September 21, 2021 marked the fourth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the fourth year...more
The US Court of Appeals for the Federal Circuit endorsed for the first time the “all substantial rights” test to determine whether inventions are commonly owned for purposes of obviousness-type double patenting validity...more
We previously reported on the decision by the District of New Jersey (Cecchi, J.) to uphold the validity of U.S. Patent No. 8,063,182, related to “the fusion protein etanercept, the active ingredient in Immunex’s product...more
In a patent owner’s declaratory judgment action under the Biologics Price Competition and Innovation Act (“BPCIA”) a Federal Circuit panel in Amgen Inc. v. Sandoz Inc., Appeal No. 2018-1551 (Fed. Cir. May 8, 2019) narrowly...more
Federal Circuit Finds Claims Directed to Tabbed Spreadsheets Patent Eligible and Claims Directed to Tracking Changes in Documents Ineligible Under Section 101 - In Data Engine Technologies LLC v. Google LLC, Appeal No....more
In This Issue: Ontario Court of Appeal allows Sanofi and Schering to plead that Federal Court ramipril patent invalidity decision was flawed due to “promise doctrine” - In an action by Apotex for compensation from...more
The Federal Circuit recently affirmed the Patent Trial and Appeal Board’s (“PTAB”) final written decisions finding the claims of Yeda Research and Development Co., Ltd.’s (“Yeda”) U.S. Patent Nos. 8,232,250, 8,399,413, and...more
Federal Circuit Summary - Before Judges Reyna, Bryson, and Stoll. Appeals from the Patent Trial and Appeal Board and the United States District Court for the District of Delaware. Summary: Non-prior art evidence may...more
As we previously reported, Sandoz appealed the PTAB’s decision not to institute an IPR regarding AbbVie’s U.S. Patent No. 9,512,216, which relates to a method for treating moderate to severe chronic plaque psoriasis using...more
Federal Circuit Summaries - Before PROST, WALLACH, and TARANTO. Appeal from the District of Delaware Summary: (1) A party may not avoid inducement based on “substantial non-infringing uses,” and (2) prosecution history...more
On July 17, 2017, the United States Court of Appeals for the Federal Circuit reversed, in a precedential opinion in Millennium Pharmaceuticals, Inc. v. Sandoz, Inc., No. 2015-2066 (Fed. Cir. July 17, 2017), a district court...more
The Circuit issued only one precedential patent case this week, reversing a determination of obviousness as to a Millennium Pharmaceutical patent covering its blockbuster cancer drug Velcade®, thus extending the life of...more
In Sandoz Inc. v. Amgen Inc. (which you can read more about here), the Supreme Court held that 42 USC § 262(l)(9)(C) sets forth the exclusive federal remedy for failing to provide a copy of the biosimilar application to the...more
On June 12, 2017, in Sandoz Inc. v. Amgen Inc., the United States Supreme Court unanimously held that a drug manufacturer may give a required 180-day notice of its intent to market a biosimilar drug before receiving FDA...more
On April 26, 2017, the U.S. Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. (Nos. 15-1039, 15-1195), on appeal from the Federal Circuit's July 21, 2015, opinion interpreting various provisions of the Biologics...more
On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. F.3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 F.3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the...more
Pre-AIA and Post-AIA Issues Presented by the On-Sale Bar - The “on-sale” bar to patentability refers to a sale or offer for sale of an invention that can invalidate the patent for that invention. The...more
In March 2015, the FDA approved the first biosimilar application, which was for a follow-on biologic drug of Amgen’s reference product NEUPOGEN® (filgrastim). Yet, before the applicant, Sandoz, could launch its biosimilar...more
Many prior cases have addressed whether a pure stereoisomer is obvious when the corresponding 50/50 mixture is known in the prior art. In upholding a finding of summary judgment, however, the U.S. Court of Appeals for the...more
On October 16, 2015, the Court of Appeals for the Federal Circuit (“Federal Circuit”) opted not to rehear its previously issued split decision in the court’s first analysis of the Biologics Price Competition and Innovation...more
Last month, a divided panel of the Federal Circuit issued a split decision in Amgen v. Sandoz (summary; opinion). Amgen (in which Patterson Belknap represented one of the amici supporting Amgen) is the court’s first decision...more
The Federal Circuit issued a ruling on July 21, 2015 in the Amgen Inc. et al. v. Sandoz Inc., Case No. 2015-1499, appeal after hearing oral arguments on June 3, 2015. See BPCIA: A “Choose Your Own Adventure” Statute?...more
The Court of Appeals for the Federal Circuit yesterday heard oral arguments on the applicability and interpretation of two key provisions of the Biologics Price Competition and Innovation Act (BPCIA). Briefly, oral argument...more
Overly Narrow Statement Of Problem Can Show Reliance On Hindsight - In INSITE VISION INCORPORATED v. SANDOZ, INC., Appeal No. 2014-1065, the Federal Circuit held that enunciating an overly narrow statement of the problem...more
The Federal Circuit yesterday granted Amgen’s motion for a preliminary injunction to keep Sandoz’s biosimilar form of Neupogen off the market until the Court renders its decision on the merits of the appeal. The parties had...more