Patient Advocacy Group Seeks PTO Review of Wyeth's Tygacil Patent

A patient advocacy group is using a recently created pathway for challenging generic drugs through the U.S. Patent and Trademark Office to contest the patent on Wyeth’s antibiotic Tygacil outside a Hatch-Waxman ANDA.

The Initiative for Responsibility in Drug Pricing filed what is known as an inter parties review challenge against Tygacil (tigecycline) on August 8 in front of the PTO’s Patent Trial and Appeal Board. The group argues in its petition that Tygacil’s ‘828 patent would have been obvious for other drugmakers to try and is therefore invalid.

Tygacil is already facing a separate patent review board challenge filed by generics maker Apotex, IRDP notes, a challenge due for oral arguments on January 23, 2015. A separate challenge is necessary in case the two parties settle outside of the review process and delay market entry of Apotex’s generic Tygacil, the group says in requesting that the PTO take up the second trial.

In its petition, IRDP touts the fact that it has no ties with any pharmaceutical company, giving it the ability to exclusively serve the public interest rather than the interests of negotiating parties. The group exists explicitly to give Americans more access to lower-cost generics by challenging and invalidating drug patents, the petition says. Outside challengers are important because generics companies will often settle litigation with the brand manufacturer rather than fully invalidate what IRDP calls “dubious patents,” the petition adds.

There are growing signs that other generics companies also are catching on to IPR challenges and two other forms of PTO review created by the 2011 America Invents Act. Such reviews are cheaper and faster than their Hatch-Waxman counterparts and may be friendlier to patent challengers.

There were means beyond ANDAs to challenge drug patents in the past, says Amir Naini, a lawyer with Russ August & Kabat who is representing IRDP. The AIA reviews simply represent the latest means for outside parties to challenge drug patents.

Wyeth parent Pfizer confirmed the challenge but declined to comment further. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.