By Donald Zuhn --
Last week, a panel of biopharma attorneys participated in a breakout session at the BIO International Convention to discuss the impact of the Supreme Court's decision in KSR Int'l Co. v. Teleflex Inc. on biopharma patent prosecution and litigation. Participating in the panel, entitled "Biopharma IP Strategies in the Post-KSR World," were Eric Marandett, a Partner at Choate, Hall & Stewart LLP; Kerry Flynn, Vice President, Intellectual Property and Licensing for Shire Human Genetic Therapies, Inc.; Dr. Christine Bellon, Senior Patent Counsel and Director of Intellectual Property for Infinity Pharmaceuticals, Inc.; and Dr. Hans Sauer, the Associate General Counsel of the Biotechnology Industry Organization.
Dr. Bellon began the discussion by reviewing six pharma obviousness decisions issued in the past fifteen months:
1. Pfizer, Inc. v. Apotex, Inc. (Fed. Cir. 2007)
2. Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd. (Fed. Cir. 2007)
3. Forest Labs., Inc. v. Ivax Pharm., Inc. (Fed. Cir. 2007)
4. Aventis Pharma Deutschland GmbH v. Lupin, Ltd. (Fed. Cir. 2007)
5. Ortho-McNeil Pharma., Inc. v. Mylan Labs., Inc. (Fed. Cir. 2008)
6. Altana Pharma AG v. Teva Pharma. USA, Inc. (D. N.J. 2007)
As we reported in March, the first four cases are being used (along with seven other obviousness cases) in Group 1600 to teach examiners how to examine applications for obviousness (see "USPTO's Bruce Kisliuk Addresses ACI Conference"). Patent Docs has provided summaries of all but the Altana Pharma case (a summary of that case will be provided in the coming week).
Contrasting the Pfizer and Forest Labs. decisions, Mr. Marandett observed that while 53 anions were found to be a finite number of solutions in the pre-KSR Pfizer case, two enantiomers did not constitute a "finite number of identified, predictable solutions" in Forest Labs. He also contended that Ortho-McNeil Pharma. was an interesting case because the Federal Circuit determined that the use of a flexible TSM test comports with KSR. According to Mr. Marandett, the Federal Circuit likely recognizes that the Supreme Court will be reluctant to take another obviousness case, and therefore in Ortho-McNeil Pharma., the CAFC has begun to test the boundaries of KSR. Finally, Mr. Marandett contended that the cases above show that each of the Graham secondary considerations is merely the "tail that wags the dog," since these considerations seem to be applied only when they produce the result desired by the court.
Dr. Sauer next turned the discussion to two biotech obviousness decisions: Pharmastem Therapeutics, Inc. v. Viacell, Inc. (Fed. Cir. 2007) and Ex parte Kubin (B.P.A.I. 2007), each of which has been previously discussed by Patent Docs. According to Dr. Sauer, Pharmastem Therapeutics constituted a "plain vanilla" obviousness case (i.e., a combination invention case) that could be decided just as "harshly" as KSR. In Kubin, however, the question is whether the classical rules of chemical obviousness law (i.e., whether there is structural similarity between new and old compounds; whether there is some teaching that would have led the skilled artisan to look to the new compound) still apply, or whether the Federal Circuit will determine that KSR mandates that the availability of a routine method renders a new compound obvious. While these classical chemical rules were applied in In re Deuel, Dr. Sauer acknowledges that in the intervening years between Deuel and Kubin, "we've had the KSR case and technology has advanced." Nevertheless, Dr. Sauer seemed to be leaning towards a reversal in Kubin (which is perhaps not surprising, given that BIO submitted an amicus brief in support of Amgen; see "Briefs for In re Kubin filed by Amgen and BIO").
Ms. Flynn concluded the panel discussion by presenting some interesting statistics on obviousness cases. With respect to obviousness decisions rendered in the past eight years, Ms. Flynn noted that a University of Houston Law Center study (www.patstats.org) had produced the following results:
With respect to recent biopharma obviousness cases, Ms. Flynn stated that 30 decisions have been issued since KSR (16 pharma cases and 14 biotech cases). In those cases, the patentee prevailed 60.9% of the time and the accused infringer prevailed 39.1% of the time. Thus, the outlook for biopharma patentees may not be as bleak as it would first appear to be.
For additional information on this and other related topics, please see:
• "Docs at BIO: "Gotcha" Games Continue at USPTO," June 25, 2008
• "Docs at BIO: Panel Discusses Impact of USPTO Rules Changes and Patent Reform Legislation on Biotech Patenting," June 23, 2008
• "Docs at BIO: Representatives from JPO, EPO, SIPO, and USPTO Discuss Recent Developments in Japan, Europe, China, and the U.S.," June 22, 2008
• "Docs at BIO: Steve Burrill's State of the Biotechnology Industry Report 2008," June 19, 2008
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