A Judicial Perspective on Using Technology at Oral Argument | Judge John Owens | Texas Appellate Law Podcast
In our previous article, we reported that the Federal Circuit affirmed the district court’s decision requiring Teva to delist certain patents related to its Teva’s ProAir® HFA metered-dose inhaler from the FDA’s Orange...more
In 2019, Edwards Lifesciences Corporation sued Meril Life Sciences Pvt. Ltd. for patent infringement in the Northern District of California, with Fenwick representing Meril in the district court case and the recent appellate...more
The Federal Circuit’s decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., has garnered significant attention, especially concerning the application of the “safe harbor” provision under 35 U.S.C. §...more
A fractured affirmance of a district court decision to dismiss an infringement action under 35 U.S.C. § 271(e)(1) was the occasion for the Federal Circuit to illustrate the continued debate over the scope of the safe harbor...more
There has been, since the turn of the century, a steady, seemingly inexorable trend towards limiting patent rights and focusing the application of U.S. patent law towards an emphasis on preventing innovators from obtaining...more
In 2021, the Federal Circuit determined that Amgen’s biotech antibody patents lack enablement, i.e., the specification did not teach one of ordinary skill in the art how to make and use the invention without undue...more
On March 16, 2022, the Federal Circuit denied Biogen’s petition for rehearing of its November 2021 decision in Biogen Int’l GmbH v. Mylan Pharms., Inc., 18 F.4th 1333, 1343 (Fed. Cir. 2021), which found that Biogen’s patent...more
The US Court of Appeals for the Federal Circuit denied a patent owner’s request for en banc rehearing of a panel decision that invalidated a patent for lack of written description on the basis that a person of skill in the...more
On March 16, 2022, the Court of Appeals for the Federal Circuit denied Biogen’s petition for en banc review in Biogen International GmbH et al. v. Mylan Pharmaceuticals Inc. ("Petition Denial"), in which a Federal Circuit...more
The US Court of Appeals for the Federal Circuit denied a generic drug manufacturer’s petition for en banc review of a panel opinion finding induced infringement liability despite the manufacturer’s adherence to skinny...more
Adapt Pharma Operations Limited v. Teva Pharmaceuticals USA, Inc., Appeal No. 2020-2106 (Fed. Cir. Feb. 10, 2022) - In our Case of the Week, the Court of Appeals for the Federal Circuit, in both the majority opinion and...more
As we have previously discussed, on February 11, 2021, the Federal Circuit decided Amgen Inc. et al. v. Sanofi, Aventisub LLC, et al. The Federal Circuit affirmed the district court’s grant of JMOL that Amgen’s Repatha®...more
July 1, 2021 In a development having significant ramifications for many biopharma companies, the Federal Circuit has denied Amgen’s petition for rehearing en banc a decision invalidating a genus patent covering its antibody...more
Based on the denial of rehearing and the Amgen v. Sanofi decision itself, inventors should: Claim as many separate species as possible. Attempt to fashion genus claims that have a limited number of members supported...more
Patenting antibodies has long been challenging. Although most inventions can be patented based on their functionality, assuming the functionality is new and non-obvious, for antibodies and other biomolecules there is a higher...more
An en banc rehearing petition to the Federal Circuit seeks to breathe life back into the widespread practice of patenting a genus of compounds by claiming their common functional characteristics. This claiming practice was...more
Whether you are pursuing patents on your new technology, thinking about bringing patent infringement litigation or defending patent infringement claims in court, knowing the important developments in patent law will help you...more
Although argument week isn’t until next week, the Federal Circuit heard oral argument today in two cases. One was rescheduled from earlier this month for medical reasons. But the other, GlaxoSmithKline LLC v. Teva...more
Federal Circuit Determines Time-Barred Petitioner Joined to an IPR Has Appellate Standing - In Mylan Pharmaceuticals Inc. v. Research Corporation Tech., Appeal Nos. 2017-2088, -2089, -2091, the Federal Circuit held that a...more
PATENT CASE OF THE WEEK - Polara Engineering Inc. v. Campbell Company, Appeal Nos. 2017-1974, -2033 (Fed. Cir. July 10, 2018) In this wide-ranging opinion, the Court provided a rare and lengthy opinion on the public use...more
Last month, the USPTO issued a memorandum to its patent examining corps clarifying its guidance concerning the written description requirement for claims drawn to antibodies. In the memorandum, the USPTO adopts the Federal...more
As we reported previously, Amgen is seeking en banc review of the Federal Circuit panel decision vacating a permanent injunction that would have otherwise prohibited the sale of Sanofi and Regeneron’s Praluent® (alirocumab)...more
Shearman & Sterling’s IP litigation team has published its quarterly newsletter. The newsletter covers a number of current IP topics, including a look at the America Invents Act, five years in; the U.S. International Trade...more
In The Medicines Co. v. Hospira Inc., Appeal No. 2014-1469 (Fed. Cir. July 11, 2016), the Federal Circuit issued a unanimous en banc decision ruling that the on-sale bar was not triggered by a supplier’s sale of manufacturing...more
On July 11, 2016, the Federal Circuit, en banc, overruled the merits panel and affirmed the District of Delaware’s decision in The Medicines Company v. Hospira, Inc. finding that an assignee’s entry into a manufacturing...more