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
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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)