Tuesday, March 21, 2006

Metabolite case: Patent Office as Thought Police?

Lori B. Andrews wrote of Metabolite: University researchers from Columbia University and the University of Colorado were the inventors in the patent. In fact, it was originally assigned to an entity called University Patents, whose goal was to
commercialize the discoveries of university professors. But by greedily
going beyond their invention - a medical test - to claim rights to a
basic fact of human physiology, those professors and their institutions set
in motion a patent nightmare that could limit their own academic freedom
as well as that of everybody else.
[from The Patent Office as Thought Police, The Chronicles of Higher Education, February 17, 2006]

Andrews also wrote: But after LabCorp published an article stating that high homocysteine levels might indicate a vitamin deficiency that could be treated by vitamins, Metabolite sued LabCorp for patent infringement and breach of contract, and was awarded more than $5-million in damages. LabCorp appealed to the U.S. Court of Appeals for the Federal Circuit, which hears all patent appeals. Astonishingly, it held that LabCorp had induced doctors to infringe the patent by publishing the biological fact that high homocysteine levels indicate vitamin deficiency. The court also ruled that the doctors had directly infringed the patent by merely thinking about the physiological relationship. (Metabolite had not sued the doctors,
probably because such lawsuits would have cost more than they would have netted
the company and would have produced negative publicity.) By considering publishing and thinking about a law of nature to be actionable under patent law, the Federal Circuit court has severely threatened academic freedom.

To give some procedural background. The initial assignment of the patent was to UPI. UPI’s successor, Competitive Technologies Inc., licensed the patent to Metabolite, which in turn sublicensed the patent to Roche Biomedical Laboratories (now LabCorp). LabCorp, a laboratory testing company, originally performed total homocysteine assays under the sublicense. But in 1998, LabCorp switched to a total homocysteine assay developed by Abbott Laboratories (Abbott test) and discontinued royalty payments to Metabolite for total homocysteine assays. In response, Metabolite sued LabCorp for infringement.

It is important to note that LabCorp was accused of indirect, not direct, infringement. The jury found LabCorp liable for indirect infringement. The record must show the presence of direct infringement, however, to support the verdict of indirect infringement. Joy Techs., Inc. v. Flakt, Inc., 6 F.3d 770, 774 (Fed. Cir. 1993) (“Liability for either active inducement of infringement or for contributory infringement is dependent upon the existence of direct infringement.”). Thus, this court must examine whether there is substantial evidence in the record of the physicians’ direct infringement.

The parties decided to frame this question on whether or not the physicians performed the correlating step.

An interesting line in the CAFC case is the following: Inventor Dr. Sally Stabler also testified that it would be malpractice for a doctor to receive a total homocysteine assay without determining cobalamin/folate deficiency.

The issue of publication of the correlation came in to support intent in active inducement of infringement. Section 271(b) of title 35 provides: “Whoever actively induces infringement of a patent shall be liable as an infringer.” The CAFC noted: LabCorp publica­tions stated that elevated total homocysteine correlates to cobalamin/folate deficiency and that this deficiency can be treated with vitamin supplements. LabCorp’s articles thus promote total homocysteine assays for detecting cobalamin/folate deficiency.

Note that the trial court in this case involved a jury. Thus, the CAFC's determination relates to a review of a jury verdict:

Accordingly, a reasonable jury could find intent to induce infringement because LabCorp’s articles state that elevated total homocysteine correlates to cobalamin/folate deficiency. Moreover, the publications recommend treatment of this deficiency with vitamin supplements. Because “[i]ntent is a factual determination particularly within the province of the trier of fact,” Allen Organ Co. v. Kimball Int’l, Inc., 839 F.2d 1556, 1557 (Fed. Cir. 1988), this court sees no reason to disturb the jury’s finding regarding LabCorp’s intent. Therefore, this court affirms the finding of indirect infringement based on the inducement analysis. This court declines to consider contributory infringement.

The greater issue of current interest is the VALIDITY of the patent.

At the CAFC, LabCorp argued that claim 13 is invalid on grounds of indefiniteness, lack of written description and enablement, anticipation, and obviousness. Likewise, LabCorp contended that claim 18, directed to the panel test, is also invalid on grounds of indefiniteness, and lack of written description and enablement.

There was an injunction issue (relevant to current issues in eBay v. MercExchange): The district court granted Metabolite’s motion “to enjoin LabCorp from performing ‘any homocysteine-only test, including without limitation homocysteine-only tests via the Abbott method.’”

One notes that the CAFC cited to Gore, not to Richardson v. Suzuki: While this statement does not explicitly set forth detailed reasons, the district court properly granted the injunction because LabCorp was found to infringe. See W.L. Gore & Assocs., Inc. v. Garlock, Inc., 842 F.2d 1275, 1281 (Fed. Cir. 1988) (“[A]n injunction should issue once infringement has been established unless there is a sufficient reason for denying it.”).

Thus, one observes that various assertions that a "new" rule of injunction was created in the CAFC's MercExchange v. eBay are clearly in error.


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