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Oct 1, 2010 (Vol. 30, No. 17)

Biotechnology Patent Validity in Jeopardy

Recent Decisions on Qualifying Subject Matter Weaken Enforceability of Method Claims

  • 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.


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