The recent district court ruling in the Myriad Genetics case, holding that because genes are found in nature the company’s key patents covering “isolated DNA” are invalid, is just the latest major test of what is and is not patentable — and that definition appears to be shifting but not settling. Though many experts predict the Myriad ruling will not survive the next round of appeal, when combined with several other recent cases on patentability, some in the technology transfer arena see the patent system continuing a steady trend toward weaker and narrower protection. Given a growing number of cases like Myriad, Bilski, KSR and others, they advise TTOs not to over-react, but to adjust their strategies accordingly as the dust continues to settle, particularly in the quality and breadth of patent claims.
“I generally don’t take a single district court ruling as an impending landslide,” says Jim Baker, PhD, director of technology and economic development at Michigan Technological University, Houghton. “And there appears to be ample room in the Myriad decision for contrary opinions from higher courts. So it won’t have any substantive impact — except to Myriad, of course — until the appeals are over.” If the lower court ruling stands, he adds, gene-based treatments and diagnostic tests will still likely be patentable, as long as they fit within the confines of method patents as ultimately
defined by the Bilski case. “While the genes may or may not be patentable all by themselves, methods involving genes that satisfy post-Bilski criteria will remain patentable.”
Still, the trend toward stricter interpretation of patentability is undeniable, Baker says. “This decision, if upheld, combined with what seems to be expected out of Bilski and what came out of KSR v. Teleflex, does present an arguable erosion of the extent of subject matter available for patenting.” That said, though, he emphasizes that the current
shift should be viewed in the context of swings that have characterized patent law for decades. “Arguments and cases around the balance between a patent system that promotes innovation and one that inhibits innovation have been under way for a long time and will continue. It is too early to tell whether what appears to be the current trend is a good thing or a bad thing, and sound arguments can be made for both cases. There will be winners and losers regardless of where things wind up specifically, and the pendulum will likely swing again at some point,” Baker comments.
Lindsay Adams, IP attorney with New York City’s Day Pitney LLP, sees the pendulum swinging as well, but has a less sanguine view of the long-term impact. “There’s a paradigm shift taking place,” he says. “It’s going to be tougher getting patents going
forward. If you’re a TTO, it’s time to start thinking more about the quality of the patents you’re applying for than the quantity.” In addition to Myriad, Bilski, and KSR, he points to the federal circuit’s recent ruling in Ariad Pharmaceuticals Inc. v. Eli Lilly, part of which addresses the distinction between basic research results and patentable subject matter. “It’s a game-changer, a shot across the bow,” he says. “There’s a quote in the slip opinion that TTOs should know about: ‘Patents are not awarded for academic theories, no matter how groundbreaking or necessary to later patentable inventions of others.’” Citing another case, Brenner v. Manson, the majority opinion noted that “[a] patent is not a hunting license. It is not a reward for the search, but compensation for a successful
conclusion.” That’s problematic for TTOs, Adams says, because it goes to the heart of a common campus scenario. “PIs want to patent their basic research,” he explains. “Now, though, you’ve got to have it fleshed out in much more detail or you won’t get a patent. That’s a scary one, and I doubt the Supreme Court will touch it, because it’s in line with its current thinking.” An in-depth article analyzing the Myriad case and its impact on TTO patent activity appears in the May issue of Technology Transfer Tactics. To start a subscription, including access to three years of archived articles, CLICK HERE.