Ortho-McNeil Pharmaceutical v. Mylan Labs.

Citations: 520 F.3d 1358; 86 U.S.P.Q. 2d (BNA) 1196; 2008 U.S. App. LEXIS 6786; 2008 WL 834402Docket: 2007-1223

Court: Court of Appeals for the Federal Circuit; March 31, 2008; Federal Appellate Court

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The United States Court of Appeals for the Federal Circuit affirmed the decision of the United States District Court for the District of New Jersey, which permanently enjoined Mylan Laboratories, Inc. from infringing Ortho-McNeil Pharmaceutical, Inc.'s U.S. Patent No. 4,513,006, related to the anticonvulsant drug topiramate (marketed as TOPOMAX). The patent was upheld following a challenge by Mylan, which had filed an Abbreviated New Drug Application (ANDA) claiming the patent was invalid or not infringed. The district court's ruling on claim construction, inequitable conduct, obviousness, and enablement was found to be correct, leading to Mylan's stipulation of infringement on multiple claims of the patent.

Dr. Bruce Maryanoff invented topiramate during research aimed at finding new antidiabetic drugs, ultimately discovering its anticonvulsant properties. Following extensive testing and investment, Ortho-McNeil obtained FDA approval for the drug. The case arose under the Hatch-Waxman Act, which allows for such patent disputes. After the district court ruled against Mylan's defenses, including claims of inequitable conduct and invalidity, Mylan appealed the decision. The appellate court reviewed the summary judgment de novo, confirming that the evidence supported the district court's conclusions without material factual disputes.

In reviewing the construction of the term 'and' in independent claim 1 of the '006 patent, the court favors justifiable inferences for the nonmovant and treats claim construction as a matter of law without deference. Mylan contends that the district court incorrectly interpreted 'and' as 'or', arguing this interpretation excludes topiramate from the claim. However, the court upholds the district court's ruling, asserting that 'and' in this context links mutually exclusive possibilities rather than requiring both conditions to be met simultaneously. The claim specifies that R2, R3, R4, and R5 can independently be hydrogen or lower alkyl, while also allowing for R2 and R3, or R4 and R5, to form a group of formula (II). In topiramate, R2 and R3, as well as R4 and R5, are grouped together, fitting the claim's criteria. The inclusion of the terms independently and together clarifies that 'and' denotes alternative conditions. Additionally, a conjunctive interpretation of 'and' would render dependent claims meaningless, contradicting the court's obligation to maintain the validity of all claims. The court emphasizes the importance of considering the broader context of the patent and other claims to accurately interpret claim terms.

The specification supports the district court's interpretation of the term 'and,' indicating that it links alternative chemical structures. Specifically, it states that R2, R3, R4, and R5 may independently be hydrogen or lower alkyl, and under certain conditions, may form alkenes or a methylenedioxy group. The court emphasizes that intrinsic evidence, such as the specification and claims language, takes precedence over extrinsic evidence when determining claim meaning. Although dictionary definitions of 'and' typically denote addition, they also acknowledge alternative meanings, which align with the applicant's intent in this case. The court highlights the necessity of interpreting patent claims as written, rejecting any redrafting efforts that could lead to nonsensical outcomes. In contrast to the precedent set in Chef America, where the claim interpretation resulted in absurdity, the current claim can be meaningfully construed with 'and' indicating alternatives. The district court's interpretation is affirmed as correct.

Additionally, Mylan accuses Ortho-McNeil of inequitable conduct for not disclosing non-public test results on Kochetkov compounds to the Patent Office. While Ortho-McNeil submitted the Kochetkov references, it did not disclose the results of Dr. Maryanoff's tests. Mylan argues that Ortho-McNeil's prosecution statements about the Kochetkov references conflicted with their own knowledge of the compounds' anticonvulsant properties, claiming that Ortho-McNeil presented the references as having limited utility without acknowledging their actual potential.

Mylan alleges misrepresentation by Ortho-McNeil regarding the Kochetkov compounds' anticonvulsive properties, citing in-house test results. However, both the district court and the reviewing court found no misrepresentation was made to the Patent Office. Ortho-McNeil accurately characterized the Kochetkov references as claiming limited utility without asserting the compounds' utility. The applicant simply reiterated the disclosures of the Kochetkov references, which did not disclose any utility. Consequently, the court dismissed Mylan's defense of inequitable conduct.

Mylan's expert, Dr. Laurens Anderson, argues that a skilled artisan would necessarily design an FBPase inhibitor when seeking a diabetes drug. Citing KSR International Co. v. Teleflex Inc., Mylan claims that market pressure would lead an artisan to pursue known options. However, the record indicates that a skilled artisan would not have selected topiramate as an FBPase inhibitor. The invention does not involve a finite or easily traversed set of options, as outlined in KSR. Rather, the skilled artisan would not have started with 2,3:4,5 di-isopropylidene fructose, and would need compelling reasons to select the specific route to topiramate. Dr. Anderson's reasoning, based on hindsight, fails to consider the complexity and variety of alternatives available at the time of invention. The obviousness test requires a holistic analysis of the subject matter as it existed during the invention, acknowledging the inventor's insights and creativity.

The district court applied a rigorous teaching, suggestion, or motivation (TSM) test prior to the Supreme Court's KSR decision, which criticized such rigidity as incompatible with established precedents. Mylan argues that the district court's strict application of the TSM test was erroneous. The Supreme Court emphasized that obviousness determinations should not be overly constrained by formal definitions of teaching, suggestion, and motivation or by a reliance on written prior art, as this limits the knowledge and creativity of a skilled artisan. A flexible TSM test is essential to prevent hindsight reasoning in obviousness analyses. The court found that the district court’s finding of nonobviousness was supported by ample evidence, including powerful unexpected results from topiramate, expert skepticism, evidence of copying, and commercial success. These factors are not merely supplementary but serve as independent evidence of nonobviousness. Mylan's claims that method of use claims 6-8 are obvious are invalidated because they depend on a nonobvious claim 1. Furthermore, Mylan's assertion that claims 6-8 lack enablement due to unclear dosage requirements is countered by the necessity for a specification to enable skilled artisans to utilize the claimed invention without undue experimentation.

The '006 patent specification indicates that the average adult requires 30-2000 milligrams of the claimed compounds in two to four doses ranging from 10-500 milligrams. It guides skilled artisans to administer these compounds similarly to phenytoin and references L.S. Goodman’s teachings on dosage adjustments based on seizure control and toxicity. The court upholds the district court's determination that this information sufficiently enables claims 6-8, asserting that extensive testing is not required for implementation, leading to the dismissal of Mylan's non-enablement defense.

Under the Hatch-Waxman Act, when a generic manufacturer files an Abbreviated New Drug Application (ANDA) with a paragraph IV certification, the brand-name manufacturer receives a 30-month stay for litigation. After the 30-month period, the ANDA automatically gets approved unless a preliminary injunction or an infringement finding occurs. Since neither happened before the 30-month expiration, Mylan's ANDA was approved by default. The district court, having found infringement, reset the effective approval date in line with 35 U.S.C. 271(e)(4)(A), which mandates that the effective approval date cannot precede the patent expiration date.

Mylan contends that the district court's actions contradict 21 U.S.C. 355(j)(5)(B)(iii), which outlines conditions for delaying ANDA approval. However, the court found that the district court did not overlook these conditions and maintained the authority to reset the effective date based on legislative history, which supports such actions in analogous circumstances. Therefore, the district court's decision to reset the effective date under 35 U.S.C. 271 was appropriate.

The court also affirmed the district court's interpretation of claim 1, concluding it covers Ortho-McNeil's topiramate epilepsy drug. Consequently, the court upheld the permanent injunction against Mylan for infringing the '006 patent and confirmed the dismissal of Mylan's invalidity defenses, finding no errors in resetting the ANDA's effective date. The decision was affirmed.