Docs at BIO: Panel Addresses Narrowing Scope of Biotech Patents

    By Donald Zuhn --

In a Breakout Session entitled "The Narrowing Scope of Biotech Patent Claims: What Does It Mean for the Industry?" at last week's BIO International Convention, a panel consisting of Anne Dollard, the Deputy General Counsel and Chief Patent Counsel for Takeda San Francisco; Thomas Kim, Senior Director of Intellectual Property for VGX Pharmaceuticals, Inc.; Jane Gunnison of Ropes & Gray LLP; John Tessensohn of Shusaku Yamamoto Patent Law Offices; and Dr. Hans-Rainer Jaenichen of Vossius & Partner, discussed how practices in the United States, Europe, and Japan have led to a narrowing of biotech patent claim scope.  The panel was moderated by James Haley of Ropes & Gray LLP and Len Smith, Senior Intellectual Property Counsel for Novo Nordisk, Inc.

Ms. Dollard began the presentation by discussing how the statutory subject matter requirement of 35 U.S.C. § 101 has recently moved to the forefront of biotech patenting.  She reviewed the impact of Laboratory Corp. v. Metabolite Laboratories, Inc. (LabCorp), In re Bilski, Classen Immunotherapies, Inc. v. Biogen Idec, and the pending appeal in Prometheus v. Mayo on medical diagnostic claims, and then provided a review of Association for Molecular Pathology v. U.S. Patent and Trademark Office, a recently-filed case concerning gene patents assigned to Myriad Genetics.  Speaking of the ACLU case, Ms. Dollard stated that the clear intent of the plaintiffs was "to take down patents on human genes."  As for Bilski, Ms. Dollard compared the case with KSR International Co. v. Teleflex Inc., "where we thought the world was going to end," and stated that the impact of Bilski could ultimately be less significant than first thought.

Mr. Kim followed with a discussion of recent obviousness caselaw.  After reviewing KSR International Co. v. Teleflex Inc. and Takeda Chemical Industries, Ltd. v. Alphapharm Pty., Ltd., Mr. Kim addressed two recent obviousness Federal Circuit decisions:  Procter & Gamble Co. v. Teva Pharmaceuticals USA, Inc. and In re Kubin.  With respect to the future of biotech claims in a post-KSR world, he cautioned that trouble may lie ahead since biotechnology was becoming more predictable.  Mr. Kim also noted that while applicants might be able to point to secondary considerations of nonobviousness, such considerations would be unlikely to trump a strong case of obviousness.

Using antibodies as a paradigm, Ms. Gunnison next addressed the issue of written description.  She first reviewed Examples 13 and 14 of the Written Description Training Materials issued by the Patent Office just over a year ago, and then turned to a recent Board decision (Ex parte Xia), where the Board determined that a description of an epitope was not required for compliance with the written description requirement.  Ms. Gunnison then discussed Chiron Corp. v. Genentech, Inc., where the Federal Circuit determined that an antibody format that did not exist at the time of filing could not be adequately described.  She concluded her presentation by observing that changes in the written description standard have been costly for applicants.  Touching on a theme raised earlier by Mr. Kim, Ms. Gunnison responded to a question by stating that we could be reaching a point where monoclonal antibodies to known sequences would be considered obvious, but that this would depend on whether antibodies were viewed as chemical compounds (requiring application of structural nonobviousness caselaw) or whether Kubin would prevail. 

The last two panelists, Mr. Tessensohn and Dr. Jaenichen provided informative presentations regarding the state of biotech practice in Japan and Europe, respectively.  Mr. Tessensohn began his presentation by focusing on recent acquisitions by Japanese biotech companies, noting that these companies were facing the same issues (i.e., "anemic pipelines and expiring patents") that many U.S. biotech companies are currently facing.  Turning to patent practice in Japan, Mr. Tessensohn argued that the environment was not "hostile," but acknowledged that patentability standards were evolving and becoming more narrow in Japan (he noted that he was "not here to be a JPO apologist, but you have to know what you're dealing with").  With respect to written description and enablement, he stated that the Japan Patent Office (JPO) required disclosure of pharmacological test results in the application, adding that if such results were submitted after filing that was "too bad."  As for those who would suggest that the JPO was applying a heavier hand with regard to non-Japanese applicants, Mr. Tessensohn humorously contended that there was "no grand conspiracy theory" at work, and that the tough standards in Japan were affecting U.S. companies (e.g., Pfizer) and Japanese companies (e.g., Astellas) alike.  And his solution for dealing with these tough standards was simple:  "crank out as much disclosure as possible."  He added that applicants could not go wrong by following his "ABCD" rule when drafting applications, and remember to provide data that is All-inclusive, Broad, Comprehensive, and Detailed.  Mr. Tessensohn observed that it was best to avoid inferences and prophetic examples in favor of lots of data and working examples.  On the issue of obviousness, he noted that many Japanese IP High Court decisions have been decided on an "obvious to try" standard, which is alive and well in Japan, but that the "silver bullet" for dealing with obviousness rejections in Japan was to show unexpected results (which can be submitted after filing in Japan).

The session's last panelist, Dr. Jaenichen, began by discussing a few favorable differences between European and U.S. patent practice.  For example, he noted that in Europe, claims to hybridization variants are readily obtainable, provided that the claims include a functional limitation.  He stated that the same is also true for claims reciting percent identity, adding that a functional limitation is not required for claims to allelic variants.  Dr. Jaenichen also contended that the sequencing of the human genome did not mean that human genomics claims were all but dead, as there would be continue to be avenues open for genomics claiming (e.g., splice variants).  With respect to the European Patent Office's recent decision to crack down on "abuses" related to divisional filings, Dr. Jaenichen argued that only 0.35% of all applications were considered to be abuses of the system, and thus concluded that the EPO's new rules regarding divisional practice were simply a money-making device.

Comments

[Keep It Real]

"As for Bilski, Ms. Dollard compared the case with KSR International Co. v. Teleflex Inc., "where we thought the world was going to end," and stated that the impact of Bilski could ultimately be less significant than first thought."

Who is "we"?

[Saddlepack Maker]

Ex parte Xia?!?

[Saddlepack Maker]

Ex parte HAIYING XIA and ZHIDA HUANG
__________
Appeal 2008-3329
Application 10/242,092
__________
Decided: January 28, 2009

http://des.uspto.gov/Foia/ReterivePdf?system=BPAI&flNm=fd20083329-01-28-2009-1