coming leadership team.  The new team is excellent.  They are going to improve our Committee.  I urge you to get involved, stay involved. 

Some have asked me why I approached things the way I did, and of course there are many reasons, but primarily, IT WAS FUN!  I got to work on important, interesting issues with smart, dedicated people.  I really enjoyed the opportunity to serve AIPLA and the Biotech Committee and to get to know and to work with so many people.  As a result, I have many people to thank for their contributions, but I fear if I tried to name everyone I will forget someone.  If you look back at all the Biotech Buzz issues, you will see their names.  Suffice to say that ~100 people on our ~900-member committee have done something “more than simply pay dues” over the last few years.  That is actually incredible.  Thank you, each and all.  Keep it up.  Get involved, stay involved.

 

Biotech Work Plan for 2013-14 Submitted to AIPLA Leadership

In-coming committee leaders, Suzannah Sundby and Tim Meigs, prepared the committee’s 2013-2014 Work Plan, which includes the following items:

  1. Expand Educational Services – for members and the public.
  2. Broaden Breadth of Biotech Issues – including new subcommittees Industrial Biotech, Biotech Litigation, and PTAB Actions, and refreshing the objectives of other subcommittees
  3. Strengthen Relationships with Sister Committees/Organizations and the USPTO – including especially the Chemical Practice, Food and Drug, Education, and Corporate Practice Committees within AIPLA and with ABA, BIO, CIPA, EPI, IPO, IPTA, JPAA, and LES outside of AIPLA.
  4. Increase Community Involvement – including encouraging and organizing informal membership interactions for social purposes, and forming new subcommittees, such as Corporate Biotech Practice, Academia and Research Institutions, and regional subcommittees.

Please volunteer to work on something that interests you by contacting any of the in-coming leaders:

 

Case Law Review

 

Link to Case Law Review

Bayer CropScience AG v. Dow AgroSciences LLC., Case No. 2013-1002 (Fed. Cir. Sept. 3, 2013)

Reviewed by Alice O. Martin, Lynn C. Tyler, and Michael Brunelle of Barnes & Thornburg, Indianapolis, IN.

Aria Diagnostics, Inc. v. Sequenom, Inc., Case No. 2012-1531 (Fed. Cir. 2013)

Reviewed by Alice O. Martin, Lynn C. Tyler, and Michael Brunelle of Barnes & Thornburg, Indianapolis, IN.

BIOTECH BUZZ September, 2013

BIOTECH BUZZ

September, 2013

 


Committee Meetings……………………………………………………………………………………………………………………… 2

Introduction of New Committee Leaders and Plans, 25 October, Washington DC……………………. 2

Biotech Social, Stone’s Throw Restaurant, Washington DC, Thursday, 24 October, 6:00-7:00…. 2

Programs……………………………………………………………………………………………………………………………………….. 2

CLE: Overcoming Barriers to New Technologies, 25 October, Washington DC…………………………. 2

USPTO Relations Subcommittee…………………………………………………………………………………………………….. 3

Report from BCP Customer Partnership Meeting – 9 September 2013……………………………………. 3

Committee Annual Survey……………………………………………………………………………………………………………… 4

 


Committee Meetings

Introduction of New Committee Leaders and Plans, 25 October, Washington DC

Suzannah K. Sundby of Smith, Gambrell & Russell, LLP will become chair and Tim Meigs of Becton Dickinson will become vice chair at the annual meeting.  Please join them for a short business meeting at 3:30-3:40 just prior to the CLE session described below.  They will present a brief description of their plans for the next year.

Biotech Social, Stone’s Throw Restaurant, Washington DC, Thursday, 24 October, 6:00-7:00.

While you’re at the annual meeting, please join us for drinks and socializing with panelists and committee members at the Stone’s Throw restaurant on the first floor of the Wardman Park Marriott hotel on Thursday, 24 October, 6:00-7:00.  The time was selected to give you many options for managing your business, the meeting, and other social engagements.  As usual, it’s a cash bar.

 

Programs

CLE: Overcoming Barriers to New Technologies, 25 October, Washington DC

The Biotechnology Committee and the Food and Drug Committee will sponsor a joint educational session (120 minutes of CLE) that will consider the history of the public’s love-hate relationships with new technologies and will include discussion of causes of these conflicting attitudes and their effects on progress. The global status of intellectual property protection in patent offices, regulatory agencies, and the courts will be analyzed to elucidate the issues involved. Solutions for meeting these concerns and attitudes and proposals for developing programs of public education and fostering policies for protecting intellectual property that are beneficial to the public will be presented.

Alice Martin and Bruce Vrana, co-chairs of our Plant Biotechnology subcommittee, will moderate the all-star panel that they put together:

History of Genetic Technologies: Acceptance and Hurdles to Protection Dr. Ananda Chakrabarty, Distinguished University Professor, University of Illinois at Chicago

Addressing Public Fears of New Technologies Professor Jay P. Kesan, College of Law, University of Illinois

International IP Protection for Plants Dr. Humphrey Foote, Senior Associate, AJ Park

Regulatory Issues in Protection of Plant Products, GMOS, Diagnostics Dr. Thomas E. Nickson, International Policy Lead, Monsanto

Public Policy and Education Issues Sarah Hull, Head, Syngenta External Affairs

Please join us in Washington in October for this excellent, educational program!  The session will begin at about 3:40 PM in the Wardman Park Marriott Hotel.

 

USPTO Relations Subcommittee

Report from BCP Customer Partnership Meeting – 9 September 2013

Suzannah K. Sundby, Smith, Gambrell & Russell, LLP

Copies of the handouts from this meeting and from prior meeting can be obtained at http://www.cabic.com/bcp/

Wanda Walker and Jerry Lorengo opened the meeting.

AIA: FITF

Kathleen Bragdon (TC1600) and Gerald Leffers (OPQA) , gave a phenomenal presentation on the training being provided to examiners on AIA FITF office actions and art rejections (and exceptions).  The training/workshop materials are available from the USPTO website at http://www.uspto.gov/aia_implementation/fitf_workshop_demo20130913.pdf.  Many who participated in person said that they are going to implement similar worksheets in their case files and use for client counseling.  These are the same materials that were discussed at the Second Anniversary AIA Forum that was held on 16 September 2013.  For more information go to http://www.uspto.gov/aia_implementation/index.jsp.

Enhancing Efficiency Training and 102/103 Rejections

Jean Witz (QAS, TC1600) and Ashwin Mehta (QAS, TC1600) gave a presentation on enhancing efficiency training relating to 102 and 103 rejections focusing on inherency (including inherency as applied to obviousness), range limitations, and routine optimization.  They discussed case law and its application to specific facts.  The slide set provides a great overview of applicable case law.

Jean Witz then covered examiner training materials that are designed to help examiners provide better rejections.  This portion was also a workshop format where attendees, acting as a supervising examiner, reviewed a claim set, specification, prior art materials, and a junior examiner’s rejections, and then commented on the rejections (e.g., correctness, applicability, analysis, etc.).

Track I Analysis

Kate Gaudry of Kilpatrick Townsend gave a presentation which covered a statistical analysis of Track 1 applications including their allowance rates, speed of prosecution, and cost as compared to regular applications.

The meeting concluded and many of us continued our lively discussions at the Trademark Bar.

Next Meeting – 10 December 2013

The next BCP meeting will be held 10 December 2013.  This meeting will be a special BCP meeting as Acting Director Teresa Rea will be attending. 

If there are any issues or topics that you wish to hear, please let the biotechnology committee know about them or send your ideas to Cecilia Tsang (571-272-0562 or cecilia.tsang@uspto.gov) or to the Group Directors.

Happy Hour

For those wanting more mix and mingle opportunities, come join us for Happy Hour after each BCP meeting at the Trademark Bar for   and lively discussions having little to do with patent law.

 

Committee Annual Survey

We would like your input about the committee.  If you care to, please go to http://www.surveymonkey.com/s/LS7PB5R and provide your answers to one or more of the five questions on the survey.  The five questions are:

1. How can the leadership of AIPLA’s Biotechnology Committee better meet your expectations?

2. What issues or subcommittee(s) would you like to be involved in? (Options are: Diagnostic and Gene Patenting, Biosimilars, Tech Transfer and Licensing, Plant Biotech, Litigation, PTAB Proceedings, and Industrial Biotech)

3. Other / comments to clarify your answers.

4. How can the leadership of AIPLA’s Biotechnology Committee better communicate developments of interest to you?

5. Other / comments to clarify your answers, for example, frequency (e.g., monthly /weekly/daily/newsflash); content (detailed analyses/short summaries); and/or format (Biotech Buzz/emailed or posted weekly newsletter/daily blog or linked-i

BIOTECH BUZZ, August 2013

BIOTECH BUZZ

August, 2013

 


Programs……………………………………………………………………………………………………………………………………….. 2

2013 Annual Meeting, Washington DC, Friday October 25, 3:30-5:30: Overcoming Barriers to New Technologies (120 minutes CLE) 2

Case Law Reports…………………………………………………………………………………………………………………………… 3

Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., reported by Sung Park, George Washington University Law School, Washington, D.C., USA…………………………………………………………………………………………………………………………………………………… 3

Novozymes A/S v. Dupont Nutrition Biosciences APS, reported by Yeu-Yan Perng, University of Washington Law School, Seattle, Washington, USA……………………………………………………………………………………………………………………….. 3

USPTO Relations Subcommittee…………………………………………………………………………………………………….. 3

HELP!  Agenda of First BCP Meeting (1996) Needed…………………………………………………………………. 3

Plant Biotechnology Subcommittee Report…………………………………………………………………………………… 3

Plant IP Protection in Europe…………………………………………………………………………………………………….. 3

Claims must encompass more than a single plant variety……………………………………………………… 3

Claims must recite more than “essentially biological processes for the production of plants” 3

Claims to markers useful for breeding may be acceptable……………………………………………………. 4

Biosimilars Subcommittee Report………………………………………………………………………………………………….. 5

Biocomparable Medicaments in Mexico…………………………………………………………………………………… 5

Legal Framework in Mexico………………………………………………………………………………………………….. 6

Requirements for Bio-comparable Medicaments…………………………………………………………………. 6

 


Programs

2013 Annual Meeting, Washington DC, Friday October 25, 3:30-5:30: Overcoming Barriers to New Technologies (120 minutes CLE)

Periodically the public appears to turn against what is new, yet it wants the benefits attending the new technologies. At present, antagonism is evident towards new technologies including GMO plants and resulting foods, medical advances in diagnostics and use of stem cells, and computer related innovations. As result of this antagonism, coupled with an attitude that all “natural” things belong to the public, protection of intellectual property is increasingly difficult to obtain. On the other hand, the public wants to ensure accessibility to food, better medical diagnosis through, for example, biomarkers, repair of body parts through use of stem cells, and convenience of computers.

In this context, the Biotechnology Committee and the Food and Drug Committee will sponsor a joint educational session (120 minutes of CLE) that will consider the history of the public’s love-hate relationships with new technologies and will include discussion of causes of these conflicting attitudes and their effects on progress. The global status of intellectual property protection in patent offices, regulatory agencies, and the courts will be analyzed to elucidate the issues involved. Solutions for meeting these concerns and attitudes and proposals for developing programs of public education and fostering policies for protecting intellectual property that are beneficial to the public will be presented.

Alice Martin and Bruce Vrana, co-chairs of our Plant Biotechnology subcommittee, will moderate the all-star panel that they put together:

History of Genetic Technologies: Acceptance and Hurdles to Protection Dr. Ananda Chakrabarty, Distinguished University Professor, University of Illinois at Chicago

Addressing Public Fears of New Technologies Professor Jay P. Kesan, College of Law, University of Illinois

International IP Protection for Plants Dr. Humphrey Foote, Senior Associate, AJ Park

Regulatory Issues in Protection of Plant Products, GMOS, Diagnostics TBD

Public Policy and Education Issues Sarah Hull, Head, Syngenta External Affairs

Please join us in Washington in October for this excellent, educational program!

Case Law Reports

Case Law Report Link

Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., reported by Sung Park, George Washington University Law School, Washington, D.C., USA.

Nos. 2012-1567 – 1570 (Fed. Cir. July 26, 2013) (holding invalid as indefinite claims directed to average molecular weight values). 

Novozymes A/S v. Dupont Nutrition Biosciences APS, reported by Yeu-Yan Perng, University of Washington Law School, Seattle, Washington, USA.

Nos. 2012-1433 (Fed. Cir. July 22, 2013) (holding invalid for lack of adequate description claims directed to alpha-amylase variants). 

 

USPTO Relations Subcommittee

HELP!  Agenda of First BCP Meeting (1996) Needed

The PTO organizers of the Biotech/Chem/Pharma Customer Partnership Meetings would like a copy of the agenda of the very first BCP meeting, which was held in November 1996.  Please search your records and if you have a copy, please send to Suzannah at ssundby@sgrlaw.com.  Thanks!

Plant Biotechnology Subcommittee Report

Plant IP Protection in Europe

Contributed by Frances Salisbury of Mewburn Ellis LLP, Manchester, UK

Patents for plant inventions have made headlines in Europe recently, confirming that, despite the European Union’s strict policies on growing genetically modified crops, there is still considerable commercial interest in this area and the associated intellectual property rights.  Nearly 3000 applications for a community plant variety right (PVR) are received by the Community Plant Variety Office annually, with the EPO receiving around 700 applications for patents relating to plants. 

Claims must encompass more than a single plant variety

The European Patent Convention (“EPC”) prohibits the granting of patents to plant varieties (in favour of plant variety rights), and this exclusion has been interpreted as excluding only claims to specific varieties.  It is now established that the exclusion is not an absolute bar to the granting of patent rights for plants per se.

Protection for plants under patent law potentially extends further than under PVRs, encompassing all plants exhibiting a particular trait.  Moreover, the exceptions to that protection are different; European patent law, for example, generally does not include an exception for cultivating farm saved seed.

Claims must recite more than “essentially biological processes for the production of plants”

The EPC does exclude protection for “essentially biological processes for the production of plants or animals,” and this has recently been the subject of high profile cases before the Enlarged Board of Appeal, the highest judicial authority at the EPO. 

The recent “Broccoli” (Enlarged Board of Appeal Decision G2/07) and “Tomatoes” (Enlarged Board of Appeal Decision G1/08) cases both claimed methods for producing plants.  In Broccoli, plants with high levels of particular glucosinolates were obtained by marker-assisted breeding. In Tomatoes, plants with better preservation properties were screened by selecting ripe fruit with lower skin wrinkling (and thus lower fruit water content).  In each case the Enlarged Board determined that the claims defined an essentially biological process (namely sexual crossing and selection), and thus were excluded from patentability.  In order to escape the exclusion, the Board concluded that a claimed method needs to include something more than just a human intervention or technical step; the necessity for human intervention to perform the method steps was not enough.  Instead, the technical means or human intervention has to be decisive to the result obtained.

The decisions make it clear that the exclusion does not apply to methods where a gene is introduced by methods other than sexual crossing.  Established genetic engineering methods using particular genes could therefore still be patentable.  However, in order to escape the exclusion, the method must not explicitly or implicitly include the crossing or selection steps, so careful claim drafting is required.

These recent decisions apply to methods of producing plants, not to the patentability of the products obtained, and thus the patentability of plants obtained by essentially biological processes is consequently uncertain.  Relevant questions have been asked of the Board in a further referral of the Tomatoes case (pending referral G2/12), but both parties subsequently withdrew their appeals, and so the legal status of this case is somewhat unclear.  In any case, it appears that the Enlarged Board will have to decide on the issue, with similar questions having now been asked in a new referral of the Broccoli case (G1/13).

The Enlarged Board may also be questioned on this issue in another case.  Monsanto’s “melon” patent, which claims a virus resistant melon plant and its fruit, is presently the subject of opposition proceedings before the EPO.  This opposition is, however, at a very early stage and it will likely be several years before the relevant questions can even be asked of the Enlarged Board.

As mentioned above, plants are not excluded from patentability per se, provided that the claims encompass more than a single plant variety, so the question is how far the exclusion relating to essentially biological processes extends. 

The Dutch courts recently decided that to allow claims encompassing radish plants obtained by essentially biological processes would be in direct contradiction to the EPC exclusion.  The decisions of member states are not binding on the EPO, but this decision of an experienced court will undoubtedly feature in the opposition proceedings.  Moreover, the EPO face considerable pressure from political bodies and pressure groups not to allow such cases.

Of course, inventions relating to plants and production methods that involve genetic engineering and the introduction of genes through techniques other than sexual crossing and selection can still be patented in Europe, provided that those crossing and selection steps are not included in the method.

Claims to markers useful for breeding may be acceptable

It is also worth noting, in this post-Myriad world, that nucleotide and amino acid sequences remain patentable in Europe (indeed, the patentability of such sequences is written into the EPC).  The molecular markers useful in crossing and selection processes may therefore be patentable in their own right.  

Biosimilars Subcommittee Report

Biocomparable Medicaments in Mexico

Contributed by Eugenio Perez and Janett Lumbreras, Uhthoff Gomez Vega + Uhthoff, Mexico City, Mexico.

Mexico has an estimated population of 118 million people. It is the second largest market of pharmaceuticals in Latin America and the eleventh in the world. Also, it is one of the ten largest drug producers worldwide. This position in the global scenario puts Mexico in a strategic position for the biotech and pharmaceutical industry.  For these reasons, Mexico now has a clear and transparent regulation on biotechnology-derived medicaments for both innovator and non-innovator participants.

The legal regulatory authority for approval of medicaments in Mexico is the Federal Commission for the Protection against Sanitary Risks (COFEPRIS). It is a decentralised organ of the Secretary of Health with technical, administrative and operational autonomy; it is responsible for protecting the Mexican population against sanitary risks, through sanitary regulation, control and promotion.

In September of 2009, an amendment to Mexican Health Law was enacted and provided the initial legal framework for regulating biotechnological medicaments. Article 222bis of the General Health Law provides that a biotechnological medicament is considered as any substance that has been produced by molecular biotechnology and that has a therapeutic, preventive or rehabilitative effect, which is presented in a pharmaceutical form and identified by its pharmacological activity, physical, chemical and biological properties.

The Article also provides that the innovator biotechnological medicaments shall be reference for non-innovator biotechnological medicaments, named bio-comparable medicaments. The way to identify these products will be determined in the Mexican Regulations.

The term “biosimilar” was not adopted in Mexico, as in other countries, due to the existence of a Mexican pharmaceutical company called “Similares”, which is translated as “Similars” in English, which would have rendered the possibility of creating confusion among consumers. 

The main distinction between bio-comparable drugs and generics of small molecule or chemical synthesis drugs are that bio-comparable medicaments and the innovator medicaments are not to be considered identical, mainly due to the production processes from which they derive (i.e., different cell lines, different cell batches, different cell culture conditions, different downstream processing of proteins, etc.).

To obtain a Sanitary Registration (Regulatory Marketing Authorization) for biotechnological medicaments, the applicant must meet with the requirements and tests to demonstrate the quality, safety and efficacy of the product, in accordance with the General Health Law, its Regulations and other legal provisions, and once the biotechnological medicament is sold, strong pharmacovigilance should be performed and passed under the corresponding regulations.

Applicants for a Sanitary Registration of a bio-comparable drug have to provide their own data with regard to the integrity of the active substance molecule, the biological activity of the medicament, and certain safety and efficacy clinical data in patients with the same disease or condition as the innovator.

When a bio-comparable medicament shows different and improved activities due to its differences with the innovator, it may be patentable as a selection invention.

Some of the risks of treating bio-comparable medicaments as generics could be: they may have different effect in the body, different potency, different half-life, potential for cross-reactivity, potential for immunogenicity, etc…

Legal Framework in Mexico

  • Ø  Health General Law;
  • Ø  Regulation for Health Supplies;
  • Ø  Guidelines for biocomparables published by COFEPRIS (in force on April 17, 2012);
  • Ø  Applicable related regulations;
  • Ø  Regulation for New Molecules Committee (in force on February 24, 2012); and
  • Ø  Subcommittee for the Assessment of Biotechnological Products.

Requirements for Bio-comparable Medicaments

Under the new regulations, bio-comparable drugs must be reviewed under strict regulatory rigor to ensure the same level of patient safety as the innovator and to assure that the bio-comparable drug responds and acts through the same mechanisms of action as the innovator in the body, for this, in vivo and in vitro studies are foreseen. Only tests that are considered unnecessary and are not related to patient safety may be foregone in the reviews for bio-comparable drugs. Other important tests are those related to the pharmaceutical form of the medicament, dose, efficacy, and form of administration. The reference product must have a Sanitary Registration in Mexico and non-infringement patents related to the innovator product must be observed by COFEPRIS before issuing a Sanitary Registration to a bio-comparable product .

The regulations for bio-comparable drugs have been developed in accordance to the complexity of the process. The concept of “case by case” review has been implicitly accepted, so it depends on each product as well as the quantity and quality of studies and tests required.

The registration procedure and release of the batch take place in working groups of increasing complexity, where academic participation will be encouraged.

The biotechnological medicaments must include on their labels:

  • ·         name of the manufacturer,
  • ·         country of origin,
  • ·         place of packaging, and
    • ·         name of importer, if any.

The bio-comparable product must have the same International Commune Denomination that the medicament of reference without denoting a separation on the Basic Table keys and of the catalogs of medicaments of the health institutions assigned for these.

For more information, see the following websites:

http://dof.gob.mx/nota_detalle.php?codigo=5214882&fecha=19/10/2011

http://www.cibiogem.gob.mx/Norm_leyes/Documents/normatividad-SSA/LGS.pdf

http://www.diputados.gob.mx/LeyesBiblio/regla/n328.pdf

BIOTECH BUZZ

July, 2013

 


Programs……………………………………………………………………………………………………………………………………….. 2

2013 Annual Meeting, Washington DC, October 2013: Overcoming Barriers to New Technologies (120 minutes CLE)            2

Webinars……………………………………………………………………………………………………………………………………….. 3

ACLU v. Myriad Genetics: Navigating the Isolated DNA Patentability Jungle – July 24, 2013……… 3

Plant Biotechnology Subcommittee Report…………………………………………………………………………………… 4

Plant IP Protection in Canada…………………………………………………………………………………………………….. 4

“Plant cells”, but not “plants”, are patentable……………………………………………………………………….. 4

Plant cells generated through traditional plant breeding……………………………………………………… 4

Blaming-the-bean………………………………………………………………………………………………………………….. 4

Biosimilars Subcommittee Report………………………………………………………………………………………………….. 5

New Biosimilar Guidelines in Europe…………………………………………………………………………………………. 5

Introduction………………………………………………………………………………………………………………………….. 5

Background and Problems with the Current Guidelines……………………………………………………….. 6

The New Draft Guidelines……………………………………………………………………………………………………… 6

Conclusions, Outlook and Recommendations……………………………………………………………………….. 8

More clarity for complex biosimilars: Europe approves the first follow-on mAb……………………… 8

Supreme Court Denies Cert in Momenta: Section 271(e)(1) Safe Harbor Converted to a “Land of Confusion”?         9

Case Law Reports…………………………………………………………………………………………………………………………. 11

Wyeth v. Abbott Labs., reported by Lynn C. Tyler and Michael R. Brunelle, Barnes & Thornburg LLP, Indianapolis, IN, USA.   11

 


Programs

2013 Annual Meeting, Washington DC, October 2013: Overcoming Barriers to New Technologies (120 minutes CLE)

Periodically the public appears to turn against what is new, yet it wants the benefits attending the new technologies. At present, antagonism is evident towards new technologies including GMO plants and resulting foods, medical advances in diagnostics and use of stem cells, and computer related innovations. As result of this antagonism, coupled with an attitude that all “natural” things belong to the public, protection of intellectual property is increasingly difficult to obtain. On the other hand, the public wants to ensure accessibility to food, better medical diagnosis through, for example, biomarkers, repair of body parts through use of stem cells, and convenience of computers.

In this context, the Biotechnology Committee and the Food and Drug Committee will sponsor a joint educational session (120 minutes of CLE) that will consider the history of the public’s love-hate relationships with new technologies and will include discussion of causes of these conflicting attitudes and their effects on progress. The global status of intellectual property protection in patent offices, regulatory agencies, and the courts will be analyzed to elucidate the issues involved. Solutions for meeting these concerns and attitudes and proposals for developing programs of public education and fostering policies for protecting intellectual property that are beneficial to the public will be presented.

Alice Martin and Bruce Vrana, co-chairs of our Plant Biotechnology subcommittee, will moderate the all-star panel that they put together:

History of Genetic Technologies: Acceptance and Hurdles to Protection Dr. Ananda Chakrabarty, Distinguished University Professor, University of Illinois at Chicago

Addressing Public Fears of New Technologies Professor Jay P. Kesan, College of Law, University of Illinois

International IP Protection for Plants Dr. Humphrey Foote, Senior Associate, AJ Park

Regulatory Issues in Protection of Plant Products, GMOS, Diagnostics TBD

Public Policy and Education Issues Sarah Hull, Head, Syngenta External Affairs

Please join us in Washington in October for this excellent, educational program!


Webinars

ACLU v. Myriad Genetics: Navigating the Isolated DNA Patentability Jungle – July 24, 2013

The AIPLA will host a webinar at 12:30 pm EDT on July 24, 2013 to discuss the implications of the Supreme Court’s landmark decision in ACLU v. Myriad Genetics.  The confirmed speakers are Greg Castanias, who was counsel for Myriad, Josh Sarnoff, who filed an amicus brief on behalf of 15 law professors, and Manny Vacchiano, who is Lead Patent Counsel of Life Technologies, Inc. 

Debora Plehn-Dujowich of Drinker, Biddle & Reath LLP, chair of our Webinars subcommittee, will moderate the webinar. Below are the expected topics.

  • Constitutional questions, answered?
  • Consequences of the case for § 101 jurisprudence; does splitting the baby make sense?
  • Legislative action to “remedy”?
  • Where do comparative diagnostic claims stand after both Myriad and Mayo
  • Are claims to all primers now invalid? What about if the primer is made of synthetic DNA that is somehow modified, but the sequence is the same as that found in nature?
  • Future litigation at U.S. Supreme Court and Court of Appeals for the Federal Circuit.
  • Practical claiming strategies in light of Myriad and Mayo
  • What does “markedly different” mean? What changes have to be made to a natural product to make it patentable?
  • Are claims to isolated polypeptide sequences covering human proteins that are in therapeutic use no longer valid? Or is Myriad limited to isolated DNA?
  • What method claims are still possible?
  • What affect on patent office prosecution tactics? 
  • How will existing gene patents be challenged in post-grant proceedings at the USPTO?
  • How can one protect one’s existing gene patents from future challenges?
  • Will holders of gene patents seek reissue? What types of claims will they seek?
  • What does the decision mean for future litigation?
  • What does the decision mean for protein therapeutics, and other products that are arguably “found in nature”? What about antibodies?
  • How does this extend beyond biotech and chemical cases, e.g., software?
  • When will the USPTO issue guidelines and what will they be?
  • Comments on EPO practice
  • The Myriad versus Mayo “sandwich” and the Myriad versus Mayo “ocean of grey space.”
  • In-house perspectives
  • Clearing molecular diagnostic products
  • Licensing issues? Do licenses have to be re-negotiated?
  • Is the reaction of the press and public appropriate?

Further information about cost and CLE can be found at the AIPLA site.
Plant Biotechnology Subcommittee Report

Plant IP Protection in Canada

Contributed by Mark Pidkowich, Smart & Biggar Fetherstonhaugh, Vancouver, BC, Canada

The Canadian agriculture and agri-food system is a modern, competitive, and growing part of the international economy.  Canada is the sixth-largest exporter in the world after the EU, U.S., Brazil, China and Argentina, and the sixth-largest importer, with exports and imports valued at $40.3 billion and $31.0 billion, respectively.  Of the $40.3 billion in exports, oilseeds and oilseed products accounted for 26.2%, while grains and grain products accounted for 24.4%.  In 2011, Canada was the single largest producer of rapeseed (~$4.5 billion in exports), the seventh largest producer of both wheat and soybeans (~$4.5 billion and ~$1.4 billion in exports, respectively), and the eleventh largest producer of maize (~$0.6 billion). 

Unsurprisingly, Canadian patents will be an essential component of many agribusiness portfolios.

“Plant cells”, but not “plants”, are patentable

The Canadian Intellectual Property Office (“CIPO”) considers that “higher life forms”, including plants and plant seeds or parts, are not patentable. However, it is possible to claim “a cell” of a plant, or a method of making or using the plant.  In Monsanto Canada Inc. v. Schmeiser (“Schmeiser”), 2004 SCC 34, the Supreme Court of Canada held that a claim to a “plant cell” is infringed by someone who grows plants from seed.

It is also possible to claim “use” of a plant for a particular purpose, such as for producing a crop or a plant product (e.g. oil), thereby avoiding the need to claim a cell per se

Plant cells generated through traditional plant breeding

Canadian patents issue routinely in connection with inventions involving plants that have been transformed with a heterologous coding sequence, without limitation to a particular variety.

However, complications arise where conventional breeding methods are involved in the production of the plant.  CIPO historically has considered cross-breeding methods to be non-statutory subject matter and, with some exceptions, will not grant claims to methods involving the straightforward breeding of known varieties.  Claims to plant cells produced by such methods, and uses of such plants, may be permitted, but CIPO generally requires limitations to a particular plant variety as deposited under the Budapest Treaty.

According to CIPO, cross-breeding methods are not patentable because they are processes which occur “essentially according to nature, with no significant technical intervention by man.”   CIPO’s policy is based largely the Supreme Court of Canada’s 1989 decision in Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents), in which the Court expressly declined to decide whether or not plants produced by cross-breeding were statutory subject-matter under the Canadian Patent Act.  Furthermore, the Court opined that human intervention was indeed necessary for breeding where the male and female reproductive organs of the soybean are contained in the same flower, and require artificial intervention to hybridize two different lines and produce a new one.  Accordingly, CIPO’s position with respect to cross-breeding may be ripe for a challenge.

Blaming-the-bean

In its recent decision in Bowman v. Monsanto Company (“Bowman”), the U.S. Supreme Court held that the initial authorized sale of a patented seed does not permit a farmer to reproduce patented seeds through planting and harvesting without the patent holder’s permission.   Whereas the U.S. Supreme Court decision was based on the finding that Bowman’s reproduction of the patented seeds constituted “making” new copies of the invention, Canadian courts could possibly be more receptive to a “blame-the-bean” defense.

In Schmeiser, the Supreme Court of Canada held that cultivation of a plant constituted “use” of the patented plant cell contained therein.  However, the Schmeiser decision did not involve plant material obtained through an authorized sale so as to make patent exhaustion an issue.  Accordingly, whether the purchase of commodity seed from a grain elevator would exhaust the patentee’s right to control the use of that seed in Canada, including production of a crop from the seed, remains an open question of law.  Nevertheless, the Supreme Court of Canada indicated that, contrary to Bowman, that it was not inclined to view the growth of a plant containing patented cells as “making” the claimed cells.

While it is quite possible that Canadian courts would conclude that growing a second generation of plants from purchased commodity seed constitutes infringing “use” of the patented cells, as in Bowman, Canadian patentees would be wise to buttress their patents with licensing terms that precisely express any conditions that are intended to affect the rights of subsequent purchasers of a patented item, and consider mechanisms putting such potential purchasers on notice.

 

Biosimilars Subcommittee Report

New Biosimilar Guidelines in Europe

Contributed by Kapil Tuladhar and Simon Wright, JA Kemp, London, UK.

Introduction

Most drugs currently on the market are small-molecule modulators.  Extensive studies are required to demonstrate the efficacy and safety of such molecules, prior to regulatory approval.  Generic small-molecule manufactures can take advantage of existing studies when seeking market authorisation, as active molecules can be faithfully copied.

However over the last 30 years, increasing numbers of biological molecules have gained approval.  With patents for these often lucrative molecules expiring, those considering entering the generic biological space face additional challenges over the traditional generics manufacturer.  This is largely down to the difficulty in independently reproducing biological molecules, owing to their complexity and sensitivity to manufacturing processes.

Thus, generic manufactures generally look to develop new biological medicinal products that are similar to an approved reference product, so-called biosimilars.  These follow-on products must undergo comparability studies to confirm their similarity to a reference, in terms of quality, safety, efficacy and biological activity.  However, determining just how similar a subsequence biological molecule is and how far existing data can be extrapolated to the follow-on compound, has challenged policymakers and regulators across the globe, including in Europe.

In the past three months, the European Medicines Agency (EMA) has released for consultation updated guidelines.  See Draft Guidelines on Similar Biological Medical Products (May 22, 2013 and June 3, 2013)  These seek to clarify some of the outstanding issues surrounding biosimilars.  Here, we provide a review these two documents.

Background and Problems with the Current Guidelines

The European overarching guidelines on biosimilar medicinal products entered force in 2005 and 2006.  See Guidelines on Similar Biological Medical Products (Oct. 30, 2005, Feb. 22, 2006 (Non-Clinical and Clinical Issues), and Feb. 22, 2006 (Quality Issues)).  Since 2006, 14 biosimilar medicines have received marketing authorization in Europe.  Many more are under development or awaiting regulatory approval.  In 2011, the EMA took the view in a series of concept papers that, in light of knowledge gained and the development of more complex biosimilar medicinal products, the existing guidelines needed to be reviewed, refined and updated.  See Concept Papers (Sept. 22, 2011 and Nov. 17, 2011).  In particular, the following points were considered.

  • ·         The principles of biosimilarty need to be explained more clearly.
  • ·         The term “biosimilar” needed to be better defined, given that numerous terms are currently used, often inappropriately.
  • ·         The feasibility of carrying out compatibility studies when pharmaceutical form, strength and route of administration are not the same between biosimilar and reference products.
  • ·         Whether a “very simple” biological molecule, could be authorised on the basis of comparative quality and bioequivalence only.
  • ·         Selection of the appropriate animal models, considering the “3R’s” principal of “replacement, reduction and refinement”.
  • ·         The list of surrogate markers for use in Phase III clinical trials could be expanded.

The New Draft Guidelines

The proposed new European guidelines on biosimilars finds legal basis largely in Directive 2001/83/EC of the European Parliament, as amended, relating to medicinal products for human use in the European Community.

Similar Biological Medicinal Products

The updated guideline on similar biological medicinal products outline the general principles to be applied for biosimilars and refine the application of the biosimilar approach, the choice of reference product and the principles of establishing biosimilarity.  Most significantly, and in contrast to the existing guidelines, it has been proposed that the EMA will accept, for “some studies,”[1] comparison to a reference product that has gained authorisation outside the European Economic Area (EEA).  However, the comparator will have to be authorised by an authority with similar scientific and regulatory standards as the EMA (i.e. ICH[2] countries).  In such cases, it will be necessary for an Applicant to demonstrate that an externally authorized comparator is representative of the reference product authorized within the EEA.  However this should, in theory, be easier than repeating non-clinical and clinical trials just for the EEA.

In this guideline, the EMA does not provide explicit guidance as to what a significant difference would be, other than stating that studies must be sensitive enough to find such differences.  Rather, taking the approach of other regulators, the EMA acknowledges that a difference between a reference and test compound will depend on each product specifically.  Indeed, it is suggested that small differences, including added benefit, may not disqualify a product.  The Applicant will likely have to provide justification if comparative data suggests this applies to their product.  Unhelpfully in this regard, the guideline does not define any automatically disqualifying characteristics.

Non-clinical and Clinical Issues

A new draft guideline setting out the EMA’s current position on the non-clinical and clinical issues surrounding biosimilars has also issued.  This is similar in many ways to the guideline discussed above, calling for a step-by-step approach to allow for heterogeneity between different biosimilars.  The steps in the process should move sequentially through in vitro studies, in vivo studies (if necessary) and clinical studies before moving on to pharmacokinetic, pharmacodynamic, safety and efficacy studies.  Further highlighting the step-wise approach, the guideline identifies the need to fine tune studies according to the results of the preceding studies.

The EMA states that in vitro studies need to be sensitive enough to detect differences between a biosimilar and reference, while also covering the pharmacological and toxicological aspects known to be relevant to the given reference formulation and/or product class.  When progressing to in vivo studies, the Applicant will need to justify that in vitro data is predictive of in vivo data.  The guidelines also discuss the need to choose an appropriate model system.  There is also the provision to proceeding straight to clinical studies if an appropriate animal system is not available.  The EMA provides additional guidance on the risk-baked approach for the design of non-clinical studies, together with the use of pharmacodynamic markers to demonstrate clinical comparability. 

The EMA updated their guidance on clinical study design, discussing the use non-inferiority studies versus equivalence studies.[3]  The agency states that equivalence studies with the appropriate sensitivity are preferred, unless the Applicant has a strong scientific reason to use non-inferiority methodologies.  The agency suggests that this should be discussed with the EMA prior to commencing the trial.  The choice of an appropriate patient population and of surrogate endpoints in efficacy trials is also discussed.  Finally, the design of immunogenicity studies and the extrapolation of efficacy and safety data from one therapeutic indication to another are discussed.

Specifically, the new guideline recommends that studies should be carried out on the follow-on product derived from the final manufacturing process, thus most closely reflecting the quality profile of commercial batches.  Deviations from this process will have to be “justified and supported by adequate additional bridging data.”

The EMA also discusses immunogenicity.  Applicants will have to justify and discuss in detail possible safety concerns associated with use of product.  The amount of data needed will depend on the nature of the reference product and/or product class.  It is highlighted that immunogenicity must be investigated in a comparable manner to studies conducted for the reference product, again unless the Applicant can justify otherwise.

Furthermore, data concerning one therapeutic indication cannot automatically be extrapolated to another indication.  While the EMA states that “this is not an argument for additional studies,” it will be necessary for manufacturers to provide additional arguments (and probably data, too) if they wish to gain approval for other indications.

The Present Position in Europe

In addition to the two guidelines discussed, a third guideline addressing quality issues (a revision of which was released for consultation in May 2012) will form part of the three overarching biosimilar guidelines defining the concept of biosimilars in Europe, and replacing the existing set of overarching guidelines.  These are, and will be, complemented by a set of existing and planned product-specific guidelines.

At present, a public consultation period is open on all three drafts, which is due to close in the fourth quarter of 2013.  The EMA is open to comments from stakeholders, with a view to refining the draft set of guidelines if necessary.  It is likely the revised guidelines will then enter force in 2014.

Conclusions, Outlook and Recommendations

At present, the European guidelines on biosimilars seem to be more developed than those in the USA.  However this may change in the future as the FDA develops its own set of guidelines.

Sensibly, the proposed European guidelines aim to facilitate global research, rather than requiring duplication of studies.  The power of large studies is highlighted and it will be even more necessary to consider the totality of evidence.  A clear understanding of the characteristics of the reference product will also be required.

There are, however, still outstanding issues and not all of the points set out in the original concept paper were fully considered in the draft guidelines.  The regulatory framework will continue to evolve with the field, become wider and providing more guidance.  For example, the first two monoclonal antibody biosimilars have been recommended for approval in Europe, and draft guidelines on monoclonal antibodies are currently being finalised.  See Press Release (June 28, 2013).

The EMA seems to acknowledge that guidelines are general and simplified.  Thus, if specific points relating to a sophisticated biosimilar arise, we recommend discussing this with the EMA prior to commencement of development.  It should be noted that the EMA evaluates biosimilars solely for the purpose of authorization, and does not recommend whether or not a biosimilar should be used interchangeably with its reference.  If differences between a biosimilar and reference are discovered early on, there may be advantages to independently developing the follow-on compound, for example as a best-in-class therapy.

More clarity for complex biosimilars: Europe approves the first follow-on mAbs

Contributed by Ainslie Parsons and Noel Courage, Bereskin & Parr LLP, Toronto, ON, Canada.

The European Medicines Agency (EMA) recently recommended granting marketing authorizations to two biosimilar versions of Johnson & Johnson’s rheumatoid arthritis blockbuster drug Remicade®.  See Press Release (June 28, 2013). The active substance of Remicade® is infliximab, a chimeric humane-mouse monoclonal antibody (mAb). Remicade® has been authorized in the European Union since August 1999. The EMA’s acknowledgment that Celltrion’s Remsima and Hospira’s Inflectra can be compared to Remicade is the first time that mAbs have been deemed to be biosimilar in the EU.  In the bigger picture, this provides further insight on the EMA’s criteria for approving biosimilars of complex biologics. 

Unlike generic versions of small molecule pharmaceuticals, follow-on versions of biologic drugs (biosimilars) have a similar, but not identical, active ingredient as an approved innovator drug. In particular, there can be differences in structure, formulation, impurities or immunogenicity between the two products which can make it difficult to compare the biosimilar to the innovator drug. The biosimilar manufacturer must provide substantial supporting data to regulators in comparison to conventional follow-on small molecule pharmaceuticals. 

The EMA has authorized a total of 12 biosimilar medicines to date including biosimilar versions of somatropin (recombinant human growth hormone), filgrastim (granulocyte colony-stimulating factor analog) and epoetin alfa (synthetic erythropoietin). However, mAbs present additional comparability challenges compared to these early commercial biologics given their size and complexity. For example, mAbs can be 10 to 15 times larger than human growth hormone and erythropoietin.

In May of 2012, the EMA released guidance setting out an approval pathway for mAbs. See Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues (May 30, 2012). The EMA issued its opinions on Remsima and Inflectra by reference to this Guideline. This Guideline, like all the EMA biosimilars guidelines, emphasizes the demonstration of comparability to the reference drug. The EMA found that both Remsima and Inflectra had a comparable quality, safety and efficacy profile to Remicade.

The recommendation by the EMA to approve Remsima and Inflectra provides additional guidance to those planning to market their own biosimilar antibodies. Indeed, it has been estimated that there were at least 49 biosimilar mAbs under development as of September 2011. See Citeline’s Pipeline Database. It will also be interesting to see how other jurisdictions such as the United States, which introduced a specialized, abbreviated approval pathway for biosimilars in March of 2010[4] but has yet to approve a biosimilar, will treat follow-on antibodies.

Supreme Court Denies Cert in Momenta: Section 271(e)(1) Safe Harbor Converted to a “Land of Confusion”?

Contributed by Lynn Tyler and Michael Brunelle, Barnes & Thornburg LLP, Indianapolis, IN, USA.

The May issue of the Biotech Buzz included commentary on the then-pending cert petition in Momenta Pharms., Inc. v. AmphaStar Pharms., Inc., 686 F.3d 1348 (Fed. Cir. 2012) (“Momenta”), a case interpreting the infringement safe harbor in 35 U.S.C. § 271(e)(1). The Supreme Court has now denied cert in Momenta, as it did in Classen Immunotherapies, Inc. v. Biogen-IDEC, 659 F.3d 1057, 1070 (Fed. Cir. 2011), which also concerned the scope of § 271(e)(1). This article offers some thoughts on the current state of the law on this issue.

As previously summarized by Angie Sebor and Vicki Norton (Biosimilars sub-committee co-chair), the partially-overlapping Federal Circuit panels that decided Classen and Momenta were divided on the issue of whether 35 U.S.C. § 271(e)(1) can shield post-approval use of a patented technology.  Judge Newman wrote for the majority in Classen, addressing the question of whether § 271(e)(1)’s safe harbor shielded the defendants’ post-approval activities from infringement where Classen’s method patents were directed to methods of screening and identifying immunization schedules associated with lower risk of chronic disease. The defendants’ post-approval activities included evaluating suggested associations between vaccines, reporting on recommended immunization schedules, and reporting adverse vaccine effects to the FDA.  The Federal Circuit majority reversed the district court’s ruling that the defendants’ activities fell within the § 271(e)(1) safe harbor provision and held instead that the safe harbor is “limited to activities conducted to obtain pre-marketing approval of generic counterparts of patented inventions” and that the “statute does not apply to information that may be routinely reported to the FDA long after marketing approval has been obtained.”  Judge Moore dissented, opining that the majority’s analysis and construction of the safe harbor provision were “contrary to the plain language of the statute and clear Supreme Court guidance” (referencing Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005), among other cases), and “[n]owhere does that statute limit the safe harbor to pre-approval uses.”

In Momenta, Judge Moore wrote for the majority, reaching a conflicting result by holding that Amphastar’s use of Momenta’s patented process for analyzing drug quality during the manufacture of enoxaparin (generic Lovenox) for commercial sale fell within the safe harbor.  Amphastar argued that because the continued testing was an FDA condition for marketing approval, its post-approval testing fell within the plain language of the safe harbor of § 271(e)(1). The Federal Circuit panel majority sided with Amphastar, concluding that the language of §271(e)(1) is broad and unambiguously applies to submissions under any federal law, provided that the law regulates the manufacture, use or sale of drugs, and is not only directed to activities related to submission for FDA approval. The court further held that the phrase “reasonably related to the development and submission of information” in the statute does not mean that the use of the patented invention must necessarily result in the actual submission of information to the FDA. The majority found that Amphastar’s requirement to retain testing records to be readily available for authorized inspection by the FDA upon request satisfied the requirement.  In a dissenting opinion, Chief Judge Rader urged that Amphastar’s activity was not solely for developing and submitting information to the FDA, but also for manufacturing a product to sell in commerce. Chief Judge Rader further commented that by ignoring the meaning of the term “solely” in the statute, the majority expanded the limited reach of § 271(e)(1) to “essentially render manufacturing method patents worthless.”

At the time the Solicitor General weighed in against granting cert, it was widely reported (at least in patent law circles) that the Solicitor’s advice was to deny cert because the Federal Circuit had limited Classen in Momenta. That may be a correct reading of the cases. On the other hand, one could easily argue that some of the broad language of Judge Moore’s majority opinion in Momenta is simply inconsistent with Classen, as shown by her reliance on similar reasoning in her Classen dissent and notwithstanding the fact that, in Momenta, she recognized that the court was “bound” by Classen. 686 F.3d at 1358. To the extent the cases conflict, Classen controls, not Momenta, because a “panel is obligated to follow the earlier case law which is the binding precedent,” not the more recent case. See Johnston v. IVAC Corp., 885 F.2d 1574, 1579 (Fed. Cir. 1989). This is “[b]ecause a panel of [the Federal Circuit] lacks the authority to overrule one of the court’s precedents.” Midwest Indus., Inc. v. Karavan Trailers, Inc., 175 F.3d 1356, 1359 (Fed. Cir. 1999); see also Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863 F.2d 867, 876 n.16 (Fed. Cir. 1988) (en banc) (“[P]recedent may not be changed by a panel.”).

The result, unfortunately, is that any firm operating in a regulated industry to which § 271(e)(1) may apply continues to face unnecessary risk and uncertainty over the scope of the “safe” harbor. Can one rely on the seemingly broad language of the statute? Will any activities other than the precise ones at issue in Classen be deemed to fall within its “routine reporting” exception (if that is a proper characterization)? If so, which one(s)? How much expense will be added to any litigation to resolve these issues? Companies evaluating whether to spend tens or hundreds of thousands on patents that may protect methods of testing the purity, quality or other aspects of a biologic or multi-million dollar investments in development of a biosimilar would like to be, and should be, able to answer these questions in advance with a high degree of confidence. Based on the current state of the law, they cannot and that should be intolerable.

Another relevant question: Wasn’t the Federal Circuit created to promote uniformity in patent law? The apparent conflict between Classen and Momenta should be resolved en banc at the earliest opportunity.

Case Law Reports

Case Law Report Link

Wyeth v. Abbott Labs., reported byLynn C. Tyler and Michael R. Brunelle, Barnes & Thornburg LLP, Indianapolis, IN, USA.

Nos. 2012-1223, -1224 (Fed. Cir. June 26, 2013) (affirming district court’s finding of lack of enablement for claim encompassing broad class of compounds where specification only disclosed one such compound). 


[1]The key phrase “some studies” is yet to be defined.

[2]International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

[3]In contrast to equivalence studies, non-equivalence studies typically require fewer patients, but are unable to reveal if a follow-on product is superior to the reference.

[4] The Biologics Price Competition and Innovation (BPCI) Act was enacted on March 23, 2010 as part of a US Health Reform Bill (the Patent Protection and Affordable Health Care Act).

BIOTECH BUZZ JUNE, 2013

Programs

2013 Annual Meeting, Washington DC, October 2013: Overcoming Barriers to New Technologies (120 minutes CLE)

Periodically the public appears to turn against what is new, yet it wants the benefits attending the new technologies. At present, antagonism is evident towards new technologies including GMO plants and resulting foods, medical advances in diagnostics and use of stem cells, and computer related innovations. As result of this antagonism, coupled with an attitude that all “natural” things belong to the public, protection of intellectual property is increasingly difficult to obtain. On the other hand, the public wants to ensure accessibility to food, better medical diagnosis through, for example, biomarkers, repair of body parts through use of stem cells, and convenience of computers.

In this context, the Biotechnology Committee and the Food and Drug Committee will sponsor a joint educational session (120 minutes of CLE) that will consider the history of the public’s love-hate relationships with new technologies and will include discussion of causes of these conflicting attitudes and their effects on progress. The global status of intellectual property protection in patent offices, regulatory agencies, and the courts will be analyzed to elucidate the issues involved. Solutions for meeting these concerns and attitudes and proposals for developing programs of public education and fostering policies for protecting intellectual property that are beneficial to the public will be presented.

Alice Martin and Bruce Vrana, co-chairs of our Plant Biotechnology subcommittee, will moderate the all-star panel that they put together:

History of Genetic Technologies: Acceptance and Hurdles to Protection

Dr. Ananda Chakrabarty, Distinguished University Professor, University of Illinois at Chicago

Addressing Public Fears of New Technologies

Professor Jay P. Kesan, College of Law, University of Illinois

International IP Protection for Plants

Dr. Humphrey Foote, Senior Associate, AJ Park

Regulatory Issues in Protection of Plant Products, GMOS, Diagnostics

TBD

Public Policy and Education Issues

Sarah Hull, Head, Syngenta External Affairs

Please join us in Washington in October for this excellent, educational program!

Webinars

ACLU v. Myriad Genetics: Navigating the Isolated DNA Patentability Jungle – July 24, 2013

AIPLA will host a webinar at 12:30 pm EDT on July 24, 2013 to discuss the implications of the Supreme Court’s landmark decision in ACLU v. Myriad Genetics.  The confirmed speakers are Greg Castanias, who was counsel for Myriad, Josh Sarnoff, who filed an amicus brief on behalf of 15 law professors, and Manny Vacchiano, who is Lead Patent Counsel of Life Technologies, Inc.  Look for a formal announcement in your email.

Debora Plehn-Dujowich of Drinker Biddle, chair of our Webinars subcommittee, has led the development of this program together with the On-line Programs Committee of AIPLA.  Lynn Tyler of Barnes & Thornburg will moderate the webinar.  Below are the expected topics. 

  •          Constitutional questions, answered?
  • ·         Consequences of the case for §101 jurisprudence; does splitting the baby make sense?
  •          Effect on post-grant proceedings at USPTO
  •          Legislative action to “remedy?”
  •          Future litigation at Supreme Court and Fed Circuit
  •          Practical claiming strategies in light of Myriad and Mayo
  • ·         Method patents that are still possible
  •          What affect on patent office prosecution tactics?
  •          What does the decision mean for future litigation?
  •          How does this extend beyond biotech and chemical cases to, say, software?
  •          When will the USPTO issue guidelines and what will they be?
  •          The Myriad versus Mayo “sandwich” and the Myriad versus Mayo “ocean of grey space.”
  •          In-house perspectives
  •          Clearing molecular diagnostic products
  •          Is the reaction of the press and public appropriate?

 

1.  How will existing gene patents be challenged in post-grant proceedings at the USPTO?  How can one protect one’s existing gene patents from future challenges?

2.  Will holders of gene patents seek reissue?  What types of claims will they seek?

3.  What does the decision mean for protein therapeutics, and other products that are arguably “found in nature”?  What about antibodies?

4.  What does “markedly different” mean?  What changes have to be made to a natural product to make it patentable?

5.  Are claims to isolated polypeptide sequences covering human proteins that are in therapeutic use no longer valid?  Or is Myriad limited to isolated DNA?

6.  Where do comparative diagnostic claims stand after both Myriad and Prometheus?

7.  Are claims to all primers now invalid?  What about if the primer is made of synthetic DNA that is somehow modified, but the sequence is the same as that found in nature?

8.  Licensing issues?  Do licenses have to be re-negotiated?

9.  Changes at the USPTO in view of Myriad?  Will they issue thorough guidelines?

10.          Comments on EPO practice

 

Diagnostic and Gene Patenting Subcommittee: Members Reflect on Myriad

Karen Canady: Supreme Court Limits Gene Patents to Sequences Not Found in Nature

By Karen Canady, Canady + Lortz, Los Angeles, CA

In an opinion authored by Justice Thomas, a unanimous Supreme Court held that a naturally-occurring segment of DNA is not patent-eligible because it is a product of nature.  The decision was released June 13, 2013, in Association for Molecular Pathology et al. v. Myriad Genetics, Inc. et al., and is referred to as “the Myriad case.”  More background on the claims at issue and the history of the case can be found here.  

The Court found the act of isolating the segment of DNA from surrounding genetic material, even though chemical bonds are broken to create a non-naturally-occurring molecule, is not sufficient to create an invention.  DNA that differs from natural DNA, including complementary DNA (cDNA) from which the non-coding introns have been removed, is eligible for patenting.  While the opinion closed with a clear statement of what was not within the ruling, such as methods of manipulating genes or altered natural genetic sequences, the narrow ruling itself has broad implications for all natural products.

The decision emphasized that the claims before the Court “are simply not expressed in terms of chemical compositions, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA.”  The distinction was made between claims that “focus on the genetic information encoded in the BRCA1 and BRCA2 genes” and patents based on the “creation of a unique molecule.”  This emphasis on claims directed to the genetic information raises the question of whether recitation of “synthetic” or “recombinant” in a claim directed to a segment of DNA that is otherwise based on a nucleotide sequence found in nature will be considered enough to distinguish the non-natural chemical entity.  Today’s decision does, however, lend certainty to the patenting of cDNA, which may have significant value for biotechnology developments based on gene discovery. 

Clearly implicated by this ruling are patent claims directed to isolated proteins and purified natural products.  It is unclear how much alteration by human intervention is sufficient for a product derived from nature to be deemed eligible for patenting.  For example, the decision suggests (but does not directly state) that purification may not be a sufficient human intervention to create a patent-eligible invention.  Going forward, patent applicants will want to choose language that clearly defines human-made products and excludes entities that differ from their natural counterparts solely by isolation from a natural source.  Looking back, patentees will likely seek to correct issued patents written when “isolated” was considered sufficient to distinguish a composition of matter relating to a newly-discovered gene or protein from a corresponding product as it occurs in nature.

For technologies that rely on discovery of previously unknown natural genetic sequences or isolated biomolecules, investors may be hesitant to expend resources to bring natural products to market, particularly in light of last year’s Supreme Court decision in Mayo v. Prometheus.  The Mayo decision held certain claims to diagnostic methods were not patent-eligible as directed to a natural principle.  To ensure the public obtains the benefits of new biomedical developments, it will be important to maintain the incentive to seek patent protection.  Patenting requires the applicant to disclose how to make and use the invention in exchange for a limited period of exclusivity.  The alternative for innovators is to withhold new discoveries in the form of trade secrets.  Trade secret protection can be maintained indefinitely for products and processes that cannot easily be reverse engineered. Historically, the U.S. has recognized the benefits of public disclosure provided by patent publications, and has supported commercialization of natural products through issuance of patents. 

Going Forward

While it is unknown at present to what extent the holding of Myriad will be applied to natural products beyond genomic DNA, it is reasonable to assume that claims to other nucleic acid molecules such as primers and probes as well as proteins, including antibodies and enzymes, and cells, are likely to be scrutinized for patent eligibility.  Practitioners drafting new patent claims and those prosecuting pending applications will want to ensure ample support for products clearly defined as a new molecule or other composition of matter.  Rather than relying on terms such as “isolated” or “purified”, claim drafters should recite in the claim features that cannot be found in a corresponding natural form. 

For example, if the isolation from its natural environment means the product no longer has other entities bound to it, it may be advantageous to recite it as free of such entities.  If the protein in isolated form is only stable when fused to a heterologous polypeptide or formulated with a sugar, it could be claimed in this form.  Some natural products may be difficult to define in a manner that clearly distinguishes a new entity that differs from the natural form.  In such cases, one could recite a composition comprising the entity at a concentration clearly beyond any occurring in nature, or include within the composition an additional ingredient that would be necessary to practical and effective use of the composition, such as an adjuvant or vehicle for storage, transport and/or delivery.  In the case of unmodified stem cells, it may be necessary to recite critical components of a culture medium.

Although the Court in the Myriad case made it clear that synthetic or human-made molecules would constitute patent-eligible subject matter, it is not certain that recitation of “synthetic” or “recombinant” in the claims is sufficient.  Such terms should suffice, and would be a suitable compromise to most parties seeking patent protection.  In view of the uncertainty, however, a back-up claim should be retained that recites an additional feature further distinguishing the claimed subject matter from any naturally-occurring counterpart.

Looking Back

Patentees can review their patent portfolios and identify claims whose validity may be in question as a result of the holding in Myriad.  Correction of claims that are now invalid as directed to a product of nature can form the basis for a reissue application.  Care should be taken to review the support in the original specification to ensure suitable amended claims can be pursued without being considered new matter.  Where related applications are still pending, these can be used to further bolster the patent protection through an alternate claim strategy, an option that may be particularly appealing where the validity of issued claims in not clearly in question.

 

Alice Martin: Facing the Issues in Myriad as Interpreted by the United States Patent and Trademark Office

By Alice O. Martin, Ph.D., J.D., Barnes & Thornburg LLP, Chicago, IL.

The U.S. Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc. (“Myriad”) that isolated DNA is not patentable because it is a “product of nature” is one more step in the global attack against ownership of anything “natural.” The problems are what is “natural” and why is ownership “bad”? In the landmark decision Diamond v. Charkrabarty, the U.S. Supreme Court allowed patenting of genetically altered microorganisms that eat oil, opening the door for incredible advances in medicine and agriculture. In Myriad, the Court indicated that the bacterium in Chakrabarty was different from natural strains, whereas the BRCA DNA isolated by Myriad was also found in nature. Following that reasoning the Court carved out some wiggle room for patent eligibility under 35 U.S.C. § 101 of (1) cDNA, which is not found in nature because generally introns are removed from genomic DNA; (2) DNA with coding sequences not found in nature; e.g., the order of nucleotides is altered; (3) “synthetic” DNA if the structure not found in nature; and (4) methods of using or manipulating DNA. So all is not lost for medical and agricultural innovations of the future. In fact, the patent at issue in Myriad still has many unchallenged claims.

This Supreme Court decision, following on other decisions from the Federal Circuit and the Supreme Court making it more difficult to obtain patents on inventions that involve any kind of biological material, will still have a chilling effect on progress. Many granted patents could be at risk in view of Myriad. Inventors and legal practitioners trying to obtain sufficient patent protection to justify receiving sufficient financial support to fully develop basic inventions and carry them through extremely expensive clinical trials and regulatory approvals, have an added burden. Inventors and practitioners will have to examine the inventions to see at what stage they might be patentable, and how they should be claimed. This could result in improved patents, but could also increase reliance on “trade secrets.”

On June 13, 2013, the United States Patent and Trademark office (USPTO) issued a Memorandum to the Patent Examining Corps for the Patent Examination Policy under Myriad.  The memo can be found here

Myriad significantly changes the Office’s examination policy regarding nucleic acid-related technology. The purpose of this memorandum is to provide preliminary guidance to the Patent Examining Corps.

In the past, isolated and/or purified molecules were patent eligible To be in an issued patent, other criteria had to be satisfied, e.g., novelty, utility and non-obviousness. The June 13, 2013 memo changes the game:

Examiners should now reject product claims drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or not, as being ineligible subject matter under 35 U.S.C. § 101.

Although not stated, there may be requirements to prove a nucleic acid sequence could not appear nature, which may be difficult. This kind of argument was raised by examiners in the early days of recombinant DNA patent seeking. Also, although method claims are patent eligible according to Myriad, the United States Patent and Trademark Office instructed examiners that “[o]ther claims, including method claims, that involve naturally occurring nucleic acids may give rise to eligibility issues and should be examined under the existing guidance in MPEP 2106, Patent Subject Matter Eligibility.”

The Myriad holding is likely broader in scope than just referring to human DNA. There is no assurance the decision is limited to human DNA and cDNA, e.g., plant DNA, microorganisms with no introns removed from DNA, an isolated RNA sequence complementary to the full length of a DNA sequence, may not be eligible. Proteins and other compounds “simply isolated” from nature are likely not eligible.

Questions to consider in claim drafting include: What does the invention do in nature? Does it have “markedly different” characteristics as the court indicated was why the Chakrabarty microorganisms were patent eligible?

Inventions can be modified with non-naturally occurring claim elements such as constructs that do not exist in nature, fusion molecules, and vectors with molecules. However, “comprising” in claims will likely cause problems if, natural products could fall within claim scope. Can “something more” required by the court to be contributed by the inventor be shown? For cDNA, the “something more” was intron removal, but that is likely to be an obvious process at present, therefore not likely to end in a patent.

According to Myriad, synthetic DNA is only patent eligible if it is not also found in nature, e.g., fragments of genomic DNA are not patent eligible. Non-natural nucleic acids or amino acids in sequences could make molecules patent eligible, but if such do not affect function compared to the natural sequence, there could still be rejections.

The issues raised by Myriad are far from settled, even in the United States Patent and Trademark Office:

The USPTO is closely reviewing the decision in Myriad and will issue more comprehensive guidance on patent subject matter eligibility determinations, including the role isolation plays in those determinations.

What needs to be considered for patents already issued or pending applications? Narrowing reissues may be filed if there is support. Can patents and patent applications be challenged by third parties under Myriad? Post-grant review is limited to patent claims with effective filing dates on/or after March 16, 2013; Ex Parte Reexamination, Inter Partes Reexamination, and Inter Partes Reviews are limited to §§ 102 and 103 rejections using patents and printed publications.

In a broad sense, this step by the Supreme Court down a path of increased difficulty in obtaining patents is not the end of progress in medicine and agriculture.  However, if certain segments of the public continue to chip away at a system that has benefitted mankind in the past, progress is compromised not only for diagnostics and treatments, but also for other biological inventions such as beneficial plants.

It is not clear what benefits the public receives by restricting protection of patents. Some of the end results the public desires—biomarkers to test for disease risks to facilitate prevention and crops to feed the world despite adverse environments and climate change—require funding and funders require patent protection. The closer biomarkers and drugs are to nature, the more likely they are to be effective, but the more likely they will be found patent ineligible! No anti-patent forces have produced a model to replace patents and demonstrated that the model will facilitate progress. “Trade secrets” increasingly touted as solutions, have the effect of hiding innovation, something the founding fathers who developed the patent system wanted to prevent. A useful consequence of the Myriad decision may be stimulation of more dialogues and joining of more groups interested in fostering new technologies.

 

USPTO Subcommittee

Report from BCP Customer Partnership Meeting – June 4, 2013

Reported by Julie Broadus Meigs, Womble Carlyle Sandridge & Rice, LLP, Tysons Corner, VA.

Copies of the handouts from this meeting and from prior meetings can be obtained at http://www.cabic.com/bcp/.  The materials are also available at the American Intellectual Property Law Association (AIPLA) Biotechnology Committee web page.

TC 1600 Directors Wanda Walker, Jerry Lorengo, and Marjorie Moran (Acting) gave a brief introduction and welcome.

TC Quality and QAS Shop

By Bennett Celsa (Quality Assurance Specialist, TC 1600) and Joe Woitach (Supervisory Patent Examiner, AU 1633)

Mr. Celsa gave an overview of the new Corps Wide Quality Metrics:  (1) final disposition compliance rate, (2) in-process compliance rate, (3) first action on the merits search review, (4) complete first action on the merits review, (5) quality index report (QIR), (6) external quality survey, and (7) internal quality survey.  The first four metrics are based upon data from reviews of specific applications and are measured by the Office of Quality Assurance at the USPTO.  The last two metrics are based upon surveys performed by an independent party.  The fifth metric (QIR) is based upon statistical data taken from the USPTO PALM database that provide insight into USPTO’s ongoing efforts toward compact prosecution and pendency reduction. 

Mr. Woitach summarized the TC1600 efforts to improve QIR by developing training resources and best practices.  In 2012, 5 QIR factors were incorporated into the examiner review process:  (1) actions per disposal, (2) number of RCEs in total disposals, (3) re-opening of prosecution after final, (4) non-final actions other than first action on the merits, and (5) restrictions after first action on the merits.  Based upon examiner training efforts last year, including an emphasis on telephonic communications, the percentage of restrictions not made on a second or subsequent action has improved.  The main focus for 2013 is to decrease the number of actions per disposal and the number of RCEs.  In particular, the USPTO has encouraged interviews after final and during prosecution, patterns in repeated filing of RCEs are being investigated, and examiners with a disproportionate number of disposals for RCE are being identified so that docket management issues may be addressed.  In an effort to reduce overall application pendency, the effective filing date (not the RCE filing date) is used for prioritization of examiner dockets, and counts for consideration of RCEs have been reinstated. 

There were numerous questions from practitioners about training being provided to examiners with a high number of actions, as well as to examiners with an unusually low number of actions per disposal, which may similarly indicate poor examination.  There was also discussion of the benefits of examiner interviews and the challenges associated with conducting in-person interviews with examiners who are part of the hoteling program.  The presenters discussed USPTO efforts to incorporate video interviews at USPTO campuses, and there were views expressed from the audience that the webex video interviews were nevertheless not ideal.  To formalize an expression of these perceived shortcomings, the presenters suggested that practitioners associate with a high level corporation, law firm, or association that could submit a letter of concern. 

Best Practices in Reissue, Before and After September 16, 2012

By Jean Vollano (Quality Assurance Specialist, TC 1600)

Ms. Vollano provided a tutorial of best practices for pursuing reissue applications, including key changes imposed by the America Invents Act.  A review of her slides is an excellent first step prior to filing documents in a reissue application.  Ms. Vollano is eager to assist practitioners as they navigate through the relevant rules so that reissue applications proceed efficiently.  She may be contacted at 571-272-0648.

Recent Case Law: Narrowing/Broadening Reissues

By Bennett Celsa (Quality Assurance Specialist, TC 1600)

Mr. Celsa presented highlights of recent judicial decisions impacting reissue practice.  With respect to narrowing reissues, the CAFC has held that a new dependent claim can be the basis of a reissue application under 35 U.S.C. § 251 (In re Tanaka (98 USPQ2d 1331 (Fed. Cir. 2011)).  With respect to broadening reissues, the CAFC has held that an intent to broaden within two years following issuance permits later broadening of disclosed, but unclaimed embodiments in a manner unrelated to any broadening aspect identified within the two-year period (In re Stats, 671 F3d 1350, 101 USPQ2d 1930 (Fed. Cir. 2012)).  Mr. Celsa also discussed the recapture rule for reissue claims of intermediate scope.  To avoid recapture, a narrowing limitation in a broadened reissue claim must be related to the surrendered subject matter and be distinguishable over the prior art, for example, by modifying but not eliminating the added limitation (In re Mostafazadeh, 643 F3d 1353, 98 USPQ2d 1639; In re Youman, No. 2011-1136, 2012 WL 1598089).  Several examples addressing recapture were presented. 

Petitions

By Thurman Page (Supervisory Patent Examiner, Office of Petitions)

Mr. Page gave a summary of the various petitions reviewed by the Office of Petitions and provided guidance about specific petition requirements, including new requirements under the America Invents Act.  Practitioners are encouraged to use the ePetition process, which has been recently expanded to include the following ePetitions:  Request for Withdrawal as Attorney or Agent of Record (37 CFR 1.36), Petition to Withdraw from Issue after Payment of the Issue Fee (37 CFR 1.313(c)(1), (2), or (3)), Petition to Accept Late Payment of Issue Fee (37 CFR 1.137(b)), Petition for Revival of an Application based on Failure to Notify the Office of a Foreign or International Filing (37 CFR 1.137(f)), Petition for Revival of an Application for Continuity Purposes Only (37 CFR 1.137(b)), Petition for Revival of an Abandoned Patent Application Abandoned Unintentionally (37 CFR 1.137(b)), and Petition to Correct Assignee After Payment of Issue Fee (37 CFR 3.81(b)).  In contrast to the prior PDF-based ePetitions (Petition to Make Special (37 CFR 1.102) and Petition to Accept Unintentional Delayed Payment of the Maintenance Fee (37 CFR 1.378(c)), which require download and completion of a fillable PDF Form, the new web-based ePetitions are completely filled out online and granted immediately upon submission if the petition meets all of the requirements.  A Quick Start Guide with additional information is available at http://www.uspto.gov/patents/process/file/efs/guidance/epetition-quickstart.pdf

There were numerous questions and concerns about the current pendency of petitions.  Mr. Thurman responded that practitioners should call the Office to ensure that the petition was not miscoded upon filing.  With respect to petitions for reconsideration of patent term adjustment (37 CFR 1.705(d)), he advised that the Office was waiting for the Federal Circuit’s decision in Exelixis, Inc. v. Kappos prior to acting upon these petitions. 

Future Meeting

The next scheduled meeting will be 10 September 2013.  Please refer to http://www.cabic.com/bcp/  for the schedule announcement and agenda.  If there are any issues or topics that you wish to be discussed, please share your ideas with the Customer Partnership Team: Bennett Celsa (QAS TC 1600); Sue Lie (SPE AU 1616); Karlheinz Skowronek (SPE AU 1654); and Cecilia Tsang (571-272-0562 or cecilia.tsang@uspto.gov).

Questions

If you have any questions regarding the content of this summary, or would like further details of the live discussion, you are welcome to the Biotech Committee/USPTO Relations Subcommittee co-chairs: Julie Meigs (jmeigs@wcsr.com) and Suzannah Sundby (ssundby@sgrlaw.com).

Case Law Reports

Case Law Report Link

Organic Seed Growers and Trade Ass’n v. Monsanto Company, reported by Bruce Vrana, Syngenta Biotechnology, Inc., Research Triangle Park, NC, USA.

No. 2012-1298 (Fed. Cir. June 10, 2013) (affirming lack of declaratory judgment jurisdiction where patentee stated that it had no intention of suing the declaratory judgment plaintiffs).

Dey, L.P. v. Sunovion Pharmaceuticals, Inc., reported by Lynn C. Tyler and Michael R. Brunelle, Barnes & Thornburg LLP, Indianapolis, IN, USA.

Nos. 2012-1428 (Fed. Cir. May 20, 2013) (reversing district court’s finding of invalidity based on prior use under 35 U.S.C. § 102(b)). 

 

Announcement: 2013-2014 Biotechnology Committee Chair and Vice Chair

Chair: Suzannah Sundby

Wayne Sobon, in-coming AIPLA President, invited Suzannah Sundby of Smith, Gambrell & Russell in DC to become chair of the Biotechnology Committee for the period October, 2013 – October, 2014.  Suzannah accepted the invitation. 

Suzannah has served as co-chair of our USPTO Relations subcommittee for the last 3.5 years.  She participated actively in the preparation of AIPLA’s written submissions in 2012 to the USPTO on genetic testing and on the USPTO’s proposed change in sequence listing protocol.  In 2013, she led the development of AIPLA’s comments to the USPTO about improving the sequence listing process.  She has spoken and written widely on a wide variety of IP issues and she was a panelist at AIPLA’s 2013 spring meeting in a session titled “An Evolving Patent Claim Quagmire of Eligibility and Infringe-ability – Recent Developments in Patent Claim Eligibility and Joint Infringement.” 

Carol Nielsen of Nielsen IP Law, who was in-line to become Biotech Chair, decided to invest her passion and talent in the Chemical Practice Committee as vice chair.  We wish her and them all the best.  We expect to collaborate with Carol and the Chemical Practice group on many things.

Vice Chair: Tim Meigs

Wayne Sobon also invited Tim Meigs of Becton Dickinson to become Vice Chair for the period October, 2013 – October, 2014.  Tim accepted the invitation. 

Tim is very well-known on the Biotechnology Committee and around AIPLA.  He served the Biotechnology Committee as microsite steward for a few years and since 2011 he has chaired our Programs subcommittee.  Tim participated for many years as a trainer in AIPLA’s Biotech Boot Camp and he held the Chair position on the Education committee.  

Suzannah and Tim are working with the committee’s present leadership team on transition.