"A Method of Preparation" and Patent Eligibility Under Section 101

Attorney: 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

Listing the Medical Device Part of a Combination Product in the Orange Book May Trigger Antitrust Liability

Attorney: Richard D. Kelly
March 30, 2020

A patent listing in the Orange Book provides the innovator drug company with a potent tool for excluding generic competitors who wish an ANDA application or 505(b)(2) drug approval applications relying upon the innovator's efficacy and safety data. If a patent is listed in the Orange Book the generic applicant must provide notice to the NDA holder and the patentee (if different) of the application's filing. The patentee then has 45 days to initiate litigation which would cause a 30-month stay of the FDA approval of the generic drug. Normally patents to a drug's packaging are not listable in the Orange Book, however, an exception exists for packaging which also functions as the drug's applicator. Sanofi took advantage of this provision to list U.S.P. 8,556,864 (‘864 patent) which was directed to the drive mechanism used in its injector pen for its Lantus® insulin product. The product plus injector was sold as Lantus Solostar®.... Read more

Patent Eligible Method of Treatment/Prevention Claim

Attorney: Yuki Onoe
March 23, 2020

特許適格性を満たす治療/予防方法クレーム の例<... Read more

Battle of the Biologics: Lilly's IPRs Clear Six Teva Patents

Attorney: Lisa M. Mandrusiak
March 5, 2020

Several companies have received FDA approval for antagonist antibodies against calcitonin gene-related peptides. These so-called anti-CGRP biologic drugs are a relatively new type of injectable medication for preventing migraines without side effects.<... Read more

Pharma Claiming Practice Under Fire

Attorney: 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[1] involving the limitation “consisting essentially of” and the second, Idenix[2], 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

Persion v. Alvogen: Inherency in Obviousness Attacks

Attorney: 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

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

Attorney: 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

Oblon Named Number One Filer for the IAM/ktMINE US Patent Elite

December 23, 2019

Oblon has been recognized as the law firm that has worked with the most members of the US Patent Elite on patent prosecutions at the USPTO. In addition, Oblon representatives are identified to have filed the highest volume of patent applications for the US Patent Elite, according to analysis conducted using Anaqua’s AcclaimIP Analytics Software.<... Read more

Not-So-Safe Harbor for Hospira's Erythropoietin Biosimilar

Attorney: 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

Solicitor General on Patent Eligibility

Attorney: 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 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.... Read more