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March 30, 2010

AIPLA Reports

A Periodic Notification of AIPLA Activities and

Current Developments in Intellectual Property Law

Copyright © 2010 AIPLA

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Patents/Section 101 Subject Matter/Gene Claims
Gene and Related Method Patents Are Not Patentable Subject Matter
Assoc. for Molecular Pathology v. U.S. Patent and Trademark Office, 09 Civ. 4515 (RWS), 3/30/2010.

Composition claims on isolated DNA sequences and method claims on the use of those sequences for diagnosing breast and ovarian cancer fail to qualify as patentable subject under 35 U.S.C. 101, according to the U.S. District Court for the Southern District of New York.  However, the court dismissed claims that the Patent and Trademark Office, in issuing the subject patents, violated the Patent and Copyright Clause and the First Amendment to the Constitution.

Composition Claims

This lawsuit was brought by the American Civil Liberties Union, doctors, medical researchers, and patients concerned about the control exercised under a set of patents directed to BRCA1 and BRCA2 genes relating to breast and ovarian cancer. The plaintiffs filed a declaratory judgment action against the PTO, the patentee Myriad Genetics, and other defendants, challenging the validity of the patents.

Judge Robert W. Sweet noted that the PTO grants patents on DNA sequences as long as the sequences are claimed in the form of “isolated” DNA.  The premise, he explained, is that DNA should be treated no differently from any other chemical compound, and that its purification from the body using well-known techniques renders it patentable by transforming it into something different in character.

However, Judge Sweet was persuaded that an “isolated” gene is no different from a gene in its natural environment of the body.  He acknowledged the Supreme Court case law stating that products of nature can be rendered patentable with a change that results in the creation of a fundamentally new product, citing the requirement of “markedly different characteristics” in Diamond v. Chakrabarty, 447 U.S. 303 (1980).

The Court found that DNA possesses unique characteristics that distinguish it from traditional chemical compounds that change readily when isolated and purified.  Judge Sweet particularly mentioned the informational quality of DNA, not as content about DNA itself but about organism whose development it instructs.  Those unique qualities, both structural and functional, are identifiable in DNA’s naturally occurring state and do not change into something “markedly different” when DNA is removed from the body, according to the Court. 

Method Claims

In analyzing the eligibility of the DNA method claims, Judge Sweet drew extensively on the Federal Circuit’s decision in In re Bilski, 545 F.3d 943 (Fed. Cir. 2008).  He was not persuaded by the argument that the method claims here are “transformational” in the same way that the claims in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 581 F.3d 1336 (Fed. Cir. 2009), were found by the Federal Circuit to be transformational.  Unlike the claims here, the Prometheus claims were directed to “determining” metabolite levels in the body, which involved extraction and measurement of metabolite concentrations.  The claims here, by contrast, are directed to the abstract mental processes of “analyzing” or “comparing,” according to the court.

Constitutional Allegations

As for the allegations against the PTO for violations of the Patent and Copyright Clause and First Amendment in issuing the patents, Judge Sweet invoked the doctrine of “constitutional avoidance.”  Under that doctrine, courts should avoid addressing claims based on the Constitution if the same result can be reached under other theories.  “With the holding that the patents are invalid, the Plaintiffs have received the relief sought in the Complaint and the doctrine of constitutional avoidance precludes this Court from reaching the constitutional claims against the USPTO,” Judge Sweet wrote.

To read the opinion (156 pages) in this case, click here.

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