On March 24th, Patents4Life forgot to celebrate its 4th anniversary. On March 24, 2009, I started the blog (or is it “blawg”) by posting three articles on fairly recent Fed. Cir. decisions. One of the articles discussed the application of the then-recent “Bilski test” to the claims in suit in Classen v. Biogen (2008 WL 5273107) which involved a method of developing improved immunization schedules. The summary affirmance of the district court’s decision was based on the “machine or transformation test” developed in Bilski. Since at least one of the claims recited immunizing subjects, I wrote:
“The Bilski standard, now being applied in the area of biomedical technology, poses a significant threat to the viability of patents claiming diagnostic methods.”
Well that turned out to be quite an understatement, didn’t it. Following the disposal of the “M or T test” by the Supreme Court (and its replacement by the “something more than a natural phenomenon” standard), the Supreme Court GVR’d the Classen cert. petition and the Fed. Cir. found that at least some of the claims that recited immunization steps squeezed through the “coarse filter” of patent eligibility applied by s. 101. The second cert. petition did not address this aspect of the decision.
I don’t intend to summarize the last four years of the development of patent law, but the Supreme Court’s continuous involvement in rejecting what it sees as overly rigid tests developed by the Fed. Cir. has led to as much uncertainty in 35 USC as I have experienced in my more than 30 year career in this increasingly abstract, if not metaphysical area of “philosophical inquiry” (as Justice Story might put it – even today).
The Supreme Court is poised to address the question of whether or not “human genes” are patentable without any consensus on what the term “human gene” means in chemical terms, or much less why the gene has to be “human” in the first place. Practicing patent law in 2013 is a bit like a view from the bridge of the Starship Enterprise – a term Webster’s defines as “a project or undertaking that is esp. difficult, complicated, or risky.”