Legal

A newly introduced item of legislation proposes to eliminate co-payments for patients when they receive a biosimilar rather than an originator biologic in Medicare Part B.

Using data compiled for BiologicsHQ.com, we analyzed 2 bills that propose changes to patent litigation by limiting the number of patents a reference product sponsor can assert in a patent litigation to see how many biosimilar cases they would have impacted so far and whether they would really help bring biosimilars to market sooner.

In an email to The Center for Biosimilars®, a Pfizer representative said that, after having agreed to the terms of a settlement with Genentech and Roche that provides the biosimilar developer with global licenses for its product, Pfizer plans to launch its biosimilar bevacizumab, Zirabev, in the US market on December 31, 2019.

In the US context, legal issues surrounding patents are often cited as one of the main hurdles to biosimilars. Despite the fact that patents on innovator drugs are often fewer in Europe, the patent landscape in the European Union remains complex and continues to evolve. During the SMi 10th Annual Biosimilars Conference, Gregory Bacon, DPhil, GDipIPLaw, partner at Bristows LLP, gave attendees a closer look at one emerging feature of the EU patent landscape that is of particular concern to biosimilar developers: the Arrow declaration.

The United States Court of Appeals for the Third Circuit has sided with Johnson & Johnson (J&J) and its Janssen division, requiring a dispute between the Remicade maker and Rochester Drug Cooperative to be sent to arbitration.

Genentech has reached a memorandum of understanding with JHL Biotech in its civil lawsuit related to the theft of Genentech’s trade secrets.

Last week, the Patent Trial and Appeal Board (PTAB) instituted 3 inter partes review proceedings concerning patents on Alexion’s brand-name eculizumab, Soliris, a complement inhibitor that treats rare diseases. Amgen is the petitioner in all 3 cases, which were filed in February of this year.

Amgen, maker of the brand-name pegfilgrastim (Neulasta), and Mylan, which partnered with Biocon to develop a biosimilar (Fulphila), have entered a joint status report in the District Court for the Western District of Pennsylvania.

In a one-page order filed last week, a panel of judges for the US Court of Appeals for the Federal Circuit denied Genentech’s motion for an injunction that would have blocked Amgen from selling its biosimilar bevacizumab, Mvasi, pending the outcome of an appeal.

A judge for the United States District Court for the District of New Jersey has ruled in favor of Amgen in a long-running patent litigation concerning Sandoz’s biosimilar etanercept, Erelzi.

A panel of judges for the United States Court of Appeals for the Federal Circuit has denied Genentech’s motion to block sales of Amgen’s biosimilar trastuzumab pending the outcome of an ongoing appeal.

Alexandra Valenti, JD, associate at Goodwin, discusses the future of the Biologics Price Competition and Innovation Act (BPCIA) in light of challenges to the Affordable Care Act.

According to the Congressional Budget Office (CBO), enacting the bill would increase direct spending by about $18.7 billion and increase direct revenues by $26.2 billion, resulting in a net decrease in the deficit of $7.6 billion by 2029.

Samsung Bioepis, developer of the biosimilar trastuzumab, Ontruzant, and Genentech, maker of the reference trastuzumab, Herceptin, have asked a court to dismiss their patent litigation.

In this case, Pfizer hoped to launch its biosimilar bevacizumab in the UK market after the basic patent on the reference product, Genentech and Roche’s Avastin, expires in June 2020. However, the biosimilar maker has been hindered by what it has termed a patent thicket related to secondary patents.

Under which situations might the International Trade Commission (ITC) be the right choice for biosimilar patent disputes instead of federal district court? A panel discussed these questions at the ACI 10th Summit on Biosimilars on Monday in New York City.

The Center for Biosimilars® recaps the top news for the week of May 13, 2019.

AbbVie announced today that it has settled its patent litigation with Boehringer Ingelheim over adalimumab.

Yesterday, the federal circuit affirmed a district court’s decision in a patent dispute between Amgen and Sandoz.

The House of Representatives has passed a pair of bills that make changes to the FDA’s Orange Book and Purple Book, which provide information on generic drugs and biosimilars, respectively.

Last week, biosimilar developer Coherus BioSciences announced that it has reached a settlement with innovator drug maker Amgen over a trade secret case that was pending in the Superior Court of California. Separately, Amgen filed a new complaint against biosimilar developer Samsung Bioepis.

Amgen has now answered Coherus BioSciences’ complaint and denies that it has infringed on Coherus’ patents. Amgen also said that the patents are invalid for failure to comply with requirements of the law.

Earlier this month, pharmacy benefit managers (PBMs) were called before the Senate Finance Committee to answer questions about how their businesses impact drug prices for Americans. While the executives deflected criticism and pointed to issues like legal challenges to biosimilars as playing a key role in keeping drug prices high, lawmakers and officials are taking steps to rein in PBMs.

This month, US magistrate judge Richard A. Lloret granted Boehringer Ingelheim (BI)’s motion to compel AbbVie to produce prelitigation disclosures and settlements concerning its brand-name adalimumab, Humira.

Genentech, together with City of Hope, has filed a new complaint for patent infringement against Pfizer over PF-06439535, Pfizer’s proposed bevacizumab biosimilar referencing Genentech’s Avastin.

A class action lawsuit has been filed by United Food and Commercial Workers Local 1500 (UFCW Local 1500) against AbbVie for alleged use of a patent thicket to maintain a monopoly for its brand-name adalimumab, Humira. The complaint also alleges that AbbVie and a number of its biosimilar competitors colluded to divide the market for adalimumab between Europe and the United States.

This month, US District Judge William Alsup granted biologic developer Genentech some relief in its civil case against biosimilar developer JHL.

This month, biosimilar developer Sandoz filed suit against Amgen, asking the United States district court for the Northern District of California for a declaratory judgment of patent noninfringement and invalidity.

A United States District Judge in New Jersey has allowed a proposed class-action lawsuit against 3 major insulin makers to proceed.

In a long-running patent dispute with biosimilar developer Boehringer Ingelheim, AbbVie, maker of the brand-name adalimumab, Humira, has been ordered to produce documents related to its efforts to obtain patents that could shield its blockbuster drug from biosimilar competition.