In an article published on November 20, 2024, in Law360, AGG Intellectual Property partner Matt Zapadka and AGG patent agent John Schneible discuss the patent infringement case, Wyeth LLC v. AstraZeneca Pharmaceuticals LP, and takeaways for practitioners that may help mitigate the risk of future patents being invalidated should the Federal Circuit adopt the reasoning employed in the case.
Matt and John explain the background of the case, which began when Wyeth sued AstraZeneca in September 2021. The case eventually proceeded to trial after which a jury found Wyeth’s claims valid. The jury also found AstraZeneca liable for infringement, awarding Wyeth $107.5 million in damages.
While it is unclear whether the Federal Circuit will affirm the district court’s decision, Matt and Jon suggest practitioners avoid drafting claims where a therapeutic agent is defined only by its function. Practitioners should also draft claims to expressly recite numerical dosages, which may help mitigate the risk of having a patent invalidated as a consequence of the specification being read into the claims during litigation.
Finally, Matt and John emphasize the importance of advising clients to undertake pre-clinical studies to evaluate upper bounds for the safety and toxicity of novel compounds that they are seeking to patent.
“While these studies may not give the exact value for the upper bounds of safety and toxicity in humans, they can provide a rough estimate,” said Matt and John. “This information can be used by practitioners to draft claims that can help mitigate the risk of invalidation.”
To view the full article, please click here (subscription required).
- Matthew D. Zapadka
Partner
- John D. Schneible Ph.D.
Patent Agent
