The U.S. Court of Appeals for the Federal Circuit upheld a decision that Janssen Pharmaceutica NV’s patent covering a method for treating Alzheimer’s disease was invalid after it was attacked by a whole gaggle of generic-drug companies.

In a 2-1 decision, the Federal Circuit agreed with the district court’s decision that Janssen’s patent was invalid because of lack of enablement, finding that the patent application did not establish utility.  In Re ‘318 Patent Infringement Litigation (a/k/a Janssen Pharma and Synaptech v. Teva, Mylan, Dr. Reddy’s, Barr and Purepac), 08-1594, 2009-1070.

Janssen’s U.S. Pat. No. 4,663,318 claims a method for treating Alzheimer’s disease with galanthamine (also spelled “galantamine”).  Claim 1 is for:

“[a] method of treating Alzheimer’s disease and related dementias which comprises administering to a patient suffering from such a disease a therapeutically effective amount of galanthamine or a pharmaceutically-acceptable acid addition salt thereof.”

galanthamineAt the time of the ’318 patent’s application in early 1986, researchers had observed a correlation between Alzheimer’s disease symptoms and a reduced level of the neurotransmitter acetylcholine in the brain. At that time, galanthamine was known to inhibit acetylcholinesterase, an enzyme that breaks down acetylcholine. Acetylcholinesterase inhibitors like galantamine increase the amount of acetylcholine available for binding to muscarinic or nicotinic receptors.

The court noted that the specification for the ’318 patent was only just over one page in length, and it provided almost no basis for its stated conclusion that it was possible to administer “an effective Alzheimer’s disease cognitively-enhancing amount of galanthamine.”

The specification provided short summaries of six scientific papers in which galantamine had been administered to humans or animals. The specification then provided brief summaries of four scientific papers reporting brain effects and positive effects on memory from administering galantamine to animals.  The specification did not provide analysis or insight connecting the results of any of these six studies to galantamine’s potential to treat Alzheimer’s disease in humans.

The specification noted that another prior art scientific paper described an animal testing model for replicating in animals the acetylcholine deficit and other effects of Alzheimer’s disease.  However, the specification did not refer to any then-existing animal test results involving the administration of galantamine in connection with this animal model of Alzheimer’s disease.

The district court found that the ’318 patent was neither anticipated nor obvious. However, the district court concluded that the ’318 patent was invalid for lack of enablement on two distinct grounds. The district court found that the specification did not demonstrate utility because relevant animal testing experiments were “not finished . . . by the time the ’318 patent was allowed” and the specification provided only “minimal disclosure” of utility. ’

The district court alternatively found that the specification and claims did not “teach one of skill in the art how to use the claimed method” because the application “only surmise[d] how the claimed method could be used” without providing sufficient galantamine dosage information.

The enablement requirement of 35 U.S.C. § 112, ¶ 1 requires that the specification adequately discloses 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 of 35 U.S.C. § 101 mandates that any patentable invention be useful and, accordingly, the subject matter of the claim must be operable. If a patent claim 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.

The utility requirement prevents mere ideas from being patented. The utility requirement also prevents the patenting of a mere research proposal or an invention that is simply an object of research. As the Supreme Court stated in Brenner, “a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.”

The Federal Circuit noted that:

Typically, patent applications claiming new methods of treatment are supported by test results. But it is clear that testing need not be conducted by the inventor. In addition, human trials are not required for a therapeutic invention to be patentable. Our predecessor court, the United States Court of Customs and Patent Appeals, held in In re Krimmel that patent applications need not “prove that compounds or other materials which [the applicant] is claiming, and which [the applicant] has stated are useful for ‘pharmaceutical applications’ are safe, effective, and reliable for use with humans.” 292 F.2d 948, 954 (CCPA 1961). As we observed in In re Brana, “[w]ere we to require Phase II testing [human trials] in order to prove utility, the associated costs would prevent many companies from obtaining patent protection on promising new inventions, thereby eliminating an incentive to pursue . . . potential cures.”

We have held that results from animal tests or in vitro experiments may be sufficient to satisfy the utility requirement. Our predecessor court held in Krimmel that animal tests showing that a new nonobvious compound “exhibits some useful pharmaceutical property” are sufficient to demonstrate utility. 292 F.2d at 953. We noted in Cross v. Iizuka that “[w]e perceive no insurmountable difficulty, under appropriate circumstances, in finding that the first link in the screening chain, in vitro testing, may establish a practical utility for the [pharmaceutical] compound in question” in order for a patent to issue. 753 F.2d 1040, 1051 (Fed. Cir. 1985). We concluded that in vitro test results for a claimed pharmaceutical compound, combined with animal test results for a structurally similar compound, showed “a reasonable correlation between the disclosed in vitro utility and an in vivo activity, and therefore a rigorous correlation is not necessary where the disclosure of pharmacological activity is reasonable based upon the probative evidence.”

In this case, however, neither in vitro test results nor animal test results involving the use of galantamine to treat Alzheimer’s-like conditions were provided. The results from the ’318 patent’s proposed animal tests of galantamine for treating symptoms of Alzheimer’s disease were not available at the time of the application, and the district court properly held that they could not be used to establish enablement.

The decision of the district court was affirmed.

Circuit Judge Gajarsa dissented, noting that:

The parties do not dispute that Dr. Davis’s insight regarding galantamine’s utility for treating Alzheimer’s Disease (AD) was correct; later animal studies and human clinical trials proved and confirmed galantamine’s effectiveness. The relevant question here is whether, at the time Dr. Davis filed her application, the patent’s written description would have credibly revealed to an ordinarily skilled artisan galantamine’s utility for AD treatment. See In re Cortright, 165 F.3d 1353, 1356 (Fed. Cir. 1999) (noting that the patent’s written description must “illuminate a credible utility” to meet the enablement requirement). The district court failed to answer that question.

  Print This Post Print This Post  

Comments are closed.