NEWS

The Tribal Exemption Strategy and Patent Litigation of Allergan

Release time:

2018-08-31 14:46

Recently, the U.S. Patent Trial and Appeal Board rejected the motion of the St. Regis Mohawk Tribe (American Indian Tribe) and rejected Aljian (Allergan) Its drugsRestasisSix patent-related claims.

Restasisis a kind of containing0.02%concentration of cyclosporine, an immunomodulator used to treat glaucoma and chronic dry eye(A condition in which decreased tear production due to inflammation), this drug.2003Listed in, patented in the United States.2014years due,2013YearFDAThe door was opened to generics, and Al-Jian appealed to the U.S. Patent Office for an extension of the patent.10The approval of the year, but the United States.Actavis/WatsonThe company had already produced generic drugs before the end of the patent litigation, so patent disputes continue.2016YearRestasisBrings Total Exceeding to Eljian15Billion US dollars of income, accountingAllerganprofitable15%, with sales second only to the best-selling Botox.

The U.S. Patent Trial and Appeal Board has an internal review process that usually challenges the validity of patents. According to the current law of the United States, a sovereign tribe is regarded as a sovereign country that is exempt from civil litigation and has immunity from the patent trial and appeal board. Taking advantage of this "loophole", some companies holding potentially problematic patents will pay some fees and transfer these patents to the tribe first. If the patents are successfully protected, they can use the patents directly only by paying royalties. The company has previously signed a patent agreement with the St. Regis Mohawk tribe that willRestasisThe patent was transferred to the Mohawk tribe and hopes to use the move to obtain the privilege of patent protection. Legal experts say the deal can shield the company's patents from administrative litigation or protect them from challenges in federal court. This may eventually hit competitors and have a significant impact on the generic drug market.

Once the patent case is approved, it cannot be sold, used and used in the market.RestasisGeneric drugs with the same active ingredients can gain a monopoly in this field, but this move has triggered calls in the industry to revoke the tribe's sovereign immunity privilege in patent protection.2017A Texas District Court judge ruled that Eljian had no right to renewRestasisright of patent protection, which is alsoRestasisThe early listing of generic drugs provides conditions.

2018Year2Month23S. Patent Trial and Appeal Board dismissed the San Regis Mohawk Tribe's motion on multiple grounds. The Committee considered that it was not possible to establish the principle of tribal sovereignty immunity applicable to the review by both parties (IPR) procedure, in addition, even if tribal sovereignty immunity applies to this case, the intellectual property litigation can continue because Aljian retains patent ownership of the drug.

References:https://mp.weixin.qq.com/s/DrgDS6PySMHh1cNCjzdU4w