Last Friday, the Department of Justice (DOJ) submitted an amicus curiae brief in the Association for Molecular Pathology v. United States Patent and Trademark Office case (the “Myriad genes case”), which is currently before the Federal Circuit. Commentators, including the author of an opposing amicus brief, have been quick to criticize the DOJ’s amicus efforts on several grounds.
The Myriad genes case involves the fight over the patentability of isolated genes. In an epic 156 page summary judgment order issued in March, the Honorable Robert Sweet invalidated certain Myriad Genetics’ patents that related to the BRCA 1 and 2 genes. The decision held that isolated genes were not patent eligible under 35 U.S.C. § 101.
So, why all the criticism directed toward the DOJ? To begin, the DOJ represents the positions of the United States and the Obama administration. Two interests which are clearly important. Additionally, as one might expect, DOJ amicus filings have been highly influential upon the Federal Circuit. Recent high-profile cases heard by the Federal Circuit reflect the influence that the DOJ commands, two of which are examined below.
In Ariad v. Eli Lilly, the Federal Circuit noted the government’s position regarding the role of written description doctrine in the day-to-day function of patent prosecution. Specifically, the court took notice that “[t]he government submitted an amicus brief in which it asserted that the written description doctrine is ‘necessary to permit USPTO to perform its basic examination function’ and claimed that the Patent Office applies § 112, paragraph 1 to over ‘400,000 patent applications each year.’ Br. of Amicus United States 19-20.” The case, of course, held that written description was a § 112 ¶ 1 requirement, separate and unique from enablement. Thus, the position advocated by the DOJ prevailed.
In Enzo Biochem, Inc. v. Gen-Probe, Inc., the Federal Circuit confronted the question whether a rehearing en banc should be order. Again, the court was well aware of the DOJ’s position and made mention of the DOJ’s amicus brief in their opinion. Specifically, they remarked that “[t]he United States’ brief as amicus curiae [was] in support of rehearing en banc[.]” The Federal Circuit adopted the position advocated by the DOJ and “grant[ed] Enzo’s petition for rehearing[.]”
With the weight of the executive branch behind anti-patent sentiments, should the proponents of gene patenting be worried? It’s hard to say, but gene patenting has become a common practice in the United States, favoring a Federal Circuit finding of patentability. The Supreme Court has traditionally been a non-entity in shaping patent law doctrine (although this appears to be changing in recent years). So, it seems unlikely that the Federal Circuit will be willing to overturn decades of precedent, especially when the trend of case law would cut against a narrowing of patentable subject matter. As commentators in the field have noted “[t]he overall trend of decisions in the Federal Circuit is toward expansive interpretation of the scope of patent-eligible subject matter – even for categories of inventions that prior decisions seemed to exclude from the protection of the patent statute – in order to make the patent system ‘responsive to the needs of the modern world.’” Rebecca S. Eisenberg, How Can You Patent Genes, in Am. J. Bioethics (2002) (quoting AT&T Corp. v. Excel Communications, Inc., 172 F.3d 1352 (Fed. Cir. 1999)). Will the DOJ continue to have sway over the Federal Circuit? The future of gene patenting may be decided by the answer.