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Myriad: "Isolated" DNA § 101 Patent-Eligible

Aug 16, 2012
Harold C. Wegner

(at least until Supreme Court Review)

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Today, a 2-1 split panel in the Myriad case, Association for Molecular Pathology v. Myriad Genetics, Inc., __ F.3d __ (Fed. Cir. 2012)(Lourie, J.), again reversed the trial court holding that the isolated DNA claims are not drawn patent-eligible subject matter under 35 USC ˜ 101. The decision today follows the Suprme Court GVR Order to reconsider the previous panel opinion in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012).

Back on the Road to the Supreme Court: The Supreme Court petition falls due November 14, 2012 (absent a petition for rehearing en banc and/or an extension of time to file the petition for certiorari). Under this time frame, a successful grant of review would likely place the Myriad case on the Supreme Court argument calendar during its last month of hearings (April 15-17 and 22-24) with a merits decision by the end of June 2013.

Factors Favoring Supreme Court Review: Two factors make it likely that the Supreme Court will grant certiorari in this case. First, the dissent (Bryson, J.) by itself may well garner sufficient votes for review. Second, the answers given to the Mayo-keyed GVR Order at best manifest a serious intra-circuit split on the patent research "preemption" and at worst present a clear encouragement to grant of certiorari.

A 20 Year Iron-Clad Patent-Based Bar to Research (Myriad Majority): Against the Supreme Court view in Mayo v. Prometheus that any patent "preempts" research, the majority presents two arguments, only the first of which deserves any serious consideration from a legal standpoint:

First,

"[w]hen the patent expires, the public is entitled to practice the invention of the patent. That is true of all inventions; during the term of the patent, unauthorized parties are epreemptedf from practicing the patent, but only for its limited term."

The majority thus argues, in essence, that a patent should block any research on a patented invention even to the point of studying the invention or making improvements to design around the patented invention. This view is in direct conflict with Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1072 (Fed. Cir.@2011), as discussed in the next section.

There is yet a second argument that is not felt to warrant discussion. The majority states: "[P]atents are rarely enforced against scientific research, even during their terms."

Intra-Circuit Split, the Classen Majority Opinion: It has been the mainstream view within the United States for 199 years that a patent does not preempt basis research or, indeed, experimentation on a patented invention of any kind. As recently stated by the Chief Judge (quoting a majority opinion where his was the deciding vote):

"[P]atents properly remain a tool for research and experimentation because the system encourages publication and sharing of research results.c[T]he inventor receives a limited term of exclusivity to benefit from commercialization of his invention. c 'The information in patents is added to the store of knowledge with the publication/issuance of the patent.... [It] is not insulated from analysis, study, and experimentation for the twenty years [term] until patent expiration.' Classen [Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1072 (Fed. Cir.@2011)]. Rather, information shared through patent applications is immediately available for others to build upon. It speeds the progress of scientific endeavor. In other words, the patent system's modern benefits facilitate experimentation c."

Momenta Pharms., Inc. v. Amphastar Pharms., Inc., __ F.3d __, __, 2012 WL 3140303 (Fed. Cir. 2012)( Rader, C.J., dissenting)(emphasis added).

Intra-Circuit Splits are Best Resolved within the Circuit: It should hardly be controversial that where, as here, there is a clear split within the Federal Circuit that it is better for the Federal Circuit to resolve this matter en banc than to simply leave this matter up for grabs at the Supreme Court.

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