Saturday, June 16, 2012

BIO, AUTM and the Coalition for 21st Century Medicine file amicus brief in Myriad Remand

The Biotechnology Industry Organization (BIO), joined by the Association of University Technology Managers (AUTM) and the Coalition for 21st Century Medicine (representing diagnostic companies) has filed an amicus brief in the Myriad case, available here.

BIO et al. argue that Mayo  (a Supreme Court decision specifically addressing the patent eligibility of process claims) does not apply to manufacture or composition of matter claims, and thus should not alter the Federal Circuit’s original decision finding all of the challenged isolated DNA claims patent eligible. They also argue that were the court to rule that the isolated DNA claims are patent ineligible, it would have far-reaching negative consequences for innovation, pointing out many examples in which important innovations that have benefitted healthcare and the environment have been incentivized by patents on isolated DNA molecules and other isolated natural products.

With respect to claim 20, the cell-based assay claim, they argue that the claimed method is clearly patent eligible since it recites the use of a transformed (i.e., genetically modified) cell that would itself be patent eligible.

U.S. Governemnt Files Brief in Myriad

The U.S. has filed a brief in Myriad, available here, which argues that under Mayo “isolated but otherwise unmodified DNA molecules are not patent-eligible because they are products of nature, not human-made inventions.” The government also argues that under Mayo the claims are patent ineligible because they effectively preclude the public from using a product of nature, and because the need for financial incentives in a particular field does not alter the requirements of § 101.

The brief I filed is available here.

Friday, June 15, 2012

And Many More Myriad Briefs

And here are links to more Myriad briefs for those interested:

Supplemental Brief for Appellant (Myriad)

Brief of Amici Curiae The National Women’s Health Network, et al

Brief of Amici Curiae New York Intellectual Property Law Association

Brief of Amici Curiae American Medical Association, et al

Brief of Amici Curiae AARP, et al

Brief of Amici Curiae Intellectual Property Owners Association

Brief of Amici Curiae professor Eileen M. Kane in Support of Plaintiffs-Appellees and Affirmance

Brief of Amici Curiae Mark J. Gatschet, et al.

Brief for Amicus Curiae American Intellectual Property Law Association

More Myriad Briefs

Here are some more briefs recently filed in the remanded Myriad case.

ACLU and the Public Patent Foundation have filed their supplemental brief on behalf of plaintiffs, available here. Not surprisingly, they argue that the challenged isolated DNA claims, and claim 20 of the '282 patent (these cell based assay claim) are all patent ineligible under Prometheus, and for affirmance of the district court decision.

Knowledge Ecology International and Universities Allied for Essential Medicines have filed an amicus brief in support of the plaintiffs, available here. They argue that isolated DNA patents hinder science and harm healthcare, and that adequate non-patent incentives for pharmaceutical innovation are available (such as FDA data/marketing exclusivity), and ask the Federal Circuit to affirm the District Court's decision.

Gilead Sciences, Confluence Life Sciences and Euclises Pharmaceuticals have filed a joint amicus brief that focuses exclusively on claim 2 of the ‘282 patent, i.e., the cDNA claim, and argues that cDNA is clearly man-made patent eligible subject matter. The brief, available here, asks the Federal Circuit not to reverse its earlier decision.

Amicus Briefs In Remand of Myriad

Today is the deadline for filing amicus briefs for the Federal Circuit to consider when it decides the Myriad gene patent litigation, i.e. The Association for Molecular Pathology v. US Patent and Trademark Office, on remand. The first time the Federal Circuit heard the case, I joined with Robert Cook-Deegan in filing a brief arguing that the isolated DNA claims should not be declared patent ineligible, but rather that their validity should be assessed under the more conventional requirements of patentability, i.e., novelty, nonobviousness and enablement. This time I went it alone, and filed a brief on my own behalf, available here (I believe that Bob will also likely be filing his own brief).

In my latest brief, I focus largely on the nature of genomic DNA and cDNA, and the processes by which they are "isolated," and argue that the challenged isolated DNA claims (when properly interpreted) are limited to synthetic molecules that did not originate in the human body, and which are substantially different from naturally occurring chromosomal DNA both structurally and functionally. I also address an argument made by the US government in its amicus brief, i.e., that cDNA is fundamentally different from isolated genomic DNA, and as a result claims limited to isolated cDNA should be considered patent eligible, while claims encompassing isolated genomic DNA are not patent eligible. To the contrary, I argue that isolated genomic DNA and cDNA are quite analogous, and are not different in a way that would justify differential treatment under the patent eligibility doctrine.

I also point out that the Federal Circuit’s earlier decision includes a number of unfounded assumptions regarding the utility of isolated genomic DNA, and the impact of isolated DNA patents on genetic testing and whole genome sequencing. The brief concludes by observing that a determination that any of the challenged isolated DNA claims is patent ineligible could cause serious unintended collateral damage to biotechnology, and should not be made cavalierly based on an overly simplistic and imprecise interpretation of the claims and speculation as to their potential preemptive effect.

Protein Sciences Corporation has filed its own Amicus brief, available here, which argues that:
Prometheus applies to method claims and does not change this Court’s correct decision as to the Representative Composition Claims, i.e., that isolated DNA molecules and cDNA are patent eligible subject matter under § 101; and that applying Prometheus to the Comparing or Analyzing Claims produces the same result as in Myriad, because the “transformed cells containing an altered BRCA1 gene causing cancer” are not naturally occurring cells, [and thus] the growing of those cells in the presence and absence of a putative cancer therapeutic in the Growth Rate Claim cannot be a method calling for applying a law of nature.
Eli Lilly has also submitted a brief, available here, which does not address the isolated DNA claims, but argues that claim 20 (the method claim reciting the use of BRCA gene in cell-based assay to screen for potential drug candidates) is patent ineligible if it includes a "mental step."