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Federal Circuit Upholds Injunction Against Roche, but Puts Some Amgen Patents at Risk
The National Law Journal
September 18, 2009
A recent U.S. Court of Appeals for the Federal Circuit ruling on Amgen Inc.'s lucrative patents relating to the production of the protein erythropoietin upheld a permanent injunction barring Roche, F. Hoffman-La Roche Ltd.'s Swiss parent, from selling Mircera in the United States. But in making rulings that place some of Amgen's patent claims at risk, the decision highlights how careful patent filers must be when filing nearly identical claims.
The panel issued several rulings in the Sept. 15 decision, Amgen Inc. v. F. Hoffman-La Roche Ltd., including a number upholding jury findings that concluded that Roche's renal anemia treatment drug Mircera would infringe on Amgen patents if imported into the United States. The Federal Circuit also reversed a noninfringement ruling of the lower court, the District of Massachusetts, on a fifth patent and ordered a new trial.
But the key ruling for the patent bar involves the Federal Circuit's decision to vacate the lower court's summary judgment and judgment as a matter of law for Amgen on just five of the claims in three patents.
The Federal Circuit ordered the lower court to reanalyze those claims in light of the so-called obviousness-type double patenting doctrine.
Under the doctrine, courts can invalidate nonidentical patent claims that are so close that the differences between them are "obvious," meaning that the advancement could have been anticipated by someone skilled in the technology, said William McNichol, a Philadelphia intellectual property and corporate partner at Reed Smith, who was not involved in the case.
McNichol, however, is familiar with the patent in question. He filed an amicus brief in a Federal Circuit case involving an expired Amgen patent, one that Roche claimed in the recent case should have invalidated the claims in question for obviousness-type double patenting. McNichol represented Washington-based importer Parliament Imports supporting Amgen's opponent, Chugai Pharmaceutical Co. Ltd., in the case, which was an appeal from the International Trade Commission.
The recent Federal Circuit ruling describes the obviousness-type double patenting doctrine as a way to prevent patentees from making extremely similar claims in different applications in order to extend the patent protection period of the invention.
The case is important because "Amgen was certainly not unique in proceeding the way it did," and managing patent life cycles is a very big deal in the pharmaceutical industry, McNichol said.
McNichol said that patent filers can avoid such court fights by filing divisional applications, which divide patent claims into multiple applications, in response to a U.S. Patent and Trademark Office determination that there's more than one invention described in an application for very similar claims. Division applications expire at the same time as the original application, McNichol said.
"All pharmaceutical companies are working to make sure they legitimately get the longest protection available," McNichol said. "What Amgen encountered here, at least with respect to these patents, [is that] it may have gone too far."
Amgen's main lawyers in the Federal Circuit case, from Washington-based Howrey, did not return a call for comment.
In a press release, Amgen's senior vice president and general counsel David Scott stated that the company is pleased with the decision because "successful enforcement of intellectual property rights enables Amgen to continue to invest in truly innovative new medicines."
"Biotechnology innovation is complex, expensive and extremely risky," Scott stated. "Companies and investors need appropriate intellectual property protection to justify the risk and to realize an appropriate return on investment." The company's press release also said the obviousness-type double patenting issue sent back to the district court "only impacts Amgen's later expiring patents."
Roche's main attorneys at New York-based Kaye Scholer also did not return calls for comment.
In an e-mailed statement, Roche's public affairs director, Christopher Vancheri, stated that Roche is pleased that the court ruled in the company's favor on some of the matters, but disappointed in the court's other findings.
Vancheri also stated that the Federal Circuit ruling doesn't change the company's business operations because it upheld the lower court's injunction barring Roche from selling its anemia-treatment drug, Mircera, in the United States. "Roche maintains its position that all of Amgen's patents asserted against Roche are invalid and not infringed, and believes the facts and the law support that position," stated Vancheri.
