As we previously reported, the Federal Circuit recently conducted a panel rehearing in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. In this case, Teva petitioned the en banc court to reconsider the panel’s decision that Teva induced infringement through use of a skinny label on its generic version of GlaxoSmithKline’s (GSK) drug Coreg. Teva pointed to Hatch-Waxman and asserted that Congress provided a statutory “carve-out” mechanism allowing a generic to adopt a skinny label for unpatented uses that cannot be blocked by a patent on one method of using the drug. The panel treated the motion as requesting panel rehearing and granted panel rehearing. This is our recap of the rehearing oral argument.
Juanita R. Brooks argued for GlaxoSmithKline (“GSK”). She began by asserting that two supplemental cases cited by Teva before oral argument, HZNP Medicines LLC v. Actavis Laboratories UT, Inc., and Grünenthal GMBH v. Alkem Labs. Ltd., did not apply in this case. HZNP, she argued, did not apply because the patented method at issue in that case had never been approved by the FDA. Grünenthal did not apply, she continued, because the drug label in that case was a “true skinny label.” Chief Judge Prost asked if what made this case different was the fact that Teva’s label was a “partial label” rather than a “skinny label,” and Brooks agreed.
Brooks provided background information about how the case came before the court. In particular, she highlighted different clinical studies. She explained how two studies focused on patients with mild to severe chronic heart failure, while another study, the Capricorn study, focused on patients who had recently suffered a heart attack. She cited to expert testimony that explained the results of the different clinical trials, as well as to the court’s construction of “congestive heart failure.”
Judge Moore asked Brooks about the cross-examination of one of Teva’s witnesses and what was present on the Teva website in 2004. In particular, Judge Moore noted that the jury had been presented with press releases from 2004 and 2007, and Teva never refuted that those press releases had been on the website. She also came back to Chief Judge Prost’s question, asking if this would be a different case with a different outcome if GSK did not have an infringing indication on the Teva partial label. Brooks clarified that if the label indication at issue did not meet all limitations of the asserted claim, that this would be a true skinny label case.
Lastly, Brooks noted the actual jury verdicts: the jury found 3 of the 7 asserted claims infringed by the partial label, and all 7 claims infringed by the full label. The only difference in the verdicts, she explained, was the content of the labels, and the claims found not infringed contained limitations that could not be found on the partial label itself.
William Jay argued for Teva Pharmaceuticals. Jay started his argument by highlighting the purpose of the carve-out – “enabling the sale of drugs for non-patented uses.”
Judge Newman almost immediately started the questioning, noting the policy of interpreting Hatch-Waxman and the carve-out. She highlighted that, while Hatch-Waxman addressed the sale of drugs for non-patented uses, Congress was also very concerned about promoting research to develop new drugs. She asked Teva to focus on the public interest involved. In response, Jay noted that Hatch-Waxman strikes a balance between the interests of the patent owner and the interests of the public to access non-patented uses. Judge Newman highlighted concern about whether studies such as the Capricorn study would have been conducted without patent protection. Jay responded that nothing has changed with respect to the functionality of the carve-out from when those studies were conducted until today. Additionally, Jay stated that the patent owner has to prove that the generic encourages, promotes, or recommends the patented use, and he argued that Teva’s skinny label does not encourage, promote, or recommend it.
In response to a question from Chief Judge Prost, Jay cited a redline at the FDA, provided by GSK, that he argued Teva relied on to properly fall within the carve-out. He argued the redline reflected what Teva carved out in its label. Jay also focused on a claim construction that a patient needed to have been diagnosed with congestive heart failure. He also argued that mentioning heart failure or ace inhibitors would not induce doctors to perform the patented method.
Judge Moore began her questioning by noting that, while GSK’s expert stated that there was inducement, Teva’s expert did not disagree with that assessment. She also asked if it should be for the jury to determine whether there was infringement. Jay responded that case law supported the conclusion that Teva’s label did not encourage use of the patented method.
Judge Moore also noted that Teva’s use of the phrase “archived press release” seemed to indicate that the press releases were difficult to find, but she explained she was able to find the press releases upon a simple internet search.
In rebuttal, Brooks addressed Teva’s argument about how the carve-out was based on what GSK disclosed to the FDA. She read what the jury heard from the FDA’s regulatory expert: that FDA approval of Teva’s label did not mean that Teva had been found not to infringe any of GSK’s patents.