By Donald Zuhn --
Last week, the Federal Circuit determined that the District Court for the District of New Jersey properly construed claim 1 of U.S. Patent No. 4,513,006 to encompass Plaintiff-Appellee Ortho-McNeil Pharmaceutical, Inc.'s epilepsy drug topiramate, and affirmed the District Court's decision to (1) permanently enjoin Defendants-Appellees Mylan Laboratories, Inc. and Mylan Pharmaceuticals, Inc. (Mylan) from infringing the '006 patent, (2) dismiss Mylan's invalidity defenses based on inequitable conduct, obviousness, and non-enablement, and (3) reset the effective date of Mylan's Abbreviated New Drug Application (ANDA).
Ortho-McNeil manufactures and sells TOPAMAX®, which is used to treat epilepsy and which comprises the active ingredient topiramate. Ortho-McNeil researcher Dr. Bruce Maryanoff invented topiramate during a search for new antidiabetic drugs, discovering that the reaction intermediate topiramate had unexpected anticonvulsant properties.
Seeking approval to market generic topiramate, Mylan filed an Abbreviated New Drug Application (ANDA) with the FDA. In response, Ortho-McNeil filed an infringement suit under 35 U.S.C. § 271(e)(2) in the District Court of New Jersey.
Following a Markman hearing, the District Court rejected Mylan's construction of claim 1 as excluding topiramate. On summary judgment, the District Court also rejected Mylan's affirmative defenses of invalidity based on obviousness and non-enablement and unenforceability due to inequitable conduct. As a result of these determinations, the District Court enjoined Mylan from infringing the '006 patent and reset the effective date of Mylan's ANDA.
On appeal, Mylan argued that the District Court improperly construed the word "and" in claim 1 of the '006 patent, which recites:
According to Mylan, the phrase "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)" in claim 1 specifies two independent limitations:
[1] R2, R3, R4 and R5 are independently hydrogen or lower alkyl and
[2] R2 and R3 and/or R4 and R5 together may be a group of formula (II),
both of which must be met for a compound to infringe the claim. In topiramate (at left), R2 and R3 and R4 and R5 together are a group of formula (II), and therefore, none of R2, R3, R4 and R5 are hydrogen or lower alkyl. Mylan argues that when claim 1 is properly construed, it does not encompass topiramate.
The Federal Circuit disagreed with Mylan's construction, finding that the District Court properly interpreted claim 1. According to the CAFC, the term "and appears in conjunction with the adverbs independently and together," and therefore, "links alternatives that occur under the different conditions of independence or togetherness." In other words, R2, R3, R4 and R5 need not always be hydrogen or lower alkyl.
In support of this construction, the Federal Circuit noted that if the term "and" were construed to require a conjunctive meaning, dependent claims 2, 5, 9, and 10 would be rendered meaningless. The CAFC also noted that the specification supported the above construction. Finally, while stating that it need not consult extrinsic evidence, given the plain language of claim 1, the dependent claims, and the specification, the Federal Circuit pointed out that "dictionary definitions of [the term] and, while most often listing the additive sense as the most common usage of the term, also show usage of the term to connote alternatives."
With respect to the issue of unenforceability, the Federal Circuit rejected Mylan's argument that during prosecution of the '006 patent, Ortho-McNeil made statements about prior art compounds that were inconsistent with its own testing of those compounds. Instead, the CAFC agreed with the District Court that Ortho-McNeil "merely accurately characterizes the references as claiming limited utility."
The Federal Circuit also rejected Mylan's arguments for invalidity. As to obviousness, the CAFC stated that "this invention, contrary to Mylan's characterization, does not present a finite (and small in the context of the art) number of options easily traversed." Moreover, "the ordinary artisan in this field would have had to (at the time of invention without any clue of potential utility of topiramate) stop at that intermediate and test it for properties far afield from the purpose for the development in the first place (epilepsy rather than diabetes)." As to Mylan's assertion that claims 6-8 are not enabled, the Federal Circuit again agreed with the District Court, stating that it would not require undue experimentation to determine an "anticonvulsively effective amount" of topiramate.
Finally, with respect to Mylan's argument that the District Court's order resetting the effective date of Mylan's ANDA was inconsistent with 21 U.S.C. § 355(j)(5)(B)(iii), the Federal Circuit determined inter alia that 21 U.S.C. § 355 is directed to the FDA and does not limit a court's authority to reset the effective date of an ANDA that is approved before the court grants a preliminary injunction or finds infringement, as in the instant case.
Ortho-McNeil Pharmaceutical, Inc. v. Mylan Laboratories, Inc. (Fed. Cir. 2008)
Panel: Chief Judge Michel and Circuit Judges Rader and Linn
Opinion by Circuit Judge RaderAdditional information regarding this case can be found at the Orange Book Blog and Patently-O.
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