The US Court of Appeals of the Federal Circuit – often the last stop on the patent litigation train before the Supreme Court – has deemed valid two contested biotechnology methods patents in the much-watched case, Classen Immunotherapies v. Biogen Idec. The case, decided yesterday, may shore up the foundation under patents based on methods – a cornerstone of the biotechnology industry’s intellectual property portfolio.
Classen Immunotherapies holds patents on a method to determine whether a vaccine given on a certain schedule could produce adverse side effects. The patents essentially describe the comparison of a control group of animals to an experimental group of animals that receives the vaccine on the immunization schedule in question.
Challengers took what is becoming a familiar approach: they argued that the patents were invalid under a section of the patent law called §101. That section limits the subject matter of a patent, and forbids patents on abstract ideas and phenomena of nature. Patent lawyers say §101 challenges have become increasingly popular in recent years, particularly for methods patents.
But yesterday the court ruled in favour of two of the three methods claims that were under fire. Not only that, but two members of the three-judge panel issued a strong statement: enough with the §101 challenges.
“The language of §101 is very broad,” wrote Chief Judge Randall Rader and Judge Pauline Newman in a statement of ‘additional views’ tacked on to the end of their opinion. “Nevertheless, litigants continue to urge this court to impose limitations not present in the statute.”
“What I sense here is irritation,” William Simmons, an associate at the law firm Sughrue Mion in Washington, DC, said of Rader and Newman’s comments. “They think this is a waste of the court’s time.”
And that, says Simmons, could bolster a biotechnology industry that has been biting its nails over a recent spate of §101 patent cases. The gene patenting case against Myriad Genetics, which holds patents on several genetic mutations linked to breast cancer, hinged on the interpretation of §101. So did a case that was looked to as a test of methods patents: Bilski v. Kappos, a patent challenge that was decided in the Supreme Court last year. Bilski dealt with a financial method, but was closely watched by the biomedical industry. Coming up before the Supreme Court is a case that is more directly relevant to that industry: Prometheus v. Mayo Clinic, another biomedical methods case.
As with Classen, an anxious biotechnology industry has watched each of these cases for signs that their patents may be in danger. The message from the court today, says Simmons, is not to worry too much about those §101 challenges. But, he adds, that doesn’t mean that litigants won’t find other ways to pick away at patents. In the Classen majority opinion, Rader and Newman explicitly noted that although Classen’s two patents were safe under §101, they were vulnerable to other tests of patent validity that were not argued in the Classen case.
It also doesn’t mean that poorly written patent claims are safe from §101 challenges, says Simmons. The court yesterday determined that the third Classen patent was invalid because it lacked sufficient specificity to elevate it beyond an abstract idea. And the same court found several of Myriad Genetics’ methods claims to be invalid as well.
Meanwhile, it’s worth noting that the court was not united in its embrace of Classen’s broad methods claims. “I believe that the claims at issue are to a fundamental scientific principle so basic and abstract as to be unpatentable subject matter,” wrote Judge Kimberly Moore in a dissenting opinion. “Classen claimed a monopoly over the scientific method itself.”