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UTRF Administrator / September 7, 2023

How much information needs to be included in a patent?

By Haley Rainwater, UTRF Legal Extern

Patent law is a little odd in that it creates a monopoly for the patentee for a limited time, and monopolies are generally disfavored under the law. However, this limited monopoly is considered beneficial to the public because in exchange for the patent, the patentee must teach the public in their patent how to make and use the new invention in their patent application.

In this way, the public gets the benefit of how to make and use the new technology, whereas the patentee gets rights to the invention for a limited time. That quid pro quo exchange is the fundamental bargain upon which patents are granted. In Amgen v. Sanofi, the U.S. Supreme Court recently considered how much information needs to be disclosed in order to obtain a patent. 

Amgen makes the drug Repatha, which is an injectable antibody that helps reduce low-density lipoprotein (LDL) cholesterol by inhibiting the enzyme PCSK9. Amgen has several patents covering Repatha, including one which claims any antibody that inhibits PCSK9. Such claims are often referred to as “genus” claims because they cover all of the individual species that make up the genus.

A genus claim has broad coverage of an invention; it is often a patent that covers a group of structurally related chemicals rather than one specific chemical. A clear genus claim provides enough information for a person skilled in the art to determine whether his/her invention will fall within the genus. In other words, the subsequent inventor should have enough information to make and use part of the genus without undue experimentation. The broader a claim’s scope, the more information the inventor must disclose.

In Amgen’s case, their patent application disclosed twenty-six PCSK9 inhibiting antibodies, as well as directions on how more might be made, and using that they sought to patent all possible PCSK9 inhibiting antibodies. After obtaining that patent, Amgen then sued Sanofi for patent infringement, asserting that Sanofi’s drug Praluent, which is also an antibody against PCSK9, infringed Amgen’s patent.     

At issue was the scope of Amgen’s patent claims, which sought to cover all antibodies against PCSK9. The provided twenty-six antibodies were accepted by the Court, and their validity was not questioned. The claims to the antibodies themselves were accepted because the patent application sufficiently enabled a person skilled in the art to make and use Repatha.

However, the claims encompassed a scope broader than the antibodies. Sanofi argued that Amgen’s patents were invalid because they covered more material than was actually disclosed in patent applications. In essence, Amgen did not live up to their end of the bargain with the patent office because they did not disclose enough information such that the public could make antibodies under the full scope of the claims, i.e., all possible PCSK9 antibodies.

The Court concluded that Amgen’s functional claims over the entire genus of antibodies that bind to and block all PCSK9 were invalid for lack of enablement. The twenty-six antibody examples were not enough to fully enable the make and use of the potentially millions of PCSK9 antibodies without an “undue amount of experimentation” and left the user to “trial and error.” In other words, the twenty-six antibodies were not representative of the entire genus, and Amgen failed to enable a person skilled in the art to fully make and use the entire scope of the claimed invention.

However, a specification does not necessarily need to describe how to make and use every embodiment or “species” of a genus claim. Methods such as those questioned in Amgen may be sufficiently enabling where the specification identifies a quality of the class that is common to every functional element. There, it may suffice to give several examples that otherwise demonstrate a common element that would be consistent in other embodiments. Furthermore, a specification is not necessarily inadequate where it requires a person skilled in the art to conduct a reasonable amount of testing needed to adapt the invention for a particular use. Reasonableness will depend on the nature of the invention.  

For questions concerning patenting, technology transfer, or licensing, contact the University of Tennessee Research Foundation here.

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