Pharma's Creative Strategies to Hold Off Generic, Biosimilar Competition

Last week, Irish drug maker Allergan announced that it had transferred its patents for its cyclosporine ophthalmic emulsion, Restasis, to the Saint Regis Mohawk Tribe. Allergan said in a statement that the Tribe now owns all Orange Book-listed patents for the dry eye treatment, and that the Tribe is filing for a motion to dismiss an ongoing inter partes review (IPR) on the basis of sovereign immunity.

Under the agreement, the Tribe will receive $13.75 million from Allergan when the agreement is executed, and an additional $15 million per year in royalties on sales of the drug. According to the Mohawk Tribal Council, “This is a viable and sound opportunity for the Saint Regis Mohawk Tribe to enter into the patent, technology and research sector as part of our overall economic diversification strategy.”

A spokesperson for Teva Pharmaceuticals, which is one of the companies challenging Allergan’s patents on Restasis, told The New York Times that Teva “will be interested to see what comments are made about this tactic by regulatory agencies.”

The rest of the pharmaceutical industry, taken by surprise by Allergan’s strategy, will likely also look with interest on how the United States will address this unusual tactic to block generic drug makers from creating competing versions of its product. Pharma may also look to Allergan’s example as a model for how to transfer their patents to sovereign entities in exchange for regular royalties.

While Allergan’s latest tactic may be novel, reference product sponsors have used other approaches to delay generic and biosimilar competition for some time. Among practices that have been called into question are the following:

Restricted distribution. In order for a generic or biosimilar maker to develop a product, the company will require access to samples of the originator product. Some drug makers, critics allege, inappropriately restrict competitors’ access to samples by implementing safety programs that restrict distribution of samples.

Product-hopping. This practice involves making slight alterations that hold no significant therapeutic value to an existing drug and patenting the resulting product as though it were a new drug. Changes to drugs under a product-hopping strategy might include a change of form from a short-acting capsule to an extended-release tablet.

Pay-for-delay agreements. In recent testimony to the House Judiciary Committee, FDA Commissioner, Scott Gottlieb, MD, described pay-for-delay agreements as settlements in which drug companies resolve patent disputes by agreeing with generic drug makers to delay competitive products’ entry in exchange for payment. Gottlieb stopped short of saying that approach stymied competition, saying “we do not know when generic products would have entered the market if the patent litigation had continued and the companies had not settled with an agreement to delay marketing.”

Delivery device changes. According to Stat News, complex generics like Mylan’s EpiPen, an epinephrine product, which was recently the subject of controversy when its price suddenly spiked, can attain “virtual immortality” when they make adjustments to delivery devices. Mylan’s patent-protected change to the EpiPen’s push-button injector device effectively allowed it to stave off competition.

Extensive patenting. AbbVie has protected its reference adalimumab, Humira, with what Goodwin attorney Robert Cerwinski, JD, has called “a veritable patent thicket.” While the majority of patent protection for Humira has already expired, AbbVie has secured additional patents to the product that biosimilar developers must litigate either in IPR proceedings or under the Biologics Price Competition and Innovation Act pathways, both of which can be lengthy and costly.