Supreme Court to rule: When are medical patents too broad?

The U.S. Supreme Court for the first time in 25 years will examine patent law boundaries in a case that opposing sides -- the medical community and patent lawyers -- say could threaten medical research and testing if the case doesn't go their way.

Specifically, the Supreme Court asked during oral arguments March 21 whether Metabolite Laboratories Inc.'s patent for testing vitamin B deficiency is so overly broad that it covers a basic scientific relationship and goes against precedent that "laws of nature, natural phenomena and abstract ideas" are not patentable.

The implications of how the court rules on that question could be wide-reaching, influencing patents on everything from biomedicine to business methods. At minimum, the ruling is expected to affect how medicine is practiced. The case galvanized many organizations' interest in the form of friend-of-the-court briefs, including a brief from the American Medical Association/State Medical Societies Litigation Center and five national medical organizations. Organized medicine's brief contends that the patent is too broad, making it possible for a doctor to infringe on a patent in the course of routine care.

If the high court upholds a patent of scientific fact, it would stifle technical innovation in medicine and "prevent physicians from exercising their best medical judgment in treating their patients," said AMA Trustee William A. Hazel Jr., MD.

"Physicians should be allowed to focus on helping patients without worrying that providing quality health care could infringe on a manufacturer's patent," he said.

But patent lawyers and technology companies disagree that removing the patent benefits health care. Metabolite attorney Mark Lemley said "precedent supports the idea that while you can't patent an abstract idea or natural relationship, you can patent a practical application of that idea," which he said is what Metabolite did.

If the court finds this type of invention is not patentable, he said, patents on medical tests, DNA and a wide variety of drugs would be at risk.

"While some doctors might see this as a good thing in the short run, in the long run it will reduce investment in research and development in the biomedical field," Lemley said.

What ideas can be patented?

The case before the Supreme Court, LabCorp v. Metabolite, stems from a 1990 Metabolite patent that links elevated levels of total homocysteine to a deficiency of cobalamin (B12) or folate (folic acid). The patent includes a test to identify the deficiencies, and a broader description in the patent covers a more general two-step process that first assays blood or urine by any method for an elevated homocysteine level, then correlates the high level with the vitamin deficiency.

Metabolite sued Laboratory Corp. of America for violating the general patent claim when LabCorp in 1998 began using a different testing method for total homocysteine and discontinued royalty payments.

The U.S. Appeals Court for the Federal Circuit in 2004 upheld a $6 million verdict against LabCorp, finding the company caused its labs to infringe on the patent by performing the correlation in the homocysteine tests.

LabCorp appealed the decision to the U.S. Supreme Court, asking whether the patent is a "prohibited monopoly over a basic scientific relationship rather than a patentable invention." The lower courts didn't address the bigger question.

Given the federal court's finding, "every doctor who orders a homocysteine test and simply thinks about what the result might signify has infringed" the patent, the LabCorp brief to the Supreme Court argues.

Doctors say homocysteine tests are commonly conducted to diagnose patients for common medical conditions such as cardiovascular disease. Physicians say they are obligated to share discoveries like this one, which have a number of useful medical applications, to promote patient care.

"As this case demonstrates, upholding a claimed patent on a scientific fact would directly undercut the goal of making diagnostic treatment advances widely accessible," the organized medicine brief says.

Experts doubt such patents will pose legal problems for individual doctors because federal law prevents physicians from being sued for infringing a patent on medical and surgical procedures. The AMA lobbied Congress for the statute, prompted by Pallin v. Singer, a 1995 decision that stirred the medical community.

However, the AMA and other physician groups are concerned that doctors could still be held liable because Metabolite successfully argued to a lower court that physicians were the ones interpreting test results that the company says the patent covers.

The broader picture

Patent experts believe the court's acceptance of the case might signal a change after years of broadening patents. The court hasn't heard a patent case since 1981, when it allowed the patent of an invention relying on a mathematical formula.

Legal experts say it is unlikely the Supreme Court will extensively change federal patent law. But because the court has recently accepted a number of patent cases, it might begin to construe a more narrow interpretation of the law, they say.

But even a narrow ruling could limit sources doctors might use for treatments, said Michael Bednarek, a Washington patent lawyer with Pillsbury Winthrop Shaw Pittman.

Shubha Ghosh, professor at Southern Methodist University Dedman School of Law, said, "the question for the court now is, do they want to set a precedent such that the field gets split up by different diagnostic techniques? It doesn't seem like a good way to guide [the medical] industry."