In re 318 Patent Infringement Liti.,
Janssen Pharmaceutica N.V., et al. v. Teva Pharmaceuticals USA, Inc., et al. (583 F.3d 1317 (Fed. Cir. 2009)).
I. Facts
The Appellant is the exclusive license owner of a patent for treating Alzheimer’s disease. The claimed inventor filed the patent application January 15, 1986. During prosecution of the patent, the USPTO rejected the claims for indefiniteness and obviousness. In responding to these specific rejections, the inventor also stated experiments were underway to show the method does result in the improved condition of Alzheimer’s sufferers and the results would be submitted later. The patent issued on May 5, 1987. The test results were not known until July of that year, but were still never submitted. The inventor licensed the patent to the Appellant in 1995. The Appellant received FDA approval to use it in 2001 to treat Alzheimer’s. In 2005, generic drug manufacturers filed applications to the FDA covering the same drug as the patent. The Appellant sued for infringement.
II. Procedural History
Patent licensee sued in the United States Court for the District of Delaware alleging infringement of its ‘318 patent. The generic drug manufacturers conceded infringement, but raised the invalidity issues of anticipation, obviousness, and enablement. The district court, after a bench trial, found the claims of the patent invalid for lack of enablement because (a) “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,†and (b) “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 claimed method could be used’ without providing sufficient . . . dosage information.†Patent licensee appealed to the United States Court of Appeals for the Federal Circuit
III. Holding
The Court held that the patent’s description did not satisfy the enablement requirement because the patent application did not establish utility.
IV. Critical Analysis
The Court immediately notes that the specification for the patent was only just over one page in length and provided no basis for the stated conclusion that it was “possible to administer an ‘effective Alzheimer’s disease cognitively-enhancing amount of galanthamine.†583 F.3d at 1321. In fact, the specification was merely summaries of scientific papers about the administering of galanthamine to humans and animals. It did not show a connection between the substance and Alzheimer’s.
The Court stated that the enablement requirement is closely related to utility as enablement requires the specification adequately disclose to one skilled in the art how to carry out the claimed invention without undue experimentation and if a patent claim fails the utility requirement by not be useful or operative it also fails this enablement requirement. It proceeds to discuss the utility of the patent claims to determine if the patent is enabled.
The Court states that though typically test results are submitted with patent applications claiming new methods of treatment, the testing is not required to be done by the inventor, nor must the tests be human trials. However, in the present case, no tests had been submitted by anyone involving the use of galanthamine to treat Alzheimer’s prior to the filing date. The tests by the inventor were only available after the patent had been issued, but were not presented until this litigation. The Court seems to make it clear that tests submitted with the filing or at the latest during prosecution can be used to establish utility.
The appellants at trial stated the specification does not establish utility because of the lack of testing the treatment in the same or similar environment, but instead utility is established through analytical reasoning. The Court states that while no case has found utility based on analytical reasoning, it is a possibility under the USPTO Manual of Patent Examining Procedure for therapeutic utility. In a footnote it does make it a point that the procedures are not binding on the Court. Then the Court states that the Appellants proposed inferences from the specification that one skilled in the art would see is not supported by the evidence. It further seems to say that if these inferences could be seen that may not be enough to replace explicit descriptions of the inferences for utility purposes.
VI. Future Importance/Unanswered Questions
Whether or not analytical reasoning, as seemingly approved by the USPTO, for establishing utility in lieu of certain other testing appears to be answered in the negative in this opinion. If one wanted to show utility through analytical reasoning, they would need to show a high level of correlation between the prior art and the proposed use. Additionally, this was only in the case of a therapeutic use where patent in question eased the condition of Alzheimer’s. Different standards for the analytical reasoning may apply in different cases.
Also, the Court makes a strong link between enablement and utility to a point where the two are synonymous it seems. It discusses no evidence under a typical analysis as to whether one skilled in the art could make and use it as the statute states. This point is raised in the dissent as it states the majority takes on the role of one skilled in the art, which it is not to do.
Janssen Pharmaceutica N.V., et al. v. Teva Pharmaceuticals USA, Inc., et al. (583 F.3d 1317 (Fed. Cir. 2009)).
I. Facts
The Appellant is the exclusive license owner of a patent for treating Alzheimer’s disease. The claimed inventor filed the patent application January 15, 1986. During prosecution of the patent, the USPTO rejected the claims for indefiniteness and obviousness. In responding to these specific rejections, the inventor also stated experiments were underway to show the method does result in the improved condition of Alzheimer’s sufferers and the results would be submitted later. The patent issued on May 5, 1987. The test results were not known until July of that year, but were still never submitted. The inventor licensed the patent to the Appellant in 1995. The Appellant received FDA approval to use it in 2001 to treat Alzheimer’s. In 2005, generic drug manufacturers filed applications to the FDA covering the same drug as the patent. The Appellant sued for infringement.
II. Procedural History
Patent licensee sued in the United States Court for the District of Delaware alleging infringement of its ‘318 patent. The generic drug manufacturers conceded infringement, but raised the invalidity issues of anticipation, obviousness, and enablement. The district court, after a bench trial, found the claims of the patent invalid for lack of enablement because (a) “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,†and (b) “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 claimed method could be used’ without providing sufficient . . . dosage information.†Patent licensee appealed to the United States Court of Appeals for the Federal Circuit
III. Holding
The Court held that the patent’s description did not satisfy the enablement requirement because the patent application did not establish utility.
IV. Critical Analysis
The Court immediately notes that the specification for the patent was only just over one page in length and provided no basis for the stated conclusion that it was “possible to administer an ‘effective Alzheimer’s disease cognitively-enhancing amount of galanthamine.†583 F.3d at 1321. In fact, the specification was merely summaries of scientific papers about the administering of galanthamine to humans and animals. It did not show a connection between the substance and Alzheimer’s.
The Court stated that the enablement requirement is closely related to utility as enablement requires the specification adequately disclose to one skilled in the art how to carry out the claimed invention without undue experimentation and if a patent claim fails the utility requirement by not be useful or operative it also fails this enablement requirement. It proceeds to discuss the utility of the patent claims to determine if the patent is enabled.
The Court states that though typically test results are submitted with patent applications claiming new methods of treatment, the testing is not required to be done by the inventor, nor must the tests be human trials. However, in the present case, no tests had been submitted by anyone involving the use of galanthamine to treat Alzheimer’s prior to the filing date. The tests by the inventor were only available after the patent had been issued, but were not presented until this litigation. The Court seems to make it clear that tests submitted with the filing or at the latest during prosecution can be used to establish utility.
The appellants at trial stated the specification does not establish utility because of the lack of testing the treatment in the same or similar environment, but instead utility is established through analytical reasoning. The Court states that while no case has found utility based on analytical reasoning, it is a possibility under the USPTO Manual of Patent Examining Procedure for therapeutic utility. In a footnote it does make it a point that the procedures are not binding on the Court. Then the Court states that the Appellants proposed inferences from the specification that one skilled in the art would see is not supported by the evidence. It further seems to say that if these inferences could be seen that may not be enough to replace explicit descriptions of the inferences for utility purposes.
VI. Future Importance/Unanswered Questions
Whether or not analytical reasoning, as seemingly approved by the USPTO, for establishing utility in lieu of certain other testing appears to be answered in the negative in this opinion. If one wanted to show utility through analytical reasoning, they would need to show a high level of correlation between the prior art and the proposed use. Additionally, this was only in the case of a therapeutic use where patent in question eased the condition of Alzheimer’s. Different standards for the analytical reasoning may apply in different cases.
Also, the Court makes a strong link between enablement and utility to a point where the two are synonymous it seems. It discusses no evidence under a typical analysis as to whether one skilled in the art could make and use it as the statute states. This point is raised in the dissent as it states the majority takes on the role of one skilled in the art, which it is not to do.