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Protecting Against Big Pharma's Tactics for Delaying Market Entry of Generics

December 21, 2016

Branded companies make millions of dollars each day that a generic version of a drug is held from the market. Therefore, the branded companies are highly motivated to obstruct the path of generic pharma companies. For some branded companies, this includes "by any means necessary."

We have noticed branded pharma's increased use of certain tactics in delaying the market entry of generics.* Amongst all of the other considerations and obstruction tactics to be wary of, there are two tactics often overlooked when settling an ANDA dispute and drafting a settlement agreement – citizen petitions and Risk Evaluation and Mitigation Strategies (REMS). Both of these can be effectively used by a branded company to prevent generic market access for months or years.

Often times branded pharma's citizen petitions and REMS are not approved and are unsuccessful in their stated purpose. Courts have held that "objectively baseless" citizen petitions could potentially violate the antitrust laws. Baseless use of REMS to delay or deny generic drug companies' access to the market may also amount to an antitrust violation. However, these do not need to be successful to cause delays for generics and antitrust litigation, which is another layer of complexity on top of the patent issues.

While citizen petitions and REMS are not new, their increased use for delaying generic competition seems to be on the rise. When settling an ANDA litigation, it is important to keep these brand strategies in mind and negotiate clauses that protect the generic company against their use.

* Our experience coincides with Professor Robin Feldman's research in this area included in her publication Drug Wars, Harvard J. of Legislation, Vol.53 2016.

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