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5 January 2021AmericasMuireann Bolger

Teva fails to reclassify MS drug to thwart generics

Teva Pharmaceuticals has failed to redefine its multiple sclerosis drug Copaxone (glatiramer acetate) as a biological product instead of a drug, after the US District Court for the District of Columbia dismissed its efforts as “uncompetitive” on December 31.

In 1996, the Food and Drug Administration (FDA) approved Copaxone as a drug under the Food, Drug, and Cosmetics Act (FDCA), and in “the face of concerted resistance” by Teva, the agency subsequently approved generic glatiramer acetate products, including those manufactured by Sandoz and Mylan.

In March, the Israeli company filed a suit against the FDA and the Department of Health and Human Services, arguing that its product should be considered a protein biologic because this reclassification was mandated by the Biologics Price Competition and Innovation Act of 2009.

A biologic is a type of drug derived from natural, biological sources such as animals or microoorganisms in contrast to traditional drugs, which are typically synthesised from chemicals. Both drugs and biological products are used to treat and prevent disease in the human body.

If Copaxone had been reclassified a complex “biologic” rather than an easily recreated “drug” then it would be harder for generic companies to get the required permission to reproduce copies. However, the FDA concluded that Copaxone did not satisfy the specific requirements to qualify as a protein,” an interpretation Teva denounced as “arbitrary and capricious”.

The court concluded that Teva’s arguments all rested on the same premise: that the FDA should have formulated an approach to defining and identifying proteins and analogous products that would have resulted in Copaxone’s classification as a biological product.

The court, however, dismissed Teva’s suit as “yet another effort to stifle Copaxone competitors” after its “concerted resistance” to the approval of generic versions of the product. It held that over the past 25 years Teva had pursued every available avenue to prevent other glatiramer acetate products from coming to market.

In its “last ditch” attempt to prevent generic makers from producing and selling copies of its product, Teva failed to point to any scientific evidence indicating that Copaxone could meet the standard of specificity the FDA outlined, the court found.

It further sided with the FDA in its assessment that Copaxone’s short, conserved sequences which were “capable of replication in generic glatiramer acetate products, and its determination that those sequences should be considered when approving generics”, was in no way equivalent to a finding that Copaxone molecules as a whole have the “specific, defined sequence” characteristic of proteins.

In September, The European Patent Office invalidated and revoked a patent related to Copaxone, in a win for Mylan. In an announcement shared on September 15, Mylan said that the decision to invalidate European patent number 2,949,335 cleared a legal pathway to expand access for patients living with multiple sclerosis in markets across Europe.

At the time, a spokesperson for Teva said the company was “disappointed” with the decision.

“We continue to believe in the value of Copaxone, a treatment that has been studied extensively for more than 20 years and which has provided so far already 2.5 million years of patient experience. We remain strongly committed to reducing patient suffering in the field of multiple sclerosis,” said the spokesperson.

LSIPR has approached Teva for comment.

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More on this story

Americas
1 March 2017   Speciality pharmaceutical company Orexo has filed a complaint against Actavis and its parent company Teva for infringing patents protecting Orexo’s Suboxone and Subutex.
Asia
27 July 2015   Pharmaceutical company Teva has bought Allergan Generics from drugs business Allergan in a $40.5 billion deal.