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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.
Gemmy Industries Corporation v.
Chrisha Creations Limited et al.
Decided June 22, 2006
Judge Newman with Judges Mayer and Schall
The “ready for patenting” standard, which covers on sale bar determinations, requires that the for-sale product meet the elements of a patent claim.
Gemmy and Chrisha sued each other in Kansas and New York over Chrisha’s exploitation of a large inflatable Santa Claus, which Gemmy had patented. After consolidation in the Southern District of New York, Judge Robert Sweet granted Chrisha summary judgment of invalidity on the basis that Gemmy had offered to sell the Santa world wide more than 12 months before filing a Santa patent application. The court also granted a preliminary injunction against Gemmy’s patent marking of Santa, prompting an interlocutory appeal to the Federal Circuit.
The Federal Circuit vacated the invalidity judgment because the patent claims recite a Santa that is inflated with a fan in the base, whereas the alleged first sale offer concerned a Santa filled with vacuum cleaner exhaust, and lacked this claim element. The early for-sale offer thus did not meet the Pfaff “ready for patenting” standard.
A patent practitioner should consider early marketing history during patent drafting but may craft claims creatively to avoid an on-sale bar from an evolving product.
Motionless Keyboard
Company v. Microsoft et al.
Decided May 29, 2007
Judge Rader with Judges Dyk and Moore
“Public use” of an invention for invalidation under 102(b) is limited to use of the invention “for its intended purpose.”
Motionless sued Microsoft and others at the U.S. District Court for the District of Oregon, over alleged infringement of a keyboard with a “cluster of keys” within a “concavity” of the surface. Judge Ann Aiken found no infringement because the accused devices lacked surface cavities. However, the patents were found invalid on 102(b) public use grounds because the inventor had shown his keyboards to others more than one year before his filing date. Motionless appealed to the Federal Circuit.
The Federal Circuit reversed the invalidity holding because the inventor’s unprotected public disclosures only “visually displayed the keyboard design without putting it into use.”
The inventor in this case stayed out of trouble by obtaining a non-disclosure agreement on the same day that he tested for his intended use with a professional typist. Non-disclosure agreements are helpful to prevent 102(b) public use bars before filing a patent application.
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.
Arthrocare Corporation, and Ethicon, Inc., v. Smith & Nephew,
Inc.
Decided May 10, 2005
pdf copy
Judge Bryson with Judges Mayer and Lourie
* Prosecution history of a prior art patent reference can be used to determine anticipation.
ArthroCare sued Smith at the U.S. District Court for the District of Delaware for allegedly infringing patent claims that recite electrosurgical systems that have "an electrically conducting fluid supply." A jury found the patent claims valid and infringed and Judge Sue Robinson denied Smith's motions for judgment of invalidity as a matter of law based on an anticipating patent by Ross. Smith appealed to the Federal Circuit.
The Federal Circuit reversed the district court's denial of Smith's motion for judgment of invalidity for some of the claims, noting that "it was error for the district court to limit the disclosure of the prior art reference to a preferred embodiment." The Federal Circuit explained that prosecution history statements for the asserted prior art patent indicated that the patent must "provide the necessary electrical conductor" and thus "discloses an electrically conducting fluid" in anticipation of this claim element.
The district court also dismissed Smith's antitrust counterclaim without providing Smith an opportunity to amend the counterclaim. The district court had stayed proceedings related to the antitrust issue before Smith's response was due to a dismissal motion from AnthroCare. The Federal Circuit vacated this dismissal because a "court should dismiss only if the complainant is unable or unwilling to amend the complaint."
In this case a district court narrowly construed not a litigated patent, but rather the disclosure of a prior art patent by limiting that patent to a preferred embodiment. The Federal Circuit, however, reached into the prosecution history to interpret the patent more broadly, and overturned a validity holding.
In Re. Carol F. Klopfenstein and John L.Brent Jr.
Decided August 18, 2004
Judge Prost with Judges Michel and Schall
*
A disclosure is a printed publication under 102(b) if it is "publically
accessible" according
to a 4 part
test.
Carol applied for a patent to methods of making doubly extruded soybean fiber. The PTO refused claims to the process because single extrusion processes that cause the desired effect (lowering serum cholesterol) were known and Carl had presented his double process results at a conference more than one year before his filing date. Carl appealed to the Federal Circuit.
The Federal Circuit affirmed because Carl's presentation of the invention at a research conference met a four factor test for public accessibility regarding i) the length of time of the disclosure; ii) the expertise of the audience; iii) expectations of whether the displayed material would be copied; and iv) ease with which the material displayed could have been copied. Carl's display was deemed public because the display was presented 3 days to an audience with skill in the field of the invention, the viewers were not precluded from photography or from taking notes, and the relevant information was easily copied.
Schering Corporation v. Geneva Pharmaceuticals, Inc. and
Novartis Corporation et al.
Decided August 1, 2003, Petition for Rehearing denied October 28, 2003
Judge Rader with Judges Plager and Bryson, Judges Newman and Lourie dissent from
denial of rehearing
* "inherency operates to anticipate entire inventions as well as single limitations within an invention"
Schering sued Geneva and other generic drug makers at the U.S. District Court for the district of New Jersey for infringing patent claims to a metabolite ("DCI") of its popular drug CLARITIN (TM) after the makers filed applications to the Food and Drug Administration for approval of their generic equivalents of CLARITIN (TM). The generic makers asserted that Schering's FDA Orange Book listed patent, which claims the CLARITIN metabolite, is invalid. Judge John Bissell granted summary judgment of invalidity because Schering's earlier patent for the CLARITIN active ingredient "inherently anticipates" the claims of this later patent to the metabolite found in the body. Schering appealed to the CAFC.
The CAFC pointed out that the district court properly construed the claims "to cover DCL in all its forms, including 'metabolized within the human body.'….(and) that DCL was necessarily formed as a metabolite by carrying out the process disclosed in" the earlier Schering patent. Furthermore "[t]he parties agreed to that construction." Thus, the CAFC affirmed, because the broad claim, which includes the metabolite compound in the body made from CLARITIN, was inherently anticipated.
This is the first case wherein all aspects of a claimed invention were unknown and not even capable of being known until later, yet were anticipated inherently by prior art. Unfortunately Schering did not claim the invention of obtaining the metabolite in an isolated form and/or administering the metabolite in a pharmaceutical form. The opinion comports with the fact that a naturally occurring compound is "invented" via its isolation from nature and simultaneous conception/appreciation of its use. This point apparently was lost on Judge Newman, who dissented from denial of rehearing en banc by arguing that "[i]t was and is well understood that an inventor may discover something that already existed." In fact, the isolated form and pharmaceutical preparation of the DCL metabolite did not exist before. Instead of claiming the invention, Schering's second patent claimed the compound per se, including all of its naturally occurring forms and concentrations in the body.
Judge Lourie also seemed to miss this point in dissenting from denial of rehearing en banc. Judge Lourie argued that "[t]his decision holds that an enabling disclosure of 'how to make' metabolites is provided by the mere recitation that one can administer a prior art compound to humans." This statement overlooks the fact that a novel chemical process for synthesizing a properly claimed metabolite also should be patentable.
If a drug company wants to protect a discovery of a drug metabolite as a new drug itself, it should file a patent application to a) that new use, to b) that new drug formulation and/or to c) the new chemical synthesis method of its formation. Drug companies have to follow the same patent rules as biotech companies who isolate naturally occurring chemicals from nature.