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Honigman client first to win District Court ruling on Patent Term Adjustment calculations

Court ruling could be worth millions of dollars to pharmaceutical and biotechnology companies

November 8, 2012

On November 1, 2012, the U.S. District Court for the Eastern District of Virginia ruled in favor of Honigman Miller Schwartz and Cohn LLP client regarding the United States Patent and Trademark Office’s (USPTO) calculation of Patent Term Adjustment (PTA). While numerous companies are also challenging the USPTO’s application of PTA, this is the first decision that has been made on this issue by a court.  It is uncertain whether the USPTO will appeal this decision.  This victory, if maintained by the courts, will have a significant impact on the calculation of PTA in cases where the applicant was denied PTA after filing a Request for Continued Examination (RCE).

The District Court’s ruling will benefit companies with patents in which the value of the invention remains, or is even amplified, towards the end of the patent term.  In particular, companies in the pharmaceutical and biotechnology industries are likely to benefit, as the regulatory approval process often results in the product being introduced into the market late in the term of the patent. 

Honigman’s suit focused on the USPTO’s application of the statutory provisions that provide for an increase in patent term to compensate patentees for undue delay by the patent office when prosecuting and issuing patents.  Honigman argued that the PTO’s denial of PTA after an applicant had filed a Request for Continued Examination was inconsistent with Congressional intent.  Judge T.S. Ellis III agreed, finding that a RCE has no impact on PTA if it is filed more than three years after the filing date or the commencement of the national phase.

J. Michael Huget, who leads the Honigman Intellectual Property Litigation Group and argued the case, said “the Court’s ruling brings clarity to important subject matter for many companies, namely the term of their patents.” 

The Honigman team involved in this matter included partners Jonathan P. O’Brien, Ph.D. (chair of Honigman’s IP Department), Noel Day, Ph.D., J. Michael Huget, Heidi Berven, Ph.D., Emily Zelenock Tait and Bea Swedlow.

Honigman's IP Department, which includes 36 transactional, procurement and enforcement attorneys, provides a wide variety of patent, trademark, copyright and trade secret services, including search, registration, enforcement and anti-counterfeiting. The professionals in the IP Practice Group have experience in numerous industries, including automotive (OEM and suppliers), retailing, publishing (newspapers, books, magazines, multi-media), gaming and hospitality, e-commerce, food and beverage, restaurant, advertising, insurance, software, electronics, consumer products, fashion, banking, transportation, telecommunications, medical services and devices, pharmaceuticals, biotechnology, and real estate.