Sanofi-Aventis v. Glenmark (Fed. Cir. 2014)
In a post on the Patent Ethics site, Professor Hricik highlights this case with the following headline: CAFC Affirms Adverse Inference Instruction Due to Spoliation.
Post Filing Recognition of Synergy: For patent prosecutors, an important headline from the case would also be: “Synergy” of patented combination that was only recognized after the application filing can still be used to prove non-obviousness. Here, that principle was applied by the appellate panel in affirming the jury’s decision that Glenmark had failed to prove Sanofi’s patent obvious.
Some background: Sanofi’s patent No. 5,721,244 covers the combination of both trandolapril (an ACE inhibitor) and a calcium channel blocker, combined “in amounts effective for treating hypertension.” A licensed drug covered by the patent is distributed by Abbott under the brand name Tarka. Mumbai-based manufacturer Glenmark filed an abbreviated new drug application (ANDA) with the FDA requesting permission to begin selling its generic version of the drug prior to patent expiry. In order for a generic manufacturer asking to receive permission to sell a drug that that the branded manufacturer has listed in the Orange Book as covering the product, the generic manufacturer must also submit a “Paragraph IV Certification” indicating their allegation that the patent is either invalid or will not be infringed by the generic activities. See 21 U.S.C. §355(j)(2)(A)(vii).
Under the Hatch-Waxman rules, an FDA filing with a Paragraph IV certification is a form of patent infringement and here Sanfi sued – alleging infringement. That lawsuit then triggered a 30-month stay in FDA approval of the generic product. However, once the stay concluded Glenmark launched its generic product (all while the district court case continued). Glenmark’s defense was invalidity, but the jury sided with the patentee that Glenmark’s proof was insufficient and the resulting damages were $16 million in lost profits and price erosion damages.
Patent Validity: The patented invention is a combination of two known hypertension medications. However, there was no evidence that the combination was known. The question thus, was whether the combination was obvious. The appeal of obviousness questions is tricky because obviousness itself is a question of law that must be supported by factual conclusions drawn from the evidence. A jury’s factual conclusions must be supported by “substantial evidence” (a fairly low standard), but any legal conclusions are reviewed de novo. “When the question of obviousness is tried to a jury, on appeal we ascertain whether the jury was correctly instructed on the law, whether there was substantial evidence in support of factual findings necessary to the verdict, and whether the verdict was correct on the supported facts.” Here, the jury was apparently not asked to report its particularly factual conclusions but instead only whether the claims were obvious. In these black-box scenarios, the jury verdict is difficult to overturn on appeal because the implicit factual findings are so difficult to pin-down and therefore challenge.
At the time of the invention (1986) it was apparently already known to combine ACE inhibitors with CC-blockers and Glenmark argued that the use of trandolapril was merely a substitution of one known ACE inhibitor for another. Sanofi argued that there were thousands of potential ACE inhibitors and none of the prior art suggested that the particularly claimed drug (trandolapril) was the best. In reviewing these arguments, the court sided with the patentee.
Post-Filing Recognition of Benefits: Some of the “synergistic benefits” of the drug combination were not recognized until after the patent application was already filed. In the appeal, the Federal Circuit held that those benefits were perfectly acceptable as evidence of non-obviousness. The court writes: “patentability may consider all of the characteristics possessed by the claimed invention, whenever those characteristics become manifest.”
How Many Plaintiffs to Screw in a Lightbulb? Another interesting aspect of the decision is whether the four plaintiff here had standing to sue. According to the case, Sanofi-Aventis Deutschland GmbH is the owner of the patent at issue and Aventis Pharma S.A. is the exclusive licensee of that patent. Abbott GmbH contracted with Aventis for the “irrevocable sole and exclusive right” to sell the drug product under the patent and Abbott Labs is the holder of the FDA-approved new drug application. Finally, ALI is the exclusive U.S. distributor for Abbott Labs.
Based upon this mess, Glenmark argued that only Abbott Labs held rights to sue on Hatch-Waxman claims (as holder of the FDA-filing) but that it did not have standing because it was neither owner nor exclusive licensee of the patent rights. On appeal, the Federal Circuit rejected this argument – agreeing with the district court that the relationships and agreements amongst the various plaintiffs resulted in Abbott Labs holding exclusive rights to the patent and thus having standing to sue. In addition, the court saw that it was important that “all entities in the license chain joined in the suit, such that there is no danger of multiple suits for infringement.”