Government Brief Faults Tribal Immunity Logic

On June 4th, the Federal Circuit will hear arguments in Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc.  As a reminder this case will explore whether principles of sovereign immunity prevent the Patent Trial & Appeal Board (PTAB) from conducting an Inter Partes Review (IPR) of a patent owned by a Native American tribe.

In advance of the upcoming hearing, the U.S. Dept. of Justice has filed its amicus brief supporting the agency’s decision to deny immunity.  The government brief explains that “[n]o principle of sovereign immunity entitles an Indian tribe to withhold a public franchise from reconsideration by the superior sovereign that granted it.” Continue Reading PTAB’s Sovereign Power Superior to State/Tribes

Stay To Force PTAB Outside of Statutory Time Limit?

Today, the Federal Circuit issued a stay of further Patent Trial & Appeal Board (PTAB) proceedings pending the St. Regis Mohawk Tribe’s sovereign immunity appeal. The appeal challenges the Board’s determination that the Tribe is not immune from its proceedings as a sovereign entity. As a reminder, the tribe is alleged to be the new owner of Allergan patents relating to the ophthalmic Restasis®  Continue Reading CAFC Shuts Down PTAB Pending St. Regis Mohawk Tribe Appeal

Preserving Access to Cost Effective Drugs (PACED) Act

Senator Tom Cotton (R-Arkansas) and Senator Claire McCaskill (D-Missouri) along with Senators Pat Toomey (R-Pennsylvania), Joni Ernst (R-Iowa), David Perdue (R-Georgia) introduced the Preserving Access to Cost Effective Drugs (PACED) Act (S.2514), to “restore the power of the Patent and Trademark Office and federal courts, and the International Trade Commission to review patents regardless of sovereign immunity claims made as part of sham transactions.”

Introduced this past Wednesday, S.2514 is backed by a host of health care entities, including America’s Health Insurance Plans (AHIP), Association for Accessible Medicines, Patients for Affordable Drugs Now, BlueCross BlueShield Association, and Blue Shield of California.

The bill would prevent any patent owner from advancing a sovereign immunity defense, including the sovereign immunity accorded to Indian tribes in any USPTO derivation proceeding, reexamination, Inter Partes Review (IPR) or Post Grant Review (PGR) proceeding.

The background accompanying the bill explains:

  • By avoiding review, pharmaceutical firms can prevent generics from coming to market and raise the cost of drugs.
  • Similarly, if non-practicing entities, often referred to as “patent trolls,” can skirt a review or use a tribe as a straw plaintiff, it becomes harder for businesses to defend themselves against dubious patent claims.
  • This legislation would do nothing to prevent pharmaceutical firms from partnering with Indian tribes for research, development, and licensing of drugs.

Given the bipartisan support, and interest of states in controlling health care costs, this bill may make quick progress. So much for that bit of excitement.

Federal Statutes Applicable to Tribes Absent Expression to the Contrary

In addition to the state sovereign immunity dispute now headed to the Federal Circuit, you might recall that the Patent Trial & Appeal Board (PTAB) was also considering the related question of whether sovereign immunity applies to Board proceedings involving Native American tribes. Last Friday, the Board decided that tribal immunity does not apply to USPTO proceedings in Mylan v. Saint Regis Mohawk Tribe. Continue Reading PTAB Denies Tribal Immunity Bid

Federal Circuit to Consider PTAB Sovereign Immunity Defense

State-affiliated entities enjoy immunity from suit in federal courts under the 11th amendment. To date, a handful of such entities have successfully leveraged the same immunity theory to avoid review of their patents before the Patent Trial & Appeal Board (PTAB). While still other Patent Owners have aligned themselves with Native American Tribes in an effort to benefit from their sovereign status in the hopes of avoiding PTAB review.

More recently, in Ericsson v. Regents of the University of Minnesota.the PTAB has determined that sovereign immunity is waived where the sovereign entity files an infringement suit. (here)

Appeal was taken from this decision this week. Continue Reading PTAB Sovereign Immunity Dispute Heads to CAFC