[Ip-health] Rochester newspaper on UR loss of Cox-2 patent

[James Love]

This is the home town newspaper account of the patent dispute.  jl

*  =93This is one judge=92s opinion,=94 Dodson said. =93This is a patent wh=
ose
potential value is huge. There are important broad issues of patent law
and the principle of the patentability of basic research involved.

*  When the U.S. Patent and Trademark Office awarded the patent to the
university in April 2000, UR officials and others said it could become
the most lucrative pharmaceutical patent in history.

*  Cox-2 inhibitors are a class of drugs that have the ability to
relieve pain and inflammation without causing the side effects of
stomach cramps, bleeding and ulcers. The drugs may have many other uses
as well, including reducing the number of cases of colon cancer and the
effects of Alzheimer=92s disease.

*  The university=92s patent argument is straightforward: Celebrex and
other cox-2 inhibitors would not have been found without the discovery
by UR scientists of cox-2, the gene that produces it and cox-2=92s
relationship to inflammation.  The broad patent protects that discovery
and the method of treatment, even if the university did not produce a
specific cox-2 inhibiting pill, the university claimed.

*  Richard Collier, Pharmacia=92s senior vice president and general
counsel, said the ruling confirms the company=92s position that UR had no
role in the discovery or development of Celebrex.  Pharmacia said a
reversal of Larimer=92s decision is unlikely.

*  UR still believes the patent is valid, Dodson said. =93Discovering a
method for finding diamonds is at least as valuable as the diamonds,=94
Dodson said.



http://www.democratandchronicle.com/biznews/0306story1_business.shtml

UR loses first round in patent lawsuit

Judge distinguishes between cox-2 discovery and new drug

By Michael Wentzel
Democrat and Chronicle

(March 6, 2003) =97 The University of Rochester=92s hopes for a plentiful
source of money for research and education suffered a significant
setback Wednesday with a loss at the initial stage of a patent
infringement lawsuit.

If upheld, the decision could affect basic research and patents at
universities across the country.

U.S. District Judge David G. Larimer ruled invalid a patent awarded to
UR for a new class of pain-killing drugs called cox-2 inhibitors.

Larimer dismissed UR=92s infringement complaint, ruling in favor of Pfizer
Inc. and Pharmacia Corp., makers of the drug Celebrex, a best-selling
cox-2 inhibitor.

The university will appeal the decision to the U.S. Court of Appeals for
the Federal Circuit as soon as possible, said Gerald P. Dodson, UR=92s
attorney.

=93This is one judge=92s opinion,=94 Dodson said. =93This is a patent whose
potential value is huge. There are important broad issues of patent law
and the principle of the patentability of basic research involved. This
is a good time to take an appeal and get a clear finding.=94

Larimer=92s decision surprised Kathleen Williams, a patent lawyer at
Palmer & Dodge in Boston who found the case law cited in the opinion
=93off-base.=94

=93There=92s no way to predict what an appeals court will do, but this cour=
t
might have made a mistake in its interpretation,=94 Williams said.

But Ronald Cahill, a patent attorney with Nutter, McClennen & Fish in
Boston, found the ruling well-reasoned and consistent with the law.

=93This doesn=92t necessarily mean the university is out of the game, but
they do face an uphill battle in the appeal,=94 Cahill said.

When the U.S. Patent and Trademark Office awarded the patent to the
university in April 2000, UR officials and others said it could become
the most lucrative pharmaceutical patent in history.

The money that could go to the university in the 17-year life of the
patent would be measured in billions of dollars, not millions, UR
officials said.

If upheld, the decision could threaten the plans of many universities
that see the basic research discoveries as paths to revenue, growth and
jobs. The ruling could require universities to conduct advanced research
and even develop compounds to get patents and royalties -- an expense
that some might not be able to afford.

Cox-2 inhibitors are a class of drugs that have the ability to relieve
pain and inflammation without causing the side effects of stomach
cramps, bleeding and ulcers.

The drugs may have many other uses as well, including reducing the
number of cases of colon cancer and the effects of Alzheimer=92s disease.

The university=92s patent argument is straightforward: Celebrex and other
cox-2 inhibitors would not have been found without the discovery by UR
scientists of cox-2, the gene that produces it and cox-2=92s relationship
to inflammation.

The broad patent protects that discovery and the method of treatment,
even if the university did not produce a specific cox-2 inhibiting pill,
the university claimed.

Larimer disagreed strongly.

In his opinion, he wrote that the university=92s claimed method depends on
finding a compound that selectively inhibits cox-2.

=93Without such a compound, it is impossible to practice the claimed
method of treatment,=94 the judge wrote.=94It means little to invent a
method if one does not have possession of a substance that is essential
to practicing that method. Without that substance, the claimed invention
is more theoretical than real ... .=94

Larimer described UR=92s patent as =93a wish or plan or first step for
obtaining a desired result=94 and not an invention at all.

=93Scientific discoveries, and theories based on those discoveries,
frequently lay the groundwork for later inventions, but that does not
make the discoverer the inventor as well,=94 Larimer wrote.

Richard Collier, Pharmacia=92s senior vice president and general counsel,
said the ruling confirms the company=92s position that UR had no role in
the discovery or development of Celebrex.

Pharmacia said a reversal of Larimer=92s decision is unlikely.

UR still believes the patent is valid, Dodson said.

=93Discovering a method for finding diamonds is at least as valuable as
the diamonds,=94 Dodson said.

E-mail address: mwentzel@DemocratandChronicle.com