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Federal Circuit: And can mean or, if it makes the claim make sense

April 08, 2008
Post by Blog Staff

In a decision last week, the Federal Circuit affirmed a district court's permanent injunction against a defendant to prevent infringement of a patent. The district court held the patent not invalid and infringed, based in part on a claim construction that construed the word "and" to mean "or." Specifically, based on the specification and other claims, the court determined such a construction was consistent with the intrinsic evidence. The court also rejected each of the defendant's affirmative defenses.

The Federal Circuit affirmed. Turning first to claim construction, the court held "and" can be interpreted to mean "or" in claim language when the specification warrants that construction. In this case, interpreting "and" as requiring both elements would have rendered some dependent claims meaningless, as well as excluded the preferred embodiment from the claims. The court also affirmed the rejection of the affirmative defenses of inequitable conduct, obviousness, enablement. Notably, in discussing the obviousness issue, the court stated: "a flexible TSM test remains the primary guarantor against a non-statutory hindsight analysis such as occurred in this case." It will be interesting to see whether the non-TSM grounds for an obviousness rejection outlined in the USPTO's examination guidelines will survive scrutiny by the Federal Circuit.

Mylan Laboratories (Mylan) filed an ANDA with the FDA, seeking to market a generic version of Ortho-McNeil Pharmaceutical (Ortho-McNeil) anti-convulsive drug topiramate (marketed as brand name Topamax™), commonly used to treat seizures associated with epilepsy. The structure of topiramate is illustrated below:TopiramateTopiramate is covered by U.S. Patent 4,513,006 ("the '006 patent"). In response to the ANDA filing, Ortho-McNeil filed suit for infringement. The relevant claim is claim 1, which reads (emphasis added): A sulfamate of the following formula (I):Claim 1 formula Iwherein X is oxygen;
R1 is hydrogen or alkyl; and
R2, R3, R4 and R5 are independently hydrogen or lower alkyl and R2 and R3 and/or R4 and R5 together may be a group of the following formula (II):Claim 1 formula IIwherein R6 and R7 are the same or different and are hydrogen, lower alkyl or are alkyl and are joined to form a cyclopentyl or cyclohexyl ring.Mylan argued, as a matter of claim construction, that the language of the claim required that both alternatives be present in the compound. Under this construction, Mylan's proposed generic would not infringe the '006 patent, but the claim would also not cover topiramate. As a result, the district court held that given the language of the claim, the "and" should be interpreted as "or." Under this construction, Mylan stipulated that its generic infringed several claims of the patent. On summary judgment, the district court rejected Mylan's affirmative defenses of invalidity and inequitable conduct, and once final judgment was entered, Mylan appealed.On appeal, Mylan once again argued the use of "and" in the claim required both limitations be met for a compound to infringe the claim. The Federal Circuit looked to not only the claims but also the meaning of the claims based on the specification. It noted, "and appears in conjunction with the adverbs independently and together." Based in part on this rationale, the court noted that the subunits (R2, R3, R4, or R5) do not always have to be either a hydrogen or lower alkyl. The court also noted that were claim 1 construed as Mylan argued, it would result in several dependent claims becoming meaningless. The court stated it "strives to reach a claim construction that does not render claim language in dependent claims meaningless." The court also found passages throughout the specification which use the word "and" to join alternatives. In addition, while the court noted that it was unnecessary to use extrinsic evidence to construe the claims, even the dictionary definition of "and" showed the term can be used to connote alternative as well as additive use. While the additive meaning was most common, applying that definition produces a nonsensical result wherein topiramate is not covered by the claims. As a result, the extrinsic evidence also supported the district court's claim interpretation. Therefore, the Federal Circuit determined the district court properly interpreted the claim.The court also affirmed the district court's rejection of Mylan's affirmative defenses. Mylan first asserted inequitable conduct, arguing Ortho-McNeil failed to adequately disclose non-public test results conducted relating to a prior art reference cited to the Patent Office. The references were submitted, but not the results from various testing which were arguably inconsistent with statements made about the references during prosecution. Ortho-McNeil in fact characterized compounds from the prior art reference, but did not assert that the compounds themselves possess no utility, as alleged by Mylan. As a result, the Federal Circuit agreed with the district court in determining that no misrepresentations were made to the Patent Office, and therefore affirmed the rejection of Mylan's inequitable conduct allegation. Mylan also asserted the '006 patent was obvious. Specifically, Mylan cited KSR International Co. v. Teleflex Inc., arguing that persons of ordinary skill in the art, when trying to formulate a new diabetes drug (as the inventor of the '006 patent was trying to do at the time of invention of topiramate), would have necessarily designed an FBPase inhibitor, the chemical classification of topiramate. Mylan further cited KSR for the proposition that "when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp." The Federal Circuit affirmed district court's holding of nonobviousness, stating that numerous intermediates, chemical pathways, as well as means of testing for certain chemical properties as done by the inventor, would not have been obvious at the time of invention to one of ordinary skill in the art. The court stated that Mylan's expert simply retraced the chemical pathway used by the inventor based on impermissible hindsight, and improperly minimized the complexity of the inventive process and invention of topiramate. It further noted that "the inventor's insights, willingness to confront and overcome obstacles, and yes, even serendipity, cannot be discounted." The Federal Circuit also highlighted the necessity for the flexible application of the teaching suggestion motivation (TSM) test in order to prevent such hindsight, as utilized by Mylan's expert. Notably, the court stated that "a flexible TSM test remains the primary guarantor against a non-statutory hindsight analysis such as occurred in this case." As a result, the Federal Circuit affirmed the district court's finding of non-obviousness. Additionally, the court also upheld the determination that numerous dependent claims were not obvious because they depend from a non-obvious claim.Mylan additionally asserted claims requiring an "anti-convulsively effective amount" were not enabled, because the phrase is unclear and would require a person of ordinary skill to embark upon undue experimentation. The district court found sufficient enablement within the specification and the Federal Circuit affirmed, finding disclosures including average dosage and dosing schedules in the specification. For example, the specification disclosed an average adult dosage of 30-2000 mg to be administered in 2-4 daily doses of 10-500 mg. Moreover, the specification directed readers to a commonly-used text in the art noting dosages may be increased at appropriate intervals to control seizures as well as limit toxicity. Accordingly, the Federal Circuit affirmed that no undue experimentation would be required to practice the instant invention.Finally, the Federal Circuit reviewed the district court's adjustments of Mylan's effective date for its ANDA approval. The 30-month stay granted to Mylan's ANDA allows the parties to litigate its case. At the expiration of such 30 months, an ANDA is automatically approved unless a court enjoins the ANDA or finds infringement. In this case, the l


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