On March 27, 2023 the U.S. Supreme Court heard oral arguments in Amgen Inc. v. Sanofi and Aventisub LLC (Docket No. 21-757), a patent dispute originally filed by Amgen in late 2014. Amgen contends that Sanofi and Aventisub’s biologic, Praluent®, infringes seven U.S. patents, including U.S. Patent Nos. 8,829,165 (“the ‘165 Patent”) and 8,859,741 (“the ‘741 Patent”).
The ‘165 and ‘741 Patents purportedly cover antibodies that lower low-density lipoprotein (LDL) levels by preventing Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) from binding to LDL receptors which remove LDL from the bloodstream. The ’165 and ‘741 Patents share a common written description and abstract which describe the invention as:
- Antigen binding proteins that interact with Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) are described. Methods of treating hypercholesterolemia and other disorders by administering a pharmaceutically effective amount of an antigen binding protein to PCSK9 are described. Methods of detecting the amount of PCSK9 in a sample using an antigen binding protein to PCSK9 are described.1
Amgen contends that as early as 2007, it embarked on a path to research and develop fully human monoclonal antibodies to treat dyslipidemia.2 Amgen contends that, through its research, it discovered that the PCSK9 protein reduces the liver’s ability to remove LDL-C from the blood. In April 2013, Amgen filed the U.S. patent application that resulted in the issuance of the ‘165 Patent. In April 2014, Amgen filed the U.S. patent application that resulted in the issuance of the ‘741 Patent.
On August 28, 2014 Amgen filed a Biologics License Application (BLA) with the FDA seeking approval to market Repatha® (evolocumab) for the treatment of high cholesterol. The FDA approved Amgen’s BLA in August 2015. Amgen contends that it invested a total of $2.6 billion in the research and development of evolocumab and another 384 amino acid structures, 26 of which are disclosed in the common specification of the ‘165 and ‘741 Patents.
In their Counterclaims, Sanofi/Aventisub contend that Praluent® does not infringe the asserted patents and they allege that the ‘165 and ‘741 Patents are invalid for lack of enablement. As discussed during the oral argument, the issue before the Supreme Court is the scope of the legal standard for the enablement requirement of the U.S. Patent Act. Section 112(a) addresses enablement and states:
- The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.3
A patent or a specific claim of a patent may be invalidated for lack of enablement if a Federal court finds that a person skilled in the art would not be able to make or use the invention without "undue experimentation."
During oral argument, counsel for Sanofi/Aventisub conceded that Amgen should be awarded patent protection for the 26 amino acid structures explicitly disclosed in the ‘165 and ‘741 Patents, but argued that Amgen should not have been awarded patent protection for the other 384 amino acid structures because Amgen did not disclose the amino acid structures. According to counsel for Sanifo/Aventisub, “the roadmap Amgen provides is a trial-and-error process. . . . [It] is a routine process that people use to make independent inventions such as Pfizer, Merck, and Sanofi have done.”
Counsel for Amgen argued that the biotech industry “can’t take it any longer because you can’t invest $2.6 billion if the breadth of your claims is such that it means you can’t get adequate protection because, if you cover everything you invented, then it’s invalid because it’s too hard to make them all.” According to Amgen’s counsel, “the Patent Act requires patents to be concise and with only 26 amino acids [these patents are] already 380 pages long. They shouldn’t be required to have listed all 384 amino acid structures.”
In reply, Sanofi/Aventisub argued that “[t]he more you claim, the more you need to enable. If you claim a lot and enable a little, the public is short-changed, and the patent is invalid . . . They’ve overclaimed, they’ve underenabled, their patent is invalid.”
The court’s decision, expected in June, could impact numerous genus and similar patents that contain functional claims, and could dictate patent prosecution practices going forward not only for life sciences innovation, but for other technologies as well.
1 U.S. Patent 8,829,165; U.S. Patent 8,859,741.
2 Supplemental and Second Amended Complaint for Patent Infringement and Declaratory Judgement of Patent Infringement, September 15, 2015, p. 8.
3 https://www.law.cornell.edu/uscode/text/35/112