University's Drug Patent Is Invalidated by a Judge
By ANDREW POLLACK [NYT]
March 6, 2003
A federal judge yesterday invalidated a broad patent held by the University of Rochester on a popular class of painkillers and dismissed the school's lawsuit seeking royalties from Pharmacia and Pfizer on sales of their big-selling drug Celebrex.
The decision is a big blow to the university, which had envisioned billions of dollars in royalties that would have helped turn its medical school into a research powerhouse. When the patent was granted and the patent infringement lawsuit was filed in April 2000, school officials predicted the patent might become the most lucrative ever held by a university.
That is because Celebrex is one of the world's best-selling drugs, with worldwide sales of $3 billion last year, of which $2.4 billion came from the United States. If the university had won, it would also have been in a position to seek royalties on sales of other painkillers of the same type, known as Cox-2 inhibitors, like Merck's Vioxx.
But Judge David G. Larimer of United States District Court in Rochester ruled the patent invalid because it did not contain a detailed enough written description of the invention nor enough information to enable others to duplicate the work.
The university's patent covered a method for treating pain and inflammation by inhibiting the Cox-2 enzyme and a test to screen potential drug candidates. But the university did not develop a drug nor specify sufficiently how such a drug could be developed, Judge Larimer said. Therefore, although university scientists made an important discovery, he said, it "did not blossom into a full-fledged complete invention."
"While the court does not mean to suggest that the inventors' significant work in this field is on a par with alchemy, the fact remains that without the compound called for in the patent, the inventors could no more be said to have possessed the complete invention claimed by the '850 patent than the alchemists possessed a method of turning base metals into gold," he wrote in his 33-page decision, referring to the last digits of the university's patent number.
The university said it would appeal, and added that the ruling could hurt universities, which often make fundamental discoveries but do not go on to develop commercial products. "While courts are comfortable with narrow patents, there is widespread interest among research universities in ensuring that our broader, more basic research work is likewise protected by the nation's patent laws," Thomas H. Jackson, the university's president, said in a statement.
Richard T. Collier, the general counsel of Pharmacia, said in a statement that the decision "confirms what we have said all along that the University of Rochester's patent was invalid on its face" and that the university "had no role in the discovery or development of Celebrex."
Pfizer, which helps market Celebrex, has agreed to buy Pharmacia, which would give it all the revenue of Celebrex and of a newer Cox-2 inhibitor, Bextra. Shares of Pfizer rose 55 cents, to $29.19, while Pharmacia rose $1, to $40.55.
Rochester scientists led by Dr. Donald Young discovered in the 1980's and early 1990's that the Cox-2 enzyme was involved in inflammation and pain. Before then it was thought a different enzyme, now known as Cox-1, was involved. But it turned out that Cox-1 protects the lining of the stomach from acids.
Many painkillers, including aspirin, inhibit both Cox enzymes, reducing inflammation but also causing ulcers. Drugs that inhibit only Cox-2, like Celebrex, should cause fewer ulcers, although the Celebrex label includes an ulcer warning.
Patents like the university's, which covered an entire method of treatment, are somewhat controversial. Most drug patents cover a specific compound, allowing other drug companies to develop competing drugs that work the same way.
Pfizer itself received a patent last October covering a way of treating male impotence by inhibiting the same enzyme that is blocked by its drug Viagra. It promptly sued the developers of two competing drugs that are close to reaching the market and that work the same way as Viagra but are made with different compounds.
Gerald P. Dodson, the lawyer representing the university, said Pfizer's victory yesterday might hurt it in the Viagra case. "If our claims are flawed, then so are theirs," said Mr. Dodson, of Morrison & Foerster in Palo Alto, Calif.
Gerald Sobel of the law firm Kaye Scholer in Manhattan, who is representing Pfizer in both the Rochester and Viagra lawsuits, disputed that. In the case of the university's patent, he said, "there was no way to implement the method of treatment." In the case of the impotence treatment patent, he said, "there is a concrete way; there is a drug." |
