Supreme Court Hears Arguments in Patent Case

March 29, 2006

Pharmaceutical Executive

Pharmaceutical Executive, Pharmaceutical Executive-03-29-2006, Volume 0, Issue 0

The high court could fine-tune the definition of what is patentable in deciding LabCorp v. Metabolite. Legal experts weigh-in on the nuances of the case.

The Supreme Court heard arguments March 21 in a case that could influence the legal definition of what can and cannot be patented, or at least the language of patent claims.

    The suit, which pits Laboratory Corp. of America Holdings against Metabolite Laboratories Inc., involves Metabolite’s patent on a diagnostic test for the amino acid homocysteine. An excess of homocysteine is linked to cardiovascular disease, according to the National Institutes of Health. And because homocysteine is broken down by vitamin B, an excess of homocysteine is also linked to a deficiency of certain types of vitamin B.

    In the lower court cases, LabCorp asserted that one section of the patent, claim 13, was too broad. This claim states that the patent covers all tests that detect high levels of homocysteine and correlate this with decreased levels of vitamin B. LabCorp, which lost both the initial suit and the appeal, said this could include other homocysteine assays, not just the one in the patent, explained George Hovanec, an attorney at Buchanan Ingersoll PC, who is not involved in the case.

    But when it reached the Supreme Court, the case took on larger implications. The case addressed the issue of whether or not this claim crosses the line of trying to patent a natural law or phenomenon, which everyone agrees is not allowed, Hovanec continued.

    The concern, explained Ron Daignault, partner at Jenner & Block LLP’s New York office, is that a doctor could infringe on the patent by simply thinking or suggesting that elevated levels of homocysteine could indicate a vitamin B deficiency. Daignault is not involved in this case.

    “They’re trying to patent a law of nature,” Daignault said.

    An extreme example, Daignault said, would be a medical school professor infringing the patent by explaining the correlation between homocysteine and vitamin B to students.

    But Stephen Maebius, partner at Foley and Lardner LLP, said the main issue of contention in this case is the language of Metabolite’s patent, not the intent.

    “The language is responsible for making this a questionable case, in what otherwise did not need to be,” he said.

    In patent litigation each claim is considered separately. The goal of writing a patent, Maebius explained, is to have some claims that are broad enough to increase the likelihood of infringement, but to also have at least one of the infringed claims be strong enough to be upheld. The stronger claims should be directed at commercial ways of using the patented product. The broader claims should be worded very carefully to avoid problems.

    When writing claims, companies always try to look at possible future methods and applications, Hovanec indicated.

    “Nobody wants to cover the doctor’s thought processes,” Maebius said.

    Although this case has caused a lot of worry, the court will probably not make any drastic changes to what is considered patentable subject matter, experts agree.

    If the Supreme Court addresses this issue at all, it will probably be a matter of fine-tuning or remanding the case to the lower courts, said Cono Carrano, a partner at Dewey Ballantine LLP.

    If they do set precedent about patentable subject matter, Maebius said, it will probably be in a nuanced opinion that sets forth a general framework. This would be similar to the Merck v. Integra decision last year, he continued.

    But the high court may decide not to address this issue at all, according to Carrano, because it was not raised in the two lower court cases.

    Section 101 of the patent code sets the limits of what is patentable subject matter. This section was not addressed in the previous cases, which focused on other parts of the code.

    Because Metabolite’s compliance with section 101 was not previously argued, it makes this case a difficult vehicle to address the issue, Maebius indicated.

    The court could simply focus on compliance with section 112 of the patent code, Carrano explained. In this case, section 112 deals with how the company described and claimed its product beyond natural phenomenon, he said.

    But the fact that the court took the case indicates that at least some of the justices are interested in refining what is patentable material, according to Hovanec.

    “The Supreme Court was waiting for the opportunity to speak on this issue,” he said.

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