Marina I. Miller, Ph.D.
March 30, 2020
Before LOURIE, MOORE, and REYNA, Circuit Judges. Illumina, Inc. and Sequenom, Inc. ("Illumina") filed suit against Ariosa Diagnostics, Inc., Roche Sequencing Solutions, Inc., and Roche Molecular Systems, Inc. ("Roche") alleging infringement of U.S. Patents 9,580,751 and 9,738,931. Roche moved for summary judgment that the asserted claims were invalid under 35 U.S.C. § 101. The district court granted Roche's motion holding that the claims of the '751 and '931 patents were directed to ineligible subject matter. Illumina appealed. The Federal Circuit ("the Court") reversed the district court's grant of summary judgment and remanded for further proceedings.... Read more
Richard D. Kelly
February 28, 2020
The Federal Circuit has launched an assault on common claiming techniques in pharma and chemical patents. In October 2019 the Federal Circuit issued two opinions, the first was HZNP Medicines involving the limitation “consisting essentially of” and the second, Idenix, striking at Markush Groups. This post concerns the HZNP decision. On February 25 the Federal Circuit denied HZNP’s request for a rehearing and rehearing en banc. According the Drug Patent Watch reported there were 244 drug patents using the language “consisting essentially of,” a number which seems low based on my experience.<... Read more
Jeffrey B. McIntyre
January 13, 2020
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."... Read more
Marina I. Miller, Ph.D.
January 3, 2020
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").... Read more
Lisa M. Mandrusiak
December 19, 2019
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... Read more
Richard D. Kelly
December 16, 2019
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 Bilskias 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 as continuing the Court's Bilski practice of not tying patent eligibility to any of the statutory or Constitutional language. Alice characterized the Mayo decisional approach as a two step process.... Read more
Todd W. Baker
December 9, 2019
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.... Read more
November 20, 2019
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.... Read more
Richard D. Kelly
October 16, 2019
In patents for diagnostic methods, which natural phenomena the patent is directed to may be just as important as whether it is directed to a natural phenomenon at all. A January 2019 decision of the Patent Trial and Appeal Board (PTAB) suggests that which natural phenomena a court determines the patent claim is directed to under Alice step one could have significant implications for Alice step 2. The Board’s decision in Ex parte Lee stands in contrast to the Federal Circuit’s decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc. And comparing the two side-by-side reveals that patent applicants have an incentive to not only argue whether their patent is directed to a natural phenomenon, but also to which natural phenomena it is directed.
Ex Parte Lee concerned an appeal from the Examiner’s determination that the diagnostic claims were patent ineligible. Claim 1 of the application was representative and describes:<... Read more
Daniel J. Pereira, Ph.D.
October 11, 2019
The Federal Circuit in a precedential opinion in Osai Pharmaceuticals, LLC v Apotex et al (Fed. Cir., October 4, 2019) reversed the USPTO's determination of obviousness in an IPR for patent claims directed to the treatment of non-small cell lung cancer (NSCLC). Just reading the background of the first three or four pages of the decision, it was already apparent that the Court was not going to be affirming the PTAB's decision. Notably:... Read more