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Federal Circuit Case Law |
Impax Laboratories, Inc. v. Aventis
Pharmaceuticals, Inc.
“The enablement requirement for prior art to anticipate under section 102 does not require utility, unlike the enablement requirement for patents under section 112.”
“When a reference discloses a class of compounds, i.e., a genus, a person of ordinary skill in the art should be able to ‘at once envisage each member of th[e] … class’ for the individual compounds, i.e., species, to be enabled.”
Impax sued Aventis at the U.S. District Court for the District of Delaware for declaratory judgment of no infringement and invalidity of Aventis’s drug patent after Impax filed an Abbreviated New Drug Application. Judge Joseph Farnan Jr. found claims not invalid as anticipated over a prior art that described the drug compound within a much larger group and an earlier reference that did not even teach medical usefulness of the disclosed compounds. Impax appealed to the Federal Circuit.
A Federal Circuit panel majority affirmed no anticipation by the earlier reference because of the large number of compounds included with no specific identification of the drug. However, the court vacated the no anticipation holding from the later reference because such “reference does not have to be effective to be enabling.” Judge Rader dissented from this second holding on the basis that the later reference “does not even make a suggestion of disclosure” of the compound and cannot anticipate.
Enablement for an anticipating reference differs from that needed to obtain a patent, but determining this difference remains difficult, especially for a use invention that requires appreciation of an effect.
Michael P. Callicrate v. Wadsworth Manufacturing, Inc.
Decided October 31, 2005 pdf
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Judge Rader with Judges Newman and Prost
* "[A] patent specification may sufficiently enable a feature under 112(1), even if only the background section provides the enabling disclosure."
Michael sued Wadsworth at the U.S. District Court for the District of Montana for infringing his patent claims to a cattle castrator. Michael’s patent claims had elements that were supported in the background section of his earliest patent disclosures, where he had disparaged those features. Judge Donald Molloy responded to this anomaly by declaring that the later patent claims were not supported by the earlier disclosures. A jury then found that intervening prior art invalidates the later patent claims. Michael appealed.
The Federal Circuit reversed because the description of claim elements in the background section of the earlier priority documents supported the earlier priority date. Neither party argued the written description requirement and this opinion revolved around whether enablement was met in the earlier applications.
A practitioner often avoids detailed description in the background section of a specification. This case shows however, that a nuanced description of prior art may be a useful reference for adding features to a later asserted claim. In the biotechnology arts in particular, practitioners tend to cite and describe many alternative procedures in a patent specification to fortify enablement of a claimed invention. This technique may be useful even for mechanical patent applications.
Novo Nordisk Pharmaceuticals, Inc. v. Bio-Technology General
Corp et al.
Decided October 5, 2005
pdf copy
Judge Schall with Judges Archer and Bryson
* A prophetic example in the past tense can made a patent unenforceable, particularly when the applicant tried but failed to carry out the invention.
This is another recent case where a fictitious example in a patent evinced fraud on the patent office, making the patent unenforceable. Novo sued Bio-Technology at the U.S. District Court for the District of Delaware for infringing patent claims to human growth hormone made from bacteria via an enzyme processing step. Judge Sue Robinson found the patent anticipated over an earlier journal article and also unenforceable due to inequitable conduct. Novo appealed to the Federal Circuit.
The Federal Circuit affirmed anticipation and unenforceability. In finding anticipation, the court cited the recent Rasmusson case, wherein "[t]he standard for enablement of a prior art reference for purposes of anticipation under section 102 differs from the enablement standard under (section 112)," and that "anticipation does not require actual performance of suggestions in a disclosure." Unenforceability was amply supported by evidence that the inventor could not practice the claimed invention after the filing date and that the inventor made up and relied on "prophetic data."
Enthusiasm for a hotly competitive technology with obvious commercial advantages can lead an inventor to file aspirations as inventions. A patent practitioner should ensure that all technical fantasies in a patent application are properly designated as prophesies, preferably by describing them in present or future tense.
Warner-Lambert Company et al. v. Teva Pharmaceuticals USA,
Inc.
Decided August 11, 2005
pdf copy
Judge Schall with Judges Linn and Prost
* Broad claims to multiple compounds may be unenabled if a disclosure only teaches how to make and use one or two of the compounds.
Warner sued Teva under 35 USC 271(e)(2)(A) for infringing Warner's Accupril drug formulation patent claims, at the U.S. District Court for the District of New Jersey. Judge Dickinson Debevoise granted Warner summary judgment of infringement and non-invalidity on enablement grounds. Teva appealed to the Court of Appeals for the Federal Circuit.
A Federal Circuit panel reversed summary judgment of no invalidity on enablement grounds. The court noted that "while the patent claims numerous combinations…..the specification only discloses two working examples, both of which are based on the same general combination…." In particular, Teva's expert witness had presented a genuine issue of material fact by declaring that "one of skill in the art would need to undertake a range of experimentation in order to practice the invention."
An expert declaration can help a party survive summary judgment by demonstrating the existence of a fact dispute, as seen here. In this case, a complicated fact determination arose because a huge list of compounds was claimed but only one type was taught in the specification. To minimize fact analysis of enablement during litigation, a practitioner should provide as many examples as possible in a patent specification.
Northpoint Technology, Ltd. v. MDS America, Inc. and MDS
International, SARL
Decided June 28, 2005
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Judge Bryson with Judges Schall and Dyk, Dyk dissenting in part
* A claimed invention that requires use of "additional parameters and techniques" for operation may lack enablement.
Northpoint sued MDS at the U.S. District Court for the Southern District of Florida for alleged infringement of claims to methods and apparatus for video reception of two signals on a common frequency based on different "directional reception range" (e.g. one signal is from an overhead satellite and the other is from a different direction on the ground). Judge James Cohn construed "directional reception range" broadly to mean reception of a signal from a different 3-D space and not necessary from an antenna pointed in a different direction. A jury found 3 claims infringed but invalid on anticipation grounds over a reference that uses "adaptive array techniques" (i.e. switching techniques to make an antenna pick up signals in a different direction without actually moving it). The jury also found invalidity on non-enablement grounds. Northpoint appealed to the Federal Circuit.
A Federal Circuit panel majority opinion affirmed. The opinion noted that a co-inventor admitted lack of enablement by testifying that "numerous parameter values and interference mitigation techniques were used" in the first test of the technology" but that "none of these techniques were described or disclosed" in the asserted patents.
Judge Dyk dissented with a view that the claims should have been construed more narrowly, which would have avoided the adaptive array prior art. Judge Dyk also lamented the finding of "lack of enablement in the absence of expert testimony that the experimentation was excessive or not routine."
It is helpful to actually make and test an invention so that newly encountered variables in the field of reality can be added to an application to more fully enable others to use the invention.
Gary H. Rasmusson and
Glenn F. Reynolds v. Smithkline Beecham Corp.
Decided June 27, 2005
pdf copy
Judge Bryson with Judges Plager and Prost
* "[U]tility must be disclosed [by
real data or believable logic] to satisfy the
section 112 enablement requirement."
* "[A]nticipation does not require actual performance of suggestions in a
disclosure."
This case affects the use of prophetic claiming in biotech patent applications. Gary and Smithkline each filed a series of progressively more detailed patent applications covering ideas in the field of prostate cancer treatment. The PTO Board of Patent Appeals and Interferences held an interference and declared Smithkline the first inventor for use of an enzyme inhibitor because Gary’s first 8 applications failed the enablement requirement. Gary had asserted in early applications that a compound was an anticancer agent but did not provide any data to challenge conventional wisdom and thus was not "obviously correct." The PTO also found that a European patent application did not anticipate Smithkline’s disclosure because the European application was not enabled for the same reason as. Both sides appealed various issues to the Federal Circuit.
The Federal Circuit affirmed that Gary’s applications were unenabled for lack of persuasive support (i.e. either a showing of real data or an obviously correct argument). The Federal Circuit explained that "[I]f mere plausibility were the test for enablement under section 112, appliants could obtain patent rights to ‘inventions’ consisting of little more than respectable guesses as to the likelihood of their success." The court also reversed the non-anticipation holding because enablement of prior art for 102 purposes can be proven by later results and the European reference inherently was enabled. That is, enablement for patentability purposes and enablement of prior art for anticipation purposes differ because section 112 requires a disclosure to teach how to make and use an invention, wherein section 102 lacks this requirement.
Prophetic inventions often are easy to write but are not enabled unless an ordinary skilled artisan would believe the assertions of utility as obviously correct. Unfortunately for Gary, a scientific report finally confirmed the prophetic clinical usefulness of his claimed compound 10 months before his ninth application. Enablement was not possible until that date because his data-less prophesy was not believable until proof was available.