Pursuant to the Supreme Court’s March 26, 2012 order remanding Association for Molecular Pathology v. Myriad Genetics, Inc. (the ACLU ”gene patenting”/BRCAI case), the Federal Circuit has issued an order requesting supplemental briefing to be filed by June 15, 2012.  Biotechnology companies interested in the patent-eligibility of  newly discovered, biologically relevant DNA sequences (and other similar compounds) should consider filing amicus briefs to explain their views and concerns to the court.

The Court’s Order

As set forth in the Federal Circuit order, “[t]he parties are requested to file simultaneous supplemental briefs, not exceeding 20 pages, not later than June 15, 2012, addressing the following issue:

What is the applicability of the Supreme Court’s decision in Mayo to Myriad’s isolated DNA claims and to method claim 20 of the ’282 patent?

The court also invites amicus briefs (limited to 15 pages) filed by the same deadline, and notes that “any such amicus briefs may be filed without consent and leave of court,” although they must comply with comply with the other requirements for amicus briefs, including Federal Rule of Appellate Procedure 29 and Federal Circuit Rule 29.

The court also “expressly invite[s]” the United States to file an amicus brief.

Oral Argument

According to the order, oral argument will be held at 10:00 a.m. on July 20, 2012.

The Claims At Issue

Claim 1 of U.S. Patent 5,747,282 is representative of the “isolated DNA” claims:

An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

I explained in this article how the Supreme Court’s Prometheus decision might be applied to such claims, and discussed in this vlog why the outcome in Prometheus should not govern the issues raised in Myriad.

Claim 20 of the ’282 patent recites:

A method for screening potential cancer therapeutics which comprises: growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and comparing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.

I hope that Myriad does not need to devote many of its 20 pages to explain why this claim recites a method that “amounts to significantly more” than any natural law that might be embodied in the underlying biological processes, but perhaps an amicus brief should focus on this claim to ensure that biotechnology patents are not completely eviscerated!