Interim Term Extension Can Only be Granted Before a Decision on a Term Extension

Somerset Pharmaceuticals, Inc. v. Dudas, [2007-1447](July 31, 2007)[MOORE, Michel, Prost] The Federal Circuit dismissed Somerset's request to compel the Patent Office to issue a decision as moot, but otherwise affirmed the district court.
BRIEF: Somerset filed a Patent Term Extension Application with the USPTO, as well as a request for an interim extension, to extend the term of RE34,579. Somerset the sued the Patent Office to compel the Patent Office to act on its interim request for an extension. The PTO subsequently denied both the term extension and the interim extension on the merits. Because the Patent Office acted on the interim request on the merits, Somerset withdrew the portion of the appeal that sought to compel the Patent Office to act on its request for interim relief, but continued its appeal of the refusal to grant interim relief. Because the statute only gives the Director authority to grant an interim extension until a decision on the extension is rendered, the Federal Circuit found that Somerset did not have a reasonable likelihood of success, and affirmed the denial of a preliminary injunction.

Motion to Dismiss Amended Complaint Does Not Toll Time to Asnwer or Counterclaim

General Mills, Inc. v. Kraft Foods Global, Inc., [2006-1569, -1606](July 31, 2007)[LINN, Bryson, Clevenger) The Federal Circuit clarified but affirmed its original holding.
BRIEF: General Mills sued Kraft for patent infringement, and Kraft counterclaimed. General Mills filed an amended complaint, and Kraft successfully moved to dismiss. The Federal Circuit held that Kraft's filing of a motion to dismiss did not toll its deadline to answer the amended complaint or reassert its counterclaim. The Federal Circuit affirmed its original holding that FRCP 12 was unambiguous only changing the term to answer a Complaint, and in not affecting the term to answer an amended complaint.

Claim Dismissed Against One Defendant Can Still Be The Basis for Conspiracy Claim Aganist Another Defendant

Boynton v. Headwaters, Inc., [2006-1471](July 27, 2007) [SCHALL, Bryson, Holderman] NON-PRECEDENTIAL The Federal Circuit affirmed in part, reversed in part, and remanded the trial court's dismissal of Boynton's patent infringement claim on the pleadings, and summary judgment on his interference with contract and constructive trust claims.
BRIEF: The inventor, Davidson, assigned U.S. Patent No. 5,238,629, assigned the invention to Adtech after Adtech had been administratively dissolved and never reinstated. Davidson conspired to defraud the investors in Adtech by forming and operating a second Adtech entity, and executing documents apparently by the first Adtech entity, assigning rights in the patent to Headwaters. Plaintiffs settled with Davidson, and sued for patent infringement, interference with contract, and constructive trust. Plaintiff's settled with Davidson, and the district court dismissed the patent infringement claim, and granted summary judgment on the interference with contract and constructive trust claims. The Federal Circuit affirmed the dismissal of the patent infringement claim, as there was no allegation of infringement of the patent. The Federal Circuit reversed and remanded the dismissal of the civil conspiracy claim. The Federal Circuit noted that a civil conspiracy claim requires an actionable substantive claim. The Federal Circuit found that the district court erred when it equated the dismissal against Davidson, the co-conspirator, with an inability to show an actionable substantive claim. The reversal as to the civil conspiracy claim, necessitated the reversal as to the constructive trust claim as well.
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35 USC 271(e)(1) Provides a Broad Exemption for Experimentation for FDA Purposes

Integra Lifesciences I, Ltd. v. Merck KGaA, [2002-1052, -1065](July 27, 2007)[NEWMAN, Rader, Prost] On remand from the Supreme Court, the Federal Circuit reversed the district court judgment of infringement.
BRIEF: The Federal Circuit applied the Supreme Court's interpretation of 35 USC 271(e)(1) that the FDA Exemption includes experimentation on products that are not ultimately the subject of an FDA submission. The Federal Circuit found that the exemption applies to any research, which if successful, would be appropriate for FDA submission. The experimentation is not limited to experiments conducted to show that the candidate drug can safely be administered to human subjects in clinical trials. Nor is it limited to experiments that meed the FDA's "good laboratory practice" protocols. Integra also argued that experiments should be classified as either "discovery" or "routine" and only "routine" experiments be protected by the FDA Exemption, but the Federal Circuit rejected this argument. The Federal Circuit concluded that there was not substantial evidence to support the verdict of infringement, and reversed the judgement of infringement.

35 USC 271(e)(1) Provides a Broad Exemption for Experimentation for FDA Purposes

Integra Lifesciences I, Ltd. v. Merck KGaA, [2002-1052, -1065](July 27, 2007)[NEWMAN, Rader, Prost] On remand from the Supreme Court, the Federal Circuit reversed the district court judgment of infringement.
BRIEF: The Federal Circuit applied the Supreme Court's interpretation of 35 USC 271(e)(1) that the FDA Exemption includes experimentation on products that are not ultimately the subject of an FDA submission. The Federal Circuit found that the exemption applies to any research, which if successful, would be appropriate for FDA submission. The experimentation is not limited to experiments conducted to show that the candidate drug can safely be administered to human subjects in clinical trials. Nor is it limited to experiments that meed the FDA's "good laboratory practice" protocols. Integra also argued that experiments should be classified as either "discovery" or "routine" and only "routine" experiments be protected by the FDA Exemption, but the Federal Circuit rejected this argument. The Federal Circuit concluded that there was not substantial evidence to support the verdict of infringement, and reversed the judgement of infringement.

It is not Enough for Infringement that a Claimed Step is Capable of Being Performed

Cybersettle, Inc. v. National Arbitration Forum, Inc., [2007-1092] (July 24, 2007) [BRYSON, Michel, Lourie] NON-PRECEDENTIAL The Federal Circuit vacated one aspect of the district court's claim construction of U.S. Patent No. 6,330,551 that resulted in a finding of infringement, and remanded.
SIGNIFICANCE: One does not infringe a method claim merely by being capable of performing the required step, but only if the step is performed.
BRIEF: The claim was directed to a method of dispute resolution which required the step of "receiving a plurality of demands". The patentee argued that this meant that the system be capable of receiving a plurality of demands, while the accused infringer argued that it required actual receipt of a plurality of demands. The district court agreed with the patentee, but the Federal Circuit did not, stating "a patented method is a series of steps, each of which must be performed for infringement to occur. It is not enough that a claimed step be 'capable' of being performed." The Federal Circuit added: "A party that does not perform a claimed step does not infringe a method claim merely because it is capable of doing so." The patentee argued that the accused infringers construction was illogical, because it would require the running of a second round, even if the dispute was settled in the first round. However, the Federal Circuit did not find that construction illogical. The patentee also argued that the construction was wrong because it excluded the preferred embodiment, but the Federal Circuit noted that while that was the case, other claims in the patent covered the "excluded" embodiment. The accused infringer also argued that the claims required receipt of multiple demands and offers before the first comparison, but the Federal Circuit rejected this construction because methods steps need not be performed in the order in which they are recited.

Double Patenting is Alive and Well in the Federal Circuit

In re Metoprolol Succinate Patent Litigation, [2006-1254] (July 23, 2007) The Federal Circuit affirmed the district court's holding of invalidity for double patenting, but vacated the district court's inequitable conduct holding and remanded the case.
BRIEF: In March 1991 U.S. Patent No, 5,001,161 issued on metoprolol succinate with a sustained release pharmaceutically acceptable carrier. In January 1992 U.S. Patent No. 5,081,154 issued on metoprolol succinate. In October 1988 U.S. Patent No. 4,890,318 issued on an improved oral release composition comprising metoprolol succinate. The defendants moved for summary judgment of invalidity of the '161 and '154 patents for invalidity for double patenting and unenforceability. Astra appealed the grant of summary judgement of invalidity of the '154 patent, and of unenforceability of both patents. Non-statutory or obviousness type double patenting is a judicially created doctrine adopted to prevent claims in separate applications or patents that do not recite the same invention, but nonetheless claim inventions so alike that granting both exclusive rights would effectively extend the life of patent protection.
The Federal Circuit agreed that a patent on Metoprolol was a double patent of an earlier patent on Metoprolol and pharmaceutically acceptable carriers. The Federal Circuit reversed the finding of unenforceability because the court erred in equating the presence of an incentive to device with intent to deceive.

Requirement of PTO not so Extreme or Unreasonable as to Warrant Judicial Intervention

In re Omega SA, [2006-1234] (July 23, 2007) [NEWMAN, Friedman, Dyk] The Federal Circuit affirmed the TTAB sustaining the refusal to register AQUA TERRA because the definitions of goods "chronographs" was unclear.
SIGNIFICANCE: The PTO has broad discretion to require description of goods in trademark applications more extensive and specific than established by WIPO
BRIEF: Omega's application to register AQUA TERRA for chronographs in International Class 14 was refused because chronographs could be scientific apparatus in Class 9 or watches in Class 14. The Examiner required Omega to specify chronographs s used as watches. Omega resisted, pointing out that only watches were included in Class 14. The Federal Circuit said that it was within the PTO's authority to develop particularized definitions that are more extensive and specific than the Alphabetical List of Goods and Services that is published by WIPO. The Federal Circuit confirmed that it is within the discretion of the PTO to require that one's goods be identified with particularity.
The Federal Circuit agreed with Omega that consistency is highly desirable, and that the time and expense of complying with inconsistent applications burdens both the PTO and the public that depends on its services. However, the Federal Circuit found that the requirement imposed by the PTO was not so extreme or unreasonable as to warrant judicial intervention.

Where the Underlying Infringement is Eliminted, the Court May Not Have Jurisdiction Over an Invaldity Counterclaim

Benitec Australia, Ltd. v. Nucleonics, Inc., [06-1122](July 20, 2007)[WHYTE, Rader, Dyk] The Federak Curcuit affirmed the dismissal of Nucleonics declaration judgment counterclaims against Benitec for lack of subject matter jurisdiction.
SIGNIFICANCE: Medimmune did not eliminate the requirement of a controversy.
BRIEF: Benetic sued Nucleonics for patent infringement, and Nucleonics counterclaimed. After Merck v. Integra applied an expansive experimental use exception to infringement, Nucleonics moved to dismiss without prejudice. The district court granted Benitec's motion, and dismissed Nucleonics' counterclaim for lack of subject matter jurisdiction. Recognizing that under Cardinal Chemical the infringement suit created a case and controversy, the Federal Circuit examined whether subsequent events could divest the district court of subject matter jurisdiction. Because Benitec withdrew its infringement claim after it became clear that Nucleonics was not doing anything that could be regarded as infringement, the court found that there was no controversy between the parities concerning infringement by Nucleonics. Benitec tried to salvage jurisdiction by planning to use the technology on animals, but the Federal Circuit found that Nucleonics had failed to establish a justiciable controversy. The Federal Circuit recognized "that Nucleonics would like to remove any concerns it or its potential investors might have over possible infringement of the Benitec patent" but failed to show a present controversy."

Same Term or Phrase Should be Interpreted Consistently

Automed Technologies, Inc. v. Microfil, LLC, [2006-1620](July 16, 2007)[LINN. Mayer, Clevenger] NON-PRECEDENTIAL The Federal Circuit affirmed grant of summary judgment of non-infringement, and affirmed the award of nominal damages for breach of contract.
SIGNIFICANCE: 1. The same term or phrase should be interpreted consistent where it appears in claims of common ancestry. A claim term with the definite article "the" needs proper antecedent basis.
BRIEF: At issue was the meaning of the term "controller". The Federal Circuit considered the use of the term is related patents, noting "the same term or phrase should be interpreted consistently where it appears in claims of common ancestry," citing Epcon Gas. The Federal Circuit found no basis to limit controller to a single device rather than a system. Also at issue was the term "vibratory dispenser". The Federal Circuit found no basis to limit vibratory dispenser to a dispenser that only used vibration, and affirmed the district court's interpretation. Also at issue were the terms "container" and "canister" and the Federal Circuit affirmed the district court which refused to limit these structures to unitary structures.
The Federal Circuit also pointed out an error in claim 27 which appeared to be mistakenly dependent on 20 because it referred to "the controller" when claim 20 did not provide antecedent basis for the term, citing NTP, Inc. for the proposition that a claim term employing the definite article "the" requires an antecedent basis.
Regarding infringement, the Federal Circuit rejected AutoMed's assertion of infringement, noting that a device is capable of being modified to operate in an infringing manner is not sufficient by itself to support a finding of infringement.

Level of Skill in the Art Dipositive on Obviousness Question

Daiichi Sankyo Co. v. Apotex, [2006-1564](July y11, 2007)[ARCHER, Michel, Dyk] NON-PRECEDENTIAL The Federal Circuit reversed the finding that Daiichi Sankkyo's U.S. Patent No. 5,401,741 was not valid, finding that the invention would have been obvious in view of the prior art.

BRIEF: The case turned on the level of ordinary skill in the art, the district court finding the level of ordinary skill was a person with a medical degree and experience treating persons with ear infections, while Apotex argued that the proper level was a person engaged in developing new ear pharmaceuticals or a specialist in ear treatments with training in pharmaceutical formulations. The factors that are considered in determining the level of ordinary skill in the art include (1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of active workers in the field. The Federal Circuit noted that the inventors were an otorhinolaryngologist and a drug development specialists, and that others in the field were of the same level of skill. The Federal Circuit also noted that the problem was to develop an antibiotic to treat ear infections that did not damage the ear. The Federal Circuit noted that this frequently involved animal testing, which was outside the realm of regular physicians. Accordingly the Federal Circuit found that the level of skill was higher than the trial court found. The patentee discounted the defenses expert testimony because the reference did not convey the same teaching to one of lower skill in art. Because the Federal Circuit found a higher level of ordinary skill in the art, the prior art make the invention obvious to a person of ordinary skill in the art.

SIGNIFICANCE: Although non-precedential the case is significant in that the level of ordinary skill in the art was dispositive on the question of obviousness.

DYKES ON BIKES CAN'T BE OPPOSED BY MIKE

McDermott v. San Francisco's Women's Motorcycle Contingent, [07-1101](July 11, 2007)[PER CURIAM, Mayer, Lourie, and Linares] NON-PRECEDENTIAL The Federal Circuit affirmed the TTAB's dismissal for lack of standing McDermott's opposition to registration of the mark DYKES ON BIKES.
BRIEF: The TTAB dismissed the opposition because McDermott failed to show that McDermott failed to show a reasonable basis to believe he would be damaged by the registration. The Federal Circuit held that McDermott lacked standing to complain that the mark was disparaging or immoral or scandalous. One method for establishing reasonableness of the belief of damage is whether the opposer possess the trait or characteristic is clearly and directly implicated in the proposed mark. McDermott was not so implicated. Another method of demonstrating reasonableness is to allege that others share the same belief of harm. McDermott did not establish that others shared his belief. The Federal Circuit agreed that McDermott did not have standing, and affirmed the dismissal.

Level of Skill in the Art Controls Obviousness Determination

Daiichi Sankyo Co., Ltd. v. Apotex, Inc., [06-1534](July 11, 2007)[ARCHER, Michel, Dyk) NON-PRECEDENTIAL The Federal Circuit reversed the trial court's finding that U.S. Patent No. 5,401,741 on a method of treating bacterial ear infections was validity, holding that the patent would have been obvious in view of the prior art.
BRIEF: The Federal Circuit began with the level of ordinary skill in the art. Factors that may be considered in determining the level of ordinary skill in the art include: (1) the educational level of the inventor; (2) type or problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational levels of active workers in the field. Noting that the inventors were specialists, that others working in the field were also specialists, and that the problem the inventors were trying to solve was one in the purview of specialists the Federal Circuit rejected the district court's finding that a person of ordinary skill in the art was a general practice physician. The Federal Circuit further found that the error is assessing the level of ordinary skill in the art tainted the obviousness analysis, because the prior art would have made the invention obvious to specialists in the field.

Obviousness Does Not Require Absolute Predictability of Success

PharmaStem Therapeutics, Inc. v. Viacell, [05-1490, -1551](July 9, 2007)[BRYSON, Newman, Prost] The Federal Circuit affirmed the trial courts grant of JMOL that U.S. Patent Nos. B1 5004681 and 5,192,553 were not infringed, and reversed the trial courts denial of JMOL that the patents were invalid.
BRIEF: The '681 patent required a sufficient supply of stem cells to effect successful hematopoietic reconstitution in adults. The trial court found that PharmaStem did not attempt to prove by testing or by reference to data collected by the defendants tht at least some of the cord blood samples preserved by defendants satisfied the requirements of the '681 patent's claims. Instead, plaintiff attempted to prove infringement solely from statements in defendant's advertising. Thus the trial court granted JMOL. The Federal Circuit agreed, noting that while there is no prohibition against using admissions of a party in its advertising, none of the statements represented that the requirements of the claims were met. Instead, defendant's advertising emphasized the potential therapeutic usefulness of the stored blood. PharmaStem also relied upon the fact that at least some of the defendants tested the blood before deciding whether to cryopreserve the sample, but the Federal Circuit said that there was no indication that the testing related to meeting the requirements of the claims.
Regarding the contributory infringement of the '553 patent, the trial court found that plaintiff did not show that Viasell sold the cryopreserved blood units, the evidence showing that defendant merely stored and distributed the blood units for others. Because liablity for contributory infringement is clearly dependent upon the accused infringer's sellling or offering to sell a component of the patent process, the court held the jury verdict could not stand,and granted JMOL. The Federal Circuit agreed, stating that the statute unambiguously reqired that the contributory infringer sell a component, and the defendants were mere bailees of the stored blood, not vendors.
The trial court denied defendant's motion for JMOL that the patents were invalid for anticipation, obviousness, or indefiniteness. The Federal Circuit reversed, finding that the patents were invalid for obviousness, and not reaching the novelty and indefiniteness defenses. The Federal Circuit found that the prior art suggested the invention, and said that issued turned on whether there was a reasonable expectation of success. PharmaStem argued that there would not be a reasonable expectation of success until it was know that the umbilical blood contained stem cells, which did not occur until after the inventors discovered this. However, the Federal Circuit found that this argument was inconsistent with the prior art references, and the specifications of the patents in suit. The Federal Circuit reitereated that "Admissions n the specification rearding the prior art are binding on the patentee for purposes of a later inquiry into obviousness." The Federal Circuit concluded that a reasonable jury could not have found the invention to be non-obvious. While the inventors may have proved conclusively what was strongly suspected, and while their work may have significantly advanced the state of the science of homatopoietic transplantations by eliminating doubt about the presence of stem cells, their experiments and the conclusions drawn from them were not inventive. Obviousness does not require absolute predictability of success. For many inventions that seem quite obvious, tehre is no absolute predictability of success until the invention is reduced to practice.
SIGNIFICANCE: Contributory infringement requires a sale of a component. Obviousness does not require absolute predictability. Say as little as possible about the prior art, because admissions from the specification can make the claimed invention obvious.

Federal Circuit Addresses Whether an Equivalent is Forseeable

Festo Corporation v. Shoketsu Kinzoku Kogyo Kabuskhiki Co., Ltd., [05-1492] (July 5, 2007) [DYK, Michel, Newman] The Federal Circuit affirmed the district courts determination that the alleged equivalent was foreseeable at the time of the amendment.
SIGNIFICANCE: The Federal Circuit held that foreseeability (for prosecution history estoppel purposes) does not require the application to be aware that a particular equivalent would satisfy the insubstantial differences test or the function/way/result test.
BRIEF: At issue was whether whether a aluminum sleeve was a forseeable alternative to Festo Corporation's claimed magnetizable sleeve such that prosecution history estoppel applies. During prosecution, the applicant added the limitation "magnetizable sleeve" while the accused structure was an aluminum (non-magnetizable) sleeve. The amendment did not create a complete bar to the doctrine of equivalents, and the doctrine of equivalents would apply if (1) the equivalent was unforeseeable at the time of the application; (2) the rationale for the amendment bore no more than a tangential relationship to the equivalent; or (3) some other reason suggests that the patentee could not reasonably be expected to have described the insubstantial substitute in question. Festo argued that it was not foreseeable at the time that aluminum could perform the same function. It was agreed that the use of an aluminum sleeve for magnetic shielding was not know at the time.
The Federal Circuit said that unforeseeable meant unforeseeable at the time of the amendment. Later-developed technology or technology was not know in the pertinent prior art usually is not foreseeable. The Supreme Court tied foreseeability to whether the application would have been expected to know of, and thus properly claim, the proposed equivalent at the time of the amendment. Conversely, when the equivalent is know in the pertinent art at the time of the amendment, it is foreseeable. Festo argued that it was not known that an aluminum sleeve would perform the same function, in the same way, to achieve the same result under the function way result test. The Federal Circuit rejected the function/way/result or insubstantial differences tests for foreseeability, and said that an alternative is foreseeable if it is disclosed in the pertinent field of the invention. The Federal Circuit declined to determine in what other circumstances an equivalent might be foreseeable.
The Federal Circuit commented that Festo was trying to include as an equivalent that which is a separate invention -- which the Court said was beyond giving the patentee the scope of its invention. Furthermore, the Federal Circuit observed that in Wilson Sporting Goods, the Federal Circuit held that where an alleged equivalent is patentable, the finding of equivalence, while not foreclosed, is considerable more difficult to make out.

A Patentee's Definition of a Claim Term Governs, Even if it is Contrary to the Ordinary Meaning

Honeywell International, Inc. v. Universal Avionics Systems Corp., [2006-1406, 1435] (July 3, 2007) [BRYSON, Plager, Gajarsa] The Federal Circuit affirmed the district courts interpretation of the U.S Patent No. 4,914,436 and affirmed the finding of infringement.
SIGNIFICANCE: A patentee's redefinition of a claim term need not be explicit, and it controls even if it is contrary to the ordinary meaning. It takes an unambiguous statement in the prosecution history to disclaim claim scope.
BRIEF: At issue was the use of the term "heading of the aircraft". The Federal Circuit found that the specification and prosecution history make clear, that the patentees used the term in a manner different from its ordinary meaning, and that "When a patentee defines a claim term, the patentee's definition governs, even if it is contrary to the conventional meaning of the term." The Federal Circuit further observed that "[a] claim term may be defined in a particular manner for purposes of the patent even 'without an explicit statement of redefinition.'" The Federal Circuit thus concluded that heading, as used in the patent, meant bearing, stating "to hold otherwise would not include within the scope of the claim a preferred embodiment that the patentees labeled an 'important feature of the present invention' and would ignore the patentees' definition of the term "heading" and their consistent use of that term throughout the prosecution history." With respect to another disputed claim term, the Universal argued that term had been defined in the prosecution history. However the Federal Circuit concluded that "[b]ecause the passage is ambiguous, we conclude that it does not constitute a sufficiently clear and deliberate statement to meet the high standard for finding a disclaimer of claim scope. Because the only challenge to the infringement determination relate to claim scope, the Federal Circuit affirmed the finding of infringement as well.