In the time since the Federal Circuit issued its Vanda Pharma decision in April, Vanda Pharm. Inc. v West-Ward Pharm. Intl. Ltd. 887 F.3d 1117 (Fed. Cir. 2018) the US Patent and Trademark Office (USPTO) has issued two memos to the examining corps which provide increased clarity and predictability in the determination of patent eligibility which is more good news for the eligibility of claims relating to diagnostic or similar tests utilized in treating patients. If you’re not familiar with the Vanda Pharma decision, and want more detail, see my previous post HERE.
Muriel Liberto, PhD, Esq. is a Member in the firm and is based in our New York office. She works with clients to obtain worldwide patent protection for their intellectual property, and has more than 10 years of experience responding to all aspects of clients’ intellectual property needs. She has drafted and procured patents for a wide variety of technologies in the biotech and pharmaceutical spaces. Muriel also focuses on IP-related aspects of corporate transactions, including confidentiality, materials transfer, licensing, and research collaboration agreements.
The Federal Circuit’s decision in Vanda Pharm. Inc. v West-Ward Pharm. Intl. Ltd. (2016-2707, 2016-2708 April 13, 2018) provided some good news on the subject matter eligibility front for innovators and other stakeholders in the personalized medicine space, as discussed in a previous post. So there is some hope for getting issued claims that will withstand a validity challenge under the Mayo/Alice framework. But what about enforcement? How does one prove infringement of claims that require various discreet steps that can, and typically are, performed by separate actors?
The Federal Circuit provided a welcome boost for stakeholders in the field of personalized medicine with its recent decision in Vanda Pharm. Inc. v West-Ward Pharm. Intl. Ltd. (2016-2702, 2016-2708 April 13, 2018). Vanda Pharma’s asserted claims relate to a method of treating schizophrenia patients with iloperidone in which the dose is adjusted based upon the patient’s CYP2D6 genotype. The Federal Circuit agreed with the court below that these claims were both directed to patent eligible subject matter and infringed.
On March 4, 2014, the U.S. Patent and Trademark Office (“USPTO”) issued a memorandum to the Patent Examining Corps with guidance for determining the patent eligibility of claims relating to products of nature and laws of nature (“the Guidance”) in view of the U.S. Supreme Court decisions in Assoc. for Molecular Pathology v. Myriad Genetics (“Myriad”) and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (“Prometheus”). While the Guidance does not have the force or effect of law, it will have a significant impact on the prosecution of pending U.S. applications having claims falling within its scope. And that scope is extremely broad.
The question of patent eligibility touches upon whether or not the claimed subject matter is something for which a patent can be granted. Although the language of the U.S. statute broadly defines the scope of this subject matter, the U.S. Supreme Court has, over the years, carved out three general exceptions: products of nature, laws of nature, and abstract ideas. The Guidance deals with the first two of these, products of nature and laws of nature. We can expect a further memo dealing with abstract ideas following the Supreme Court decision in CLS Bank later this year.