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Legal Affairs : Oct 1, 2010 (Vol. 30, No. 17)

Biotechnology Patent Validity in Jeopardy

Recent Decisions on Qualifying Subject Matter Weaken Enforceability of Method Claims
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  • Lei Fang, M.D., Ph.D.

The rules for patentability of molecular biology inventions have never before been in such flux. The courts have recently defined narrowing qualifiers for patent novelty, obviousness, enablement, written description, and even what constitutes patentable subject matter. While some of these decisions remain under appeal, they all demonstrate that determining what is a valid claim for biotechnology inventions is a fast evolving field, with a growing reliance upon method claims.

The fundamental question of whether nucleic acids qualify as patentable subject matter under 35 U.S.C. § 101 will be addressed this winter by the Court of Appeals for the Federal Circuit in AMP v. Myriad. The lower court held in March 2010 that isolated DNA (for the cancer-related BRCA1/2 mutation) is not patentable subject matter because the information contained in the isolated molecule is not sufficiently “transformed” from its natural state. The court also found that methods of its use for diagnosis were nonpatentable abstract mental processes.

It is further noteworthy that Judge Dyk from the Federal Circuit recently pontificated in an August 2010 dissent in Intervet v. Merial on “serious questions” as to why isolated native DNA should be any more patentable than individual leaves taken from a plant.

As a result, the validity of patents for methods of use, rather than the molecules themselves, must also be closely reviewed. The biotechnology method-of-use patents that have been the subject of recent judicial scrutiny are directed to methods of diagnosis and methods of treatment.

Traditionally, such method patents have been viewed as less desirable than composition patents since a competing manufacturer’s liability for inducing infringement of an end-use is indirect and must be proved through additional legal effort. However, a renewed emphasis on diagnostic and treatment patents is required, and several recent court decisions have affected the scope of such claims.

The Supreme Court issued guidance for the validity of all method claims in June 2010 in the long-awaited decision of Bilski v. Kappos. The Court indicated that the test for method claim validity is not limited to determining only whether the claim requires use of a machine or involves the transformation of matter. The Court instead provided an exclusionary test based on a prohibition against patenting abstract ideas, in addition to natural phenomenon and laws of nature.

In Bilski, the claimed business method of derivative instrument pricing was considered too abstract for patenting, but unfortunately, the Court provided scant instructions for applying this new “abstract idea” test to other method patents.  

Diagnostic Correlations Under Review

With respect to diagnostic method claims, in Laboratory Corp v. Metabolite Labs the claimed method of correlating homocysteine levels and vitamin deficiency was initially upheld by the Federal Circuit, prior to the issuance of Bilski. While the Supreme Court dismissed LabCorp’s appeal, a dissent questioned whether the diagnostic method was improperly claiming a natural phenomenon.

In September 2009, the Federal Circuit decided in Prometheus Labs v. Mayo that the claimed methods of optimizing therapeutic efficacy for treatment of immune-mediated gastrointestinal disorder, which included steps for both administrative treatment and diagnosis, qualified as patentable subject matter.

The Federal Circuit noted that both steps were transformative, since therapeutic administration necessarily affects the body and determining the levels of analyte cannot be performed by mere inspection. However, the Supreme Court has now remanded Prometheus to be reconsidered in view of Bilski.

To the extent that diagnostic method claims involve only mental correlative steps, they are at risk for being characterized as merely an unpatentable “abstract idea.” On the other hand, for claims that involve multiple steps of the medical continuum, in order to capture a more clearly patentable transformation step along with the diagnostic mental correlation step, it is more likely that a single entity will not infringe the claim, precluding any remedy.

In July 2010 the Federal Circuit further strengthened the single infringer requirement in Golden Hour Data Sys v. emsCharts, where the patent holder failed to prove that one party exercised the requisite “mastermind” control over the entire process, even though the two defendants were in a strategic partnership and joint distribution agreement to accomplish the claimed process. Therefore, “separate entities” may contract to infringe a method patent by simply performing different claimed steps.

Functional Relationship Now Required

Most recently, in August 2010, methods of treatment claims were again recognized by the Federal Circuit in King Pharm v. Eon Labs as being patentable subject matter to the extent that they are always transformative through the administration of compounds to the body. However, the Federal Circuit attacked the claimed method of treatment claims as invalid for prior-art anticipation, stating that the additional dependent claim step, although not actually found in the prior art, was not sufficiently “functionally related” to lend patentable consideration.

In King, the patent claims were directed to a method of increasing the bioavailability of metaxalone by administration with food. Dependent claim 21 additionally required informing the patient that taking metaxalone with food results in an increase in bioavailability. The district court had determined that claim 21 was not valid subject matter for a method claim, because the step did not meet the transformation requirement.

The Federal Circuit, instead, held claim 21 to be transformative as a whole, but inherently anticipated, although it agreed that nowhere did the prior art necessarily teach the further step of informing the patient.

The Federal Circuit analogized the informing step to the line of cases invalidating claims that combine known components and new printed matter (e.g., a kit with instructions for a new use) as not “functionally related” to the claimed product, and so not capable of distinguishing the invention from the prior art. Thus, in King, the Federal Circuit has effectively extended the invalidity theory for nonfunctional printed matter to include oral instructions.

The net result of this approach is to permit the use of anticipation theory on the basis of nonfunctionally related printed, oral or possibly even mental correlation method steps, rather than requiring that the element be found in the prior art. This anticipation approach prevents the patentee from asserting arguments of secondary considerations, such as unexpected results, commercial success, or opinions of nonobviousness by others in the field.

This development is a more formidable threat to method patent validity than an obviousness allegation, and even perhaps than the “abstract idea” subject matter prohibition. 

Therefore, even though method claims may survive the transformation and abstractness tests under Bilski, they must also now pass the functional relationship novelty test of King. Expansion of the single actor requirement in Golden Hour for method patent infringement also seems to increase the potential for avoiding patent infringement. These recent trends make biotechnology patent claims more difficult to obtain and increasingly subject to challenge.