(Reproduced with permission from Life Sciences Law & Industry Report, 3 LSLR 395 (Apr. 24, 2009). Copyright 2009 by The Bureau of National Affairs,Inc. (800-372-1033) http://www.bna.com)
A “perfect storm” of regulatory, legislative, and judicial decisions concerning patents has created an unsettled, ambiguous situation in the life sciences industry where there is no clear path forward, Kevin E. Noonan of McDonnell, Boehnen, Hulbert, & Berghoff, Chicago, said April 22.
Speaking at the Association of Patent Law Firms’ Web cast, “How Recent Patent Developments May Be Creating a Perfect Storm for Biotechnology,” Noonan listed the U.S. Patent & Trademark Office’s new rules packages, the Federal Circuit’s recent ruling in Tafas v. Doll on the PTO’s continuation claims rules (3 LSLR 268, 3/27/09), proposed patent and follow-on biologics reform, and other recent court decisions as the elements of this “storm.”
“For the past few years, the biotech and patent communities have always seemed to dodge the bullet. But that ends here,” Noonan said.
He focused his presentation on two decisions: In re Kubin (see related item in the Special Report section) and In re Bilski (2 LSLR 1021, 11/21/08).
After describing In re Deuel, in which the U.S. Court of Appeals for the Federal Circuit held that knowledge of a protein does not give one a conception of a particular DNA encoding it and that “obvious to try” is an inappropriate test for obviousness, Noonan discussed how in KSR International Co. v. Teleflex Inc. (1 LSLR 153, 5/11/07) the Supreme Court “elevated the relevance of instances when something that is ‘obvious to try’ is also obvious.” In its initial decision in Kubin, the PTO applied KSR basically to overrule Deuel, which Noonan said was “too broad a reading of KSR.”
And yet, Noonan said, on appeal the Federal Circuit “turned the Deuel analysis on its head, holding that the ‘routine’ nature of the cloning methods is not the issue, since methods are not being claimed. It eschews Deuel’s principles of ’structural obviousness.’ This appears at odds with the statutory proscription against using methods to establish obviousness.”
While shortly after the decision was handed down Noonan appeared to disagree with those who said the decision could have a negative effect on life sciences patents, in his Webcast remarks he took a slightly different tone. He noted that the PTO was resurrecting the guidance it had developed on “obvious to try” after it had issued its agency ruling in Kubin in 2007 and that its examiners were using the guidance.
He also suggested that the “logic of the court’s decision” could have implications beyond gene patenting. He asked, “Could known screening assays make any compounds identified in the assays obvious? Could known synthetic methods make all variants of a known compound obvious? Could known methods of making antibodies make all antibodies specific for a known antigen obvious?”
He added, “Philosophically we may be going down the wrong road.”
Victim of Own Success? Noonan then discussed the Bilski decision and the non-decision in Laboratory Corp. of America Holdings d/b/a LabCorp. v. Metabolite Laboratories Inc., 126 S. Ct. 2921 (2006), for the proposition of a problem that “is not current but is on the horizon: a confluence of anti-patent zeitgeist, an ascendence of form and doctrinal purity over sound policy, the Supreme Court’s impatience with Federal Circuit, and Federal Circuit’s response to a series of reversals by Supreme Court. It’s a microcosm of how life sciences patenting has been a victim of its own success and may have potentially significant negative consequences for health care innovation.”
In Bilski, Noonan said, the Federal Circuit created a new test: A process claim must be tied to a particular machine or apparatus or it must transform a particular article into a different state or thing. The decision is not limited to technology area or type of method claim; it applies to all method claims, Noonan said. And then, in Metabolite, which concerned a method for detecting a deficiency of cobalamin or folate in warm-blooded animals, the Supreme Court granted review, heard arguments, and then, over Justice Stephen Breyer’s strong dissent, dismissed the petition. In his dissent, Breyer claimed, “At most, respondents have simply described the natural law at issue in the abstract patent language of a ‘process.’ But they cannot avoid the fact that the process is no more than an instruction to read some numbers in light of medical knowledge.”
In the aftermath of Bilski and Metabolite, Noonan said, several district court decisions have invalidated diagnostic method claims in view of Breyer’s Metabolite dissent, two have appealed to CAFC, and the PTO is using Bilski liberally—more than 20 decisions—to reject method claims.