The war between Patents v Generics: GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc.
- Sarvesh Saxena, Attorney
- Jul 9, 2024
- 4 min read
Case Facts:
Parties Involved: GlaxoSmithKline LLC (GSK) and Teva Pharmaceuticals USA, Inc.
GSK developed and marketed the drug carvedilol under the brand name Coreg®. Carvedilol was initially approved for treating hypertension and later for congestive heart failure (CHF). Relevant patents include U.S. Patent No. 4,503,067 (expired 2007) and the '000 patent for the method of treating CHF.
Teva's Generic: Teva applied for FDA approval of a generic version of Carvedilol with a "skinny label," excluding the CHF indication to avoid infringing GSK's patent, focusing on non•patented uses (hypertension and post•myocardial infarction left ventricular dysfunction (post•MI LVD)).
A "skinny label" allows a generic drug manufacturer to market a generic version of a drug by excluding patented uses from its labeling, thereby avoiding patent infringement. This approach enables the generic drug to enter the market for non-patented uses under the Hatch-Waxman Act. It's a strategy to bring lower-cost medications to market without violating specific drug indication patents.
Legal Proceedings
GSK sued Teva in 2014, alleging that Teva induced infringement of the '000 patent by marketing its generic carvedilol.
Key Arguments:
A. GSK’s Arguments:
• Inducement of Infringement: GSK argued that Teva’s marketing of its generic carvedilol, even with a skinny label, indirectly caused doctors to prescribe it for CHF, thus infringing the '000 patent.
• Evidence of Inducement: GSK pointed to Teva’s promotional materials and the fact that generic carvedilol was marketed as therapeutically equivalent to Coreg®, which included CHF treatment
B. Teva’s Defence:
• Compliance with Skinny Label Regulations: Teva contended that its skinny label, excluding CHF treatment, was in compliance with regulatory requirements and did not induce infringement.
• Lack of Direct Evidence: Teva argued that GSK failed to provide sufficient evidence showing that Teva’s actions directly caused doctors to infringe the '000 patent
Cases Cited:
1. Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S: This case was referenced regarding the proper use of skinny labels and the statutory provision allowing generics to market drugs for non•patented uses without inducing infringement
2. Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals: Cited for the principle that a label’s content could imply inducement if it encouraged an infringing use.
3. Sanofi v. Watson Laboratories Inc.: Also referenced in relation to the impact of product labels on inducement of patent infringement.
Jury Verdict and JMOL:
• Jury Verdict: The jury found Teva guilty of inducing infringement and awarded GSK $234,110,000 in lost profits and $1,400,000 in royalty payments, totalling $235,510,000
• Judgment as a Matter of Law (JMOL): After the jury's verdict, the district court granted Teva’s motion for JMOL, stating that the verdict of induced infringement was not supported by substantial evidence, and thus overturned the jury's verdict
• Appeals Court Reversal: The Federal Circuit reversed the district court’s JMOL decision, reinstating the jury’s verdict. The court found substantial evidence supporting the jury's conclusion that Teva’s marketing led to induced infringement of the '000 patent
"The jury also found that the infringement was wilful."- Judgment
Key Points Leading to GSK's Win:
1. Substantial Evidence of Inducement:
The Federal Circuit determined that substantial evidence supported the jury's finding that Teva’s marketing actions led to the prescription of generic carvedilol for CHF, thus infringing the '000 patent.
Judge Newman noted that "the jury’s verdict of inducement to infringe the ’000 patent" was supported by "substantial evidence" which included promotional materials, press releases, product catalogues, and testimony indicating that doctors were influenced by Teva’s marketing.
2. Circumstantial Evidence:
The court emphasised that circumstantial evidence could be used to establish inducement. This included evidence that doctors were prescribing Teva's generic carvedilol for CHF because Teva marketed it as therapeutically equivalent to Coreg®, which included CHF treatment
3. Promotional Activities:
• Even though Teva's skinny label did not mention CHF, the overall marketing strategy and promotional activities were seen as indirectly suggesting that Teva’s generic carvedilol could be used for CHF.
GSK’s expert testimony indicated that doctors were influenced by Teva’s communications, including references to the generic as an equivalent to Coreg®
4. Continuity of Marketing:
The court noted that Teva continued to market its product as equivalent to Coreg® even after the '000 patent was issued, which could be interpreted as encouraging its use for CHF.
This continuity in marketing efforts, including maintaining press releases and promotional materials on their website, played a role in the court's decision
The court found that Teva’s actions met the legal standard for inducement of infringement. This included knowing that its actions would lead to direct infringement by doctors prescribing the drug for CHF.
While the dissent argued that the precedent cases like Warner Lambert and Takeda supported Teva's position, the majority found that the circumstances in this case provided sufficient evidence of indirect inducement
Conclusion:
GSK prevailed in the case because the Federal Circuit determined that the combined evidence showed Teva’s marketing efforts, even with a skinny label, implicitly promoted the use of its generic drug for the patented CHF treatment. This holistic view of Teva's promotional strategy provided enough grounds to establish induced infringement, reinforcing the importance of cautious and clear marketing practices for generic drug manufacturers.
Source: GSK v. Teva
LEGAL ANALYSIS BY: Sarvesh Saxena, Barrister, Bar of England & Wales. Authorised to conduct unreserved legal services. No Rights of Audience.
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Legal Disclaimer:
This article is for general informational purposes only and is not legal advice. It may not reflect the latest legal developments and is not guaranteed to be accurate or complete. No attorney-client relationship is created by this article. Readers should seek professional legal advice from a qualified attorney in their jurisdiction before making any legal decisions. The author disclaims all liability for actions taken based on this article's content.
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