2009 WL 3051755
September 25, 2009
Issue: Whether the filing of abbreviated new drug applications “ANDAs†and “Paragraph IV†certifications with the FDA, by several generic pharmaceutical manufacturers, infringed upon the ‘318 patent.
Facts: Dr. Bonnie Davis, inventor, claimed in the ‘318 patent a method for treating Alzheimer’s disease with galanthamine. Claim 1 stated:
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 galathamine or a pharmaceutically-acceptable acid addition salt thereof.
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 only provided short summaries of six scientific papers in which galanthamine had been administered to humans or animals. The specification also included an explanation of four scientific papers reporting brain effects and positive effects on memory from administering galanthamine to animals. The explanation contained in the specification, however, did not show any connection between those results and the potential to treat Alzheimer’s disease in humans with galanthamine. The specification also lacked reference to any then-existing animal test results involving the administration of galanthamine in connection with this animal model of Alzheimer’s disease. In April 1986, the PTO examiner rejected the claims in the ‘318 patent from indefiniteness and obviousness. In September 1986, Dr. Davis responded by narrowing the claim language, deleting certain words, and explaining that experiments were underway which the results of would be reported to the PTO. The ‘318 patent issued on May 5, 1987; however, the promised experiments results were never submitted. The patent was then license to Janssen in November 1995 and galanthamine was approved by the FDA, through Janssen, in 2001. The ANDAs that gave rise to this infringement action were filed in February 2005.
Procedural History: The district court found that the ‘318 patent was neither anticipated on obvious, but was invalid for lack of enablement on two distinct grounds-(1) specification did not demonstrate utility because relevant animal testing experiments were not finished by the time the paten was allowed†and (2) the specification provided only minimal disclosure of utility. Also, the district court 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 surmised how the method would be used without providing sufficient galanthamine dosage information. After judgment was entered in favor of the defendants, Janssen appealed.
Pre-Existing Rules: (1) Brenner v. Manson-inventions must have a “substantial utility†and “specific benefit existing in currently available form.â€
(2) In re Fisher-inventions fail to meet the utility requirement if their “asserted uses represent merely hypothetical possibilities, objectives which the claimed inventions could possibly achieve, but none for which they have been used in the real world.â€
(3) In re Krimmel-animal tests showing that a new nonobvious compound “exhibits some useful pharmaceutical property†are sufficient to demonstrate utility.
Reasoning: Typically, patent applications claiming new methods of treatment are supported by test results. In this case, neither in vitro test results nor animal test results were provided to substantiate the hypotheses. The test results were also not available at the time of the application. Furthermore, Janssen does not contend that the summaries in the specification of animal testing established utility. Dr. Davis herself made the statement at trial that to base the treatment of Alzheimer’s with galanthamine of prior tests (those in the specification) conducted without regard to the actual disease were baseless. Janssen’s testimony at trial attempted to establish utility through other insights that were not even listed in the specification. The inventor’s own testimony reveals that an ordinarily skilled artisan would not have viewed the patent’s disclosure as describing the utility of galanthamine as a treatment for Alzheimer’s disease. The specification of the ‘318 patent does nothing more than state a hypothesis and propose testing to determine the accuracy of that hypothesis.
Holding: The ‘318 patent’s description of using galanthamine to treat Alzheimer’s disease does not satisfy the enablement requirement because the patent‘s application does not establish utility. The district court holding was affirmed and the ‘318 patent was found invalid.
Dissenting: The dissent believed that the district court did not make the factual findings necessary regarding enablement. Furthermore, the dissent believed that clearly there was enough evidence to support a finding of utility because they asserted that one skilled in the art with background knowledge and the readings could conclude that galathamine could be used to treat Alzheimer’s disease in humans.
September 25, 2009
Issue: Whether the filing of abbreviated new drug applications “ANDAs†and “Paragraph IV†certifications with the FDA, by several generic pharmaceutical manufacturers, infringed upon the ‘318 patent.
Facts: Dr. Bonnie Davis, inventor, claimed in the ‘318 patent a method for treating Alzheimer’s disease with galanthamine. Claim 1 stated:
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 galathamine or a pharmaceutically-acceptable acid addition salt thereof.
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 only provided short summaries of six scientific papers in which galanthamine had been administered to humans or animals. The specification also included an explanation of four scientific papers reporting brain effects and positive effects on memory from administering galanthamine to animals. The explanation contained in the specification, however, did not show any connection between those results and the potential to treat Alzheimer’s disease in humans with galanthamine. The specification also lacked reference to any then-existing animal test results involving the administration of galanthamine in connection with this animal model of Alzheimer’s disease. In April 1986, the PTO examiner rejected the claims in the ‘318 patent from indefiniteness and obviousness. In September 1986, Dr. Davis responded by narrowing the claim language, deleting certain words, and explaining that experiments were underway which the results of would be reported to the PTO. The ‘318 patent issued on May 5, 1987; however, the promised experiments results were never submitted. The patent was then license to Janssen in November 1995 and galanthamine was approved by the FDA, through Janssen, in 2001. The ANDAs that gave rise to this infringement action were filed in February 2005.
Procedural History: The district court found that the ‘318 patent was neither anticipated on obvious, but was invalid for lack of enablement on two distinct grounds-(1) specification did not demonstrate utility because relevant animal testing experiments were not finished by the time the paten was allowed†and (2) the specification provided only minimal disclosure of utility. Also, the district court 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 surmised how the method would be used without providing sufficient galanthamine dosage information. After judgment was entered in favor of the defendants, Janssen appealed.
Pre-Existing Rules: (1) Brenner v. Manson-inventions must have a “substantial utility†and “specific benefit existing in currently available form.â€
(2) In re Fisher-inventions fail to meet the utility requirement if their “asserted uses represent merely hypothetical possibilities, objectives which the claimed inventions could possibly achieve, but none for which they have been used in the real world.â€
(3) In re Krimmel-animal tests showing that a new nonobvious compound “exhibits some useful pharmaceutical property†are sufficient to demonstrate utility.
Reasoning: Typically, patent applications claiming new methods of treatment are supported by test results. In this case, neither in vitro test results nor animal test results were provided to substantiate the hypotheses. The test results were also not available at the time of the application. Furthermore, Janssen does not contend that the summaries in the specification of animal testing established utility. Dr. Davis herself made the statement at trial that to base the treatment of Alzheimer’s with galanthamine of prior tests (those in the specification) conducted without regard to the actual disease were baseless. Janssen’s testimony at trial attempted to establish utility through other insights that were not even listed in the specification. The inventor’s own testimony reveals that an ordinarily skilled artisan would not have viewed the patent’s disclosure as describing the utility of galanthamine as a treatment for Alzheimer’s disease. The specification of the ‘318 patent does nothing more than state a hypothesis and propose testing to determine the accuracy of that hypothesis.
Holding: The ‘318 patent’s description of using galanthamine to treat Alzheimer’s disease does not satisfy the enablement requirement because the patent‘s application does not establish utility. The district court holding was affirmed and the ‘318 patent was found invalid.
Dissenting: The dissent believed that the district court did not make the factual findings necessary regarding enablement. Furthermore, the dissent believed that clearly there was enough evidence to support a finding of utility because they asserted that one skilled in the art with background knowledge and the readings could conclude that galathamine could be used to treat Alzheimer’s disease in humans.