PIPLI to the Supreme Court: Uphold the Patent System’s Promise to the Public

Alex Moss | February 20, 2023

Patents give their owners certain exclusive rights, and they’re supposed to give the public something too: information that allows others in the field to make and use the patented invention. This exchange of exclusive rights for publicly available information ensures the patent system benefits everyone, but only if owners get rights to the same invention they enable others to make. Otherwise, patents would restrict the public’s access to knowledge by more than they contribute.

Even though this exchange is fair and balanced, it is in danger. In Amgen v. Sanofi, the Supreme Court will decide whether to change the rules so that disproportionately favor patent owners. Specifically, the question before the Court in Amgen is whether patent owners must enable the full scope of the inventions they claim or whether it is enough to enable only a sliver. This legal principle is critical to the patent system, but the stakes of this case are also practical: patient’s ability to access a drug for lowering cholesterol hangs in the balance.  

Thanks to Georgetown Law Intellectual Property and Information Policy (iPIP) Clinic students Sumaia Tabassum and Ian Stubbs, and Visiting Professor and Acting Director Nina Srejovic, the Public Interest Patent Law Institute (PIPLI) submitted a brief urging the Court to confirm that patents must enable the same invention they claim. PIPLI is deeply grateful to Sumaia, Ian, and Nina for their wisdom, time, and counsel.

The patents in the case claim monoclonal antibodies (lab-made proteins which act like proteins our bodies naturally make) that help lower levels of “bad” cholesterol (low density lipoprotein or LDL). They do so by binding to an enzyme (PCSK9) in the bloodstream that would otherwise bind to bind to LDL, effectively taking LDL’s seat on the PCSK9 bus. That allows more LDL to circulate freely, which, in turn, allows the liver to remove more LDL from the bloodstream.

Both companies in the case, Amgen and Sanofi, make therapeutic monoclonal antibodies that lower bad cholesterol by binding to PCSK9: Amgen’s product is Repatha, Sanofi’s is Praluent. These antibodies function similarly, but they are not the same. They have different genetic sequences, different physical structures, different ways of binding to PCSK9, and different effects on patients. Both companies also have patents on antibodies with particular features, like genetic sequences. But this case is about patents Amgen obtained that claim much more.

These Amgen patents claim all antibodies that bind to PCSK9 in place of LDL. They do not define the antibodies based on any distinguishing features—just the result they achieve (binding to PCSK9). These broad functional claims might be appropriate if Amgen’s patents provided enough information for others to make all antibodies that can bind to PCSK9, but they do not. There are numerous, if not countless, different antibodies that can bind to PCSK9 in place of LDL, including many yet to be discovered. Amgen’s patents describe only a small number of particular antibodies that Amgen developed using decades-old technology and the age-old method of trial and error.

Given the gap between the information the patents provide and their expansive claims, the district court and Federal Circuit held the patents invalid for failing to enable the claimed invention. That decision is right on the law and good for the public. As the decision has made it more difficult for Amgen to monopolize the market for this kind of cholesterol medication, Amgen asked the Supreme Court to overturn it. The crux of Amgen’s argument is that teaching others how to make some antibodies capable of blocking LDL is enough for it to claim all such antibodies.  

If the Supreme Court agrees, the law will drastically change: patent owners will get bigger monopolies while providing less information to the public than ever. In the short term, this change could prevent patients from getting Sanofi’s product, Praluent either because it is forced off the market or because its price becomes so high that patients cannot afford it. In the long term, it could encourage patent owners to claim more expansive rights and provide less information. That would increasing the cost that future patents impose on the public while reducing the benefits they provide.

 Our brief urges the Supreme Court to prevent that from happening by confirming that patents must enable as much as they claim. This rule is faithful to the Patent Act’s text, patent system’s purpose, and the public’s interest in encouraging the development and accessibility of medical care. Research shows that broad functional patent claims are associated with higher drug prices and less competition for biologic drugs like Praluent and Repatha. Opening the door to more of them will aggravate the drug pricing crisis in this country while shrinking the space available for the development of new drugs, including those that might be safer and more effective.

Allowing patent owners to monopolize technology they do not enable is bad for the patent system, the public, and companies, like Sanofi, that develop and patent their own inventions. We will keep watching and working to ensure the patent system promotes the advancement and accessibility of scientific advances.