A patent case that has reached the United State Supreme Court has the potential to send shockwaves throughout the biopharmaceutical industry. Drugmakers and innovators in the industry have called the case a key test of their ability to earn, enforce, and defend patents for ground-breaking biological inventions.
The case pits Amgen against Regeneron and Sanofi in a dispute over blockbuster monoclonal antibody therapeutics for patients with heart disease. On Friday, November 4, the United States Supreme Court agreed to hear Amgen’s appeal. It will review the second of the Questions Presented in Amgen’s appeal petition:
Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 35 U.S.C. §112, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “‘time and effort,’” Pet.App. 14a (emphasis added).
The Supreme Court will likely hear arguments in the spring and reach a decision by the end of June 2023. That decision is anticipated to have a major impact on how companies implement patent and research strategies. The Court will likely determine whether broad functional patent claims are allowable, as they currently exist in this industry, or whether patentees will be required to more specifically identify and reach the “full scope” of all of the potential antibodies that have the same function in their claims.
The original case began in 2014, when Amgen sued Sanofi and Regeneron over sales of Regeneron’s antibody product Praluent (alirocumab), used to treat patients with heart disease by targeting the cholesterol-regulator PCSK9. Praluent competes with Amgen’s antibody product, Repatha (evolocumab). Amgen asserted a pair of patents (U.S. Patent Nos. 8,829,165 and 8,859,741—collectively, the “Amgen Patents”), which both claim a genus of antibodies that allegedly covered and included Praluent.
The Amgen Patent claims are directed to a functional genus of monoclonal antibodies that bind and block PCSK9. PCSK9 is an enzyme that binds to low-density lipoprotein (LDL) receptors and causes them to degrade. The antibodies claimed in the Amgen Patents block the binding of PCSK9 so that LDL receptors are not targeted for degradation, enabling them to continue to mop up LDL cholesterol. High levels of LDL cholesterol in the blood have a significant role in the development of heart disease. Thus, the antibodies claimed by the Amgen Patents are important tools in the treatment of individuals that suffer from heart attacks and other ailments related to elevated LDL cholesterol.
Amgen and its supporters argue that broader protection on functional genus claims is necessary to protect biopharmaceutical innovation. They believe that without the protection of these broad claims, competitors can make minor changes to their technology and generate lucrative competitive drugs without having to commit the same amount of time and resources to the R&D process. They argue that this hurts innovation by failing to reward the true innovators of new technologies, which are usually very expensive to develop in the biopharmaceutical industry.
On the other hand, critics argue that patents with broad functional genus claims—like the claims from the Amgen Patents in this case—illegitimately block entire classes of would-be rival drugs with overly broad claims. They believe that these types of patents hinder smaller incremental changes in innovation and lead to unnecessarily high drug costs. Some argue that these types of claims encourage the abuse of the patent system by allowing companies to protect far more than what they have truly invented.
The stakes are extremely high for patents that have already issued and that protect blockbuster biotechnology and biopharmaceutical inventions already on the market. In recent years, these inventions have become more vulnerable to invalidation when scrutinized (in federal district court) under a 35 U.S.C. §112 review during litigation. A decision in favor of Sanofi and Regeneron could trigger a tidal wave of litigation directed against biopharmaceutical innovators that use functional genus claims to define their inventions by their function or by a result that they achieve. Such a result could be devastating to the industry that so heavily relies on the patent protection of functional genus claims.
The Supreme Court’s decision to review the merits of the Amgen case is a positive sign that patentees in the biopharma industry will see the pendulum shift back in favor of functional genus claims without a need to meet a higher standard to show the enablement of patent claims. However, there is great concern that any change or reset of the current enablement standard will dramatically affect the industry and how patents are procured and enforced.
Industry stakeholders on both sides of this issue will be closely watching this case, and hope that the eventual decision will lead to more predictability in the outcome of patent acquisition and litigation.
Patrice P. Jean, JD, PhD, is Chair of the Hughes Hubbard’s Life Sciences group. She has more than a decade of experience counseling pharmaceutical and biotechnology companies in patent law. She earned her PhD in molecular biology and conducted research in various areas of biochemistry including virology, oncology, kidney disease, X-ray crystallography and narcotics addiction.
