Astrazeneca v. Teva

The district court granted summary judgment that the defendant did not present sufficient evidence for a jury to find inequitable conduct and the Federal Circuit affirmed. The issue is summarized as follows: “The issue presented in this case relates to the extent to which the patent applicant, having fully disclosed the relevant prior art and having provided comparative data to the satisfaction of the patent examiner, must also present any additional unpublished information in the applicant’s possession concerning other less structurally similar compounds, and must also synthesize additional compounds for comparative testing.” (p. 4.) The court concluded that the applicant need not. At least not in this case. (See p. 12 (“Although there may be situations in which the failure to conduct specific tests of specific compounds can be criticized, in this case there was no evidence that the information gleaned, if such tests had been conducted, would have been material to patentability.”).)

Regarding deceptive intent, the court made clear that a showing of a high degree of materiality does not reduce the need to show deceptive intent at least at some threshold level. “While the court must, as the final step, weigh and balance the findings of materiality and intent, this presupposes that a threshold level of both of these elements has already been established by clear and convincing evidence.” (p. 16; p. 15; p. 4.)

In Re ‘318 Patent Infringement Litigation

The ’318 patent “claims a method for treating Alzheimer’s disease with galanthamine.” The district court found that the claims were not enabled and the Federal Circuit affirmed. The court discussed the law of enablement and the policies behind it at some length, making the following general points before reaching the facts of the case at hand:

• “Enablement is closely related to the requirement for utility.” (p. 9.)
• “The utility requirement prevents mere ideas from being patented.” (p. 10.)
• “The utility requirement also prevents the patenting of a mere research proposal or an invention that is simply an object of research.” (p. 10.)
• The above is so because: “Allowing ideas, research proposals, or objects only of research to be patented has the potential to give priority to the wrong party and to confer power to block off whole areas of scientific development, without compensating benefit to the public.” (p. 11.)
• Methods of treatment are usually supported by tests, but the inventor need not conduct those tests. (p. 11.)

In this case, testing was not available as of the priority date. The patentee argued “that utility may be established by analytic reasoning” in lieu of testing. (p. 14.) The court accepted this as a possibility, but found that the specification in this instance failed to provide such reasoning. “[T]he specification, even read in the light of the knowledge of those skilled in the art, does no more than state a hypothesis and propose testing to determine the accuracy of that hypothesis. That is not sufficient.” (p. 16.)

This case was decided based on enablement although the entire discussion concerned utility. See generally In re Swartz, 232 F.3d 862, 864 (Fed. Cir. 2000) (“Lack of utility is a question of fact and the absence of enablement is a legal conclusion based on underlying factual inquiries.”) (citations omitted).

Kara Technology v. Stamps.com

This case is interesting in view of its treatment of a claim construction issue in light of a case decided just a few days earlier, Edwards Lifesciences v. Cook. (Kara Technology was decided by Schall, Plager, and Moore while Edward Lifesciences was decided by Lourie, Rader, and Moore.) In that case, discussed in a prior post, the court limited a claim based on the specification and rejected an argument that claim differentiation supported a broader construction. Here, the court seemingly took the opposite approach, refusing to limit a claim term based on the specification and relying in part on claim differentiation (under the same circumstance as were present in Edwards, namely a dependent claim included a term that was left off of its independent claim). Regarding claim differentiation, the court stated “when the inventor wanted to restrict the claims to require the use of a key, he did so explicitly. None of the claims at issue on appeal recite the term ‘key.’ By contrast, all of the other independent claims require either an ‘encryption key’ or ‘key data.’ In addition, dependent claim 2 … explicitly adds the limitation [at issue] to claim 1….” (p. 9.) The court was not convinced that the specification required the claims to be limited to having a key even though “the specification repeatedly discusses a key embedded in the preestablished data” and”[i]n the only detailed embodiments in the patent, the key is embedded in the preestablished data.” In this case, this was “not enough … to limit the patentee’s clear, broader claims.” (p. 9.) In Edwards, the court reached the opposite conclusion based in part on the fact that “the only devices described in the specification” included the limitation not expressly in the claims (Edwards, p. 11.) and despite the fact that, under the doctrine of claim differentiation, “the presence of a dependent claim that adds a particular limitation gives rise to a presumption that the limitation in question is not present in the independent claim.” (Kara, p. 9.)

Edwards Lifesciences v. Cook

In this case, the patents “relate to intraluminal grafts for treating aneurisms and occlusive diseases of the blood vessels without open surgery.” (p. 2.) The main arguments involved claim construction. The patentee argued that the use of the terms “graft” and “intraluminal graft” suggested that the term “graft” was broader. The court, relying on the written description, disagreed. First, the specification used the terms interchangeably. “The interchangeable use of the two terms is akin to a definition equating these two.” (p. 11.) Second,” the only devices described in the specification are intraluminal, supporting an interpretation that is consistent with that description.” (p. 11.) Third, “the specification frequently describes an ‘intraluminal graft’ as ‘the present invention’ or ‘this invention,’ indicating an intent to limit the invention to intraluminal devices.” (p. 12.) Fourth, the context of the claims supported this construction. The court also rejected arguments based on claim differentiation: “Even if the claim construction had rendered the dependent claim redundant, the doctrine of claim differentiation does not require us to give the ‘graft’ devices their broadest possible meaning. We may instead limit ‘grafts’ to ‘intraluminal’ devices, as demanded by the specification.” (p. 13; see also id. (“Different terms or phrases in separate claims may be construed to cover the same subject matter where the written description and prosecution history indicate that such a reading of the terms or phrases is proper.”) (quoting Nystrom v. TREX Co., 424 F.3d 1136, 1143 (Fed. Cir. 2005).)

Regarding another term, the patentee made another claim differentiation argument, this one based on the fact that a dependent claim added a requirement for a wire that was not expressly found in the independent claim. This is normally the strongest case for claim differentiation but it was dismissed quickly: “[C]laim differentiation is a rule of thumb that does not trump the clear import of the specification. Here, the specification and the parties’ agreement in the district court make clear that the claimed graft devices require wires.” (p. 16 (citation omitted).)

Concerning another term, the court stated that, for a definition provided by the patentee, “the location within the specification in which the definition appears is irrelevant.” (p. 20-21.) Accordinlgy, “the specification’s use of ‘i.e.’ signals an intent to define the word to which it refers … and that definition was not limited to the embodiment being discussed.” (p. 21.)

In Re Lister

This case involving a PTO rejection of claims for a method of playing golf using a tee for most of the shots hinged on whether a reference was “publicly accessible.” The applicant had submitted a manuscript describing the invention to the copyright office more than a year before filing an application. The key question is whether the manuscript was publicly accessible by virtue of being in the copyright office.

“In several cases involving references stored in libraries, we have considered whether the research tools available would have been sufficient to permit an interested researcher to locate and examine the reference.” (p. 6.) Cataloging and indexing are important research tools but not the whole story. “While cataloging and indexing have played a significant role in our cases involving library references, we have explained that neither cataloging nor indexing is a necessary condition for a reference to be publicly accessible.” (p. 7.) The standard for public accessibility is “whether an interested researcher would have been sufficiently capable of finding the reference and examining its contents” in light of all “the facts and circumstances surrounding the disclosure.” (p. 8.)

The court noted that “a reference can be considered publicly accessible even if gaining access to it might require a significant amount of travel” and that it is “unnecessary to show that anyone actually inspected the reference.” (p. 8.) The court also found that in this case the inability to make copies did not render the reference inaccessible. (p. 8.) Further, although the copyright database did not provide any reasonable means of searching, two other databases, Westlaw and Dialog, permitted searching of titles by keywords of materials in the copyright office. However, there was insufficient evidence to establish when the reference at issue was available in Westlaw or Dialog. “[I]n this case the government has not identified any evidence of the general practice of the Copyright Office, Westlaw, or Dialog with regard to database updates. Absent such evidence, we have no basis to conclude that the manuscript was publicly accessible prior to the critical date.” (p. 16.) The court rejected arguments that a prima facie case showing that the manuscript was in the databases was established. “We see little difference between the evidence in this case and a situation in which an examiner comes across an undated reference that discloses an invention for which an applicant is seeking the patent. We surely would not view the mere existence of the reference in the latter scenario as prima facie evidence that it was available prior to the applicant’s critical date.” (p. 16-17.)

Asymmetrx v. Biocare Medical

The Federal Circuit determined that the plaintiff in this matter did not have standing to sue since it did not have “all substantial rights” to the patent at issue. The parties and the district court had not addressed this concern, but the court noted that “an appellate court must satisfy itself that it has standing and jurisdiction whether or not the parties have raised them.” (p. 6.)

The court provided background on when a licensee can have standing to sue in its own name and concluded by stating that “the critical determination regarding a party’s ability to sue in its own name is whether an agreement transferring patent rights to that party is, in effect, an assignment or a mere license.” (p. 8.) The difference hinges on the extent of the rights retained by the patentee. In this case, the patentee retained several substantial interests, including:

• the right to sue for infringement;
• the right to make and use the patented product, p63 antibodies, for its own academic research purposes;
• the right to provide the p63 antibodies to non-profit or governmental institutions for academic research purposes;
• a great deal of control over aspects of the licensed products within the commercial diagnostic field;
• specifying that manufacture had to take place in the United States during the period of exclusivity; and
• maintaining input on sublicensing and receiving a share of those royalties. (p. 10-11.)

In addition, the licensee had “to cooperate with [the patentee] to maintain the patent rights, so as to enable [it] to apply for, to prosecute, and to maintain patent applications and patents in [its] name.” (p. 11.) The patentee, under the agreement, also had a right to join any suit, approve settlements, and brings its own infringement action. The court found that “[w]hile any of these restrictions alone might not have been destructive of the transfer of all substantial rights, their totality is sufficient to do so.” (p. 12.) The complete opinion is here.

Vita-Mix v. Basic Holding

Several issues decided on summary judgment were addressed in this decision, and certain aspects pertaining to contributory infringement and inducement are mentioned here.

Regarding contributory infringement, the court agreed that a commodity of commerce is suitable for substantial non-infringing uses non-infringing if those uses “are not unusual, far-fetched, illusory, impractical, occasional, aberrant, or experimental.” (p. 14.) However, “an infringer does not evade liability by bundling an infringing device with separate and distinct components that are capable of noninfringing use.” (p. 15.) The court found that the accused devices were capable of substantial non-infringing uses. Interestingly, it was possible that during the use of the devices in non-infringing ways, the device would occasionally infringe. This did not change the court’s analysis: “Even assuming that the device might inadvertently infringe the patent for a brief time in the majority of uses does not mean that the non-infringing use … is not substantial enough to avoid contributory liability. The analysis would be different if the [accused device] could not be operated in a non-infringing way unless the user infringed at some point. But where, as here, there is a common use that neither infringes nor requires infringement, the substantiality of that use is unaffected by any unrelated infringing operations.” (p. 16, n. 1.)

Regarding inducement, the court articulated the standard as follows: “Inducement requires a showing that the alleged inducer knew of the patent, knowingly induced the infringing acts, and possessed a specific intent to encourage another’s infringement of the patent.” (p. 16.) In this case, the court rejected the patentee’s attempt to support an inference of intent through “the product instructions and the design of the device.” (p. 17.) Since those things encouraged non-infringing uses and not infringing uses, there was no evidence that the defendant “intends to encourage infringement by its customers.” (p. 18.)