Teva Challenges the FDA Over its First-Applicant Interpretation

Attorney: Tia D. Fenton
October 22, 2018

Teva Pharmaceutical USA, Inc. filed a Complaint and Motion for Preliminary Injunction in the U.S. District Court for the District of Columbia, alleging that the FDA's recent interpretation of the definition of "first applicant" is unlawful.... Read more

Recent Pharmaceutical House and Senate Bills

Attorney: Tia D. Fenton
August 28, 2018

Over the summer, representatives introduced bills and amendments of interest to the pharmaceutical industry. First, Senator Orrin Hatch, co-author of the Hatch-Waxman Act, filed an amendment in the Senate Judiciary Committee that would require a generic manufacturer wishing to challenge a brand-name drug patent to choose between Hatch-Waxman litigation and IPR, removing the option to use both. According to Senator Hatch, this Hatch-Waxman Integrity Act of 2018 would ensure that Hatch-Waxman continues to operate as originally intended by protecting the ability of generic drug companies to develop lower-cost drugs, while at the same time providing innovators a period of exclusivity to recoup investments. Specifically, Senator Hatch commented that the availability of an alternative path to challenge patents through IPRs has threatened to upend the carefully-crafted Hatch-Waxman balance by enabling companies to put added litigation pressure on drug innovators above and beyond what Hatch-Waxman already provides.... Read more

Anacor Pharmaceuticals, Inc. v. Iancu

Attorney: Tia D. Fenton
May 17, 2018

On May 14, 2018, in Anacor v. Iancu, the Federal Circuit issued its opinion affirming the Board's invalidation of Anacor's tavaborole patent. The patent-in-suit, U.S. Patent No. 7,582,621, entitled "Boron-containing Small Molecules," is directed to the use of tavaborole to treat fungal infections. According to the disclosure, tavaborole can be used to treat a fungal infection known as onychomycosis, which is a nail disease responsible for approximately half of all nail disorders in humans. In an inter parties review, the Patent Trial and Appeal Board found all of the claims of the '621 patent unpatentable for obviousness. Anacor appealed with respect to only one of the claims and the Federal Circuit affirmed.... Read more