Justices Reach Out to Consider Patent Case - blood test for a vitamin deficiency - homocysteine

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" Another question in the case is whether doctors could infringe the

patent merely by looking at a test result for homocysteine and then

thinking about vitamin deficiency. Indeed, the lower courts said LabCorp

had not directly infringed but rather had induced doctors to infringe by

performing the correlation. "

* * * *

March 20, 2006

*Justices Reach Out to Consider Patent Case*

By ANDREW POLLACK

http://www.nytimes.com/2006/03/20/business/20patent.html

For the first time in a quarter-century, the Supreme Court will hear on

Tuesday a case involving the basic question of what type of discoveries

and inventions can be patented.

Both sides say the case, which involves a blood test for a vitamin

deficiency, could have a wide-ranging impact on the development of

diagnostics, perhaps threatening many of the underlying patents for

genetic and other medical tests.

But the array of companies filing supporting briefs -- including

American Express, Bear Stearns and I.B.M. -- indicates that intellectual

property in other fields might also be affected.

Some patent specialists say they think the Supreme Court agreed to hear

the case, against the advice of the United States solicitor general, to

rein in patenting.

" The Supreme Court reached out and grabbed this case, " said R.

Reines, a patent attorney at Weil, Gotshal & Manges who is not involved

in the case. " These circumstances suggest that some members of the court

believe there are too many patents in areas where there should be none. "

At issue is whether relationships between a substance in the human body

and a disease -- for example, the familiar association between high

cholesterol and a higher risk of heart attacks -- can be the basis of a

patent, or whether such relationships are unpatentable natural phenomena.

This case, LabCorp v. Metabolite Laboratories, stems from a 1990 patent

awarded to scientists at the University of Colorado and Columbia

University. They found that a high level in the blood of homocysteine,

an amino acid, indicated a deficiency of either vitamin B12 or another B

vitamin called folic acid.

Much of the patent describes a specific way to measure homocysteine, and

those claims are not at issue. But the 13th claim of the patent is more

general: it covers a way of determining vitamin deficiency by first

testing blood or urine for homocysteine by any means and then

correlating elevated levels with a vitamin deficiency.

The patent is owned by Competitive Technologies, a publicly traded

patent management firm in Fairfield, Conn., and licensed to Metabolite

Laboratories, a tiny company based at the University of Colorado.

LabCorp, one of the biggest clinical testing companies in the nation,

with 2005 revenues of $3.3 billion, sublicensed the test from Metabolite.

At first, LabCorp, whose full name is Laboratory Corporation of America

Holdings, tested for homocysteine using the specific method described in

the patent and paid royalties to Metabolite and Competitive

Technologies. But in 1998 it switched to a newer and faster test

developed by Abbott Laboratories.

Metabolite and Competitive sued, charging LabCorp with violating Claim

13 of the patent. In 2001 a federal jury in Denver ruled against

LabCorp, and the company was eventually ordered to pay $7.8 million in

damages and attorneys' fees. The appeals court that handles patent cases

affirmed the lower court decision in 2004.

In asking the Supreme Court to overturn the lower court decisions,

LabCorp is arguing that Claim 13, because it does not specify how

testing is to be done, patents nothing more than the natural

relationship between homocysteine and vitamin B deficiencies, blocking

other inventors from developing better tests.

" The present-day implications of such a holding are limitless -- and

dangerous, " LabCorp wrote in its brief. " Anyone who discovers a new

medical correlation could stifle medical treatment through a 'test plus

correlate' claim. "

But Metabolite and its allies argue that such correlations are the basis

of diagnostics and that not allowing patents would stifle development of

new tests. There are tests, for instance, that look at mutations in

particular genes to predict a high risk of breast cancer or to predict

which AIDS drugs will not work.

" Hundreds, if not thousands, of patents would at once be called into

question " if the ruling goes against Metabolite, said a brief jointly

submitted by Perlegen Sciences, a company developing genetic tests, and

Mohr ow Ventures, a venture capital firm that backs diagnostics

companies.

Another question in the case is whether doctors could infringe the

patent merely by looking at a test result for homocysteine and then

thinking about vitamin deficiency. Indeed, the lower courts said LabCorp

had not directly infringed but rather had induced doctors to infringe by

performing the correlation.

Partly with that in mind, the American Medical Association, the American

Heart Association and AARP have submitted briefs in support of LabCorp,

arguing, in the words of the heart association, that the patent could

have " devastating effects on patient health care. "

Millions of homocysteine tests are done each year because high levels of

the amino acid are associated with an increased risk of heart attack,

stroke, birth defects and other diseases; people often take B vitamins

to lower homocysteine and reduce the risk. (Clinical trial results

announced last week, however, suggested that taking B vitamins did not

prevent heart attacks.)

Court precedents have held that laws of nature, natural phenomena and

abstract ideas cannot be patented. " Einstein could not patent his

celebrated law that E = mc2; nor could Newton have patented the law of

gravity, " the Supreme Court wrote in a 1980 decision. '

But in a 1981 decision in Diamond v. Diehr -- the last time the Supreme

Court considered the issue -- the court upheld a patent on a method of

curing rubber that made use of a well-known equation governing chemical

reactions. The court said that the equation was only part of a broader

invention.

Glenn K. Beaton, an attorney for Metabolite, said that as in that 1981

case, " it's not the correlation itself that is patented here, " but

rather " the use of that correlation to determine B12 and folate

deficiencies. "

In recent years, controversial patents have been granted on software and

on business methods, such as ways of managing investment portfolios or

of allowing people to order merchandise on Amazon.com with one click of

a mouse.

Bear Stearns, Lehman Brothers and the Computer and Communications

Industry Association filed briefs urging the court to use the LabCorp

case to restrict such business method patents, or at least not expand

them. Other companies, including American Express and I.B.M., say the

LabCorp case is not relevant to business method patents.

The solicitor general, in urging the court not to hear the case, said

there was not enough of a record from the lower courts on the question

of patenting natural phenomena. That is because LabCorp did not raise

that argument in the lower courts, instead trying to get the claim

invalidated on other grounds. If LabCorp wins the case in a way that

weakens patents on diagnostic tests, it could be one of the bigger

losers. The company, based in Burlington, N.C., is counting on

high-priced, patented genetic tests to fuel its growth.

Bradford T. , executive vice president for corporate affairs at

LabCorp, disputed that. " We think this case can be decided very

narrowly, " without undermining other patents, many of which rely on more

than just correlations, he said.

* Copyright 2006The New York Times Company

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