Legal

This week, the United States Court of Appeals for the Federal Circuit found that Momenta lacked standing to appeal a decision upholding a patent covering abatacept (Orencia) and said that Momenta’s appeal was rendered moot by the drug makers’ choice to stop developing its biosimilar.

Coherus BioSciences announced on Friday that it has become the latest biosimilar developer to settle with AbbVie, maker of the brand-name adalimumab, Humira, over a proposed biosimilar. In an intellectual property twist, Coherus also announced that it has sued a rival biosimilar developer, Amgen.

When the shutdown ends, said Scott Lassman, JD, partner at Goodwin, “It’s not going to be like flipping a switch…this is going to have longer-term consequences.”

While many stakeholders are concerned most immediately about how a recent ruling on the Affordable Care Act (ACA) could affect US patients’ healthcare options and coverage for pre-existing conditions, the biosimilars industry is also concerned about the future of one key feature of the ACA that keenly impacts the biosimilars landscape: the Biologics Price Competition and Innovation Act.

Last week, Republicans in the House of Representatives and in the Senate introduced legislation that would restrict generic and biosimilar developers from challenging patents on reference drugs using the inter partes review (IPR) process.

Johnson and Johnson (J&J) recently filed a motion to dismiss in the antitrust claim brought against the company by Walgreen and Kroger in regard to sales of J&J’s reference infliximab product, Remicade. In early December, the District Court for the Eastern District of Pennsylvania denied the motion.

Recently, plaintiff Genentech and defendant Pfizer filed a collective stipulation and proposed order of dismissal of a patent infringement lawsuit over Genentech’s reference trastuzumab product, Herceptin.

The complaint includes a screenshot of Xanthe Lam’s Genentech-issued computer, which shows a folder titled “JHL” that contained subfolders, 4 of which were named for Genentech medicines for which JHL was in the process of developing a biosimilar.

Experts from Venable, Alkermes, and Novartis provide updates to the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and explain the differences between inter partes review (IPR) and post grant review (PGR) litigation.

Momenta Pharmaceuticals announced yesterday that it has reached a settlement with Humira-maker AbbVie over a proposed biosimilar adalimumab, M923.

Republic of Korea-based Celltrion has won a court decision that declared patents on Roche’s Herceptin invalid in Japan.

Amgen filed a cross appeal in this long-running case on October 15, 2018. The appeal challenges, among other things, the district court’s previous judgement that Hospira had not infringed on another patent named in the original suit, US Patent Number 5,756,349, which covers the production of erythropoietin.

Fresenius Kabi has become the latest biosimilar developer to enter into an agreement with Humira maker AbbVie over a biosimilar adalimumab product, MSB11022.

On Thursday, biosimilar developer Sandoz announced that it had reached a global settlement of its patent disputes with AbbVie, maker of the reference Humira. The settlements will allow Sandoz to enter some European markets with its biosimilar adalimumab, Hyrimoz, as early as October 16, 2018.

Ha Kung Wong, JD, partner at Fitzpatrick, Cella, Harper and Scinto, addresses recent changes to inter partes review (IPR) and post-grant review (PGR) proceedings with respect to biologic drugs.

Ha Kung Wong, JD, partner at Fitzpatrick, Cella, Harper and Scinto, discusses how manufacturers now approach the "patent dance" in light of Sandoz v Amgen.

Hospira had asked the court for a judgment that producing batches of a biosimilar product is an activity protected by safe harbor provisions, that Hospira did not infringe on the ’298 patent (which Hospira claims is invalid), and that damages owed to Amgen not exceed $1.5 million per batch of the drug (if those batches were later sold). Alternatively, it sought a new trial in the case.

This week, the district court of Massachusetts granted Celltrion’s motion for a summary judgment of non-infringement of the last patent in question in the long-running Janssen v Celltrion case.

On July 20, the United States Court of Appeals for the Federal Circuit ruled in the case of the St Regis Mohawk Tribe v Mylan Pharmaceuticals that sovereign immunity does not extend to inter partes review (IPR) proceedings.

Sheila Frame, vice president and head of biopharmaceuticals, North America, at Sandoz, explains how the Biologics Price Competition and Innovation Act (BPCIA) has impacted the industry.

Tahir Amin, DipLP, co-founder and director of intellectual property of Initiative for Medicines, Access, and Knowledge, discusses lessons learned from Allergan's transfer of patents to a sovereign tribe.

Imron Aly, JD, partner at Schiff Hardin, LLP, explains how lessons learned from Hatch-Waxman proceedings can be applied to Biologics Price Competition and Innovation Act (BPCIA) litigation.

The United States Patent and Trademark Office (USPTO), in a proposed rule published today on the Federal Register, seeks to amend the rules for inter partes review proceedings, and similar proceedings, before the Patent Trial and Appeal Board.

In ongoing litigation over Celltrion and Pfizer’s infliximab biosimilar, Inflectra, a Massachusetts district court has granted Celltrion’s motion for leave to file a motion for summary judgment of non-infringement.

Virginia’s House and Senate have both passed a new bill, HB1177, which prohibits PBMs from penalizing pharmacists for sharing drug pricing information with consumers.

Innovator drug developer Genentech, maker of the biologic therapies Avastin (bevacizumab) and Rituxan (rituximab), faces challenges from biosimilar developers in the United States and abroad. This week saw developments in cases concerning both molecules in US and Japanese courts of law.

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, responds to Allergan's recent transfer of patents to a soverign entity, and gives 2 takeaways for industry.

On January 2, counsel for the Saint Regis Mohawk Tribe filed a motion for discovery and requested an oral hearing concerning which judges will sit on the Patent Trial and Appeal Board (PTAB) panel that oversees its case.

The Center for Biosimilars recounts 4 of the top legal developments in the biosimilars space during 2017.

Developments at the FDA and greater physician acceptance of biosimilars made 2017 a banner year for emerging therapies, according to James Stevenson, PharmD, FASHP, professor of clinical pharmacy at the University of Michigan College of Pharmacy.