Want to Know Why Drugs Are So Expensive?

Because of stuff like this. Drug companies will do WHATEVER IT TAKES to prevent their drug from going generic. This is shady as all get out, and I will probably not Rx Restasis anymore because of this. I like Xiidra (competitor) better, anyway:

https://www.aao.org/headline/allergan-uses-unorthodox-maneuver-to-protect-resta

SEP 08, 2017

Allergan uses an unorthodox maneuver to protect Restasis’ patents

Allergan has sold the patents for Restasis to an Indian tribe in an effort to protect their top-selling dry eye drug from generic competition.

The Saint Regis Mohawk Tribe, a recognized sovereign tribal government in upstate New York, now owns the rights to Restasis and has granted Allergan exclusive licenses on the product. Under the terms of the agreement, Allergan will pay the tribe $13.75 million in initial payments and an additional $15 million in annual royalties.

According to the press release, Saint Regis will file to dismiss any patent challenges "based on their sovereign immunity from IPR (inter partes review) challenges". Three companies—Teva Pharmaceutical Industries, Mylan NV and Akorn Inc.—have filed IPR challenges related to Restasis. 

Allergan's Chief Legal Officer Bob Bailey said that Saint Regis was the one who approached the company with the strategy. The decision to proceed was based on 2 previous cases involving universities that were successful in using their sovereign status to dismiss IPR proceedings.

Sales of Restasis (cyclosporine ophthalmic emulsion, 0.05%) generated $1.4 billion in revenue last year, and its patents are expected to expire in August 2024.

"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,” the Saint Regis Mohawk Tribal Council said. “We realize that we cannot depend solely on casino revenues and, in order for us to be self-reliant, we must enter into diverse business sectors to address the chronically unmet needs of the Akwesasne community; such as housing, employment, education, healthcare, cultural and language preservation."

The deal comes at an interesting time, as congress recently passed a funding mechanism that could help speed the generic drug approval process. The FDA has also been working on a fast-track process that could reduce the approval timelines to as few as 8 months.