Wednesday, September 30, 2009
Board of Trustees v. Roche Molecular
Standing. The court never addressed the obviousness issue. Instead, it focused on the defendants’ claim regarding ownership. The court found that a state statute of limitations barred the defendants’ claim for ownership. However, the same facts on which the claim for ownership was based lead the court to conclude that the plaintiff did not have standing to bring its infringement case. Therefore, the judgment of invalidity was vacated and the case was remanded so that the case could be dismissed for lack of jurisdiction. The district court’s judgment regarding the defendants’ counterclaim was affirmed since they had standing to bring that claim. (p. 25.) The opinion is here.
Friday, September 25, 2009
Astrazeneca v. Teva
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).
Thursday, September 24, 2009
Kara Technology v. Stamps.com
Tuesday, September 22, 2009
Edwards Lifesciences v. Cook
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
“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.)
Friday, September 18, 2009
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.
Wednesday, September 16, 2009
Vita-Mix v. Basic Holding
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.)
Prometheus v. Mayo
The patents at issue “claim methods that seek to optimize therapeutic efficacy while minimizing toxic side effects,” and include two main steps: administering a drug to a person and determining the levels of the drug’s metabolites in the subject. (p. 2.) The “measured metabolite levels are then compared to pre-determined metabolite levels” to determine whether to adjust them. The court found that the two main steps were transformative and that although the remaining aspects involved only mental steps, this alone did not remove the claims from patent eligible subject matter.
Claims drawn to a fundamental principle are not patent eligible, but those drawn to an application of a fundamental principle are. The court acknowledged that determining “whether a claim is drawn to a fundamental principle or an application of a fundamental principle” is “hardly straightforward.” (p. 8.) It then quoted its “definitive test” from Bilski: “A claimed process is surely patent-eligible under § 101 if: (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.” (p. 8.) This machine-or-transformation test can be satisfied for a method claim by showing that a “claim is tied to a particular machine, or by showing that his claim transforms an article.” (p. 8.) In addition, the machine or transformation part of the claim must not be “insignificant extra-solution activity” and must “must impose meaningful limits on the claim’s scope.” (p. 8.) “This transformation must be central to the purpose of the claimed process.”
The court found that the administering and determining steps were transformative. For the administering step, the ”transformation is of the human body following” administration and for the determining step the transformation is “the various chemical and physical changes of the drug’s metabolites that enable their concentrations to be determined.” (p. 14-15.) Rejecting arguments that the transformations were natural processes, the court stated that methods of treatment “are always transformative when a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition.” (p. 15.)
Similarly, the court distinguished natural processes from transformations by noting that “quite literally every transformation of physical matter can be described as occurring according to natural processes and natural law. Transformations operate by natural principles. The transformation here, however, is the result of the physical administration of a drug to a subject to transform—i.e., treat—the subject, which is itself not a natural process.” (p. 16.)
The determining step also involved a transformation because “those levels cannot be determined by mere inspection.” Rather, “some form of manipulation, such as the high pressure liquid chromatography method specified in several of the asserted dependent claims or other modification of the substances to be measured, is necessary to extract the metabolites from a bodily sample and determine their concentration.” (p. 16-17.)
The court distinguished the present case from In re Grams, 888 F.2d 835 (Fed. Cir. 1989), a case which involved “(1) performing a clinical test on individuals and (2) based on the data from that test, determining if an abnormality existed and determining possible causes of any abnormality by using an algorithm.” (p. 18-19.) In that case the process was merely an algorithm combined with a data-gathering step,” unlike here, where “the claims are to transformative methods of treatment, not correlations.” (p. 21.).
Although the court found that the final steps did not meet the machine-or-transformation test, this did not alter the outcome. “A subsequent mental step does not, by itself, negate the transformative nature of prior steps.” (p. 20.)
Tuesday, September 15, 2009
Amgen v. Roche
Obviousness-type double patenting. The Federal Circuit held that §121’s safe harbor from obviousness-type double patenting for divisional applications did not apply to continuations. “We conclude that, because the … applications were filed as continuation—rather than divisional—applications, the … patents do not receive the benefit of § 121.” (p. 14.) It also reviewed the law of obviousness-type double patenting, which “entails two steps: (1) construction of the claims in the earlier patent and the claim in the later patent to identify any differences, and (2) determination of whether the differences in subject matter between the claims render the claims patentably distinct.” (30-31.) And the second “part of the obviousness-type double patenting analysis is analogous to an obviousness analysis under 35 U.S.C. § 103, except that the ’008 patent is not considered prior art.” (p. 32.) In this case, involving the “production of the protein erythropoietin (‘EPO’) using … DNA technology,” it found that those of “ordinary skill in the art would not have reasonably expected to successfully produce isolatable quantities of glycosylated EPO having the stated biological activities in transfected CHO cells. Put most simply, CHO cells transfected with the EPO DNA sequence and the production of recombinant, in vivo biologically active EPO glycoprotein are patentably distinct inventions.” (p. 34.)
Product-by-process claims. “It has long been the case that an old product is not patentable even if it is made by a new process.” (p.41.) “However, a new product may be patented by reciting source or process limitations so long as the product is new and unobvious.” (p.42.) Therefore, “[i]n determining validity of a product-by-process claim, the focus is on the product and not on the process of making it.” (p. 47.) And so “a product-by-process claim can be anticipated by a prior art product that does not adhere to the claim’s process limitation.” On the other hand, for infringement, “the focus is on the process of making the product as much as it is on the product itself.” This quirk creates an unusual situation:
“For product-by-process claims, that which anticipates if earlier does not necessarily infringe if later. That is because a product in the prior art made by a different process can anticipate a product-by-process claim, but an accused product made by a different process cannot infringe a product-by-process claim. Similarly, that which infringes if later does not necessarily anticipate if earlier. That is because an accused product may meet each limitation in a claim, but not possess features imparted by a process limitation that might distinguish the claimed invention from the prior art.” (p. 48.)
Indefiniteness. The court noted that the purpose of product-by-process claims is to allow “the patentee to obtain a patent on the product even though the patentee cannot adequately describe the features that distinguish it from prior art products.” They are therefore used when the patentable distinctions are “ difficult-to-describe.” “Thus, to call the process limitation indefinite in this situation would defeat one of the purposes of product-by-process claims, namely permitting product-by-process claims reciting new products lacking physical description.” (p. 55-56.)
Infringement under §271(g). This section provides for infringement when a product made by a patented process is imported. It applies unless “the product made by the patented process is ‘materially changed by subsequent processes’ prior to importation.” (p. 62.) In discussing materiality, the court noted the following: “Materiality is context-dependent.” (p. 65.) “A good source for determining whether a change in a product of a process is material under § 271(g) is the patent. Where the specification or asserted claims recite a structure or function for the product of the processes, then significant variations from the recited structure and function are material. What makes a variation significant enough to be a ‘material change,’ however, is a question of degree.” (p. 65-66.)
Jury instructions. The court left open the issue of whether jury instructions should be reviewed under its own law or the law of the regional circuit. (p. 44, n. 13.)
Saturday, September 12, 2009
Lucent v. Gateway
Regarding direct infringement, the court pointed out that, “[j]ust as anticipation can be found by a single prior art use, a finding of infringement can rest on as little as one instance of the claimed method being performed during the pertinent time period.” (p. 19.) With little direct evidence that anyone performed the claimed method using Microsoft products, the court relied on circumstantial evidence to uphold the verdict. However, it noted that the plaintiff “would have been on much firmer ground had it introduced some direct evidence of using the claimed method.” (p. 23.)
Regarding contributory infringement, as framed by the parties “the main issue reduces to whether the ‘material or apparatus’ is the entire software package or just the particular tool (e.g., the calendar date-picker) that performs the claimed method.” (p. 24-25.) This is because the entire software package had substantial non-infringing uses, but an individual component of the package did not. The court rejected the entire package argument, essentially concluding that if it were a prevailing argument, contributory infringement could be evaded by including extra features in a package with infringing features. “Here, the infringing feature for completing the forms, i.e., the date-picker tool, is suitable only for an infringing use. Inclusion of the date-picker feature within a larger program does not change the date-picker’s ability to infringe. Because Microsoft included the date-picker tool in Outlook, the jury could reasonably conclude, based on the evidence presented, that Microsoft intended computer users to use the tool—perhaps not frequently—and the only intended use of the tool infringed the Day patent.” (. 27.)
Regarding inducement, the court acknowledged, quoting DSU Medical, it “requires evidence of culpable conduct, directed to encouraging another’s infringement, not merely that the inducer had knowledge of the direct infringer’s activities.” But, in upholding the finding of infringement on thin evidence, also noted that a “plaintiff may still prove the intent element through circumstantial evidence, just as with direct infringement….” (p. 28.)
Regarding damages, the court noted two ways that litigants calculate a reasonable royalty: (1) “the analytical method, focuses on the infringer’s projections of profit for the infringing product,” and (2) “the hypothetical negotiation or the ‘willing licensor-willing licensee’ approach, attempts to ascertain the royalty upon which the parties would have agreed had they successfully negotiated an agreement just before infringement began.” (p. 33.) Concerning the hypothetical negotiation, the court discussed the differences between a running royalty and lump sum analysis. The court found that the evidence did not support the damages award. One factor was that the “evidence can support only a finding that the infringing feature contained in Microsoft Outlook is but a tiny feature of one part of a much larger software program.” (p. 48.) Thus, the resolution of the dispute concerning contributory infringement is mitigated somewhat on the damages side, with the court concluding “the glaring imbalance between infringing and non-infringing features must impact the analysis of how much profit can properly be attributed to the use of the date-picker compared to non-patented elements and other features of Outlook.” (p. 49.)
Regarding the entire market value rule, the court stated: “Although our law states certain mandatory conditions for applying the entire market value rule, courts must nevertheless be cognizant of a fundamental relationship between the entire market value rule and the calculation of a running royalty damages award. Simply put, the base used in a running royalty calculation can always be the value of the entire commercial embodiment, as long as the magnitude of the rate is within an acceptable range (as determined by the evidence).” (p. 61.) In other words, “[t]here is nothing inherently wrong with using the market value of the entire product, especially when there is no established market value for the infringing component or feature, so long as the multiplier accounts for the proportion of the base represented by the infringing component or feature.” (p. 62.)
Thursday, September 10, 2009
Fresenius v. Baxter International
Fresenius failed to provide substantial evidence of invalidity for certain means-plus-function claims because it failed to include any evidence that the corresponding structure was disclosed. “Just as a patentee who seeks to prove infringement must provide a structural analysis by demonstrating that the accused device has the identified corresponding structure or an equivalent structure, a challenger who seeks to demonstrate that a means-plus-function limitation was present in the prior art must prove that the corresponding structure—or an equivalent—was present in the prior art.” (p. 17.)
KSR and Motivation to Combine. The court noted that the trial was conducted and JMOL issues decided before KSR, and that “the district court applied the teaching-suggestion-motivation test for obviousness as it existed before it was modified by KSR.” (p. 19.) The district court had reversed the jury’s finding of obviousness, and the Federal Circuit reversed the district court. Referring to the motivation to combine test relied on in some form by the jury and the district court, the court stated: “We first note that it remains appropriate for a post-KSR court considering obviousness ‘to determine whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.’” (p. 20 (quoting KSR).) The court went on to find that, under KSR, there was substantial evidence of a suggestion to combine to support the jury’s finding of obviousness.
Regarding the granting of a permanent injunction, the court found that the district court correctly applied the four-factor post-eBay test and did not abuse its discretion, but nonetheless vacated and remanded for reconsideration in light of the other holdings in its opinion (that some of the claims at issue were invalid for obviousness). (p. 24.)
Damages. The court also vacated the royalty award for reconsideration in light of the fact that now fewer claims (and patents) were found to be infringed, noting that this may alter the hypothetical negotiation. (p. 24-25.)
Reexamination. In separate concurring opinions, Judges Dyk and Newman disagreed about whether a stay of the remaining proceedings is warranted in this case. While noting that reexam can be useful, Judge Newman cautioned: “if routinely available to delay the judicial resolution of disputes, the procedure is subject to inequity, if not manipulation and abuse, through the delays that are inherent in PTO activity.” (p. 3 of Newman concurrence.)
Tuesday, September 8, 2009
Ron Nystrom v. Trex Company
Noting that this case presents a “slightly new angle on claim preclusion,” the court concluded that it should apply: “[If t]he accused device of the second suit remains unchanged with respect to the corresponding claim limitations at issue in the first suit, then [the plaintiff] has no remaining avenue to pursue his claims now. In essence, [the plaintiff] would be attempting to prove infringement of the same claim limitations as to the same features of the accused devices. As such, this case presents the exact situation that res judicata seeks to prevent.” (p. 7.)
The plaintiff also argued that the new boards were not “insubstantially different with respect to the pertinent claim elements,” but to no avail. So the “tactical decision” to not pursue an infringement theory based on the doctrine of equivalents in the first suit “did not pay off” and the plaintiff did not get “a second bite at the apple.” (p. 8-9.)
Note: This case was decided on claim preclusion grounds but might more precisely have been decided based on issue preclusion since the products were admittedly materially different but the dispositive infringement issue was the same.
Friday, September 4, 2009
In Re Robert Skvorecz
Another issue was the interpretation of “comprising,” which the court felt the Board had taken too far. The patent required each leg of the device to have an offset and a prior art reference disclosed a device in which some but not all legs had offsets. The Board interpreted the claim “to include wire legs without offsets, because the claim uses the open-ended transition term ‘comprising.’” (p. 7.) The Federal Circuit rejected this reasoning: “The signal ‘comprising’ does not render a claim anticipated by a device that contains less (rather th[a]n more) than what is claimed.” (p. 8.) Therefore, it was incorrect “to interpret ‘comprising’ to mean that not all the Skvorecz wire legs need have offsets, despite the claims that state that ‘each wire leg’ has an offset. (Id.) In this context, the court also discussed the “protocol of giving claims their broadest reasonable interpretation during examination,” noting that it “does not include giving claims a legally incorrect interpretation. This protocol is solely an examination expedient, not a rule of claim construction. Its purpose is to facilitate exploring the metes and bounds to which the applicant may be entitled, and thus to aid in sharpening and clarifying the claims during the application stage, when claims are readily changed.” (Id.)
Thursday, September 3, 2009
Martek Biosciences v. Nutrinova
The other aspects of the opinion were unanimous. The court noted that the written description requirement can be satisfied even if the scope of the claims is broader than the disclosure. “[A] patent claim is not necessarily invalid for lack of written description just because it is broader than the specific examples disclosed.” (p. 9.) Also, in a discussion concerning prior inventorship evidence, the court said that an abandoned application does not establish reduction to practice. “[W]hile an abandoned patent application is evidence of conception, it is insufficient to corroborate testimony that an alleged prior inventor reduced the invention to practice.” (p. 18.) Regarding enablement, two narrower dependent claims were not invalid for lack of enablement even though the independent claim may have been. (p. 25.) Finally, concerning infringement, the court stated that tests were not necessarily required to establish the presence of a functional limitation. In explaining Kim v. ConAgra Foods, Inc., 465 F.3d 1312 (Fed. Cir. 2006), it stated “we did not articulate a general rule requiring one who alleges infringement of a claim containing functional limitations to perform actual tests or experiments on the accused product or method.” (p. 15.) As such, the patentee was able to rely on “testimony from two experts, each of whom conceptually analyzed the accused process and testified that it must meet the functional claim limitation based on the [accused] composition … and the known effects of chloride concentration on stainless steel corrosion.” (Id. (emphasis added))