King Pharmaceuticals, Inc. v. Eon Labels, Inc
95 U.S.P.Q. 2d (BNA) 1833, 616 F.3d 1267, 2010 U.S. App. LEXIS 15947 (2010)
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Rule of Law:
A method claim is anticipated by prior art if the prior art discloses all the method steps, even if it does not disclose a newly discovered, inherent benefit of the method. Adding a limitation that merely informs a patient of this inherent benefit does not make an otherwise anticipated method patentable unless the information has a new and unobvious functional relationship with the method steps.
Facts:
- Metaxalone, a muscle relaxant, was discovered in the 1960s and marketed under the brand name Skelaxin.
- For decades prior to King's patents, medical reference guides (such as Fathie II, Albanese, and Abrams) taught that patients should take metaxalone with food or meals to reduce side effects like nausea and gastric upset.
- King Pharmaceuticals, Inc. (King) acquired the rights to Skelaxin and obtained U.S. Patent Nos. 6,407,128 and 6,683,102.
- King's patents claimed methods for increasing the bioavailability of metaxalone based on the "unexpected finding" that administering the drug with food increases its rate and extent of absorption.
- The patent claims included administering metaxalone with food and, in some claims, informing the patient that doing so increases the drug's bioavailability.
- Eon Labs, Inc. (Eon) sought to market a generic version of metaxalone.
Procedural Posture:
- Eon Labs, Inc. filed an Abbreviated New Drug Application (ANDA) with a Paragraph IV Certification to market a generic version of metaxalone, alleging King's patents were invalid.
- King Pharmaceuticals, Inc. sued Eon in the U.S. District Court for the Eastern District of New York for patent infringement of the '128 and '102 patents.
- Eon filed a motion for summary judgment, arguing all patent claims were invalid.
- The district court granted Eon's motion for summary judgment, holding the patent claims invalid under 35 U.S.C. §§ 101, 102, and 103.
- King appealed the district court's judgment of invalidity to the U.S. Court of Appeals for the Federal Circuit.
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Issue:
Does a patent claim for a method of administering a drug with food become novel by reciting the newly discovered but inherent benefit of increased bioavailability or by adding a step of informing the patient of that benefit?
Opinions:
Majority - Gajarsa, Circuit Judge.
No. A patent claim for a method of administering a drug with food is not novel when prior art already taught administering the drug with food, even if the patent recites a newly discovered but inherent benefit of that method. The court held that the method of taking metaxalone with food was already disclosed in the prior art for the purpose of reducing gastric distress. The newly discovered benefit—increased bioavailability—is an inherent property or 'natural result' of this old process. Merely discovering and claiming a new benefit of an old process cannot render that process patentable again. Furthermore, adding a step of 'informing' a patient about this inherent benefit does not confer patentability because the information is not functionally related to the physical act of administering the drug with food; it does not transform the process, as the method is the same regardless of whether the patient is informed. Therefore, the claims are invalid as anticipated by the prior art.
Analysis:
This decision reinforces the doctrine of inherent anticipation, clarifying that a known process cannot be re-patented simply by discovering and reciting a previously unappreciated benefit. More significantly, the court extended the 'printed matter' doctrine to method claims that include an 'informing' or instructional step. By requiring a 'new and unobvious functional relationship' between the information and the method, the ruling makes it more difficult to obtain or extend patent protection on known methods of treatment by merely adding an instruction. This impacts pharmaceutical patent strategy, particularly for method-of-use patents, by limiting the ability to patent known administration routes based on newly articulated scientific understandings or patient instructions.
