What About Know-How: Heightened Obviousness and Lowered Disclosure is Not a Panacea to the American Patent System for Biotechnology Medication and Pharmaceutical Inventions in the Post-KSR Era

Marquette Intellectual Property Law Review, Dec 2010

In KSR International Co. v. Teleflex, Inc., the Supreme Court rejected the Federal Circuit's rigid application of the teaching, suggestion, or motivation test (TSM test), and replaced it with an expansive and flexible approach, in determining the question of obviousness. Nevertheless, an expansive and flexible approach to obviousness may not be consistent with the international norms of practice if it is applied literally. The U.S. Patent and Trademark Office's literal application of the decision has essentially created another set of inflexible rules, which is contrary to the Supreme Court's intent. The Federal Circuit's recent decision in In re Kubin cautiously revived obvious to try in its obviousness jurisprudence. However, In re Kubin may not represent a clear precedent for determining obviousness in the biotechnological context. Certain key technological factual issues were unclear when the court was making its judgment. Commentators have suggested that a fairly high obviousness threshold coupled with a fairly low disclosure requirement will produce a few very powerful patents in uncertain industries. Nevertheless, lowering the disclosure requirement in the biotechnological context would provide inventors incentives to retain more know-how and thus frustrate the purposes of the existing statutory exemptions, namely the medical practice exemption under 35 U.S.C. § 287(c) and the so called FDA exemption under 35 U.S.C. § 271(e)(1). Therefore, this Article suggests that the high disclosure requirement for biotechnological patent applications should not be sacrificed as a tradeoff for a heightened obviousness standard.

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What About Know-How: Heightened Obviousness and Lowered Disclosure is Not a Panacea to the American Patent System for Biotechnology Medication and Pharmaceutical Inventions in the Post-KSR Era

W hat About Know-How: Heightened Obviousness and Lowered Disclosure is Not a Panacea to the American Patent System for Biotechnolog y Medication and Pharmaceutical Inventions in the Post-K SR Era Yi-Chen Su Milner Law Office 0 The author is the managing partner of the Asian office for Milner Law Office, PLLC, New York. 2009 LL.M. in Intellectual Property Law, George Washington University Law School; J.D., City University of New York School of Law; M.S. in Genetics, National Yang Ming University; DVM, National Chung Hsing University. The Article was developed from the author's LL.M. thesis in spring 2009. The author appreciates the invaluable comments from Professor Martin J. Adelman and Professor Joseph Straus. The author can be reached at , USA Follow this and additional works at: http://scholarship.law.marquette.edu/iplr Part of the Intellectual Property Commons - Article 9 322 MARQUETTE INTELLECTUAL PROPERTY LAW REVIEW [Vol. 14:2 In KSR International Co. v. Teleflex, Inc., the Supreme Court rejected the Federal Circuit’s rigid application of the “teaching, suggestion, or motivation” test (TSM test), and replaced it with an “expansive and flexible” approach, in determining the question of obviousness. Nevertheless, an expansive and flexible approach to obviousness may not be consistent with the international norms of practice if it is applied literally. The U.S. Patent and Trademark Office’s literal application of the KSR decision has essentially created another set of inflexible rules, which is contrary to the Supreme Court’s intent. The Federal Circuit’s recent decision in In re Kubin cautiously revived “obvious to try” in its obviousness jurisprudence. However, In re Kubin may not represent a clear precedent for determining obviousness in the biotechnological context. Certain key technological factual issues were unclear when the court was making its judgment. Commentators have suggested that “a fairly high obviousness threshold coupled with a fairly low disclosure requirement will produce a few very powerful patents in uncertain industries.” Nevertheless, lowering the disclosure requirement in the biotechnological context would provide inventors incentives to retain more know-how and thus frustrate the purposes of the existing statutory exemptions, namely the “medical practice exemption” under 35 U.S.C. § 287(c) and the so called “FDA exemption” under 35 U.S.C. § 271(e)(1). Therefore, this Article suggests that the high disclosure requirement for biotechnological patent applications should not be sacrificed as a tradeoff for a heightened obviousness standard. I. INTRODUCTION Since the United States Supreme Court issued its opinion in KSR International Co. v. Teleflex, Inc. in 2007,1 the decision has created legal uncertainty concerning obviousness from at least three perspectives. First, the application of the obviousness doctrine between the Federal Circuit Court of Appeals and the U.S. Patent and Trademark Office 1. KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 ( 2007 ). (PTO) are inconsistent. Second, the PTO’s practice regarding the standard of obviousness before and after KSR lacks consistency. Third, the obviousness standard in a re-examination proceeding after KSR for a patent issued before that decision is uncertain. Though the KSR court revered Graham v. John Deere Co.2 as the highest principle in making obviousness determinations, the KSR decision has essentially created the same problem that the Graham court sought to resolve—that is, the inconsistency among the courts and the Patent Office. In KSR, the Supreme Court rejected the Federal Circuit’s rigid application of “teaching, suggestion, or motivation” test (TSM test), and replaced it with an “expansive and flexible” approach, in determining the question of obviousness.3 Before KSR, the Federal Circuit had developed a more rigid approach, the TSM test. In rejecting the rigid application of the TSM test, the Supreme Court replaced it with an expansive and flexible approach by stating that, “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”4 Nevertheless, an expansive and flexible approach to obviousness may not be consistent with the international norms of practice if it is applied literally. Moreover, even if an expansive and flexible approach to obviousness is favorable and can be justified, the PTO’s literal application of the KSR decision has essentially created another set of inflexible rules for the determination of obviousness, which is contrary to the Supreme Court’s intent. The Federal Circuit’s recent decision in In re Kubin cautiously revived “obvious to try” in its obviousness jurisprudence.5 The decision has narrowed the gaps between the court and the PTO after KSR to some extent. However, In re Kubin may not represent a clear precedent for determining obviousness in the biotechnological context because certain key te (...truncated)


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Yi-Chen Su. What About Know-How: Heightened Obviousness and Lowered Disclosure is Not a Panacea to the American Patent System for Biotechnology Medication and Pharmaceutical Inventions in the Post-KSR Era, Marquette Intellectual Property Law Review, 2010, Volume 14, Issue 2,