Bureau of National Affairs: Columbia Cotransformation Patent Extentsion

Reproduced with permission from BNA's Health Care Daily, Vol. 5, No. 96, pp. 7-8 (May 17, 2000). Copyright 2000 by The Bureau of National Affairs, Inc. (800-372-1033)

The Bureau of National Affairs

Volume 5 Number 96
Wednesday, May 17, 2000
ISSN 1091-4021

Major Patent Law Change

While the FDA appropriations approved by the House and Senate committees themselves are seemingly uncontroversial, at least three industry groups are expressing their concern with a major change in patent law tucked into the supplemental appropriations section of the Senate bill. The Biotechnology Industry Organization, the Pharmaceutical Research and Manufacturers of America, and the Generic Pharmaceutical Industry Association are voicing reservations about granting patent extensions under the Drug Price Competition and Patent Term Restoration Act (known as "Hatch-Waxman") to elemental biologics used in making a drug product. Currently, such extensions, which can be granted for up to five years, are available only to the drug products themselves rather than to the underlying process patents. According to Columbia University Executive Vice-Provost Michael Crow, Sen. Judd Gregg (R-N.H.), a 1969 alumnus of Columbia University, is the "main carrier of water" behind changing language in Hatch-Waxman in the Senate appropriations bill. Under the language of the Senate bill, Columbia University would be eligible for a patent extension on its cotransformation patent, which covers a process through which foreign DNA is inserted into mammalian cells to encourage protein production. This process is used in manufacturing several biotechnology drugs including Activase, which is used to treat heart attack and stroke victims, and Avonex, used to retard the progression of multiple sclerosis.

'Completely Inappropriate'

"We think that it's completely inappropriate to make a major change to the Hatch-Waxman law ... in a provision buried in an appropriations bill without any discussion with the Judiciary Committee or the PTO," Michael Werner, bioethics counsel and director of federal government relations at BIO, told BNA May 16. "Columbia is advocating a major change without hearings or discussions," PhRMA spokesman Jeff Trewhitt told BNA May 16. "We do have concerns and reservations because it is a matter of changing a complicated law without hearing or discussion," he said. Trewhitt said PhRMA was reviewing the Columbia matter with its members and would not have "anything further to say" until the review has been completed. Although GPIA has not taken an official position on whether Columbia University's cotransformation patent should be eligible for extension under Hatch-Waxman, Diane Dorman, GPIA's manager of communications, told BNA May 15, "GPIA is opposed to any type of patent legislation that circumvents the committee process." Dorman said GPIA fears that the Columbia patent extension could slip through the appropriations process without a debate on the merits of its claim. Responding to PhRMA's and GPIA's comments, Crow said "this is the first we've heard of it ... no one from industry has spoken to us." As far as the issue of open hearings on the cotransformation patent extension issue, Crow said, "we're not seeking a remedy from Congress; we're seeking a remedy from the PTO [Patent and Trademark Office]." Crow said Columbia has "spoken to staffers everywhere," including the House and Senate Judiciary Committees about the patent extension issue. "We weren't shy about going to everybody on this," Crow said. A spokeswoman for the Senate Appropriations Committee said she was not aware of the language in the bill. She declined to estimate when the Senate bill would go to the floor.

Matter of Fairness

For its part, Columbia says the change in Hatch-Waxman language is purely technical and a "matter of fairness." According to Crow, "everybody we talked to [on Capitol Hill] said 'this is a minor technical issue.' " Crow said Columbia is not seeking to "change" Hatch-Waxman, but rather wants Hatch-Waxman "corrected" so that it is "definitionally accurate" about what patentees can apply for an extension under the act. According to Crow, members of Congress told Columbia officials that there was "no intention to leave out" process patents such as Columbia's from being able to seek an extension. Crow, who said the university spoke to more than 25 congressional offices about prolonging its patent, told BNA "nobody says we're going to have to hold hearings on this." "It seemed to us, as a matter of fairness, that Hatch-Waxman ought to be able to apply to us," Crow said. Crow said the university was awarded its patent in 1983, but did not start making money on it until 1988. "We were delayed by the entire system," Crow said. Because drugs developed using Columbia's process were delayed in the FDA approval process, royalties to Columbia on the process patent were correspondingly delayed, he said. Crow, who in addition to Sen. Gregg, counts Sen. Patrick Moynihan (D-N.Y.) and Rep. Jerrold Nadler (D-N.Y.) as supportive of Columbia's efforts, said the only concerns he has heard about the attachment to the Senate appropriations bill are "jurisdictional." Some people have told Columbia the Senate bill was "the wrong place" to attach the cotransformation patent issue, he said. There is no corresponding language in the House agriculture appropriations bill, Crow said.

Time Running Out

However, Crow said, the issue for Columbia was time. Columbia's patent expires in August. If Columbia is able to apply to the Patent and Trademark Office for an extension, and gets it, Crow said the university likely will be able to get another 18 months on its patent. That additional time would represent an extra $150 million for Columbia's coffers, which the university would "push ... back into basic fundamental science," Crow said.

Copyright 2000 by The Bureau of National Affairs, Inc., Washington D.C.