Biogen is seeking a preliminary injunction in its BPCIA v. Sandoz case regarding Sandoz’s proposed biosimilar of TYSABRI (natalizumab). On October 20, 2022, the Court issued a sealed order on the parties’ joint stipulation and proposed timeline for a motion for a preliminary injunction. A redacted version of the schedule proposed by the parties provides that the information on Biogen’s motion must be completed by April 7, 2023, with a hearing to be scheduled later at the convenience of the Court. The joint proposal also requires Biogen to elect, by November 18, 2022, up to 5 patents and up to 10 claims to be asserted under the preliminary injunction.
Biogen also recently fielded a redacted version of his sealed 107-page complaint against Sandoz. Biogen alleges infringement of twenty-eight patents under the BPCIA based on Sandoz’s submission of an aBLA for PB006, a proposed biosimilar of TYSABRI (natilizumab). According to Biogene,[t]The patent infringement claims brought in this action are necessitated by the development and stated intent of the defendants to import, market and sell in Delaware and throughout the United States a biosimilar version of the breakthrough biologic product of Biogen, Tysabri® (natalizumab) (“Tysabri”) – which helps more than 200,000 patients in their fight against chronic, painful and life-threatening autoimmune diseases – by inappropriately exploiting Biogen’s intellectual property. Biogen seeks a judgment that Sandoz and Polpharma have infringed or will infringe the claimed patents, and a preliminary and permanent injunction.
TYSABRI is indicated for the treatment of multiple sclerosis and Crohn’s disease. TYSABRI is a humanized monoclonal antibody that targets the alpha-4 integrin component of adhesion molecules found on many white blood cells and, according to Biogen, “has been designed to selectively inhibit immune cells in the blood, preventing them from passing from the blood in the [central nervous system] where they can damage nerves.
According to Biogen, the claimed patents relate to “inventions relating to Tysabri, including relating to therapeutic uses of Tysabri, ways to make treatment with Tysabri safer for patients, and Biogen’s innovative antibody manufacturing methods, such as Tysabri”. Biogen alleges that “[i]In February 2005, after Tysabri was marketed, it was discovered that two people who had received Tysabri in clinical trials had developed progressive multifocal leukoencephalopathy (PML)”, leading Biogen to “voluntarily withdraw Tysabri from the market “. About a year later, “Tysabri was approved for reintroduction to the market[ with] a warning on the label regarding the potential risk of PML. According to the complaint, “Biogen has worked hard to develop an innovative risk management plan to provide early warning of PML cases,” including a Risk Assessment and Mitigation Program (REMS) to “mitigate the risk potential for PML in patients receiving treatment”. with Tysabri.
Biogen also alleges that its efforts led to “FDA approval of the first and only clinically and analytically validated anti-JCV antibody test, the Stratify™ JCV Antibody Enzyme-Linked Immunosorbent Assay (“ELISA”)” Stratify” or the “Stratification Test”). JCV is a “human polyomavirus” that “can remain in its most recent state in the body, usually without apparent clinical symptoms”, but “reactivation of JCV can lead to PML”. According to Biogen, its “innovative approaches to safely administer Tysabri and manage the risk of PML have been recognized by the US Patent Office.”
Biogen also alleges infringement of patents relating to the manufacture of antibodies, including methods of producing CHO cells with “enhanced growth characteristics”; methods of preventing and removing trisulfide bonds; methods of controlling glycosylation in cell culture processes; and depth filtration methods to clear mammalian cell culture. According to Biogene,[o]One of the major challenges in manufacturing therapeutic antibodies is that production is limited to cell-based expression systems which are expensive and inefficient, can have varying yields depending on the product and expression system , and require downstream treatment to remove introduced biological contaminants. of the expression system. Biogen claims it has “developed specialized cell expression systems that can be used to generate high-yield therapeutic antibodies, as well as specialized methods for culturing mammalian cells to improve the yield of therapeutic antibodies” .
Stay tuned to Big Molecule Watch for further developments on this BPCIA case.[View source.]