In today’s complex global marketplace, businesses are increasingly confronted with the challenges of supply chain disruptions, rising costs, and fierce competition—all exacerbated by trade remedy tariffs. While many of these...more
Kim Kardashian has been hit with a lawsuit by New York-based Beauty Concepts LLC over Kardashian’s recently launched skincare line, “SKKN by Kim.” Beauty Concepts filed a complaint in the Eastern District of New York against...more
The Office of the United States Trade Representative (“USTR”) announced in a notice that 81 COVID specific product exclusions would be extended for an additional 6 months, with all COVID exclusions receiving an additional...more
How is orphan drug exclusivity affected when the FDA-approved use for an orphan drug is arguably narrower than the treatment of the rare disease it was designated for? By way of background, a sponsor can obtain orphan drug...more
On April 23, U.S. President Biden signed into law two bills meant to lower prescription drug prices by limiting new drug exclusivity awards and promoting biosimilars. ...more
Pharmaceutical companies Teva Pharmaceutical Industries Ltd. and Alvotech announced on Wednesday, August 5, 2020, that they will be entering into an exclusive partnership for the commercialization of biosimilar products in...more
A federal district court recently dismissed a lawsuit against AbbVie and biosimilar manufacturers of adalimumab involving a novel antitrust claim against the Humira patent estate. Attorneys with Haug Partners LLP take an...more
On May 21, 2020, the United States Trade Representative (“USTR”) issued new product exclusions pertaining to the 25% Section 301 List 3 Tariffs. The new list of exclusions includes seventeen 10-digit HTS subheadings and...more
On Wednesday, President Donald Trump signed the United States-Mexico-Canada Agreement (USMCA) into law. The USMCA contains a number of key and last-minute revisions that implicate biologic medicines and patent obligations. ...more
For drug innovators, particularly those focusing on repurposing drugs for new indications and developing drugs that are not considered new chemical entities, understanding the scope of the clinical investigation exclusivity...more
Wednesday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the D.C. Circuit Court in Eagle...more
Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product’s success or failure could cost you millions of dollars....more
On July 18, 2018, the European Commission (Commission) imposed a fine on Google LLC for the alleged abuse of a dominant market position pertaining to Android mobile devices. Google and its parent company, Alphabet Inc....more
On Tuesday, FDA’s Center for Drug Evaluation and Research (CDER) announced a draft guidance titled “Innovative Approaches for Nonprescription Drug Products” that could aid drug manufacturers who want to sell, without a...more
Copyrights arise automatically when an original work is created. Copyrights protect “original works of authorship,” which include paintings, illustrations, sculpture, photographs, books, articles, poems, movies, songs,...more
On 27 March, Partner Eugene Low and Associate Arthur Ng from our Hong Kong office gave a presentation on e-sports at a reception event organized by the Association of Corporate Counsel, Hong Kong. ...more
In Otsuka Pharm. Co., Ltd. v. Price, No. 16-5229 (D.C. Cir. Aug. 29, 2017), the U.S. Court of Appeals for the District of Columbia Circuit affirmed the district court decision upholding FDA’s “same moiety” test for defining...more
In December, we reported that the European Commission ("Commission") had issued an Interpretive Notice (2016/C 411/03) stating products produced by essentially biological processes should not be patentable. The notice came as...more
FDA recently awarded new chemical entity (NCE) exclusivity to Austedo™ (deutetrabenazine). The Austedo approval is notable for two reasons: One, it is the first deuterated drug (i.e., a drug containing the stable isotope —...more
On April 26, 2017, the Supreme Court heard oral arguments in Amgen v. Sandoz, where the parties have asked the Court to interpret two of the biosimilar patent dance provisions of the Biologics Price Competition and Innovation...more
“Orphan drug” is a designation given to certain pharmaceutical and biological products (drugs) that would likely not be developed due to a relatively small patient population and limited potential for profitability. In the...more
Last Wednesday, the Second Circuit Court of Appeals partially vacated the judgment of the district court in In re Actos End-Payor Antitrust Litigation. In doing so, the Second Circuit allowed only plaintiffs’ claims that...more
The prior approval of a drug containing an active ingredient of the innovator drug is not necessarily a death knell for NCE exclusivity. Originally published in the Intellectual Property and Life Sciences sections of...more
This week, the U.S. Supreme Court denied a petition for writ of certiorari in a case that will give pharmaceutical companies pause when considering whether to settle patent challenges under Hatch-Waxman. The Supreme Court’s...more
On November 7, 2016, the U.S. Supreme Court declined to review an appeal from a Third Circuit decision finding that a settlement between GlaxoSmithKline (GSK) and Teva Pharmaceutical Industries Ltd. (Teva) involving the...more