The recent judgment in Amgen v Sanofi by the United States Supreme Court has generated significant attention within the legal and patent communities. The ruling addresses the crucial issue of enablement requirement, marking the first time in several decades that the apex court has opined on this matter. With implications for life sciences patents and patent strategies as a whole, the decision clarifies the boundaries of patent enablement and its impact on broad, functionally defined claims.
Enablement Requirement and Amgen's Patents:
The enablement requirement, one of the prongs of Section 112(a) of the Patent Act, mandates that patents teach a skilled person how to make and use the invention across its full scope without undue experimentation. In the case of Amgen's patents, which included broad claims regarding the use of PCSK9-inhibiting antibodies to lower bad cholesterol, the court affirmed the invalidation of these patents for lack of enablement.
The Court's Ruling and Principles of Enablement:
The Supreme Court's ruling emphasizes the fundamental principle that the broader the claims made by a party, the more extensive the enablement must be. It cites previous cases to support the notion that this principle applies across technology types and highlights that the specification need not describe every single embodiment within a claimed class with particularity. However, the specification must enable any person skilled in the art to make and use the invention in clear terms.
Roadmap and Conservative Substitution:
The court's decision scrutinizes Amgen's argument that its patents were enabled through a "roadmap" for differentiating operative and inoperative embodiments using routine techniques. However, the court finds that these approaches merely amount to research assignments and do not relieve the skilled person from engaging in undue experimentation. The ruling suggests that trial-and-error instructions alone are unlikely to satisfy the enablement requirement.
Implications for Broad Genus Claims:
The Supreme Court's ruling aligns with Federal Circuit case law, leading to concerns that broad genus claims, especially in the life sciences sector, may face challenges. The decision imposes a higher hurdle for enablement when it comes to functional limitations and double-functional limitations. It highlights the importance of a predictable relationship between structure and function in functional claiming.
Divergent Positions of Pharma Innovators:
Amgen v Sanofi has divided pharmaceutical innovators, revealing a growing trend of innovator-versus-innovator disputes in the life sciences sector. Major pharma companies have taken different positions based on their patent strategies, with broad patents being increasingly asserted to maintain market exclusivity or seek damages/royalties from competitors.
Impact on Biotechs and Tech Transfer:
Smaller biotech companies and university tech transfer departments may face challenges due to the ruling, as they often have limited resources for extensive experimentation before patent filing. The decision underscores the difficulty of maintaining broad patents and preventing premature disclosure by academics.
Written Description and Future Considerations:
While the ruling primarily addresses enablement, it does not address the written description prong of Section 112(a). This prong requires a patent to demonstrate that the inventor possessed the entire invention at the time of filing. The issue of written description has been the subject of previous Supreme Court petitions and remains a concern for the patent community.
The US Supreme Court's ruling in Amgen v Sanofi provides clarity on the enablement requirement and its implications for patent claims, particularly in the life sciences sector. By reaffirming the importance of comprehensive enablement and raising the bar for broad, functionally defined claims, the decision sets a precedent for future patent cases. The ruling has broad implications for patent strategies, pharmaceutical innovators, and the challenges faced by biotechs and tech transfer departments. As patent law continues to evolve, it is essential for innovators and legal scholars to closely examine the Amgen v Sanofi decision and its potential impact on the development and protection of intellectual property.