Life Science Compliance Update

May

2018

Update – Allergan’s Patent Transfer To Native Americans Lacks Merit

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Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

In an effort to preclude competitors including generic drug companies from entering the market, many pharmaceutical companies, most notably Allergan PLC (“Allergan”) with its dry-eye medication Restasis has sought to enter into patent transfers with Native American Tribes, taking advantage of sovereign Indian Nation status to thwart off intellectual property challenges and create additional barriers to market entry. In October 2017, a U.S. Federal Court dismissed Allergan’s lawsuit seeking to enforce its Native-American patent partnership, taking issue with Allergan’s seeking to stifle competition by way of seeking refuge by way of Native American sovereign immunity. Seeking further legal relief from the Patent Trial and Appeal Board (“PTAB”) of the U.S. Patent and Trademark Office (“USPTO”), Allergan’s latest efforts to invoke sovereign immunity as the basis to limit generic drug competition has similarly failed.


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December

2017

The New Westward Expansion – Big Pharma Partners with Native Americans to Protect Patents

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Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

As each pharmaceutical asset becomes more expensive to bring to market, patent protection and patent extension are critical to a drug company’s sustainability. Now, it seems that one drug maker (Allergan PLC) may have found a way to capitalize on the often-forgotten fact of Native American tribal sovereignty to thwart off intellectual property challenges and create additional barriers to market entry. Regardless of whether the strategy is successful, it will bring renewed interest in finding ways to work with tribal interests and one more legal area that compliance officers may need to have a working knowledge about.


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