The GSK v. Teva case is great for Amarin. See analysis of it from Cooley Law Firm below. This case may be stuck in the courts for years through a future appeal and possibly the Supreme Court. The more it is tied up / delayed the greater uncertainty generics have about what this means in terms of liability / lost profit / billions of damages. Essentially the longer they have to stay on the sidelines from having a material presence in the USA market.
No bueno especially for those smaller generics (Hikma & Dr. Reddy's).
This is like the sports analogy of just running out the clock. Delay delay delay...you can't score if you don't have the ball.
Consequences for generic drug and biosimilar cases going forward
Brand manufactures in post-launch cases now have a roadmap to seek damages for induced infringement even when the generic has expressly carved-out the infringing use from its FDA-approved label. Applying the majority's reasoning, brands can build a circumstantial case to demonstrate inducement by pointing to evidence beyond the label, including external communications that generally announce equivalence between the generic and brand drugs; testimony that physicians know of and rely on such communications; and the generic's knowledge of possible revenue from off-label infringing uses. In light of the GSK decision, brands will seek to develop evidence to prove that generics know they will profit from infringing sales even if they don't include them on their skinny label.
Generics and biosimilars pursuing a skinny label strategy to carve out patented treatment methods of an otherwise unpatented drug should carefully evaluate all external communications, promotional materials and market predictions for evidence implying the generic can or will be used for the infringing method of use. This evaluation is further complicated in situations where the FDA requires the inclusion of certain information on the drug label that could serve as additional evidence of inducement. Several existing cases may inform the steps a generic or biosimilar manufacturer could consider to avoid induced infringement liability, such as express negative statements in their label and/or marketing stating that the product is not approved for the infringing method of use.27
Teva has already stated it will appeal the decision and may seek en banc review by the full Federal Circuit. Either party might seek Supreme Court review of any future appellate ruling, giving the high court the opportunity to revisit induced infringement liability for the first time since their 2011 Global-Tech decision. Due to the timeline remaining for appeals and the importance of clear standards on this issue for the industry, expect stakeholders to utilize the majority and dissenting opinions for months if not years to come. Take home lessons for the biopharmaceutical industry
Brand manufactures and reference sponsors may more aggressively pursue induced infringement claims in skinny label cases. Proposed jury instructions that would require proof of direct, proximate causation between the defendant and the infringing physician's conduct will be challengable under GSK. Generic drug and biosimilar manufacturers pursuing skinny label strategies should scrutinize all aspects of their promotional materials, market predictions, other content of labels and any other external communications, to ensure they will not trigger liability under GSK's view of acceptable evidence for induced infringement. As further appeals continue, the standards for induced infringement liability in post-launch cases will likely remain unsettled for months to come.
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