[Ip-health] Pfizer busts U of Rochester patent on Cox-2 inhibitors, undermines its own patent cliams on Viagra type meds

[James Love]

After spending a lot of lawyers and experts, Pfizer busts the University
of Rochester US patent on Cox-2 inhibitors.   Rochester claims the
Pfizer victory will haunt company in its own litigation over Viagra
patent protection.  Jamie


http://www.nytimes.com/2003/03/06/business/06DRUG.html

University's Drug Patent Is Invalidated by a Judge
By ANDREW POLLACK

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."

--
James Love, Director, Consumer Project on Technology
http://www.cptech.org, mailto:james.love@cptech.org
tel. +1.202.387.8030, mobile +1.202.361.3040