Patent Law Practice Center

AMP v. USPTO: Myriad wins this battle, but will the war continue?

Ryan Chirnomas, Partner in the Biotechnology group at Westerman, Hattori, Daniels and Adrian, sent in this article discussing Friday’s Court of Appeals for the Federal Circuit decision in the AMP v. USPTO case.  He highlights the key points of the decision and why this decision should come as a relief to anyone in the biotechnology industry.

After nearly four months of consideration[1], the Court of Appeals for the Federal Circuit issued a decision in the controversial AMP v. USPTO case on Friday, July 29, 2011.  Weighing in at just over a hundred pages total, the decision includes a majority opinion by Judge Lourie, a concurrence by Judge Moore and a dissent by Judge Bryson.  The main point of contention between the three opinions relates to the patent-eligibility of the composition claims, particularly the claims which recite isolated long DNA sequences.

Standing

The first issue considered by the CAFC was whether the Plaintiffs had standing to sue.  The Plaintiffs were a motley crew of doctors, patients, scientific organizations and advocacy groups.  This wide breadth of Plaintiffs was one of the unusual aspects of this case.  Some Plaintiffs, such as cancer patients, claimed standing based on the fact that they could not afford the costs of the genetic tests or obtain a second opinion, due to Myriad being the exclusive provider for this test in the United States.  The Court quickly dismissed this reasoning, stating that “we fail to see how the inability to afford a patented invention could establish an invasion of a legally protected interest for purposes of standing.”  Citing MedImmune, the Court succinctly stated: “[s]imply disagreeing with the existence of a patent or even suffering an attenuated, non-proximate, effect from the existence of a patent does not meet the Supreme Court’s requirement for an adverse legal controversy of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.”

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The Clones War: Chapter Two – Myriad Files Their Brief on Appeal

The following guest post was written by Birch, Stewart, Kolasch & Birch Partner Mark J. Nuell, Ph.D.

Myriad Genetics has filed their brief in their appeal of the decision in Assoc. of Med. Pathology et al. v. Myriad Genetics et al. This case is one having effect on patent-eligibility of claims directed to purified natural products and to sequence-based diagnostic methods.  Myriad’s brief is a paper of advocacy, and it is persuasive of an asserted lack of jurisdiction.  Thus, the Federal Circuit might not even reach the questions of patentability of isolated DNA and of nucleic acid (sequence)-based diagnostic methods.  But, should the Federal Circuit choose to consider those questions, it appears that claims to “isolated DNA” meet the standard for patent-eligibility.  Despite their arguments to the contrary, some of Myriad’s diagnostic method claims are likely to fail to meet the standard, as falling within the scope of abstract ideas or laws of nature.  The other method claims that are challenged, although they can be interpreted to include a “transformative” step and so include a strong clue in favor of patent-eligibility under Bilski v. Kappos, might be deemed ineligible for patent protection because the “transformative” steps represent mere data-gathering steps. (more…)