INVENTIVE STEP

Yesterday, the Federal Circuit issued an opinion in King Pharms., Inc. v. Eon Labs, Inc. The patent at issue in King Pharms. related to a muscle relaxant for use in treating painful muscle conditions.  The drug itself was discovered and a method for producing it was patented in the 1960s.

The patent owner in this case had received a new patent for a method of increasing the bioavailability of the drug by administering a therapeutically effective amount of the drug with food.  The patent applicant had discovered that the drug worked much better when the patient took it with food.

Several prior art references had suggested taking the drug with food to decrease nausea, but had not suggested that this would increase the drug’s bioavailability.  The district court held, and the Federal Circuit affirmed, that the increased bioavailability was inherent when administered with food.  That is, although the prior art did not recognize this benefit of administration with food, it necessarily occurred when the drug was so administered.  Thus, the prior art that suggested taking the drug with food inherently anticipated claim 1.

Claim 21

The more interesting claim is claim 21 that depends from claim 1.  Claim 21 adds the limitation of “informing the patient” that taking a therapeutically effective amount of the drug with food will increase its effectiveness.  The patent owner argued that this step has the benefits of increasing the likelihood that the patient will ingest the drug with food and increase any potential placebo effect.

The district court found the claim invalid under § 101 because the informing step did not meet Bilski‘s machine-or-transformation test.  The Federal Circuit held on appeal that this was error because any patentable subject matter analysis must focus on the claim as a whole and not on one specific limitation.

The court went on to note that the Supreme Court had sent one of its method of treatment cases back after Bilski, namely Prometheus, but that the King Pharms. case was not the proper vehicle to determine the patent eligibility of method of treatment cases.

The Federal Circuit instead affirmed invalidity of claim 21 on grounds of anticipation.  The step of informing the patient of the benefits of taking the drug with food was not disclosed in the prior art.  The court held that since claim 1 was not novel, the step of informing the patient added no novelty to the claim either.

The court held that simply informing the patient of the benefits of the drug does not transform that process of taking the drug with food.  Whether or not the patient is informed, the method of taking the drug with food is the same.  The step of informing someone of an inherent property of a method does not make an otherwise unpatentable method patentable.

This entry was posted on August 3, 2010 at 11:11 am and is filed under Court Decisions, Federal Circuit. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.