Pharmaceuticals

Amgen Inc. v. Sanofi

Issues

Should the enablement requirement of a patent claim focus on whether the disclosures simply enable skilled people in the field to “make and use” the claimed invention or whether the disclosures accurately enable the “full scope” of the invention – all variations of the invention that fall within the patent claim’s description of the invention; and, would a relatively easy trial-and-error procedure equate to undue experimentation?

This case asks the Supreme Court to clarify whether Amgen’s disclosure of common techniques – a trial-and-error procedure and amino acid substitution technique – is sufficient to satisfy the enablement requirement for Amgen’s patent claim over all antibodies that bind to PSK9 protein and block PSK9 protein’s ability to bind to LDL receptors. Amgen argues that the focus of the enablement standard should be on whether the disclosure leads people to “make and use” the claimed invention and that common techniques do not amount to undue experimentation. Sanofi counters that the disclosures should be specific for broad patent claims and that Amgen’s trial-and-error techniques amount to undue experimentation. This case has significant implications on future innovation in the pharmaceutical industry and the patent law system.

Questions as Framed for the Court by the Parties

Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 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.” 

Heart disease and cholesterol named elevated low-density lipoprotein (“LDL”) are correlated. Amgen Inc. v. Sanofi, Aventisub LLC. at 1082. When cholesterol is in the blood stream, the LDL receptors remove LDL cholesterol. Id. And the degradation of LDL receptor is regulated by an enzyme named proprotein convertase subtilisin/kexin type 9 (“PCSK9”). Id. at 1082–83.

Acknowledgments

The authors would like to thank Professor Oskar Liivak for his guidance and insights into this case.

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Mutual Pharmaceutical Co. v. Bartlett

After receiving a prescription for sulindac, the generic version of Clinoril, Karen Bartlett developed Stevens-Johnson Syndrome and toxic epidermal necrolysis, rare skin disorders that causes the sufferer’s skin to deteriorate by either being burned off or by turning into an open wound. Bartlett subsequently suffered painful, permanent injuries, including near-blindness, esophageal burns, and lung damage. A New Hampshire federal jury awarded Bartlett $21.06 million for her injuries based on a New Hampshire products liability claim for defective design. Mutual Pharmaceutical Company, a sulindac manufacturer, now challenges that decision by arguing that federal law regulating generic drugs preempts New Hampshire's design-defect law. The United States Court of Appeals for the First Circuit upheld the lower court design, finding no preemption, despite Supreme Court precedent finding preemption in similar contexts. Mutual Pharmaceutical argues that the Food, Drug, and Cosmetic Act preempts the state design-defect law because the Act requires generic drug manufacturers to produce generic medications that are bioequivalent to the corresponding name brand version of the drug. Bartlett responds that the state law does not conflict with federal law because the state law imposes no duty for sellers to change their product from the name brand version. 

Questions as Framed for the Court by the Parties

Whether the First Circuit erred when it created a circuit split and held-in clear conflict with this Court's decisions in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011); Riegel v. Medtronic, Inc., 552 U.S. 312 (2008); and Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992)-that federal law does not preempt state law design-defect claims targeting generic pharmaceutical products because the conceded conflict between such claims and the federal laws governing generic pharmaceutical design allegedly can be avoided if the makers of generic pharmaceuticals simply stop making their products. 

Issue

Does federal law governing claims against generic pharmaceutical products preempt state law design-defect claims against the makers of those products?

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