On July 23, 2019, Amgen, maker of the cancer treatment drug Neupogen (filgrastim), filed patent infringement claims in the Southern District of California against Tanvex Biopharma over Tanvex’s proposed filgrastim biosimilar...more
8/6/2019
/ aBLA ,
Amgen ,
Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular
Amgen Inc. v. Coherus Biosciences Inc., No. 2018-1993, Slip op. at 6 (Fed. Cir. July 29, 2019) stems from a Biologics Price Competition and Innovation Act action brought by Amgen against Coherus seeking FDA approval to market...more
At the end of 2017, inter partes review (IPR) proceedings for biosimilar products were on the rise. 2018 and the first half of 2019, however, have seen a dip in the number of new filings. And looking back at biosimilar IPRs...more
In Enzo Life Sciences v. Roche Molecular Systems, No. 2017-2498, 2017-2499, 2017-2545, 2017-2546, Slip op. (Fed. Cir. July 5, 2019), the Federal Circuit affirmed summary judgment of invalidity for lack of enablement of Enzo’s...more
On April 17, 2019, several lawmakers from the Senate and House of Representatives released a bipartisan, bicameral framework for statutory reform of 35 U.S.C. § 101....more
On February 6, 2019, the Federal Circuit issued its latest opinion on patentable subject matter under 35 U.S.C. § 101 in Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, No. 2017-2508, slip. Op. (Fed. Cir. Feb. 6,...more
Last week, the Federal Circuit issued its long-awaited opinion in Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., No. 2017-1694, slip op. (Fed. Cir. Feb. 7, 2019). ...more
On January 7, 2019, the United States Patent and Trademark Office (USPTO) published new guidance for patent examiners intended to address concerns expressed by Federal Circuit judges, industry stakeholders, and others about...more
On December 22, 2018, the United States federal government entered a partial shutdown, which now enters its 19th day. If the shutdown continues through the weekend, it will be the longest federal government shutdown in U.S....more
Two cases decided by the Federal Circuit in 2018, Aatrix Software, Inc. v. Green Shades Software, Inc., 882 F.3d 1121, en banc rehearing denied, 890 F.3d 1354 and Berkheimer v. HP Inc., 881 F.3d 1360, en banc rehearing...more
Earlier this month, the President signed into law the Patient Right to Know Drug Prices Act (Public Law 115-263). The Act mainly focuses on eliminating so-called “gag clauses” that prevent pharmacists from telling patients...more
In Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., No. 17-1694 (Fed. Cir. argued Dec. 5, 2017), BMS challenges Momenta’s standing to appeal a PTAB decision upholding the validity of BMS’s patent relating to a...more
Earlier this month, AbbVie filed suit against Sandoz’s proposed biosimilar to AbbVie’s HUMIRA® (adalimumab). Invoking the Biosimilar Price Competition and Innovation Act (“BPCIA”), AbbVie asserts two patents protecting...more
On July 20, 2018, FDA approved Pfizer’s biosimilar of Amgen’s Neupogen® (filgrastim). Pfizer’s product, Nivestym™, is the second biosimilar of Neupogen to be approved after Sandoz’s Zarxio®, the first approved biosimilar in...more
8/10/2018
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Sandoz
Allergan’s attempt to shield its Restasis patents from inter partes review by assigning the patents to the Saint Regis Mohawk Tribe was rejected last week by a unanimous Federal Circuit panel. The Federal Circuit affirmed...more
On Friday, June 22, 2018, the Supreme Court issued its decision in WesternGeco LLC v. ION Geophysical Corporation, 585 U.S. ___, Slip. Op. No. 16-1011 (June 22, 2018), reversing the Federal Circuit and holding that...more
6/29/2018
/ 35 U.S.C. § 271(f)(2) ,
35 U.S.C. § 284 ,
Appeals ,
Domestic Injury ,
Extraterritoriality Rules ,
Foreign Sales ,
Lost Profits ,
Patent Act ,
Patent Infringement ,
Patents ,
Remand ,
SCOTUS ,
Vacated ,
WesternGeco LLC v Ion Geophysical Corporation
Analytical studies to demonstrate that a biosimilar is highly similar to its reference product are central to the biosimilar development and approval process. For this reason, there have been calls from industry for more...more
In a decision issued last month in Gowen v. Helly Nahmad Gallery, Inc., No. 650646/2014, 2018 NY Slip Op 28142, 2018 BL 164601, Commercial Division Justice Eileen Bransten found personal jurisdiction over foreign defendants...more
As biosimilar litigation between Amgen, the maker of Enbrel® (etanercept), and Sandoz, the maker of biosimilar ErelziTM (etanercept-szzs) heads toward trial before Judge Claire Cecchi in the District of New Jersey, Sandoz is...more
6/19/2018
/ aBLA ,
Amgen ,
Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Popular ,
Sandoz
Two recent Federal Circuit decisions address when a party has standing to challenge the validity of a patent. Though the cases arose in different contexts, they both center on the question of what it means for a party to be...more
The U.S. Court of Appeals for the Fourth Circuit last month handed manufacturers and wholesalers of off-patent drugs a victory by ruling that Maryland’s anti-price gouging act violates the U.S. Constitution’s dormant commerce...more
In last week’s Oil States decision, the Supreme Court upheld the constitutionality of inter partes review (IPR) under the Leahy-Smith America Invents Act (AIA), as expected by most observers. However, it was the Court’s...more
In a highly anticipated ruling, the Supreme Court upheld the constitutionality of inter partes review proceedings. Justice Thomas, writing for the seven-member majority in Oil States Energy Services, LLC v. Greene’s Energy...more
4/27/2018
/ America Invents Act ,
Article III ,
Constitutional Challenges ,
Inter Partes Review (IPR) Proceeding ,
Oil States Energy Services v Greene's Energy Group ,
Patent Trial and Appeal Board ,
Patents ,
Public Rights Doctrine ,
SCOTUS ,
Seventh Amendment ,
USPTO
On Monday, April 16, 2018, the Supreme Court heard oral argument in WesternGeco LLC, v. ION Geophysical Corporation, No. 16-1011, a case with broad implications for patent holders that sell products abroad. ...more
Biosimilar developers have been aggressive in filing petitions for inter partes reviews (IPRs) of biologics patents before the Patent Trial and Appeal Board (PTAB), many of them preceding the filing of a marketing...more
4/9/2018
/ Article III ,
Biologics ,
Biosimilars ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Patent Applications ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patent Validity ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Standing