Obvious-to-try Obviousness Of Chemical Enantiomers In View Of Pre- and Post-KSR Analysis
July 2008By: Jonathan M. Spenner
Journal of the Patent and Trademark Office Society
I. Introduction
A. Policy and Importance
The patent laws are designed to keep that which is already in the public domain from being unjustly sequestered and monopolized. The concept of an invention being completely disclosed within a single piece of prior art/ and thus being within the public domain and unavailable for patenting, is the concept of anticipation, which is codified at 35 U.S.c. § 102 (2000). Although not described within a single piece of prior art, an invention may still be unpatentable if the invention, as a whole, would have been obvious to one of ordinary skill in the art at the time the invention was made. Title 35, U.s.c. § 103(a) (2000) reads:
A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Thus, to determine if an invention is unpatentable as obvious, it is important to determine what a person having ordinary skill in the art knew at the pertinent time and what the requirements are, beyond disclosure of the elements of a given invention (such as in anticipation), to arrive at an invention being deemed obvious. Conversely, it is also important to determine how to potentially overcome an obviousness attack.
Determination of these items, and obviousness in general, is extremely important to the pharmaceutical industry. For the innovators/ the obviousness would invalidate patent claims and thus also nullify years of research and millions of dollars in investment. For the generics, a more stringent obviousness test could potentially produce a larger generic presence in the marketplace due to successful Paragraph IV certifications of patent invalidity filed with Abbreviated New Drug Applications ("A. N. D. A.s") under 21 U.S.c. § 355(j)(5)(B)(iii) (2000). A recent article cited worldwide pharmaceutical sales at over half-a-trillion dollars, with chiral drugs approaching $200 billion. Therefore, there is a lot at stake should there be a change in the patent laws regarding obviousness.
The pharmaceutical industry is also very susceptible to claims of obviousness, especially under an "obvious-to-try" rubric. This is due to the nature of the experimentation required to discover, design, and/or develop new active pharmaceutical compounds. As Judge Baldwin described in his dissent in In re Merck where a drug was found to be obvious:
The obvious-to-try analysis is an attack on the method of making an invention that specifically penalizes people in areas of endeavor where advances are won only by great effort and expense. The pharmaceutical field is particularly hard hit because there is an over abundance of structures that are obvious- to-try.
Therefore, the natural progression of science within R&D programs of the pharmaceutical industry involves what some may deem to be obvious-to-try. However, what is the meaning of "obvious-to-try" and how does it fit into an obviousness analysis? What is the state-of-the-law on obvious-to-try obviousness, and how does/will the state-of-the-art affect this determination? Where do enantlomeric drugs lie? These are questions that this paper attempts to answer.
B. Thesis
The Supreme Court case of KSR International Co. v. Teleflex, Inc. was very closely watched and has been heralded by some as causing a paradigmatic shift in the law-of obviousness. However, a close scrutiny of the case law history shows that KSR is more of an anomalous case in which the Supreme Court reminds the Federal Circuit to follow its own precedent and solidifies the "finite" obvious-to-try rationale as permissible in raising a prima facie obviousness rejection while rejecting the oft cited "non-finite" obvious- to-try rationale as impermissible ("non-finite" being used by the author to distinguish from "finite"). This paper analyzes the prior case law leading up to KSR and the subsequent application of obviousness law after KSR in an attempt to show that the law of obviousness has not experienced a substantive change. There has only been a rediscovery or refocusing of pre-existing precedent, in which the practical effects of this rediscovery/ focusing on future patent examinations and litigations may manifest in a slight increase in difficulty in refuting a prima facie obviousness argument under section 103(a). This likely would be due mostly to a heightened awareness of the finite obvious-to-try rationale and otherwise through advances in the art.
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