By Kevin E. Noonan —

Branch Rickey said "luck is the residue of design" to indicate his belief that good things happen to those who plan carefully.  However, sometimes good fortune is an unintended consequence of earlier circumstance, like a folk remedy for an illness thought to have been overcome long ago.  In view of the Supreme Court’s decision in KSR Int’l Co. v. Teleflex, Inc., the provisions of 35 U.S.C. § 103(b) may once again be useful in protecting biotechnology inventions (in this case, method claims) from the decision’s deleterious effects.

The statute reads as follows:

35 U.S.C. 103 Conditions for patentability; non-obvious subject matter.

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(b)(1)  Notwithstanding subsection (a), and upon timely election by the applicant for patent to proceed under this subsection, a biotechnological process using or resulting in a composition of matter that is novel under section 102 and nonobvious under subsection (a) of this section shall be considered nonobvious if-

(A)  claims to the process and the composition of matter are contained in either the same application for patent or in separate applications having the same effective filing date; and
(B)  the composition of matter, and the process at the time it was invented, were owned by the same person or subject to an obligation of assignment to the same person.

(2)  A patent issued on a process under paragraph (1)-

(A)  shall also contain the claims to the composition of matter used in or made by that process, or
(B)  shall, if such composition of matter is claimed in another patent, be set to expire on the same date as such other patent, notwithstanding section 154.

(3) For purposes of paragraph (1), the term "biotechnological process" means-

(A)  a process of genetically altering or otherwise inducing a single- or multi-celled organism to-

(i)  express an exogenous nucleotide sequence,
(ii)  inhibit, eliminate, augment, or alter expression of an endogenous nucleotide sequence, or
(iii)  express a specific physiological characteristic not naturally associated with said organism;

(B)  cell fusion procedures yielding a cell line that expresses a specific protein, such as a monoclonal antibody; and
(C)  a method of using a product produced by a process defined by subparagraph (A) or (B), or a combination of subparagraphs (A) and (B).

These provisions were enacted in 1995, in the wake of the continued resistance of the U.S. Patent and Trademark Office to granting claims to methods it deemed obvious.  The analogy with the factual circumstances in KSR is important:  in KSR, the Supreme Court found obvious the replacement of an electronic component for a mechanical one, in part because this was the trend in the industry (moving from mechanical to electronic components).  The Patent Office grounds for finding biotechnology method claims obvious was, inter alia, that biotechnology products (genes or antibodies) were merely being substituted in art-recognized processes, and thus were obvious.  Passage of the statute overcame this problem; however, the Federal Circuit’s decisions in In re Brouwer and In re Ochiai, rendered shortly after § 103(b) went into effect, largely eliminated the need for its protections.

Until now.  The protections provided by § 103(b) are not automatic, however, requiring an affirmative election to obtain the benefit.  They are also not absolute, requiring that the underlying biotechnology product be novel and non-obvious.  But the statute is quite broadly drafted with regard to the scope of the methods it encompasses.  These include methods for producing recombinant cells, organisms, and antibodies, and methods for affecting gene expression (including, for example, siRNA methods), as well as methods for using products produced by such processes. 

Most importantly, the statute stands as a Congressional "thou shalt not" to any Court (or the Patent Office) that attempts to prevent the patenting of methods using a novel and non-obvious biotechnology product.  This protection may be once again necessary, in view of the "fuzzy" rubrics on obviousness contained in much of the Supreme Court’s dicta in KSR.  It provides what the Court is unwilling to:  a bright-line standard for determining non-obviousness for a specific type of claim.  And it provides some measure of comfort in the face of the present uncertainties about how the Patent Office will interpret and implement the Court’s uncertain calculus on obviousness.  For biotechnology method claims this may be the best that can be had, but it may just be enough.

For additional information and commentary regarding the KSR decision, please see:

• "BIO’s Reaction to KSR v. Teleflex," May 8, 2007
• "Implications of the Supreme Court’s KSR v. Teleflex Decision for Biotechnology," May 4, 2007
• "The Patent Office Reacts to KSR: A First Look," May 3, 2007
• "KSR Int’l Co. v. Teleflex Inc. (2007)," April 30, 2007
• "Conference & CLE Calendar," which provides an updated list of upcoming KSR CLE’s