WASHINGTON - The Supreme Court on Tuesday heard oral arguments in a patent dispute that could have far-reaching ramifications for the biotech industry.
At issue is the fine line between a patentable process and an unpatentable natural phenomenon. The center of the debate is a case that involves the correlation between homocysteine levels in blood and vitamin B12 deficiencies, and the U.S. Patent No. 4,940,658.
It is held by Metabolite Laboratories Inc., of Denver, and recites a method for detecting vitamin B12 and folic acid deficiencies based on high levels of homocysteine.
That company sued Laboratory Corp. of America Holdings for infringing Claim 13 of the patent. It won, twice, at the federal circuit level and later in the U.S. District Court of Appeals. Metabolite has a license to the ’658 patent from Competitive Technologies Inc., of Fairfield, Conn.
While two lower courts found infringement, members of the Supreme Court seemed more interested in the gray area underlying a single claim in the patent in question: whether the process is patentable, and whether a patent can include correlating a test result.
"When one substance is high, the other two are low," said Justice Antonin Scalia, noting that "that’s just a natural principle" and potentially not a patentable discovery.
However, Miguel Estrada, Metabolite’s lawyer, argued against discussing the law of nature, because that issue - related to Section 101 of U.S. Code - had not been raised in the lower courts, and therefore should not be discussed by the Supreme court.
"It would be irresponsible," he said, for the matter to arise here without being discussed in previous trials, adding that invalidation by the Supreme Court because of Section 101 would "wreak havoc on the patent world."
Estrada’s opinion was echoed by Thomas Hungar of the Solicitor General’s Office. Although he acknowledged that there could be other invalidity issues related to the ’658 patent, Hungar said the federal government "would urge the court not to" use the case as a vehicle for testing whether a law of nature has been improperly claimed because the lower courts did not address such a concern.
Those thoughts garnered support from Justice Anthony Kennedy, who said "it seems imprudent" to discuss law-of-nature matters at this point if they were not brought up before. However, past Supreme Court decisions, notably Diamond v. Diehr in 1981, have dictated that a process related to a law of nature is patentable.
Nevertheless, the Section 101 issue was pressed by Jonathan Franklin, the lawyer for LabCorp, of Burlington, N.C. "This claim is invalid as a matter of law," he said, asserting that the ’658 patent violates the natural phenomenon clause and fails to meet a standard of definiteness. That latter argument, part of Section 112 of U.S. Code, failed in both lower court rulings.
But Franklin said those previous court decisions essentially provide a monopoly to Metabolite, meaning that simply thinking that high homocysteine levels correlate to vitamin B12 deficiencies is a patent infringement, and Justice Stephen Breyer agreed with Franklin that Claim 13 is too broad.
The patent dates to 1990, and the litigation began in 1998. The case, which could be decided in the next couple of months, is docket number 04-607 and will be watched closely by biotech firms. Chief Justice John Roberts recused himself from the matter.
On Tuesday, shares in LabCorp (NYSE:LH) fell 4 cents to close at $58.38.