Two pharmaceutical giants, Amgen and Sanofi, are currently locked in a fierce battle over the validity of Amgen’s patent covering cholesterol-lowering antibodies. The dispute involves patents for Amgen’s drug, Repatha, which lowers bad cholesterol by inhibiting a protein known as PCSK9. The case is set to have far-reaching effects on US patent law and competition among companies that make antibody medicines.
Dispute Over Amgen’s Patent in Supreme Court
The Supreme Court will soon decide whether Amgen’s patent is too broad to be valid under federal patent rules. The patent covers a genus of monoclonal antibodies that bind to particular sweet spots on the PCSK9 protein and block it from binding to LDL receptors. It includes details for 26 example antibodies and a process to identify others from a pool of potentially millions of candidates.
Sanofi claims that Amgen’s patent “claims a lot and discloses a little” and infringes on Sanofi’s antibody, which falls within the scope of Amgen’s patent but is not one of Amgen’s 26 examples. Sanofi argues against allowing Amgen’s broad patents to freeze out other companies.
Amgen argues that courts should not consider the “cumulative time and effort” that it may take to “reach the full scope” of the patent. The central issue is how to apply the enablement requirement when a patent claims a broad genus of things, which is defined by how the things work, and only a small number of the things are likely to work at all. The real question is whether broad “genus” patents will remain viable.
Revival of Patents on Repatha
In addition to its battle over patents for cholesterol-lowering antibodies, Amgen seeks to revive patents on Repatha. Rival Sanofi urges the Supreme Court not to stifle competition for therapies. The case involves patents on laboratory-made antibodies. Justices seek to clarify the technical issues involved and determine the validity of patents. The case carries considerable financial stakes for both companies.
The U.S. Court of Appeals for the Federal Circuit invalidated Amgen’s patents regarding a group of antibodies. President Joe Biden’s administration supports Sanofi and argues that Amgen had not disclosed the information needed to make its patents valid.
Potential Impact on US Patent Law and Competition among Pharmaceutical Companies
A ruling in the case is expected by the end of June. If successful, Amgen would claim ownership of all antibodies that inhibit the PCSK9 protein, which is the mechanism of action for both Repatha and Praluent. Sanofi and Regeneron argue that broad patent protection like that sought by Amgen is not allowed by US patent law.
The Supreme Court could either maintain the legal status quo or make it easier for pharmaceutical companies to muscle competitors out of some market areas with broad patents that cover more ground. The case might also affect newer technologies used in medicine, such as CRISPR gene editing and messenger RNA. The immediate financial impact of the decision is limited to the companies involved, although it could give some an advantage in future litigation.
According to market research consultant Global Market Insights, the monoclonal antibodies market was worth $181 billion in 2021. Under US patent law, drug companies can get 20 years of market exclusivity for publishing their inventions.
In conclusion, Amgen’s dispute with Sanofi over its patent covering cholesterol-lowering antibodies has far-reaching implications for US patent law and competition among pharmaceutical companies. The Supreme Court’s ruling will determine whether broad “genus” patents will remain viable and could have an impact on newer technologies like CRISPR gene editing and messenger RNA.
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