Assn. for Molecular Pathology v. USPTO: Constitutional Challenge to Gene Patents Survives Motion to Dismiss

Assn. for Molecular Pathology, et al. v. USPTO, et al., Case no. 09-CV-4514 (S.D.N.Y. Nov. 2, 2009)

Slip Opinion (hosted by Patent Baristas)

The United States District Court for the Southern District of New York denied defendants' motion to dismiss plaintiffs' claim that patents on a human gene violate the First Amendment and Article I of the Constitution for jurisdictional issues, lack of standing, and failure to state a claim.

District Judge Sweet found that the plaintiffs’ constitutional claims challenging the validity of Myriad Genetics’ gene patents provided subject matter jurisdiction and standing to sue the United States Patent and Trademark Office because of the lack of available statutory remedies.  The plaintiffs claim that Myriad’s patents are inappropriate because they cover “products of nature”, and seek invalidation of the patents under the Constitution of the United States. Judge Sweet held that these claims met the stricter pleading standards recently announced in Ashcroft v. Iqbal, 129 S.Ct. 1937 (2009).  In so holding, the court noted the “novel circumstances presented by this action against the USPTO”: The Patent and Trade Office is generally immune from suit due to the availability of statutory remedies for claims arising from patents. Such remedies do not provide for constitutional claims.

Ars Technica provides a brief overview of the case.  The ACLU, who represents the plaintiffs, writes in support of the decision.  Patent Baristas put forward a more skeptical view of the plaintiffs’ prospects. Patent Docs features a longer analysis of the decision.

Defendant Myriad Genetics owns interests in several patents on the human genes BRCA1 and BRCA2, both of which can indicate an increased risk of breast or ovarian cancer.  Myriad can thus control the availability of genetic testing for the BRCA1 and BRCA2 sequences, a process that can cost as much as $3000.  The patents also allow Myriad to restrict other laboratories’ research on the BRCA sequences.  The numerous plaintiffs include researchers, testing laboratories, medical societies, advocacy organizations, and cancer patients with various interests in seeing the invalidation of the patents-at-issue.

Arguing on behalf of the plaintiffs, the ACLU and the Public Patent Foundation claim that the patents violate the First Amendment’s protection of freedom of thought and Article I, section 8, clause 8’s instruction that Congress “promote the Progress of Science and useful Arts”.  In holding that the plaintiffs have standing to sue and that subject matter jurisdiction exists, the court relied on the fact that these constitutional claims fall outside the remedies provided by the Patent Act.  In holding the pleading sufficient, the court reasoned that the First Amendment claim is supported by the plaintiffs’ argument that the BRCA patents cover a product of nature, and the Article I claim is supported by the contention that the patent has inhibited research on the genes.

This suit is significant for both procedural and public policy reasons.  Using constitutional claims in an attempt to invalidate patents is a novel approach, and is probably the only approach that would allow the plaintiffs to include the USPTO as a defendant. A victory for the plaintiffs could result in an increased availability of genetic testing for breast cancer risks.  More broadly, if the plaintiffs present a successful challenge to the USPTO’s general policy of granting gene patents, the validity of patents on an estimated 20% of the human genome would be called into question.