A recent Federal Circuit ruling held that tribal sovereign immunity does not apply in reviews at the Patent Trial and Appeal Board which rejected an attempt from Allergan PLC to shield patents for its dry-eye medication, Restasis, by transferring them to a Native American tribe.
According to an article by Reuters, the drug generated $1.5 billion in revenue last year for Allergan.
So, what does this mean?
In this case, one of Allergan’s patents was subject to an inter partes review (IPR). In this type of matter, a third party has requested the patent office to reopen examination based on a contention that the examiner should not have allowed the case. Generally, the third party has identified some prior art that the examiner has not considered during the examination of the case originally, and that prior art would have prevented the case from being allowed.
In this particular case, Allergan attempted to assign the patent to a Native American tribe in to use the immunity granted to Native American tribes as grounds for making the patent ineligible to be reviewed by the Patent Office during an IPR. If this were allowed to go through, then an entire industry would have popped up overnight. Patent holding companies would have been set up by Native American tribes so that companies who have patents could be shielded from possible invalidity of the patents by the IPR practice.
The Court of Appeals for the Federal Circuit has rejected Allergan’s attempt use the Native American tribe’s immunity and noted that the patents for the drug Restasis are subject to the proceedings before the US Patent Office, regardless of being transferred to the St. Regis Mohawk tribe.
For our clients, it is business as usual and continues to allow clients access to the Patent Office in order to challenge the patents of their competitors (if necessary) using IPR proceedings before the US Patent Office.
If you have questions about a patent, please contact one of our IP team members today.