Orange Book Blog

Merck & Co. v. Hi-Tech Pharmacal, No. 06-1401 (Fed. Cir. 2007)

The U.S. Court of Appeals for the Federal Circuit held today
that a patent term extension under 35 USC 156 may be applied to a
patent that is subject to a terminal disclaimer under 35 USC 253, handing a
victory to Merck in its battle with Hi-Tech Pharmacal over generic
Trusopt (dorzolamide HCl opthalmic solution).  Hi-Tech had argued that
Merck's patent on Trusopt expired in 2004 because a patent term
extension on the patent was invalid.

As we reported last month,
a loss for Merck in this case would have had drastic effects on
pharmaceutical companies and patent owners, since the Patent Office has
routinely granted patent term extensions on patents that are subject to
a terminal disclaimer.  Brand-name drug companies would have lost years
of patent protection on some of their best-selling drugs if the Federal
Circuit had decided that a terminal disclaimer precludes a patent term
extension.

Section 156 was enacted as part of the Hatch-Waxman Act in 1984 to
allow restoration of part of a pharmaceutical patent's term "lost" due
to lengthy FDA review of a new drug application.  Section 253, on the
other hand, applies to all kinds of patent applications–not only those
relating to pharmaceuticals–and allows the filing of a terminal
disclaimer to overcome "obviousness-type double patenting" rejections
made by the Patent Office.

In reaching its decision today, the Federal Circuit properly
recognized that "the language of Section 156 is unambiguous and
fulfills a purpose unrelated to and not in conflict with that of
Section 253."  The court observed: (1) according to Section 156, a
patent term "shall be extended" if five enumerated conditions, none of
which concern terminal disclaimers, are met; (2) the legislative
history is consistent with the mandatory language of the statute; and
(3) Section 154 excludes patents in which a terminal disclaimer has
been filed from the benefit of a term adjustment for PTO delays, but
Section 156 contains no such exclusion for patents eligible for term
extensions for FDA delays, which further supports the court's interpretation of Section 156.

Additionally, the court explained why Section 156 and Section 253 are compatible:

The purpose of the terminal disclaimer–to prevent extension of
patent term for subject matter that would have been obvious over an
earlier filed patent–remains fulfilled by virtue of the fact that the
date from which any Hatch-Waxman extension is computed is the
terminally disclaimed date.  At the same time, the purpose of the
patent term extension–to restore some of the patent term lost due to
regulatory review–is also satisfied.

Hi-Tech will now have to wait until at least April 28, 2008, when
Merck's patent expires, before it can launch its generic version of
Trusopt.

RELATED READING:

• Patently-O; Patent Baristas
  
• MarketWatch.com
• Wall St. Journal (subscription)