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.

• Author: Su, Yi-Chen

ABSTRACT I. INTRODUCTION II. HISTORICAL BACKGROUND OF OBVIOUSNESS III. THE NATURE OF BIOTECHNOLOGY MEDICATION AND PHARMACEUTICALS IV. OBVIOUSNESS IN OTHER PATENT SYSTEMS A. The Practice of the European Patent Office B. Obviousness in Germany C. Obviousness in the United Kingdom D. Obviousness in Canada E. Obviousness in China F. Obviousness in Japan V. OBVIOUSNESS IN THE AMERICAN PATENT SYSTEM A. TSM Test B. KSR International Co. v. Teleflex, Inc C. Federal Circuit's Interpretation and Application of KSR D. U.S. PTO's Response to KSR E. In re Kubin VI. CONCLUSION 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 (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 technological factual issues were unclear and unanswered when the court was making its judgment. (6)

Commentators have suggested that a judge-made industry-specific standard of patentability tailored for each industry in which certain common characteristics can be found is preferable. Commentators also suggested that "a fairly high obviousness threshold coupled with a fairly low disclosure requirement will produce a few very powerful patents in uncertain industries." (7) 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. [section] 287(c) (8) and the so called "FDA exemption" under 35 U.S.C. [section] 271(e)(1). (9)

This Article starts with the introduction of the historical background of obviousness as a requirement of patentability in various countries in Part II. Part III further examines why biotechnology invention is especially vulnerable to the challenge on the ground of obviousness. Part IV examines how the European Patent Office ("EPO") and other major patent systems, such as Germany, the United Kingdom, Canada, Japan, and China have approached the issue of obviousness, especially in the biotechnological and pharmaceutical contexts.

Then the focus of this Article turns to the American patent system. Part V begins with the examination of the application of the Federal Circuit's TSM test in biotechnological and pharmaceutical contexts before KSR, followed by the Supreme Court's KSR test, and the Federal Circuit's interpretation and application of obviousness test in the pharmaceutical context after KSR. In addition, this Part examines and compares the obviousness tests and their application in biotechnology cases in the PTO's practice before and after KSR. A discussion of the Federal Circuit's decision in In re Kubin follows, which may be deemed as a step in filling the gaps between the court and the PTO on the disagreement of obviousness standard in the biotechnological context.

This Article suggests that a judge-made industry-specific standard of obviousness in biotechnological and pharmaceutical contexts is consistent with the Supreme Court's teaching in KSR that the evaluation of obviousness should remain flexible. Nevertheless, the current high disclosure requirement for biotechnological patent applications should not be sacrificed as a tradeoff for a heightened obviousness standard.

2. HISTORICAL BACKGROUND OF OBVIOUSNESS

   "Non-obviousness," "inventive step," or "inventive level" is a relatively new requirement of patentability compared to novelty and utility. (10) Novelty and utility were regarded as common law prerequisites for the issuance of a privilege and the predecessors of patentability requirements. (11) Unlike novelty or utility, non-obviousness is a product of modern patent law and was not developed until the middle of the nineteenth century and the early twentieth century. (12)

   Section 103 of the present American Patent Act provides that obviousness shall be tested by reference to the differences between the invention and the prior art. (13) The non-obviousness criterion was codified in the 1952 American Patent Act as a requirement that the claimed invention taken as a whole not be obvious to one of ordinary skill in the art at the time the invention was made. (14)

   The new provision was intended by Congress to abolish the "flash of genius" test set by the Supreme Court and to instigate a milder standard of inventiveness. (15) However, there was no case law or literature about the meaning of the new provision until 1966 in the Supreme Court's opinion, Graham v. John Deere Co. (16)

   Across the Atlantic Ocean, it was not until the British Patent Act of 1977, the inventive step, which was the European counterpart of obviousness, was fully introduced into the British patent statute as a separate patentability requirement. (17) In England, though the requirement of an inventive step was first introduced in 1932 into the British patent statute, (18) it was initially only as a ground for revocation of issued patents. (19)

   It was recognized in England, earlier than elsewhere, that a small step may advance the art. (20) Contrary to the United States' patent system, as Friedrich-Karl Beier has stated, the primary emphasis of the introduction of inventive step to the British patent system was the technical and economic importance of the differences between the prior art and the claimed invention, rather than "the kind of creative criteria or the more or less ingenious abilities of the inventor." (21)

   As commentators have observed, in the United States, much of the case law concerning the person having ordinary skill in the art arises out of the consideration of the obviousness standard in [section] 103 of the Patent Act. (22) It contributes to the result that the application of the person-having-ordinary-skill-in-the-art standard varies by industry, which led to, for example, fewer but broader software patents, and more but narrower biotechnology patents. (23)

   The development of a higher patentability requirement in Germany has its unique historical background. In Friedrich-Karl Beier's opinion, it was the creation of the protection of utility models for smaller technical improvements that freed the hands of the German patent system and German courts to demand additional prerequisites for patent protection and higher standards for the originality or works of applied arts. (24)

   The German Utility Model Act of 1891 introduced a new form of protection which came into force with the amended Patent Act. (25) Under the utility model system, in addition to the protection of examined patents, a simpler and faster protection could be obtained without previous examination. (26) The protection of utility model, which still exists today, allowed the German patent system and courts to apply stricter standards for the longer lasting and better protected patents. (27)

   Nevertheless, the requirement of patentability in Germany has changed in the process of harmonizing European patent law since the 1960's. (28) The prerequisite of inventive step was introduced into the German patent statute. (29) In addition, the advance in art, or technical progress, as a separate patentability requirement for seeking German patent protection was entirely dismissed. (30)

   Though obviousness is a relatively new concept compared to other patentability requirements, the advance of technology has continuously challenged and forced the relevant authority to re-examine the feasibility of such a standard. Specifically, the diversity of technologies today has raised the question whether a standard created before a specific industry emerging can be feasibly employed without modification to determine the inventiveness of an invention in such an industry. Biotechnology is simply one among many examples.

3. THE NATURE OF BIOTECHNOLOGY MEDICATION AND PHARMACEUTICALS

   Both traditional...