According to the Federal Circuit, $173 million was the right damages award for almost three years of patent infringement resulting from Baxalta’s sale of its biologic product Adynovate® (Antihemophilic Factor (Recombinant),...more
The fight over proposed Enbrel® (etanercept) biosimilar Erelzi® continues. Sandoz Inc., Sandoz International GmbH and Sandoz GmbH (“Sandoz”) recently filed a petition for certiorari requesting review of the judgement of the...more
On February 5, 2021, the FDA approved Juno Therapeutics, Inc.’s Breyanzi® (lisocabtagene maraleucel) for “treatment of adult patients with relapsed or refractory large B-cell lymphoma.” Juno, a Bristol-Myers Squibb Company,...more
The last two years saw the launch of several biosimilars. Looking ahead to 2021, several others may be on the horizon. In 2019-2020, the FDA approved thirteen biosimilars directed to seven reference products. Eight of the...more
The Federal Circuit has spoken. In a per curiam opinion, it denied Valeant’s petition for rehearing by the panel and rehearing en banc. A case watched closely by the biotechnology and pharmaceutical industries, the Federal...more
Last week, Mylan filed a brief in opposition to Valeant’s petition for rehearing en banc in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402. In November, a Federal Circuit panel held that venue in Hatch-Waxman...more
On October 2, 2020, India and South Africa urged the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council to temporarily waive the obligation of member states under the TRIPS...more
Earlier this month, Valeant Pharmaceuticals North America LLC (“Valeant”) filed a petition for rehearing en banc in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402, arguing that the Federal Circuit panel’s...more
FDA has published new draft guidance for industry titled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act.” ...more
On November 5, 2020, in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402, the Federal Circuit held that venue in Hatch-Waxman cases brought under 35 U.S.C. § 271(e)(2)(A) is proper “only in districts where...more
On Tuesday, November 10, 2020, the Supreme Court heard oral argument in California v. Texas, a challenge to the Affordable Care Act (the “ACA”) brought by Republican Attorneys General and the Trump Administration. ...more
On October 6, FDA issued updated guidance for industry concerning “Emergency Use Authorization for Vaccines to Prevent COVID-19,” updating the previous guidance issued in June. The updated guidance, which is being...more
The U.S. Patent and Trademark Office has announced that it will defer application fees for certain inventions relating to the fight against COVID-19. In its September 16 announcement, the PTO acknowledged its role in...more
September 17, 2020 Update: The Trump administration is currently considering accelerating the approval of an experimental Covid-19 vaccine being developed by Oxford University and AstraZeneca. In line with FDA’s June 2020...more
Last month, Judge Manish Shah of the United States District Court of the Northern District of Illinois dismissed an antitrust complaint brought by indirect purchasers of AbbVie’s blockbuster rheumatoid arthritis drug,...more
This week, Samsung Bioepis announced the U.S. launch of Ontruzant® (trastuzumab-dttb), a biosimilar of Genentech’s Herceptin (trasuzumab). Ontruzant® will be marketed and distributed in the U.S. by Merck....more
April 7, 2020 Update: FDA announced on March 31, 2020 that it has created the Coronavirus Treatment Acceleration Program (CTAP), a special emergency program to expedite the development of safe and effective treatments for...more
As the United States and countries all over the world continue to grapple with the Covid-19 pandemic, the race is on for Covid-19 treatments and vaccines....more
Last week, the U.S. Food and Drug Administration (“FDA”) issued a final rule to amend its regulation that defines the term “biological product” in line with the definition set by the Biologics Price Competition and Innovation...more
Recently, in Amgen Inc. v. Hospira, Inc., the Federal Circuit clarified the limits of the Safe Harbor defense in cases involving patented manufacturing methods....more
Last week, Mylan and Biocon announced the U.S. launch of Ogivri™ (trasuzumab-dkst), a biosimilar to Herceptin® (trasuzumab). ...more
As 2019 draws to a close, a handful of actions regarding biologics are pending in the federal courts. The current cases are listed below, in order from most-recently-filed to oldest....more
Earlier this week, the Federal Circuit declined to further extend the patent term of an antibody patent held by the Mayo Foundation. In Mayo Foundation v. Iancu, the court held that the time spent on a request for continued...more
In Amgen’s long-running dispute with biosimilar-maker Sandoz over biosimilar versions of Amgen’s filgrastim (Neupogen®) and pegfilgrastim (Neulasta®) biologics, the Federal Circuit earlier this year affirmed summary judgment...more
In Oil States Energy Services, LLC v. Greene’s Energy Group, LLC, the Supreme Court suggested that whether inter partes reviews (“IPRs”) apply to pre-AIA patents is an open constitutional question....more