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Federal Circuit Affirms Validity of Ortho-McNeil’s Patent On Epilepsy Drug Topomax
Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories, Inc., et al.
No. 2007-1223, Court of Appeals for the Federal Circuit, 03/31/2008
Companies Mentioned: Mylan Laboratories, Inc., Mylan Pharmaceutical, Inc., Ortho-McNeil Pharmaceutical, Inc.
Holding
In this appeal, the Court of Appeals for the Federal Circuit permanently enjoined defendant generic drug maker from infringing plaintiff’s patent relating to the anti-convulsive drug topiramate. Specifically, the Federal Circuit held that the term “and” found in an independent claim of the patent should be construed as “or.” Under such proper construction, the claim covers topiramate. The Federal Circuit likewise sustained the district court’s finding of non-obviousness of patent at issue. In particular, the record showed powerful unexpected results of anti-convulsive activity of topiramate. Plaintiff similarly demonstrated skepticism of experts and copying – other respected sources of objective evidence of non-obviousness – as well as commercial success. On the basis of this finding, the Federal Circuit sustained the district court’s ruling that plaintiff’s patent on epilepsy pharmaceutical was valid and enforceable.
Detailed Summary
Patent (‘006 patent) at issue relates to Topiramate, a drug that is distributed by plaintiff Ortho-McNeil Pharmaceutical, Inc. (“plaintiff”) as Topomax. It is a significant epilepsy drug that was formulated during a search for new anti-diabetic drugs. On the other hand, defendant Mylan Laboratories, Inc. and Mylan Pharmaceuticals, Inc. (“defendant”) are generic drug makers that had sought to manufacture and market a generic version of this patented drug. Under the Hatch-Waxman Act. 21 U.S.C. § 355, defendant filed an ANDA (Abbreviated New Drug Application) with the FDA (Food and drug Administration) with a paragraph IV certification asserting that plaintiff’s ‘006 patent was invalid or not infringed. Within 45 days, plaintiff filed an infringement suit under 35 U.S.C. § 271(e)(2) against defendant. This action triggered the 30-month stay on approval of defendant’s ANDA.
After a Markman proceeding to set the meaning of the claim terms, the U.S. District Court for the District of New Jersey district rejected defendant’s position that a claim of the ‘006 patent does not cover topiramate. On summary judgment, the district court also ruled against defendant’s affirmative defenses of unenforceability due to inequitable conduct and invalidity based on obviousness and non-enablement. After entry of final judgment, defendant subsequently appealed the district court’s claim construction as well as the dismissal of its affirmative defenses of inequitable conduct, obviousness, and non-enablement.
At issue in this appeal basically is the validity and enforceability of patent in dispute.
Defendant argued that an independent claim of the patent did not cover topiramate. Particularly, in the molecule topiramate, R2 and R3 and R4 and R5 together are a group of formula (II), wherein R6 and R7 are methyl. Defendant argued that the use of the term “and” precludes the claim from encompassing topiramate. The term “and” falls between several R group recitations: 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 formula (II) On this basis, defendant asserted that a particular phrase contained two independent claim limitations: (1) that “R2, R3, R4, and R5 are independently hydrogen or lower alkyl” and (2) that “R2 and R3 and/or R4 and R5 together may be a group of formula (II).” Under defendant’s construction, both of these limitations must be met in order for a compound to infringe. Hence, both of these limitations are not met in topiramate. None of the R2, R3, R4, and R5 subunits are hydrogen or lower alkyl because both R2 and R3 and R4 and R5 together are a group of formula (II).
Sustaining the finding of the district court, the Federal Circuit rejected defendant’s construction. The Federal Circuit explained that “the claim language depicts two subsets of compounds, but does not require their simultaneous existence. In one subset of compounds covered by claim 1, the groups R2, R3, R4, and R5 are independent of one another, in which case, according to the claim, they are either hydrogen or lower alkyl. In a second subset of compounds covered by claim 1, the R2 through R5 groups are not independent, but rather R2 and R3 are together, and/or R4 and R5 are together, to form either one or two groups of formula (II). Topiramate is an example of this type of compound. In it, R2 and R3 are arranged together in a group, as are R4 and R5. Thus, as used in this claim, and conjoins mutually exclusive possibilities.”
The Federal Circuit added that the claim does not use “and” in isolation but in a larger context that clarifies its meaning. Specifically, “and” appears in conjunction with the adverbs “independently” and “together.” As the district court explained, these terms signal that “and “ links alternatives that occur under the different conditions of independence or togetherness.” In context, it is clear that “one of the subunits (R2, R3, R4, or R5) does not always have to be either a hydrogen or lower alkyl.” The “larger context of this patent supports this claim meaning. Construing claim 1 to require a conjunctive meaning of and would render several dependent claims meaningless. The claim also does not use and in isolation but in a larger context that clarifies its meaning.”
Courts must interpret the term “and” to give proper meaning to the claim in light of the language and intrinsic evidence. Giving “and” its most common dictionary meaning “would produce in this case the nonsensical result of not covering topiramate and rendering several other dependent claims meaningless.” On the basis of this analysis, the Federal Circuit sustained the trial court’s ruling that, given the circumstances of this case, the claim’s use of the term “and” means “or.” Under such proper construction, the claim covers topiramate.
With regard to defendant’s contention that patent was invalid for being obvious, the Federal Circuit again ruled in favor of plaintiff. In particular, the record showed powerful unexpected results of anti-convulsive activity of topiramate. Plaintiff similarly demonstrated skepticism of experts and copying – other respected sources of objective evidence of non-obviousness – as well as commercial success. The court wrote:” The TSM (teaching, suggestion, motivation) test, flexibly applied, merely assures that the obviousness test proceeds on the basis of evidence – teachings, suggestions (a tellingly broad term), or motivations (an equally broad term) – that arise before the time of invention as the statute requires. As KSR International Co. v. Teleflex Inc. requires, those teachings, suggestions, or motivations need not always be written references but may be found within the knowledge and creativity of ordinarily skilled artisans.” 127 S. Ct. 1727, 1742 (2007).
On the matter of the patent claims’ alleged non-enablement, defendant argued that claims 6-8 are not enabled because an “anticonvulsively effective amount is unclear and its determination would require undue experimentation.” To this assertion, the Federal Circuit held that the ‘’006 pecification discloses that the average adult requires 30-2000 milligrams of the claimed compounds administered in two to four doses of 10-500 milligrams. The specification also teaches a skilled artisan to use the claimed compounds in a manner similar to the drug phenytoin. The record does not show that extensive or “undue” tests would be required to practice the invention.
On the basis of the foregoing, the Federal Circuit sustained the district court’s judgment permanently enjoining defendant from infringing patent at issue. It also dismissed defendant’s defense of invalidity based on obviousness, inequitable conduct, and non-enablement.
View a PDF of the judicial opinion.Patent Law Commentary
Read the related Patent Law commentary: Agrizap and Ortho-McNeil: Two Sides of Post-KSR Obviousness, by John R. Carr, Esq.
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