News

Patenting The Future by James F. Kamp

By Rader, Fishman & Grauer Partner, James Kamp
This article originally appeared in Michigan Lawyers Weekly on June 28, 2010

In October, Michigan hosts the World Stem Cell Summit. Billed as the flagship event of the global stem cell and regenerative medicine community, it will draw 1,200-plus participants from around the world and showcase the substantial life science resources Michigan has available to develop and support businesses that diversify its economy.

Making these businesses successful involves leveraging their intellectual capital. Patenting is one technique for doing so.

The U.S. Patent Act, 35 U.S.C. §1 et seq., implements Congress’ constitutional power to “promote the Progress of Science and useful Arts.” An issued patent allows the patent holder to exclude others from making, using, offering for sale, selling, or importing the patented invention for about 20 years from filing the related application with the U.S. Patent and Trademark Office (USPTO).

The requirements for obtaining a patent include, among others: An invention that is patentable subject matter; an invention that is useful, novel, and non-obvious; and a patent application that shows that the inventor is in possession of the claimed invention and enables one to practice the invention without undue experimentation, so-called “written description” requirements.

Although these criteria are readily stated, obtaining a patent remains challenging, even for seemingly novel, promising discoveries.

Recent decisions illustrate some of these challenges. Since the U.S. Supreme Court’s decision in Diamond v. Chakrabarty (1980), many patents have issued for cell lines, gene sequences, and the like which have been developed, purified, or isolated from a natural state. Yet, patenting life forms and derivative materials remains controversial; while the USPTO currently allows patenting of certain stem cells, some other countries do not.

Public debate continues over where the line for patentable subject matter should be drawn. In Association for Molecular Pathology v. USPTO (S.D.N.Y. 2010), nonprofit plaintiffs represented by the ACLU challenged several patents related to the human BRCA1/2 genes used to evaluate breast cancer susceptibility.

In March 2010, the federal district court granted summary judgment in the plaintiffs’ favor and against patent holders Myriad Genetics and the University of Utah Research Foundation, finding that the isolated genes and related methods were not patentable subject matter.

Some suggest that if the decision is upheld, it could affect years of gene patenting previously allowed under existing USPTO guidelines.

Assertions of public interest also underlie a recent challenge to stem cell patents on obviousness” grounds. In KSR v. Teleflex (2007), the U.S. Supreme Court held that the determination of “obviousness” involves: Whether the prior art teaches a finite number of identifiable, predictable solutions to the problem addressed; Whether there would have been a reasonable expectation of success; and Whether a skilled artisan would have been motivated by design pressures and market needs such that it would have been “obvious to try” to develop the claimed invention.

The KSR factors were at issue in a “consumer watchdog” challenge to three stem cell patents held by the Wisconsin Alumni Research Foundation (WARF). Claiming that the patents were “impeding scientific progress and driving vital stem cell research overseas,” the Public Patent Foundation and the Foundation for Taxpayer and Consumer Rights sought re-examination of the WARF patents in 2006.

In 2007, the patent examiner rejected the patents, but in 2008, the rejections were reversed. Due to procedural rules, the groups could appeal with respect to only one patent.

In April 2010, the USPTO Board of Patent Appeals and Interferences reinstated the rejection of the WARF patent claims before it, finding in relevant part that claims at issue were “obvious” under KSR because “the path to deriving human [embryonic stem] cells had a definite starting point with explicit landmarks along the way”; it was “obvious to try” to derive the stem cells; and a skilled artisan would have had “significant guideposts” to follow in doing so. The examination and the controversy continue.

Finally, Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. illustrates not only the application of “written description” requirements, but also public policy underlying the patent system.

The Ariad inventors had discovered a transcription factor, NF-kB, which could protect cells from harmful extra cellular influences.

However, too much NF-kB activity could harm the cell. The inventors surmised that artificially interfering with NF-kB activity could reduce harmful effects. The resulting patent had broad claims reciting the step of “reducing NF-kB activity,” but it did not identify specific compounds to produce this result.

In March 2010, an en banc Federal Circuit upheld an earlier reversal of a multimillion dollar infringement verdict in Ariad’s favor, finding that the patent at issue was invalid.

Defendant Eli Lilly had contended that the patent language was little more than a research plan. The Court essentially agreed, affirming that the “written description” requirement of 35 U.S.C. §112, Para. 1, has two facets and finding the patent invalid for lack of written description.

Responding to criticism that a finding of invalidity would impair incentives to do basic research, the Court emphasized public policy underlying patents: “… Patents are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others. ‘[A] patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.’ …

Requiring a written description of the invention limits patent protection to those who actually perform the difficult work of ‘invention’ — that is, conceive of the complete and final invention with all its claimed limitations …”

To patent in the life sciences, one must have an informed, cogent strategy to convince the USPTO, the courts, and the public that one’s claimed invention is patentable subject matter, meets novelty requirements, and teaches how to practice an invention that the inventor possesses.

In addition, translating promising academic work into inventions that are patentable as “useful Arts” will, in many cases, require entrepreneurial collaboration between public and private entities.

Those who pursue a patent strategy with these factors in mind increase their chances of success in capitalizing on Michigan’s substantial human and intellectual resources in the life sciences and in diversifying its economy.

James F. Kamp is a partner at Rader, Fishman & Grauer PLLC, where he practices patent litigation and patent prosecution in the biotech/life sciences and other areas. Contact him at (248) 594-0656 or jfk@raderfishman.com.