BIOTECH BUZZ, April, 2013

Join the Committee on LinkedIn!

The Biotech committee is now a sub-group on Linked-In.  We can use this social networking group to better keep in touch with each other.  For example, the linked in page will allow you to send messages to each other or engage in group discussions and informal polls without clogging the inboxes of people who do not wish to participate. 

Also, for those of you who are interested in getting more involved, the Linked-In group will be used by subcommittee chairs to call for volunteers on projects and to announce events, such as CLE webinars or interesting news items.

Of course, participation is voluntary.  If interested in joining, please follow the directions below.

Step 1.  If you are not a member of Linked-In, please join.  It’s free.  Just click on the following link and follow the directions: https://www.linkedin.com/reg/join.

Step 2. Once you have joined, go to the search spot at top (look for the magnifying glass).

Step 3.  Search “American Intellectual Property Law Association” and request to join.

Step 4.  Go back to the Search bar, search for “AIPLA FDA Committee”, and request to join.  You can restrict by “group” using the drop down menu just to the left of the search bar.  Also, joining the main AIPLA group is required because you have to join the main group to join any subgroup, such as the Biotech committee.  For each request to join, it should say that your approval is pending.  The AIPLA IT staff will check that you are actually a member, and if so, approve you.

Step 5.  Start posting.

If you have any questions, please contact William Childs at William.Childs@dbr.com.

Programs

AIPLA Spring Meeting, Seattle Westin Hotel, May 1-3, 2013

May 2, 3:30 – 5:30, Biotechnology IP Practice in Latin America (120 Minutes of CLE)

The Biotechnology Committee and the IP Practice in Latin America Committee are collaborating to present 2 hours of CLE on some of the latest and most important issues affecting patent practitioners who procure and maintain patent protection on biotechnology related inventions in Latin America. The topics to be addressed will cover (1) status of plant variety patent protection; (2) biological pharmaceuticals and biosimilars; (3) whether protection is available for diagnostics and gene patenting; and (4) any specific peculiarities in each country in obtaining and maintaining patent protection (i.e., compulsory licensing issues). The speakers will be:

Ignacio Manuel Sanchez Echagüe, Marval O’Farrell & Mairal, Buenos Aires, Argentina

Leonor Galvão de Botton, Murta Goyanes, Rio de Janeiro, Brazil

Luis Diego Castro, Castro & Pal Asociados, San José, Costa Rica

Eugenio Pérez, Uhthoff, Gómez Vega & Uhthoff, Mexico City, Mexico

May 2, 3:30 – 5:30, “Reverse Payments” – Food and Drug, Antitrust, ADR Joint Session

Biotech members may want to be aware of a session that conflicts with our joint CLE session with IP Practice in Latin America (see above).  The Food and Drug, Antitrust, and Alternate Dispute Resolution committees have planned a panel on so-called “reverse payment” settlements in ANDA litigations, which is the topic of the FTC v. Actavis case before the US Supreme Court this term.  The anticipated panel includes Steve Shadowen of Hilliard & Shadowen LLC, Guy Donatiello of Endo Pharmaceuticals Inc., an economics professor offering an economic perspective, and a representative of the ADR committee.  Look for additional details on this topical panel in April issue of the Biotech Buzz.

Biotech Social, Seattle Westin Hotel, Thursday, May 2, 5:30 – 6:30.

Please join us for drinks, light hors d’oeuvres, and socializing with panelists and committee members at a place yet to be selected within the Seattle Westin Hotel after our CLE sessions on Thursday.  ~5:30 – ~6:30.  As usual, it’s a cash bar.

AIPLA Trip to Mexico City—June 5-7, 2013

AIPLA members, including AIPLA’s Executive Director, Todd Dickinson, AIPLA’s current President, Jeffrey Lewis and at least one of the AIPLA’s Board Members, Mike Martinez, will be visiting Mexico City June 5th-7th in 2013.  Biotech committee members would be welcome to attend.  If you wish to be part of AIPLA’s delegation, go to http://www.marriott.com/hotels/travel/mexjw-jw-marriott-hotel-mexico-city/ to book your room directly over the Internet.  The normal rate is $399.99 plus tax, per night.  However, we were able to obtain a group preferred rate of $237.00 plus tax, per night.  The Group Code to use over the Internet is AIPAIPA.  If you book your rooms over the phone, then the Group Code is simply AIPLA.  If you are attending, book your room immediately and then please let James Larson know.

Webinars

Myriad: Mirth or Melancholy? Date TBD – Soon after Supreme Court decision

The AIPLA Biotech Committee plans to put on a webinar about Myriad soon after the Court issues its decision.  So far Professor Joshua Sarnoff, counsel for amici curiae “Fifteen Law Professors, and Barbara Rudolph of Finnegan Henderson have confirmed their participation.  We expect Greg Castanias, who argued for Myriad at the Court, to participate, and we are hopeful that one of the plaintiffs’ attorneys will also participate.  Stay tuned for the date and time of the webinar and the full list of presenters.

Reprise of Spring Meeting Joint Session on Biotechnology IP Practice in Latin America (120 Minutes of CLE), Date TBD

The Biotechnology Committee and the IP Practice in Latin America Committee will collaborate to present 2 hours of CLE via webinar on some of the latest and most important issues affecting patent practitioners who procure and maintain patent protection on biotechnology related inventions in Latin America. See above for specific topics and presenters.

Case Law Reports

Case Law Report Link

The Association for Molecular Pathology, et al, v. Myriad Genetics, Inc. et al.

Reported by Victoria S. Lee and Amelia F. Baur, PhD, Finnegan, Henderson, Farabow, Garrett & Dunner LLP, Washington, D.C., USA.

 

No. 12-398 (Sup. Crt. April 15, 2013) (summary of U.S. Supreme Court oral arguments in case related to patentability of isolated DNA). 

Berish Rubin and Sylvia L. Anderson v. The General Hospital Corporation.

Reported by Rachel L. Carnaggio, Fennemore Craig, P.C., Denver, Colorado, USA.

 

No. 2011-1439 (Fed. Cir. Mar. 28, 2012) (inventorship dispute between independent research teams gives rise to an interference because the parties were not collaborating). 

Biosimilars Subcommittee

Momenta Seeks Supreme Court Review of Whether Safe-Harbor Applies to Post-Approval Uses of a Drug

Contributed by Angie Sebor and Vicki Norton.

Following split decisions by the Federal Circuit in Classen Immunotherapies, Inc. v. Biogen IDEC, GlaxoSmithKline & Merck & Co., 659 F.3d 1057 (Fed. Cir. 2011) and Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., 686 F.3d 1348 (Fed. Cir. 2012), Momenta has petitioned the Supreme Court to consider the scope of the safe harbor under 35 U.S.C. § 271(e)(1).  More specifically, the Question Presented by Momenta in its petition is “[w]hether the use of a patented invention in the course of post-approval manufacture of a drug for commercial sale, where the FDA requires that a record of that manufacturing activity be maintained, is exempted from liability for patent infringement under Section 271(e)(1) as ‘solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use or sale of drugs.’”  Amphastar initially waived its right to file a response to the petition, but the Supreme Court called for a response, which suggests to some commentators that the Court is showing interest in the case.  Amicus briefs in support of Momenta are due on May 2, 2013.  If the Supreme Court decides to hear the Momenta case, it could resolve the recent split decisions by two Federal Circuit panels and provide more certainty to biologic drug and biosimilar manufacturers.  In Classen, GSK had also petitioned for certiorari, but the Supreme Court denied GSK’s petition on January 14, 2013.

The Federal Circuit panels deciding both 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)), 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 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, providing 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.”

The Biosimilar Subcommittee will continue to monitor the Momenta case, and will provide a more in depth report on the impact of Classen and Momenta following a Supreme Court ruling on the merits, or its denial of Momenta’s petition.

 

Summary of FDA Draft Guidance on Formal Meetings for Biosimilar Development Programs

Contributed by Vicki Norton, Duane Morris LLP, San Diego, California, USA.

 

On March 11, 2013 the FDA issued a “Draft Guidance on Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants” (“Draft Guidance”) (see also 78 Fed. Reg. 19492, April 1, 2013). 

Following enactment of the Biosimilar User Fee Act of 2012 (BsUFA), FDA had committed to achieving certain performance goals in a BsUFA goal letter from the Secretary of HHS to Congress (“FDA Commitment Letter”), including management goals for formal meetings that occur between the FDA and sponsors or applicants during development of a biosimilar biological product. 

The Draft Guidance provides a unified approach to the formal meetings between sponsors or applicants and the FDA during the development of biosimilar products.  In addition, the Draft Guidance discusses principles of good meeting management practices (“GMMPs”) and describes standardized procedures for requesting, preparing, scheduling, conducting and documenting the formal meetings.  The Draft Guidance describes five types of formal meetings and targeted dates: 

The Biosimilar Initial Advisory meeting is the FDA’s initial assessment limited to a general discussion regarding whether licensure under section 351(k) of the Public Health Services Act may be feasible for a particular product, and, if so, general advice on the expected content of the development program.  These meetings should be scheduled within 90 calendar days of FDA receipt of a written meeting request and meeting package.

No user fee is due for the Biosimilar Initial Advisory meeting.  However, fees for the remaining four Types of Biosimilar Product Development (BPD) meetings must be paid in advance?

A BPD Type 1 meeting is a meeting that is necessary for an otherwise stalled BPD program to proceed, and include meetings to discuss clinical holds, special protocol assessment meetings after receipt of FDA evaluation of protocols, meetings to discuss important safety issues, and dispute resolution meetings.  BPD Type 1 meetings should be scheduled within 30 calendar days of FDA receipt of a written meeting request and meeting package.

A BPD Type 2 meeting is a meeting to discuss a specific issue such as proposed study design or endpoints, or to discuss questions where the FDA will provide targeted advice regarding an ongoing BPD program.  This meeting includes substantive review of summary data but does not include FDA review of full study reports.  BPD Type 2 meetings should be scheduled within 75 calendar days of FDA receipt of a written meeting request and meeting package.

A BPD Type 3 meeting is a meeting to provide in-depth data review and advice regarding an ongoing BPD program, including substantive review of full study reports, FDA advice regarding the similarity between the proposed biosimilar biological product and the reference product, and FDA advice regarding the need for additional studies, including design and analysis.  BPD Type 3 meetings should be scheduled within 120 calendar days of FDA receipt of a written meeting request and meeting package.

A BPD Type 4 meeting is a meeting to discuss the format and content of a biosimilar biological product application or supplement to be submitted under section 351(k).  BPD Type 4 meetings should be scheduled within 60 calendar days of FDA receipt of a written meeting request and meeting package.

The five types of formal meetings were previewed in the FDA Commitment Letter and the related Proposed Recommendations for a User Fee Program for Biosimilar and Interchangeable Biological Product Applications for Fiscal Years 2013 Through 2017 (76 Fed. Reg. 76424, December 7, 2011).  However the Draft Guidance indicates that an overview of the proposed development be provided and specifies that the biosimilar application provide preliminary comparative analytical similarity data to enable the FDA to make a preliminary determination as to whether licensure under section 351(k) of the PHS Act may be feasible for a particular product. 

Itemized details of what the Meeting requests should include are summarized:   

1. Product name. 2. Application number (if applicable). 3. Proposed proper name (or proper name if post-licensure). 4. Structure (if applicable). 5. Reference product name. 6. Proposed indication(s) or context of product development. 7. The type of meeting, along with the rationale for requesting the meeting type. 8. A brief statement of the purpose of the meeting, including a brief background of the issues underlying the agenda.  It also can include a brief summary of completed or planned studies and clinical trials or data to be discussed at the meeting, the general nature of critical questions to be asked, and where the meeting fits in overall development plans.   9. A list of the specific objectives/outcomes the requester expects from the meeting. 10. A proposed agenda, including estimated times needed for each agenda item. 11. A list of questions, grouped by discipline. Each question should be precise, and there should be a brief explanation of the context and purpose for each question. 12. A list of all individuals who will attend the requested meeting from the sponsor’s or applicant’s organization and consultants. 13. A list of FDA staff, if known, or disciplines, asked to participate in the requested meeting. 14. Suggested dates and times for the meeting that are within or beyond the appropriate time frame of the meeting type being requested. 15. The proposed format of the meeting (i.e., face-to-face meeting, teleconference, or videoconference) (see Section VI of the Draft Guidance).

Items 8-14 elaborate on items 1(a-g) previously outlined in the FDA Commitment Letter, while items 1-7 in the Draft Guidance appear to relate to background information on the proposed biosimilar development program.  In other respects, the discussion of the 5 types of formal meetings in the Draft Guidance largely tracks earlier FDA’s earlier description of the five types of formal meetings.

Comments on the Draft Guidance are due May 31, 2013.

 

International Issues Subcommittee

Europe: A Family Affair: How claims of a “mother” patent were found to lack novelty in view of a “daughter” divisional application

Contributed by René Raggers, EP&C, Utrect, The Netherlands

 

The Technical Board of Appeal of the European Patent Office (EPO) recently determined in decision T 1496/11 that a divisional application (“daughter”) can be prior art against its own mother application.

Although the patent in this case is not “biotech” it is a good example on how the EPO looks at “self-collision” and validity of priority claims:

Under the European Patent Convention Article 54(3), European patent applications with an earlier filing or priority date than the filing or priority date of a second European patent application, and which are published on or after the filing date of that second application, are prior art  for the purpose of examining the novelty of this second patent application.

Thus in the below example patent application A is prior art for novelty only for patent application B, although published after the filing of B:

 

T 1496/11 concerns a “mother” application and a “daughter” application that both claimed priority from the same Australian application.

The mother was patented with claim 1 relating to a “optical lens”. However, the priority document disclosed such “optical lens” only in combination with a “printed or embossed feature.” The Board held that the claim of the mother patent was not entitled to the priority date, because the claims could be practiced with or without using a “printed or embossed feature.”

Since the filed “daughter” applications was identical to the priority document, it thus became relevant under Article 54(3) (divisional) for claim 1 of the mother application (the daughter having an earlier priority date than claim 1 of the mother, and being published on or after the filing date of the mother). Since the description disclosed “an optical lens in combination with a printed or embossed feature”, the daughter takes away novelty of claim 1 of the mother.

 

This case shows the EPO’s strict view on the right to priority and provides consideration when prosecution patent applications before the EPO.

Plant IP Protection in Australia

Contributed by David Myers and Andrew Blattman of Spruson & Ferguson (Sydney)

 

Australia has a significant agricultural industry, with a gross value of crops in the order of 20 billion dollars annually (including cereals, cotton and canola, but also a significant fruit and vegetable sector). Moreover, the Australian industry is technology intensive, and new plant varieties developed in Australia or overseas are quickly being adopted to meet yield, market, disease and climatic demands.

Importantly, plants (including genetically modified plants) can be protected under both the Australian Plant Breeders Rights Act 1994 (the “PBR Act”) and the Australian Patents Act 1990, and protection under one system does not preclude obtaining concurrent protection under the other.

Plant breeders rights

A variety (plant, fungus or alga) is defined by a combination of physical, chemical or other biological (including disease resistance) characteristics expressed by the variety.  At least one characteristic must distinguish the variety from other commonly known varieties in order to be registrable.  The variety must also be “uniform” in the characteristics it expresses and be “stable” when bred over a number of generations.  The variety need not be previously undisclosed or even uncommercialised; commercial exploitation can occur in Australia up to one year before application, and can occur overseas (in UPOV member countries) up to four years before the making of the PBR application for most plants, or up to six years for trees and vines.  UPOV convention priority from a foreign application can be claimed, although this usually introduces prosecution complications and limitations, and is typically not necessary.

Examination of a PBR application usually requires the involvement of an expert for inspection of the variety and reporting to the PBR Office.  Relevant overseas DUS (Distinctiveness, Uniformity and Stability) test reports can facilitate examination, although a Qualified Person is still required to review such reports and file a report at the Australian PBR Office.

Before grant of a PBR, a deposit of propagating material must be made at an approved Genetic Resource Centre (GRC), and maintained thereafter for the duration of PBR protection.

PBR protection for a plant variety starts as ‘provisional protection’ during prosecution of the application (from the date the application passes formalities examination) and then officially starts from the date of grant of the PBR right and extends for up to 20 years for most plants and up to 25 years for varieties of trees and grape vines.

Protection under the PBR Act includes an exclusive right to produce or reproduce propagating material from the variety, and to sell, condition for sale, import or export such material.  Under limited circumstances, rights may extend to material harvested from the variety.  Rights may also extend to “essentially derived varieties”.  Exemptions to PBR infringement include use of a registered variety privately, for non-commercial purposes or for breeding other plant varieties.  A further exemption exists for farm-saved seed.

Independent of the usual infringement remedies (damages, account of profits and/or delivery up and destruction), the PBR Act also provides for prescribed penalties for infringement.

Patent rights

Patents legislation may provide a plant variety with protection for a period of up to 20 years, from the date of filing of the patent application.

In order to be patentable, a plant variety must meet the usual requirements, including that:

•      the plant be novel in an absolute sense, non obvious, and obtained using a reproducible method;

•      the plant exhibits improved or altered useful properties; and

•      derivation of the plant involves human intervention.

In deciding what constitutes human intervention, the Australian Patent Office treats the choice of parents and their selective breeding, followed by selection of the most desirable offspring as being sufficient.

Where an aspect of the invention claimed cannot be performed without a sample of the germplasm (which is most likely to be the case for a plant variety), a deposit at a Budapest Treaty Depository will most likely need to be made before the filing date of the patent application.

The scope of protection afforded by the patents system is significantly broader than that afforded by PBR.  Unlike PBR, a patent allows protection for the plant variety per se, as well as for:

•      any part of the plant (including harvested material, genes, proteins, other molecules);

•      use of the plant variety or its part(s);

•      methods of breeding plants using the protected variety and resulting progeny; and

•      products derived from the plant.

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BIOTECH BUZZ, MARCH 2013

Join the Committee on LinkedIn!

The Biotech committee is now a sub-group on Linked-In.  We can use this social networking group to better keep in touch with each other.  For example, the linked in page will allow you to send messages to each other or engage in group discussions and informal polls without clogging the inboxes of people who do not wish to participate. 

Also, for those of you who are interested in getting more involved, the Linked-In group will be used by subcommittee chairs to call for volunteers on projects and to announce events, such as CLE webinars or interesting news items.

Of course, participation is voluntary.  If interested in joining, please follow the directions below.

Step 1.  If you are not a member of Linked-In, please join.  It’s free.  Just click on the following link and follow the directions: https://www.linkedin.com/reg/join.

Step 2. Once you have joined, go to the search spot at top (look for the magnifying glass).

Step 3.  Search “American Intellectual Property Law Association” and request to join.

Step 4.  Go back to the Search bar, search for “AIPLA FDA Committee”, and request to join.  You can restrict by “group” using the drop down menu just to the left of the search bar.  Also, joining the main AIPLA group is required because you have to join the main group to join any subgroup, such as the Biotech committee.  For each request to join, it should say that your approval is pending.  The AIPLA IT staff will check that you are actually a member, and if so, approve you.

Step 5.  Start posting.

If you have any questions, please contact William Childs at William.Childs@dbr.com.

Programs

AIPLA Spring Meeting, Seattle, Washington, May 1-3, 2013

May 2, 3:30 – 5:30, Biotechnology IP Practice in Latin America (120 Minutes of CLE)

The Biotechnology Committee and the IP Practice in Latin America Committee are collaborating to present 2 hours of CLE on some of the latest and most important issues affecting patent practitioners who procure and maintain patent protection on biotechnology related inventions in Latin America. The topics to be addressed will cover (1) status of plant variety patent protection; (2) biological pharmaceuticals and biosimilars; (3) whether protection is available for diagnostics and gene patenting; and (4) any specific peculiarities in each country in obtaining and maintaining patent protection (i.e., compulsory licensing issues). The speakers will be:

Ignacio Manuel Sanchez Echagüe, Marval O’Farrell & Mairal, Buenos Aires, Argentina

Leonor Galvão de Botton, Murta Goyanes, Rio de Janeiro, Brazil

Luis Diego Castro, Castro & Pal Asociados, San José, Costa Rica

Eugenio Pérez, Uhthoff, Gómez Vega & Uhthoff, Mexico City, Mexico

May 2, 3:30 – 5:30, “Reverse Payments” – Food and Drug, Antitrust, ADR Joint Session

Biotech members may want to be aware of a session that conflicts with our joint CLE session with IP Practice in Latin America (see above).  The Food and Drug, Antitrust, and Alternate Dispute Resolution committees have planned a panel on so-called “reverse payment” settlements in ANDA litigations, which is the topic of the FTC v. Actavis case before the US Supreme Court this term.  The anticipated panel includes Steve Shadowen of Hilliard & Shadowen LLC, Guy Donatiello of Endo Pharmaceuticals Inc., an economics professor offering an economic perspective, and a representative of the ADR committee.  Look for additional details on this topical panel in April issue of the Biotech Buzz.

AIPLA Trip to Mexico City—June 5-7, 2013

AIPLA members, including AIPLA’s Executive Director, Todd Dickinson, AIPLA’s current President, Jeffrey Lewis and at least one of the AIPLA’s Board Members, Mike Martinez, will be visiting Mexico City June 5th-7th in 2013.  Biotech committee members would be welcome to attend.  If you wish to be part of AIPLA’s delegation, go to http://www.marriott.com/hotels/travel/mexjw-jw-marriott-hotel-mexico-city/ to book your room directly over the Internet.  The normal rate is $399.99 plus tax, per night.  However, we were able to obtain a group preferred rate of $237.00 plus tax, per night.  The Group Code to use over the Internet is AIPAIPA.  If you book your rooms over the phone, then the Group Code is simply AIPLA.  If you are attending, book your room immediately and then please let James Larson know.

AIPLA Mid-Winter Institute, Tampa, Florida, February 2013

The Biotech Committee partnered with the Chemical Practice Committee to plan 3 hours of CLE in two panels for Thursday afternoon during the MWI in Tampa, Florida.

Obtaining Value from IP in Personalized Medicine

Lawyers from a very diverse spectrum of entities involved in personalized medicine and diagnostics provided views about the value of IP for the development of new products and services.  

Judith Roesler of the Roesler Law Offices, PLLC moderated the panel, which consisted of:

Manny Vacchiano, Lead Patent Attorney (PCR and Medical Sciences business units), Life Technologies;

Yuko Soneoka, Senior Corporate Counsel IP, Genome Health, Inc.;

Robert L. Sharp from Eli Lilly and Company;

Natalie Wright Curley, Managing Director of the Office of Technology Commercialization, MD Anderson Cancer Center; and

Jarett Rieger, Director and Associate General Counsel of the Office of Technology Mgmt & Commercialization, Moffitt Cancer Center and Research Institute in Tampa, FL.  

About 90 people attended this session.  Manny’s slides, Yuko’s slides, Robert’s slides, Natalie’s slides, and Jarrett’s slides are available.

To meet one of its objectives, our Diagnostics and Gene Patenting Subcommittee created a white paper titled “IP Value for Personalized Medicine” with contributions from Judy Roesler, Ling Zhang, Lynn Tyler, and Karen Canady.  This paper was provided to attendees to fulfill CLE requirements.

Mark Stewart and Robert Sharp of Eli Lilly and Company provided another paper titled “IP Considerations Associated with Companion Diagnostic Discovery and Development.” 

Aligning IP Strategies with Business Objectives Up and Down the Supply Chain

Lead intellectual property counsel from several large companies provided their views about the value of intellectual property in each of their businesses and how they work with suppliers and customers to modify their IP and licensing strategies depending on their place along the supply chain.  The panelists were:

Richard Phillips, Chief Attorney Technology, ExxonMobil Chemical;

Patrick Bengtsson, VP, Assoc. GC, IP, The Clorox Company;

Valerie L. Calloway, Chief IP Counsel, Polymer Group, Inc.; and

Nancy M. Klembus, Assistant General Counsel, Kimberly-Clark, Corp.

Carol Nielsen of Nielsen IP Law, Houston TX moderated the panel.  The panelists addressed questions, such as: How does a company’s position in a supply chain affect IP strategies?  How do companies that are suppliers and customers adjust their approaches to IP acquisition and licensing in light of business relationships?  How do companies use IP to obtain value in the marketplace even when their businesses might not be thought of as innovative?  The session was also well-attended and a dynamic interchange with the audience occurred.

Case Law Reports

Case Law Report Link

Cancer Voices of Australia v. Myriad Genetics, reported byTrevor J. Davies, PhD, Allens Patent & Trade Mark Attorneys, Sydney, Australia.

[2013] FCA 65 (15 February 2013) (confirming patentability of isolated genetic material under Australian law). 

Abbott GmbH & Co., KG v. Centocor Ortho Biotech, Inc., reported byLynn C. Tyler and Michael R. Brunelle, Barnes & Thornburg LLP, Indianapolis, Indiana, USA.

No. 09-11340-FDS (D. Mass. 2012) (update on high profile patent infringement case related to patentability requirements for antibody inventions). 

Verinata Health, Inc. and The Board of Trustees of the Leland Stanford Junior University v. Sequenom, Inc, reported byWilliam R. Schmidt, Wenderoth, Lind & Ponack LLP, Washington, D.C. , USA.

No. 4:12-cv-00865-SI (N.D. Cal. 2012) (developing case on patentable subject matter for diagnostic inventions). 

 

USPTO Subcommittee

Report from the Joint Medical Device—Biotechnology & Chemical Partnership Meeting – January 29

Contributed by Julie Broadus Meigs, Ph.D., Womble Carlyle Sandridge & Rice, LLP, Tysons Corner, VA.

This was the second meeting co-sponsored by USPTO Technology Centers 1600 and 3700.  The combined forum is intended to facilitate discussion between practitioners and the USPTO on similar issues facing both technology practice areas.  Copies of the handouts from this meeting and from prior meetings can be obtained at http://www.cabic.com/bcp/

Teresa Stanek Rea (Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of the USPTO) gave a brief introduction and welcome.

There was an announcement made regarding a joint partnership between the USPTO and the Smithsonian Institution to stage a 2013 Innovation Expo.  The Expo will serve as a template for the Innovation Pavilion to be presented at the Smithsonian’s Arts and Industries Building upon its reopening in summer 2014.  Patentees interested to showcase their technology at the Expo must apply by 31 March 2013.  For more information and link to the application form see http://www.uspto.gov/patents/init_events/innovationexpo/IE2013_main.jsp.

CPC – Cooperative Patent Classification

By Don Hajec (Director TC 3700) and Derris Banks (Director TC 2600)

The presenters gave an overview of the just-launched CPC prior art collection that will ultimately replace the current United States Patent Classification (USPC) system by 2014.  The CPC is a bilateral USPTO/EPO initiative to promote work sharing between patent offices as well as the public.  The new classification system is based upon the International Patent Classification (IPC) standards, but it is designed to be more adaptive and actively maintained.  The presenters explained CPC nomenclature and provided examples of search strategies.  A tentative schedule of upcoming external training opportunities and links to additional resources are included at the end of the presentation materials.

Evaluating Subject Matter Eligibility Under 35 USC § 101

By Marjorie Moran (Supervisory Patent Examiner, AU 1631)

Ms. Moran talked through examination guidelines for patent subject matter eligibility.  The guidelines are included in MPEP 2104, 2105, and 2106 (Ed. 8, Rev. 9, 2012).  The presentation primarily focused on the judicial exceptions to subject matter eligibility:  laws of nature, natural phenomena, and abstract ideas, guided by Mayo v. Prometheus (Sup. Ct. 2012).  Two examples were analyzed – the first pertaining to claims for treating a disorder, and a second pertaining to claims for methods of determining disease risk.  Additional examples are currently being developed and will be published for examiner training and practitioner use. 

America Invents Act (AIA) Update Including First-Inventor-To-File

By Janet Gongola (Associate Commissioner for Patent Examination Policy, Patent Reform Coordinator); Presented by Mary Till (Legal Advisor, Office of Patent Legal Administration)

Ms. Till provided an overview of AIA provisions that will become effective next month, including provisions for first-inventor-to-file, fee setting, and micro entity status.  She stated that comments submitted in response to the USPTO proposed examination guidelines for implementing the first-inventor-to-file provisions (published in July 2012) had been considered.  The final rules and examination guidelines have since published.  See 78 FR 11023-11059 (February 14, 2013) and 78 FR 11059-11088 (February 14, 2013).  The AIA Technical Corrections Legislation was also briefly discussed.  Resources are available for assistance with complying with changes under the AIA, including dedicated staff that may be contacted by phone or email (see end of presentation for contact information).

Open Round Table Discussion

Panelists:  Don Hajec (Director, TC 3700), Jerry Lorengo (Director, TC 1600), Angela Sykes (Director, TC 3700); Mary Till (Legal Advisor, Office of Patent Legal Administration); Wanda Walker (Director, TC 1600); Andrew Wang (Director, TC 3700)

The Round Table Discussion included a lively discussion of various topics, including first action interviews, the RCE backlog and delay in consideration, additional questions about the subject matter eligibility guidelines, efforts to improve communication between examiners and practitioners, compact prosecution goals, and the AIA rule changes regarding third party submissions.

Next Meeting – June 5

The next scheduled meeting will be Tuesday, 5 June 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 hear, please share your ideas with the Customer Partnership Team: Bennett Celsa (QAS TC 1600); Sue Lie (SPE AU 1616); Karlheinz Skowronek (SPE AU 1654); Cecilia Tsang (571-272-0562 or cecilia.tsang@uspto.gov); Brian Casler (SPE TC 3700); Linda Dvorak (SPE AU 3739); Tom Hughes (SPE 3731); Kevin Sirmons (SPE AU 3767); or to medical_device_customer_partnership_TC3700@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 email the Biotech Committee/USPTO Relations Subcommittee co-chairs, Julie Meigs and Suzannah Sundby.

NEW! Regional Subcommittees

The Biotech Committee is organizing regional subcommittees that will host events throughout the United States (and abroad).  The first regional subcommittee to be formed is the Maryland/DC/Virginia Events Subcommittee.  Keep an eye out for additional regional subcommittees forming in your area, or volunteer to organize a regional subcommittee by emailing Jim Kelley (kelley_james_j@lilly.com).

MD/DC/VA Events Subcommittee

For its first event, the AIPLA Biotechnology Committee MD/DC/VA Events group met for food and drink at an exquisite restaurant in Rockville, Maryland, about ten miles from Washington, DC.   The restaurant is styled after the great camps of the Adirondack Mountains that were constructed in the latter half of the nineteenth century.  The event lasted about two hours, and lively conversation allowed members to get to know one another; a good time was had by all.  The AIPLA Biotechnology Committee MD/DC/VA Events group encourages committee members in the greater Washington, DC metropolitan area to join the group by visiting http://groupspaces.com/aiplabiotechnologycommitteeWe look forward to seeing you at our next event.

International Issues

Brazil Issues Permit for Production of Follow-On Biologics

Contributed by Benny Spiewak, Zancaner Costa, Bastos e Spiewak Advogados, São Paolo, Brazil

On February 18, 2013 the Brazilian Official Gazette announced that the Brazilian company Bionovis obtained a manufacturing permit authorizing the construction of a site focused on the development of biologic drugs, mainly a follow-on biologic version of the rheumatoid arthritis therapy ETANERCEPT.  The announcement marks the initial milestone of a project that aims at creating a strong, highly competitive biopharmaceutical market in Brazil.  Bionovis is a joint-venture forged by the Brazilian Government and four (4) of the biggest Brazilian pharmaceutical players, i.e., Aché, EMS, Hypermarcas and União Química.

For the purposes of developing the follow-on version of the drug, Bionovis entered into a PDP, i.e., Partnership for Productive Development, with two (2) Brazilian public pharmaceutical and research laboratories, Vital Brazil Institute and Farmanguinhos.  The terms of the PDP are not publicly known, but Bionovis announced it contains technology transfer provisions, as well as plans to invest over US$15mi in clinical trials and development efforts.  Several PDPs are being forged by the Government that aims at creating extremely competitive and efficient Brazilian biopharmaceutical players.

Currently, the reference product to be followed-up by Bionovis is manufactured by Boehringer Ingelheim Pharma KG and is both imported into and commercialized within the Brazilian territory by Wyeth-Whitehall.  The Brazilian Unified System of Health plans to save fifty (50%) of the budget dedicated procurements of the drug in five (5) years, reaching savings of approximately US$ 300 mi.

The Brazilian follow-on biologics-related regulation is fairly recent, i.e., December 2010, and is yet to be stress tested. ANVISA, the Brazilian Regulatory Agency’s Ruling no. 55/10 created a combined, yet unclear pathway for the approval of biosimilar products. While new biologic products are to be presented and assessed from a classical full dossier approach, the so-called biologic products (i.e., ANVISA still refrains from using the international terminology for follow-on biologics) are to observe either one of the two existent systems, the biosimilar, comparative pathway or the individual, standalone pathway.

It is relevant to highlight the opinion of ANVISA on the existence of the presence at RDC 315/10 of the dual regulatory system: “while we have proposed the individual development pathway this should not be the first pathway of choice for a biotherapeutic product.” The new regulatory pathway covering new biologics and biologic products will surely push to an explosive growing of the market figures, as well as the regulatory and legal challenges associated therewith.

On a side note, please be informed that ANVISA announced its intention to issue two (2) new pieces of regulation covering and updating respectively the regulatory pathway of synthetic and semi synthetic active pharmaceutical ingredients and the Good Manufacturing Practices.

Biotech Buzz, February 2013

Webinars Subcommittee

FREE CLE: Reprise of the “Issues in Novel Venture Capital Financing for Biopharmaceutical Development” Panel from the 2012 Annual Meeting, March 26, 12:30 PM-2:00 PM EST

The Biotech Committee in partnership with the Chemical Practice Committee will present a free CLE-qualifying webinar reprising the well-attended (150+ people) and popular program from the 2012 AIPLA Annual Meeting titled “IP Issues in Novel Venture Financing of Biopharmaceutical Development.” The webinar will be held on March 26, 2013 from 12:30 pm to 2:00 pm EST.  The panel consists of Cindy Fuchs and Lili Portilla of the National Institute of Health and Translational Research Resources, Joel Nied of LeClairRyan, Mike Warner of Pfizer, and Greg Sieczkiewicz of Flagship Ventures.  They will discuss issues and opportunities in novel venture capital arrangements that are increasingly being used to fund clinical development of biopharmaceuticals.  Invitations to this program will be sent soon. Keep an eye on your inbox.

FREE: Doctrine of Equivalents, AIPLA Patent Law Committee Teleconference, March 5, 12:00 PM-1:00 PM EST

AIPLA’s Patent Law Committee invites you to a teleconference on recent Federal Circuit decisions on the Doctrine of Equivalents in Deere v. Bush Hog and Sandisk v. Kingston Technology.  The presentations should be no longer than 5 minutes per opinion to optimize opportunity for discussion.  You may use the following dial-in to participate in the teleconference:

Toll-Free call-in:                   1-(877) 219-6790 International call-in:            1-719-867-4954 Participant passcode:          610-993-4222

Case Law Reports Subcommittee

Case Law Report Link

Bowman v. Monsanto Co., et al., Brief for the United States as Amicus Curiae Supporting Affirmance, reported byCathy Kodroff, Howson & Howson, Fort Washington, Pennsylvania.

 

No. 11-796 (U.S. Sup. Crt.) (whether a patentee’s rights are exhausted as to subsequent generations of seeds after patented seeds have been purchased in an authorized sale for planting). 

Biosimilars Subcommittee

State Biosimilars Legislation Gains Foothold

Citing safety and regulatory concerns, legislatures in several states have introduced or planned bills designed to control or prevent substitution of biosimilar products – i.e., products approved under the new abbreviated pathway in 42 U.S.C. §262(k) – for biological products approved under 42 U.S.C. § 262(a).  The Alliance for Safe Biologic Medicines, which includes several biotech industry members and BIO, has also interjected concerns that the substitution of biosimilars will cause confusion in pharmacovigiliance studies.

The state bills propose varying degrees of control over substitution.  Each would prevent pharmacists from substituting a biosimilar for a pioneer biologic unless that FDA has already deemed the biosimilar “interchangeable.”  There appears to be little debate over that requirement. 

Most of the bills, however, further require pharmacists to notify doctors of substitution, acquire written consent from patients, and keep records of substitutions for a number of years in order to track adverse events.  For example, Illinois House Bill 5581 provides in part:

c) A pharmacy may substitute a prescription biosimilar product for a prescribed product only if:

(1) the biosimilar product has been determined by the FDA to be interchangeable with the prescribed product for the specified indicated use;

2) the prescribing physician does not designate in writing on the prescription that substitution is prohibited;

(3) the patient (or patient’s authorized representative) provides written consent for the substitution;

(4) the pharmacist notifies the prescriber in writing within 24 hours after the substitution; and

(5) the pharmacy and the prescribing physician retain a written record of the biosimilar substitution for a period of no less than 5 years.

Pending bills in Indiana and North Dakota appear to be identical to the Illinois bill.

                As another example, Virginia House Bill 1422, which has passed the House, provides in part:

§ 54.1-3408.04. Dispensing of interchangeable biosimilars permitted.

A. A pharmacist may dispense a biosimilar that has been licensed by the U.S. Food and Drug Administration as interchangeable with the prescribed product unless (i) the prescriber indicates such substitute is not authorized by specifying on the prescription “brand medically necessary” or (ii) the patient insists on the dispensing of the prescribed biological product…. No pharmacist shall dispense a biosimilar in place of a prescribed biological product unless the biosimilar has been licensed as interchangeable with the prescribed biological product by the U.S. Food and Drug Administration for the specific use.

B. When a pharmacist dispenses an interchangeable biosimilar in the place of a prescribed biological product, the pharmacist or his designee shall inform the patient prior to dispensing the interchangeable biosimilar and shall provide electronic, written, or telephonic notification of the substitution to the prescriber or his staff within five business days of dispensing the interchangeable biosimilar or as set forth in a collaborative agreement as defined in § 54.1-3300. Such notification shall be documented on the record of dispensing. The pharmacist or his designee shall also indicate, unless otherwise directed by the prescriber, on both the record of dispensing and the prescription label, the brand name or, in the case of an interchangeable biosimilar, the product name and the name of the manufacturer or distributor of the interchangeable biosimilar. Whenever a pharmacist substitutes an interchangeable biosimilar pursuant to a prescription written for a brand-name product, the pharmacist or his designee shall label the drug with the name of the interchangeable biosimilar followed by the words “Substituted for” and the name of the biological product for which the prescription was written. Records of substitutions of interchangeable biosimilars shall be maintained by the pharmacist and the prescriber for a period of not less than two years from the date of dispensing.

Proponents of biosimilars argue that these restrictions place unnecessary impediments on the distribution of otherwise interchangeable and more cost-effective medications. They also argue the these states are taking inconsistent positions by freely allowing substitution of regular small-molecule generics or even requiring substitution by pharmacists unless the physician or patient requests the brand-name.

Depending on particulars of state legislation, there could be conflict with the Biologics Price, Competition and Innovation Act provisions of the federal Patient Protection and Affordable Care Act.  The Act defines “interchangeability” to mean that “a biological product that is shown to meet the standards described in subsection [42 U.S.C. § 262] (k)(4), means that the biological product may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.”  Presumably, no state could enact law stating that a biological product that FDA finds to meet the stringent requirements of interchangeability in 42 U.S.C. § 262(k)(4) may not be substituted for a reference product that a health care provider prescribed.

Earlier this month, legislation proposing substitution restrictions failed to move to a vote in the Mississippi state legislature.  Similar bills remain on the table in several other states–Arizona, Arkansas, Colorado, Florida, Maryland, Massachusetts, Oregon, Pennsylvania, Texas, and Washington.  Thus, the debate over biosimilar substitution will continue as these bills move through state legislatures.

The potential impacts that restrictions on substitutability may have on the attractiveness of developing interchangeable biological products is uncertain at this time.

Submitted by Lynn Tyler and Michael Brunelle, Barnes & Thornburg LLP, Indianapolis, Indiana

Biosimilars Subcommittee: Updated Mission Statement and 2013-2014 Objectives

 

Kristin Connarn

Co-Chair

McDermott, Will & Emery LLP, Boston, Massachusetts US

Vicki Norton

Co-Chair

Duane Morris LLP, San Diego, California US

Lynn Tyler

Co-Chair

Barnes & Thornburg LLP, Indianapolis, Indiana US

 

The Biosimilars Subcommittee held an introductory call on Monday, February 4th at 1:00 PM EST to discuss objectives and plans for 2013.  The mission and objectives published in the January 2013 Biotech Buzz have been updated, as presented below, in view of that discussion.

Mission Statement 

The mission of the Biosimilars Subcommittee will be to monitor patent issues, litigation, and regulations pertinent to the development and commercialization of therapeutic and diagnostic biological products, including biosimilar and interchangeable products.  The Subcommittee will provide Committee leadership and membership with periodic reports, and play a role in advocacy considerations, when pertinent.  The Subcommittee will coordinate with AIPLA’s Food and Drug Committee in monitoring and reporting on regulatory issues relevant to biological products.

2013-2014 Objectives

The Biosimilars Subcommittee has the following objectives for 2013-2014:

  1. Work with AIPLA’s Food and Drug Committee to analyze and advise on Abbott’s citizen’s petition arguing that the BPCIA amounts to an unconstitutional taking, and comments submitted to FDA.
    1. Review the Citizen Petition and Comments submitted
    2. Consider whether to comment on the Citizen’s Petition

Estimated Event Date: First Quarter of 2013

 

  1. Reporting and Advising on FDA Guidances and Draft Guidances for the Regulation of Biosimilar and Interchangeable Products
    1. Report & Analyze Final Biosimilar Guidance(s) When Issued by FDA

1)       Once FDA issues Final Guidance(s) on Biosimilar Products, the Subcommittee will provide a practical document that summarizes the high points of the Guidances, including any changes from the draft Guidances and the FDA’s rationale for those change

    1. Analyze and Advise on FDA Proposed Interchangeable Product Regulations

1)       Once FDA proposes Guidances on the regulation of interchangeable biological products, the Subcommittee will provide a practical document that summarizes the high points of the Guidances, including the implications of the guidances on litigation strategy, in coordination with AIPLA’s Food and Drug Committee. 

2)       Consider whether to make any submissions during the FDA’s comment period.

Estimated Event Date: Soon After Issuance of Guidances or Draft Guidances

 

  1. Monitoring and Advocacy
    1. Analyze and report any possible impact from the Federal Circuit’s split decisions on the scope of the 271(e)(1) safe harbor on manufacturers of biologic drug products (CompareMomenta Pharm., Inc. v. Amphastar Pharm., Inc.. withClassen Immunotherapies, Inc. v. Biogen IDEC) 
    2. Monitor regulations and patent issues pertinent to the development of therapeutic and diagnostic biological products, including biosimilar products.
    3. Monitor litigation relating to the commercialization of biological products, including biosimilar products.
    4. Monitor for legislative proposals by Congress to shorten the biologic product regulatory exclusivity period of 12 years currently set forth in the Biologic Price Competition and Innovation Act (BPCIA).
    5. Monitor the impact of the BPCIA on state legislation.
    6. Coordinate with AIPLA’s Food and Drug Committee.
    7. Provide Committee leadership and membership with periodic reports.
    8. Play a role in advocacy considerations, when pertinent.

Estimated Event Date: Ongoing

 

  1. Outreach
    1. Hold regularly scheduled telephonic meetings to coordinate with Subcommittee members and other interested AIPLA members, and to discuss new developments

 

The Biosimilars Subcommittee would like to invite all interested AIPLA Biotech Committee members to join and participate. 

Estimated Event Date (Recurring): February 4, 2013 (first meeting)

 

Members of the subcommittee volunteered to work on Objectives 1, 2(A) and 3(A):

  • ·         Lynn, Kristin, and Sonsy will review Abbott’s citizen’s petition and consider appropriate vehicle for reporting the results of the review.  Lynn will coordinate with the FDA committee. 
  • ·         Angie and Vicki will analyze and report on any possible impact from the Federal Circuit’s split decisions on the scope of 271(e)(1) safe harbor on manufacturers of biologic drug products.
  • ·         Ronita will take the lead on monitoring when the final FDA Biosimilars guidances come out, and the committee will take action at that point to report and analyze the final documents.

 

FDA’S CDER Announces Biosimilar Guidance Documents Planned for 2013

On January 31, 2013, FDA’s CDER published a list of draft guidance document it plans to publish during calendar year 2013. At least two appear to be relevant to biosimilars, “Submission of Clinical Pharmacology Data as Evidence of Biosimilarity for Biologics and Protein Products” and “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.” So far, there is no word on when the FDA may finalize the three draft guidance documents on biosimilars issued about this time last year or issue draft guidance on interchangeability.

 

Diagnostics and Gene Patenting and Public Education Subcommittees

AIPLA Comments Again to the USPTO About Genetic Diagnostic Testing

On February 8, AIPLA submitted additional written comments to the USPTO regarding genetic diagnostic testing.  AIPLA’s written comments reiterate the comments that AIPLA submitted in March 2012 and the oral testimony that Karen Canady gave on behalf of AIPLA during a Public Roundtable at the USPTO in early January 2013.  AIPLA continues to oppose modifying patent eligibility or enforcement provisions with respect to confirmatory diagnostic testing.  

 

Plant Biotechnology Subcommittee

The “Standard Material Transfer Agreement” and Access to Plant Genetic Resources: To What are you Agreeing? 

1st of a Series on the SMTA from Mark Pidkowich of Smart & Biggar/Fetherstonhaugh, Vancouver, British Columbia, Canada

The Standard Material Transfer Agreement (SMTA) for use in the Multilateral System was drafted with the intentions of: 1) avoiding the imposition of burdens on receiving parties that may hamper access to the plant genetic resources, while 2) sealing gaps that may lead to the ‘leakage’ of material from the Multilateral System and jeopardize benefit sharing.  The tension between these objectives is somewhat difficult to resolve, as demonstrated by various practical problems the document poses for corporate players.

First, if a Recipient conserves any material that it receives pursuant to an SMTA, which it presumably would, Article 6.3 obligates the Recipient to become a “Provider” and make that conserved material available to third parties.  Article 5(a) of the SMTA dictates that the material must also be provided expeditiously in response to a request.  Essentially, utilization of material obtained under an SMTA creates the risk that the Recipient may become a de facto stock centre, with no ability to recoup its costs beyond the minimum involved (see Article 5(a)).  Moreover, the Recipient-cum-Provider is obligated to inform the Governing Body of all transfers made. 

Second, the SMTA also appears to fetter a Recipient’s control over the distribution of products that it develops with the materials it receives.  While no obligation is placed upon the Recipient to make its products incorporating the transferred material available to third parties, any such transfers that it does make must be made under the SMTA.  Accordingly, a Recipient may not itself be obligated to make its products under development available, but downstream recipients of those products would be so obligated.  This should pose a particular concern for multinational organizations accustomed to transferring material between affiliates, especially given that the Ad Hoc Advisory Technical Committee on the SMTA and the Multilateral System has recently opined that any transfer between different legal persons must be made with the SMTA.  Unless all aspects of an organization’s business are performed by a single legal entity, there seems little room for a company to avoid a transaction which triggers the obligation to transfer a product under development to third parties upon request.

Finally, while the SMTA imposes a number of anticipated and unanticipated obligations on the Recipient, it provides no mechanism to offload liability for breaches of the SMTA by subsequent recipients. Moreover, the Ad Hoc Advisory Technical Committee has indicated that the Provider should exercise some degree of due diligence when evaluating whether or not a transfer should be made in the first place.  Should a Recipient find itself obligated to serve as a stock centre as suggested above, it may also be in the unfortunate position of accepting liability for any leakage of material from the Multilateral System by an indefinite number of downstream recipients, or use of the transferred material for non-food or non-feed purposes.   The due diligence required to ensure that the material does not move to third parties without an SMTA, or that material is not used for unauthorized purposes, would create an immense burden for the Provider.

Accordingly, for-profit organizations comprising multiple legal entities would be wise to develop a strategy for the development and transfer of resources in advance of accepting any material pursuant to an SMTA.  The obligations flowing from the use of the SMTA may ultimately limit the participation in the Multilateral System.  Alternatively, recipients may choose to destroy received material after evaluating it, rather than maintaining it and invoking the obligation to provide it to third parties.  Regrettably, neither option seems to serve the larger goals of the treaty in terms of conservation of and access to plant genetic resources.

 

International Issues Subcommittee

Patentability of Plant Biotechnology Inventions in Argentina

Contributed by Cristian Bittel and Iván Alfredo Poli, Marval O’Farrell & Mairal, Buenos Aires, AR

Argentina is one of the world’s major agricultural producers, ranking third worldwide in production of soybeans and sunflower seeds and fifth in the production of maize. Argentina set forth a regulatory frame for genetically modified organisms (GMOs) in 1991, and 99% of the soybean cultivated at present are genetically modified.  Naturally, this has increased interest in protecting biotechnological inventions. What follows are the salient points of the legal situation for biotechnological inventions in Argentina.

a.             General principles

Like most jurisdictions, the general rule in Argentina is that all inventions are patentable, provided they are new, non-obvious, industrially applicable and lawful, and have been appropriately disclosed and claimed. The basic tenet provided by Article 17 of the Argentine Constitution is that “Every author or inventor is the exclusive owner of his work, invention or discovery for the term granted by law”. 

The specific rules on the patentability of biotechnology inventions are spread among various provisions of the Patent Law and its regulatory decree. The more relevant regulations are:

(a)           Section 6.g of the Patent Law (“For the purposes of this Law, the following items shall not be considered as inventions: […]  g) Any kind of living matter or substance already existing in nature”);

(b)           Section 6 of Regulatory Decree No. 260/96 (“Plants, animals, and essentially biological process for their reproduction shall not be considered to be patentable subject matter”);

(c)            Section 20 of the Patent Law and its regulating decree which set forth formal requirements of inventions involving microorganisms,

(d)           Section 7.b of the Patent Law (“The following are not patentable: […] b) The totality of biological and genetic material existing in nature or their replica in the biological processes implicit in animal, plant, and human reproduction, including genetic processes involving material capable of self-duplication in normal and free conditions, as occurs in nature”);

(e)           Article 27.3 of the TRIPS Agreement.

 

 

b.            Patentability of plants

Under the Guidelines of the Argentine Patent and Trademark Office (PTO), “product claims covering plants […] shall not be allowed, even when they are produced through a microbiological process”.  The basis for this position is the above-mentioned section 6 of the Regulatory Decree.

Legal commentators in Argentina have argued that the PTO’s view is unconstitutional as Section 6 of the Argentine Patent Law, to which section 6 of the Regulatory Decree is subordinate, only bars the patentability of plants existing in nature, but not all plants (such as GMOs).  Despite the questionable constitutionality of the PTO’s position, the limitations it places on claims directed to plants, and the importance of Argentina as an agricultural producer and exporter, no case law yet exists on this issue.  Accordingly, the time may be ripe for challenge in the courts.

c.             Patentability of proteins, genes and/or DNA sequences

Section 7 of the Patent Law provides that the “totality of biological and genetic material existing in nature or their replica” is not patentable, but then goes on to clarify “in the biological processes implicit in animal, plant, and human reproduction”.  Importantly, genetic material not used in processes implicit in animal, plant and human is not within the prohibition.

Consequently, protein and DNA sequences are protectable under the Argentine Patent Law, provided they comply with the patentability requirements (novelty, inventive step, industrial applicability).  The Argentine PTO considers that purification and/or isolation does not provide novelty to proteins or DNA sequences, and therefore only genetically modified DNA sequences or mutant proteins are patentable.

Although plants may not be patentable per se according to the Argentine PTO, a plant comprising a patented DNA sequence can be considered as infringing claims to the patented sequence.  Consequently, protection for a DNA sequence or a polypeptide may prove to be useful to obtain some protection on plants carrying them.

d.            Methods for obtaining plants

Section 7 clearly excludes only the biological and genetic material in the essentially biological processes. Thus, processes in which human intervention has a significant role in determining or controlling the desired result (such as genetic engineering) are acceptable. On the other hand, claims directed to classical cross and selection methods are not acceptable as they are considered to be essentially biological.

Usually, steps such as “growing a plant” are objected to as being essentially biological.  Including transformation steps or reference to molecular markers generally improves the chances of acceptance as this differentiates the method from an essentially biological method.

Biotech Buzz, December 2012

Programs

Two Programs and a “Table Topic” Discussion at Mid-Winter Institute, Tampa, FL, January 31, 2013

Join us in Tampa Florida on the afternoon of January 31, 2013 for three hours of CLE that the Biotechnology and Chemical Practice Committees have jointly planned.

IP Value for Personalized Medicine

Health agencies, payers, patients, and biopharma companies are on the bandwagon for personalized medicine. In-house lawyers from a spectrum of entities involved in personalized medicine will provide views about the role and the value of IP for new products and services, with focus on tech transfer and licensing. They will also touch on the effects of recent cases. How do they affect deals? Can personalized medicine correlations be validly claimed? To what extent might research exemptions limit patent rights? Have divided infringement concerns been alleviated? When could inherency be an insurmountable hurdle? How to avoid European patent exceptions. Business people and in-house lawyers from a very diverse spectrum of entities involved in personalized medicine and diagnostics will provide views about the value of IP for the development of new products and services. 

Judy A. Roesler of Roesler Law Offices, PLLC in Cary, NC will moderate a panel featuring Manny Vacchiano, Lead Patent Counsel, Life Technologies; Yuko Soneoka, Senior Corporate Counsel IP, Genome Health, Inc.; Robert L. Sharp, Patent Counsel, Eli Lilly and Company; Natalie Wright Curley, Managing Director of the Office of Technology Commercialization, MD Anderson Cancer Center; and Jarett Rieger, Director and Associate General Counsel of the Office of Technology Mgmt & Commercialization, Moffitt Cancer Center and Research Institute.  Please join us for a lively and informative discussion with in-house counsel across a broad spectrum of players in personalized medicine.

Aligning IP Strategies with Business Objectives Up and Down the Supply Chain

How does a company’s position in a supply chain affect IP strategies? How do companies that are suppliers and customers adjust their approaches to IP acquisition and licensing in light of business relationships? How do companies use IP to obtain value in the marketplace even when their businesses are not high tech? Business people and in-house lawyers along a supply chain will provide views about the value of IP for their businesses. How does a company’s position in a supply chain affect IP strategies?  How do companies that are suppliers and customers adjust their approaches to IP acquisition and licensing in light of business relationships?  How do companies use IP to obtain value in the marketplace even when their businesses might not be thought of as innovative? 

Business people and in-house lawyers along a supply chain will provide views about the value of IP for their businesses.  Carol Nielsen of Nielsen IP Law LLC in Houston will moderate a panel consisting of Richard Phillips, Chief Attorney Technology, ExxonMobil Chemical; Patrick Bengtsson, VP, Assoc. GC, IP, The Clorox Company; Valerie L. Calloway, Chief IP Counsel, Polymer Group, Inc.; and Nancy M. Klembus, Assistant General Counsel, Kimberly-Clark, Corp

“Table Topic” Leaders Needed for MWI Lunch Discussions, Thursday, January 31

If you are planning to attend the MWI in Tampa on Thursday, January 31 please join the table talk lead team to lead table discussions following the luncheon keynote address by Ford’s Bill Coughlin.  Thanks to the members who have already volunteered: Dave Cupar, Robin Chadwick, Brian Stanton, Timothy Meigs, Greg Lavorgna, Katherine Dover, Debora Plehn-Dujowich, Daniel Monaco, Roy Isaac, Dianne Elderkin, Valerie Calloway, and Brooke Schumm.

We could use a few more leaders.  Let Debora Plehn-Dujowich of Drinker Biddle know of your interest.

Webinars

Patentability of Diagnostic Methods and Biomarkers: A European Perspective – Slides and Recording Available

On December 18th, the Biotech Committee presented a dynamic and highly informative webinar titled “Patentability of Diagnostic Methods and Biomarkers: A European Perspective.”  The panelists were Oliver Kingsbury from Elkington and Fife, Russell Thom from Murgitroyd & Company, and Ana Suarez-Miles from Eli Lilly.  Debora Plehn-Dujowich moderated. 

 

Slides and a recording of the webinar are available. 

 

We thank Elkington and Fife and Murgitroyd & Company for sponsoring the webinar.

Reprise of Annual Meeting Presentations, TBD

The speakers at our Annual Meeting, discussed above, will reprise their presentations in a webinar on a date yet to be determined.  The presentations relate to antibody patenting in the US and Europe and novel venture financing for biotechs. 

Case Law Reports

Case Law Report Link

ButamaxTM Advanced Biofuels LLC, et al. v. E.I. Dupont de Nemours & Co., reported by Julia Kim.

Case No. 2012–1490 (Fed. Cir. Nov. 16, 2012) (affirming denial of preliminary injunction for patent related to biofuels because defendant raised a substantial question of validity). 

Petition to the Secretary of Health and Human Services to “March In” Against the Ritonavir Patents, reported by Nicholas Landau, Ph.D., Bradley Arant Boult Cummings, Birmingham, AL.

(Oct. 25, 2012) (PIRG petition the U.S. government to exercise its “march in” rights and force Abbott to grant a compulsory license to AIDS drug). 

PerkinElmer, Inc. v. Intema, Ltd., reported by Lynn C. Tyler and Michael R. Brunelle, Barnes & Thornburg LLP, Indianapolis, IN.

Case No. 2011-1577 (Fed. Cir. Nov. 20, 2012) (holding claims to method of diagnosing Down’s syndrome invalid under 35 U.S.C. §101 as not being directed to patentable subject matter). 

International Issues

Oh Canada! – So Promising, So Invalid

Reported by Daphne C. Lainson, Smart & Biggar, Ottawa, Ontario, Canada

There has been some continuing litigation following the Canadian Supreme Court’s finding that the sildenafil (the active ingredient in VIAGRA®) second medical use patent was void for insufficiency of disclosure (lack of utility).  A complete summary of the Canadian Supreme Court’s opinion was published in the November 2012 Biotech Buzz

Utility continues to be a common and unusual ground of invalidation of patents that cover marketed pharmaceutical products.  Eli Lilly and Company’s method of use patent covering its STRATTERA® product was invalidated on the basis of failing to meet Canada’s unique, judge-made utility requirements.  On November 7, 2012, Eli Lilly and Company served the government of Canada notice of intent to submit a claim to arbitration under Chapter 11 of the North American Free Trade Agreement in relation to the invalidation.  Lilly’s notice and the presentations and papers from a Comparative Law Symposium held in Ottawa, ON, CA on 4 April, 2012 are worth reading if you draft or prosecute applications with hopes to obtain valid protection in Canada.

CJEU Rules Against AstraZeneca in Abuse of Dominant Position Appeal (SPCs and Anti-Competition Law)

Reported by René John Raggers, EP&C, Utrecht, The Netherlands

On 6 December 2012, the Court of Justice of the European Union dismissed an appeal by AstraZeneca (AZ) against the General Court, which held that AZ had abused its dominant position with respect to its anti-ulcer drug, Losec. 

Regarding abuse of a dominant position concerning supplementary protection certificates (SPCs), the Court concludes that the General Court was fully entitled to hold that AZ’s consistent and linear conduct was a breach of competition on the merits and therefore an abuse of a dominant position.  Specifically, the General Court found that AZ’s conduct was characterized by submitting misleading representations to the patent offices and a lack of transparency by which AZ deliberately attempted to lead the patent offices and judicial authorities into error in order to keep its monopoly on the medicinal products market for as long as possible.

The judgment and the court’s press release provide additional insights into the dismissal.

Brüstle v. Greenpeace, German Federal Supreme Court, 27 November 2012, Case no. X ZR 58/07 (Neural Precursor Cell Patent Partially Invalidated).

Reported by Paul von Dongen, NautaDutilh N.V., Amsterdam, The Netherlands

On November 27, 2012, the German Federal Supreme Court (Bundesgerichtshof) ruled on the validity of the patent of Oliver Brüstle, relating to neural precursor cells and the procedure to cultivate these cells and use them in therapy of neural defects.  This invention could potentially play an important role in the treatment of diseases like Parkinson’s Disease and Multiple Sclerosis.

The European Patent Office granted the patent in 1999.  Greenpeace filed an action for annulment, arguing that the patent would violate public policy and accepted principles of morality because it relates to cells which could only be obtained by the destruction of human embryos.  The Federal Patent Court invalidated the patent for this reason.  The case went up to the Supreme Court which referred several questions to the Court of Justice of the European Union (“CJEU”).  In its decision of October 18, 2011 (Case C-34/10, Brüstle v. Greenpeace) the CJEU clarified that the prohibition to patent in case of the use of human embryos also applies if the patent relates to products for which the destruction of human embryos is necessary, even when the patent does not relates to the use of human embryos as such.

In this decision, the German Supreme Court follows the reasoning of the CJEU.  However, contrary to the Patent Court, the Supreme Court does not completely invalidate the patent.  The Supreme Court rules that the patent is valid to the extent the cells are produced without the destruction of human embryos.

The full reasoning of the Supreme Court is not yet published. See a press release regarding the judgment (in German).

Plant Biotechnology Subcommittee

Standard Material Transfer Agreement is the Gateway to the Multilateral System Under the International Treaty on Plant Genetic Resources for Food and Agriculture

The Plant Biotechnology Subcommittee was established this past July with a mission to foster awareness of key intellectual property issues that influence innovative plant research.  One institution already shaping the generation and dissemination of knowledge in the field of plant research is the Multilateral System (MLS) implemented under the International Treaty on Plant Genetic Resources for Food and Agriculture (IT PGRFA).  Under the MLS, member states agree to make the genetic diversity of the germplasm stored in their seed banks available to all in exchange for free access to commercialized products for further breeding and research (or royalty payments in lieu of free access).

The Standard Material Transfer Agreement (STMA) stands as the gateway to the MLS.  The SMTA is, in all important aspects, a non-negotiable instrument that must be executed by any party wishing to provide or receive seed under the MLS.  Under the SMTA, a recipient agrees to limit its use of transferred material to research, breeding, and training for food and agriculture, excluding any non-food or non-feed industrial purposes.  The SMTA also prohibits a recipient from seeking any intellectual property rights that may limit further access to the materials as received via the MLS.  Where the recipient conserves material received under the SMTA, it is further obligated to make such conserved material further available under another SMTA.  The SMTA further obligates the recipient to share all “non-confidential” information related to research and development using the transferred material.

The MLS and SMTA have been lauded as the first practical implementation of the fair sharing of benefits arising from the use of plant genetic resources.  However, benefit sharing under the SMTA is only triggered when a recipient commercializes a product derived from the transferred material.  Given its significance to the potential creation of any benefit that could be shared under the MLS, there remains a  surprising lack of commentary on what the SMTA means for those parties most likely to commercialize products, i.e. innovative plant biotechnology companies. 

Interestingly, of the more than 3500 shipments under the SMTA that have been disclosed by the International Rice Research Institute in the Philippines, only a handful of transfers have involved corporate recipients.  Does such anecdotal evidence illustrate a general mistrust of the SMTA on the part of corporate innovators and a corresponding reluctance to buy in to the MLS?  In a series of articles over the coming months, the Subcommittee shall seek to educate the membership on the SMTA and explore the issues that are most likely to present stumbling blocks to the wide embrace of the MLS by corporate innovators.  The Subcommittee further welcomes any contributions or comments from the membership in regards to issues they would like to see addressed.

USPTO Subcommittee

Combined TC3700 Medical Devices and TC1600 BioTech Customer Partnership Meeting, January 29, 2013 – NOTE WEBEX OPTION!

The upcoming USPTO Partnership Meeting in the Madison Auditorium in Alexandria, VA on January 29, 2013 will focus on the medical device industry, including diagnostics.  The purpose of the meeting is to bring industry stakeholders and patent examiners and directors from Technology Center 3700 (TC 3700) together to share ideas, experiences, and insights on best practices in advancing prosecution and provide a forum for discussing how the agency can improve and expand its relationship with the medical device technology community. 

Note: For the first time, you can participate via WEBEX.  More information and a link to registration (with WebEx option) can be found here.

8:30-9:00

Sign-in

9:00-9:30

Introductions

9:30-10:30

CPC

10:30-10:45

Break

10:45-11:45

Section 101 Issues

11:45-1:00

Lunch Break

1:00-2:00

AIA Update

2:00-2:15

Break

2:15-3:45

Round table discussions

 

If you would like to present a topic or would like to suggest a topic for future meetings contact the customer partnership team.

Happy Hour, January 29, 2013

Join Biotech members for a Happy Hour at the Trademark Bar in the Westin Alexandria, 2080 Jamieson Ave., 400 Courthouse Square, Alexandria, VA 22314 (just a couple blocks west of the USPTO) after the BCP Partnership meeting.