Friday, January 23, 2009

EDNY Nixes Therapeutic Pharma Patent Using Bilski

King Pharmaceuticals, Inc et al v. EON Labs, Inc., E.D.N.Y (1-04-cv-05540), Jan. 20, 2009

In a highly publicized case, King Pharmaceuticals brought an action against Eon Labs on patents relating to methods of informing patients about and administering the muscle relaxant metaxalone - marketed by King under the brand name "Skelaxin®" - with food. An exemplary patent claim follows:

A method of increasing the oral bioavailability of metaxalone to a patient receiving metaxalone therapy comprising administering to the patient a therapeutically effective amount of metaxalone in a pharmaceutical composition with food.
Relying on six prior art references, Eon moved for summary judgment, alleging invalidity under 35 U.S.C. §§ 102(b), and 103(a). Eon's primary argument was that, despite the fact the prior art did not explicitly disclose the claimed features "with food," such a feature was at least inherent (or obvious) from the prior art. The district court agreed with Eon, finding the feature inherent in the prior art:
For over forty years it has been known to give metaxalone with food. The fact that King discovered a naturally occurring side effect to the known practice of administering metaxalone with food does not entitle it to a valid patent . . . Here, the overarching purpose of both the prior art and claim 1 is to treat effectively musculoskeletal disorders with metaxalone. The fact that taking it with food happened to increase bioavailability in addition to decreasing nausea is no different from the result in the Abbott Labs case [471 F.3d 1363, 1369 (Fed. Cir. 2006)], in which the addition of water neutralized Lewis acids in both the prior art and the claimed invention, even though the prior art did not recognize that particular effect of adding water. Likewise here, the prior art's failure to recognize that taking metaxalone with food also increased bioavailability does not make it a new method.

With regard to obviousness, the court ruled:

[T]he question is whether a person of such skill, confronted with [Prior Art #1] teaching to take one 400 mg tablet of metaxalone four times daily and [Prior #2] suggestion to take metaxalone with food, would have seen a benefit to administering a 400 mg tablet of metaxalone at mealtimes. It seems quite clear that the answer is yes.

The opionion became more interesting when Eon challenged claims on the basis of 35 U.S.C. § 101 and Bilski, and tying it together with inherency/obviousness. Specifically, Eon claimed that claims reciting the features of "informing the patient that the administration of metaxalone with food results in [] . . . compared to administration without food" did not distinguish certain claims from the prior art, and rendered other claims unpatentable. Again, the district court agreen with Eon:

Because the food effect is an inherent property of the prior art and, therefore, unpatentable, then informing a patient of that inherent property is likewise unpatentable . . . [The claim] fails this test, because the act of informing another person of the food effect of metaxalone does not transform the metaxalone into a different state or thing . . . Such a claim, which effectively allows a patentee to exclude others from informing people of (unpatentable) scientific discoveries is anathema to the aims of the patent statute, which favors disclosure. [The claim] is, therefore, invalid.

Regarding an independent method claim that was based on "informing a patient", the court remarked the claim "does away with all physical steps and attempts to claim a monopoly on information. This claim is unpatentable under 35 U.S.C. § 101."

Read/download the opinion here (link)

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