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Federal Circuit Upholds Jury Award, Weighs in on Willfulness Standard, in Adynovate® Dispute

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

Sandoz Petitions the Supreme Court for Review of Enbrel® Patent License

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

FDA Approves Breyanzi®—A New Biologic for Treating Large B-Cell Lymphoma

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

2021 Biosimilar Approval and Litigation Update

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

Rehearing Denied in Federal Circuit Hatch-Waxman Venue Case

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

Rehearing Requested in Major Federal Circuit Case Narrowing Venue in Hatch-Waxman Cases

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FDA’s Draft Guidance for Industry Seeks to Answer Questions on Biosimilar Interchangeability

FDA has published new draft guidance for industry titled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act.” ...more

For the First Time Since TC Heartland, the Federal Circuit Addresses Venue in an ANDA Case – the Holding May Also Impact BPCIA...

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

The FDA Regulatory Landscape for Covid-19 Treatments and Vaccine (Updated #2)

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

Samsung Bioepis and Merck Launch Herceptin (trasuzumab) Biosimilar Ontruzant® in U.S.

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

The FDA Regulatory Landscape for Covid-19 Treatments and Vaccine (Updated)

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

The FDA Regulatory Landscape for Covid-19 Treatments and Vaccines

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

FDA Finalizes New Definition of Biological Product

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

Federal Circuit Clarifies Limits of Safe Harbor Defense in Amgen v. Hospira

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

Mylan and Biocon Launch Herceptin (trasuzumab) Biosimilar Ogivri™ in U.S.

Last week, Mylan and Biocon announced the U.S. launch of Ogivri™ (trasuzumab-dkst), a biosimilar to Herceptin® (trasuzumab). ...more

2019 Year-End Biosimilar Litigation Roundup

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

Amgen Files New Patent Infringement Suit Over Neupogen Biosimilar

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

Q2 2019 Review: Biosimilar IPRs See a Drop in New Filings and Mixed Results

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

Federal Circuit Dismisses Momenta IPR Appeal for Lack of Standing and Mootness After Momenta Abandons Orencia® Biosimilar

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

The 2019 U.S. Federal Government Shutdown and its Potential Impact on Biologics

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

Bill Requiring Disclosure of Biosimilar Settlement Agreements to the FTC and DOJ Becomes Law

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

Sandoz Uses Patent Dance to Limit Humira® Biosimilar Lawsuit to Two Patents For Now

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

FDA Withdraws Draft Guidance on Evaluating Analytical Similarity Following Industry Criticism

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

Federal Circuit Issues Two Decisions Impacting Standing to Challenge Validity of Pharma Patents

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

Fourth Circuit Rules that Maryland’s Anti-Price Gouging Act for Off-Patent or Generic Drugs is Unconstitutional

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

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