Shire obtains positive outcome in Biochem patent litigation.
On December 11, 2000, Shire and BioChem announced they had entered into an agreement to merge the two groups to form a leading global specialty pharma company. As part of this announcement, information was provided regarding patent disputes between BioChem and Emory University, relating to United States patent rights for lamivudine. The United States Board of Patent Appeals and Interferences has now invalidated Emory University's patent relating to lamivudine. Shire continues to review the detail of the decision but has not been advised of any intention by Emory to initiate any other action or appeal the decision.
Rolf Stahel, chief executive of Shire, commented, "In evaluating the merger with BioChem, Shire investigated carefully the patent situation and sought advice from external counsel on the probability of an adverse ruling. Shire welcomes the decision of the United States Patent and Trademark Office."
The Board of Patent Appeals and Interferences decision is the latest in a series of rulings around the world upholding BioChem's patent rights for 3TC/Epivir in patent disputes between BioChem and Emory University. Patent offices in Europe, Japan, Australia and Norway reviewed BioChem and Emory University's filings and universally decided in BioChem's favour.
"The decision by the United States Board of Patent Appeals and Interferences to invalidate Emory's patent underscores our long-held position that 3TC/Epivir was invented solely by BioChem scientists, including the late Prix Galien-winner, Dr. Bernard Belleau," said Dr. Francesco Bellini, BioChem Pharma's chairman and chief executive officer.
The United States Patent and Trademark Office ruled that Emory was not entitled to its patent. Emory's patent was granted five years after BioChem Pharma received its pioneering patent covering 3TC/Epivir and one year after the company's licensee, Glaxo Wellcome, began selling the drug. The invalidated Emory patent was the basis of the infringement suit Emory filed in United States District Court, Northern District of Georgia against BioChem and its licensee, Glaxo Wellcome; BioChem subsequently was granted a motion to stay the case pending the termination of the interference.
It is not known if Emory intends to appeal this decision.
Under agreement, BioChem Pharma receives royalties from Glaxo Wellcome (London, United Kingdom) on sales of 3TC/Epivir. Glaxo Wellcome has the right to develop, manufacture and sell 3TC/Epivir worldwide, except in Canada, where BioChem Pharma and Glaxo Wellcome have formed a commercialization partnership.
BioChem Pharma is an innovative and fast-growing biopharmaceutical company focused on infectious diseases and cancer.