Tuesday, March 29, 2005

Pubpat on Metabolite v. LabCorp

Although no case name is mentioned in Pubpat's press release, the case is Metabolite v. Laboratory Corp of America dba LabCorp, 370 F3d 1354 (CAFC 2004). The Supreme Court is interested in whether the patent in question (to Metabolite, on a method to diagnose a vitamin B-12 deficiency) might be invalid as unpatentable subject matter under Diamond v. Diehr.

As an aside, the infringement at issue in the case is indirect infringement, as was at issue in part of MercExchange v. eBay.

Pubpat's press release of March 29, 2005:

The issue stems from a case that involves a patent granted by the U.S. Patent Office on diagnosing B12 or folic acid deficiency, which can cause serious human illnesses such as cancer and vascular disease, simply by knowing if a patient has an elevated homocysteine level. It is a matter of natural biology that whether someone has a B12 or folic acid insufficiency is related to whether they have a high level of homocysteine, because homocysteine is an amino acid metabolized by B12 and folic acid. Lower courts ruled that doctors who use or discuss the relationship between B12 or folic acid and homocysteine committed illegal patent infringement and the Supreme Court is now deciding whether to hear an appeal of the case.

"This result is not only perverse public policy – placing the rights of patent holders above the rights of doctors to perform medical diagnosis and discuss a natural biological relationship – but it also violates patent law, which mandates that only processes, machines, manufactures, and compositions of matter are eligible for patent protection," states PUBPAT's position statement titled, Supreme Court Should Protect Medical Facts and the Right of Doctors to Use and Discuss Them From Patents. "The public, including specifically those wishing to use and learn from laws of biology, is significantly harmed by a failure to maintain the limits on patent eligibility because patents can – and often do – prevent important medical treatment and scientific research."

In addition to publishing its position statement, PUBPAT also expressed its views in a letter to the Acting U.S. Solicitor General who was invited by the Supreme Court last month to address the issue before it decides whether to hear an appeal of the case. Since the Supreme Court raised this issue after the time for briefing had expired, PUBPAT was barred from expressing its views directly to the court. As such, PUBPAT provided its perspective to the Acting Solicitor General who will be submitting a brief on the issue to the court in the near future.

"If the patent is not ruled invalid, it will continue to pose a threat to doctors wishing to diagnose whether their patients have a B12 or folic acid deficiency by measuring their homocysteine level [and it will also prevent scientists from discussing the biological relationship between B12 or folic acid and homocysteine for any purpose, including research," said Dan Ravicher, PUBPAT's Executive Director, in his letter urging the Solicitor General to adopt the view that the Supreme Court should hear an appeal of the case and rule the patent invalid. "Above and beyond harming public health, this result is entirely contrary to the basis for the patent system, which is the belief that society benefits when knowledge is disseminated and discussed."

[LabCorp has a facility in Raritan Boro, New Jersey.]


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