Following the Federal Circuit's decision in In re Bilski (Fed Cir 2008), when a method claim is not tied to a particular machine or apparatus and does not transform a particular article into a different state or thing, the patent claim will be held invalid for failing to meet the so-called machine-or-transformation test for determining patent eligible subject matter under § 101 of the US Patent Act. When the Court reaffirmed this test, it prompted commentators to wonder whether many existing business method patents might be invalid. The impact of Bilski on the future of business-method patents is a subject of much concern among the intellectual property community. However, pharmaceutical method patents claiming an abstract mental process about a natural phenomenon may also be at risk.
In the three months since Bilski was decided, three district courts have cited it. In Fort Properties, Inc v American Master Lease (Ctr Dist CA, 2009), King Pharmaceuticals, Inc v Eon Labs, Inc (EDNY, 2009), and Transamerica Life Insurance Company v Lincoln National Life Insurance Co (Nor Dist IA, 2008), the courts invalidated the patents in suit, citing Bilski. During this same period, the Federal Circuit decided Classen Immunotherapies, Inc v Biogen IDEC (2008), affirming the district court's grant of summary judgment of patent invalidity under §101 and holding that the claims "are neither 'tied to a particular machine or apparatus' nor do they 'transform[] a particular article into a different state or thing'", as required by the Bilski decision.
A closer look at both King Pharmaceuticals and Classen Immunotherapies reveals that pharmaceutical patents that merely inform patients of effects of treatments are not patentable. Claim 6 of the patent at issue in King Pharmaceuticals was such a claim. The judge criticised the claim because it "does away with all physical steps and attempts to claim a monopoly on information."
Similarly, the judge in Classen criticised claim 1 of the patent at issue in the case because it "does not claim a specific technique or technical process of testing vaccine safety".
In light of these rulings, the question now arises whether other pharmaceutical method patents are subject to attack as lacking patentable subject matter.
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| Marilyn Neiman |
Cohen Pontani Lieberman & Pavane LLP
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