A recent majority decision by the US Federal Circuit has reinforced the principle that utility and enablement (conditions of patentability) are determined as of the filing date of the patent application. A patentee cannot rely on test results that were not available at the time of filing the patent application and, accordingly, may need to delay filing until such results are available.
To meet the requirements for enablement (35 USC 112), the specification must adequately disclose to one skilled in the relevant art how to make, or in the case of a process, how to carry out, the claimed invention without undue experimentation. The utility requirement (35 USC 101) mandates that a patentable invention must be useful and, accordingly, the subject matter of the claim must be operable. Enablement is closely related to the requirement for utility - if a patent claims fails to meet the utility requirement because it is not useful or operative, then it also fails to meet the how-to-use aspect of the enablement requirement (Process Control Corp v HydReclaim Corp., 190 F.3d 1350, 1358).
In 2005, Janssen Pharmaceutica N.V sued several generic drug manufacturers for infringement of their patent for treatment of Alzheimer's disease with galanthamine (US Patent No. 4,663,318). The generic drug manufacturers conceded infringement and countersued for invalidity. In 2007, the District Court of Delaware ruled that, while the claims of the patent were not anticipated or obvious, they were invalid for the following reasons:
- the specification did not demonstrate utility because relevant animal testing experiments were not finished by the time the patent was allowed and the specification provided only minimal disclosure of utility; and
- the specification and claims did not teach one of skill in the art how to use the claimed invention because the patent only surmised how the claimed method could be used without providing sufficient dosage information.
Galanthamine is a compound that inhibits an enzyme involved in the breakdown for the neurotransmitter acetylcholine. At the time of filing the patent application, studies had shown that galanthamine modulated brain wave activity, increased short-term memory and decreased amnesia. These studies were referenced in the patent. However, the District Court found that the patent did not provide analysis or insight connecting the results of the studies to galanthamine's potential to treat Alzheimer's disease.
The patent indicated that galanthamine may be administered to a patient suffering Alzheimer's disease and discussed modes of administration and broad dosage ranges. However, the District Court found that the specification did not provide any results showing that such treatment was viable. During prosecution of the patent application, the applicant reported that experiments using animal models were underway that were expected to show the efficacy of galanthamine treatment for Alzheimer's disease. These experiments were not completed until July 1987, after the patent was issued.
Janssen appealed the decision before the US Federal Circuit and argued that the specification established utility by analytic reasoning. Janssen submitted that the specification "set[ ] forth the evidence from existing studies demonstrating galanthamine's effects on central nicotinic as well as muscarinic receptors and connect[ed] it to a model for Alzheimer's therapy rendering those effects therapeutically relevant".
However, the majority decision of the US Federal Circuit held that "the specification, even read in the light of the knowledge of those skilled in the art, does no more than state a hypothesis and propose testing to determine the accuracy of that hypothesis. That is not sufficient ... [R]esults from animal tests or in vitro experiments may be sufficient to satisfy the utility requirement ... In this case, however, neither in vitro test results nor animal test results involving the use of galanthamine to treat Alzheimer's-like conditions were provided ... The [ ] patent's description of using galanthamine to treat Alzheimer's disease thus does not satisfy the enablement requirement because the [ ] patent did not establish utility".
This case highlights the importance of including sufficient supporting data in patent applications, even if it is at the expense of an early filing date.
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