Persion v. Alvogen: Inherency in Obviousness Attacks
Last month, the Federal Circuit affirmed the District Court of Delaware's decision in Persion Pharmaceuticals v. Alvogen invalidating as obvious two Persion patents claiming methods of treating pain in patients with hepatic impairment (compromised liver functionality) using hydrocodone. Important to the Federal Circuit's decision was the concept of "inherency."
Repeated Description of an Embodiment as the Present Invention that Solves Problems in the Prior Art may Lead to Disavowal of Claim Scope, Even Without an Express Concession of Other Embodiments
Multiple companies (collectively "Techtronic Industries" or "TTI") appealed from a final determination of the United States International Trade Commission (the "Commission") that their imported product (garage door opener products) infringed the claims of U.S. Patent 7,161,319 (the "319 patent").
Not-So-Safe Harbor for Hospira's Erythropoietin Biosimilar
This week the Federal Circuit affirmed Amgen's win against Hospira with respect to Hospira's erythropoietin ("EPO") biosimilar—a drug used to increase red blood cell number—in a Delaware trial where Amgen's U.S. Patent No. 5,856,298 was found to be infringed and not invalid and Amgen was found to be entitled to $70 million for damages associated with its EPO drug Epogen®. Part of the appeal was also dedicated to examining the so-called Safe Harbor provision of 35 U.S.C. § 271(e)(1), where the Federal Circuit agreed with Amgen that Hospira manufactured at least 14 batches of the drug that were not protected by this provision. The Court's decision provides lessons in how companies should be careful to avoid stretching the bounds of the Safe Harbor provision.
Solicitor General on Patent Eligibility
The Solicitor General (SG) was invited by the Supreme Court to provide comments on the certiorari petitions filed by Berkheimer and Hikma to review the Federal Circuit's 101 decisions adverse to them. The two briefs have numerous similarities including identifying the Court's decision in Bilski[1] as starting the patent eligibility confusion by not grounding its decision on interpreting the meaning of the 35 U..S.C. 101 terms "process, machine, manufacture, [and] composition of matter." The SG asserts that in Bilski the Court did not ground its decision on the stature terms but instead found three exceptions to be not required by the statutory text: laws of nature, physical phenomenon, and abstract ideas. While these concepts are found earlier Supreme Court decisions, Bilski represented the first time they were used independent of the statutory language or constitutional concept of the "useful arts." The SG then described Mayo[2] as continuing the Court's Bilski practice of not tying patent eligibility to any of the statutory or Constitutional language. Alice[3] characterized the Mayo decisional approach as a two step process.
Motions to Amend in Inter Partes Review: Why did Ethicon Cut Against the Grain?
Motions to amend (MTAs) are generally disfavored. The prevailing approach calls for patentees to file an MTA in Inter Partes Review (IPR) only in limited circumstances. In particular, most patentees are moving to narrow or clarify claim scope via an MTA only in cases where (i) there is no related application pending at the Office and (ii) the specter of lost past damages due to intervening rights outweighs the risk of an invalidity finding. At first glance, neither (i) nor (ii) appears to be true in the case of Intuitive Surgical, Inc. v. Ethicon, LLC, (IPRs2018-00933, 00934, and 00935), yet Ethicon elected to pursue an MTA in each of the IPRs and was successful in doing so.
Short-Term Uncertainties after Arthrex
The Federal Circuit in a precedential opinion in Arthrex, Inc. v. Smith & Nephew, Inc., vacated and remanded a final written decision of the Patent Trial and Appeal Board (PTAB), finding that the Administrative Patent Judges (APJs) are not constitutionally appointed, violating the Appointments Clause. Arthrex, Inc. v. Smith & Nephew, Inc., No. 2018-2140 (Fed. Cir. Oct. 31, 2019). The opinion in Arthrex also indicates that an Appointments Clause challenge should be timely raised on appeal, and thus, is waived when not presented in an appeal that has passed or been decided.
Patent Eligibility Under 35 U.S.C. 101 of Articles of Manufacture
FYF-JB, LLC sued Pet Factory, Inc. for infringing its U.S. Patent 9,681,643 ("the ‘643 patent") covering a tug toy for animals that emits a sound when it is pulled on both sides. Pet Factory moved to dismiss FYF-JB's complaint, arguing that the asserted claims were directed to patent ineligible subject matter under 35 U.S.C. § 101. The United States District Court for the Northern District of Illinois ("the Court") denied Pet Factory's motion to dismiss.
Think Before You Sign: Protecting IP Rights with MTAs
Material transfer agreements (MTAs) are contracts that allow one party to perform research using the materials of another party. These agreements provide a mechanism to protect the interests of the owners of discoveries and inventions, while promoting data and material sharing in the research community. Although these are admirable goals in principle, MTAs have a bad reputation with some researchers and institutions for being overly complex and, in fact, hindering research. Nonetheless, MTAs are important for defining the rights, responsibilities, and obligations of the parties with respect to research collaborations and need to be carefully considered, particularly with respect to ownership of IP rights implicated by the transferred materials.