Wednesday, September 16, 2009

Prometheus v. Mayo

Seven amicus briefs were filed in this appeal of a finding by the district court that the claimed method was drawn to non-statutory subject matter. Relying on its Bilski opinion, the Federal Circuit in its opinion discussed the machine-or-transformation test and concluded that the claimed method of treatment was drawn to patent eligible subject matter.

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

Here are a few points gleaned from this 80-page opinion.

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

This case involved a patent directed towards “entering information into fields on a computer screen without using a keyboard.” (p. 3.) Several parties were involved, including Microsoft, and the case went to trial. The jury awarded $357,693,056.18 to the plaintiff. Numerous issues were on appeal. The Federal Circuit upheld the validity and infringement findings but vacated the damages and remanded. Here are a few of the highlights gleaned from the detailed and lengthy opinion:

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

(2008-1306,-1331, Sept. 10, 2009) Baxter’s argument before the trial court that Fresenius failed to show that a system was prior art was not sufficient to preserve other arguments regarding the prior art, such as that it failed to show all the limitations: “[O]ne specific challenge to an anticipation finding does not preserve all possible challenges to that finding. If a party fails to raise an argument before the trial court, or presents only a skeletal or undeveloped argument to the trial court, we may deem that argument waived on appeal, and we do so here.” (p. 10.) Further, the parties disputed what the prior art system showed, and therefore were presenting a new factual dispute on appeal that “should have been presented to the district court for its consideration in the first instance.” (p. 11.)

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

(2009-1026 Sept. 8, 2009) Claim preclusion barred the patentee from arguing that wood boards infringed because the boards were “essentially the same” with respect to the limitations at issue as boards previously found to be noninfringing. In a previous case, the defendant’s wood boards were found not to literally infringe based on two limitations. Furthermore, in that case the patentee had waived any argument for infringement under the doctrine of equivalents. In this suit, the patentee sought to argue infringement under the doctrine of equivalents for the defendants’ new product. The new boards were concededly materially different from those at issue in the first case in some respects, but not with respect to “the only two limitations leading to the judgment of noninfringement in the first suit.” (p. 6.)

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

On appeal from a rejection of a reissue application by the PTO board, the court reversed and remanded on several grounds in this opinion. One involved indefiniteness and the court emphasized that this is determined from the perspective of one of skill in the art in the context of the claim and patent while concluding that a limitation did not require further antecedent basis. With regard to written description, the court again relied on how a person of skill in the art would view certain drawings to conclude that the description was adequate.

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

A five judge panel heard this case and disagreed about the construction of “animal.” The majority concluded that the patentee defined the term in the specification and that the term carried its ordinary meaning, in which case it included humans. However, the dissent felt that this was an “unusual situation in which a purported definition of a claim term in the written description is totally negated by the remainder of the text of the patent. [The patentee’s] attempt at lexicography does not conform to the way in which it otherwise describes its invention.” (p. 2 of dissent.) In other words, the dissent felt that the claims and most of the specification used the term “animal” in a manner that excluded humans even though the explicit definition included in one sentence of the specification did not exclude humans. The majority concluded that not only had the patentee acted as a lexicographer, but that the other portions of the specification did not “constitute a clear and manifest disavowal of human animals.”

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))