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.

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