April 03, 2007

I will periodically post case citations from the Federal Circuit along with the date of the opinion/order and a brief list of the legal topics discussed therein (specifically those with additional embedded case law citations). My goal is to post new cases on a weekly basis. This posting covers the final three patent cases that were appealed from the district court level and decided by the Federal Circuit during the 13th calendar week of 2007. All opinions are precedential unless otherwise indicated.

Merck & Co., Inc. v. HI-TECH Pharmacal Co., Inc. (03/29/2007): this case presents the question of “whether a patent term extension under the Hatch-Waxman Act, 35 U.S.C. § 156, may be applied to a patent subject to a terminal disclaimer under 35 U.S.C. § 253, filed to overcome an obviousness-type double-patenting rejection” (yes it may); discussion of patent relating to carbonic anhydrase inhibitors, including dorzolamide, for the treatment of glaucoma (U.S. Patent No. 4,797,413, entitled “Thieno thiopyran sulfonamide derivatives, pharmaceutical compositions and use”); 35 U.S.C. § 156 (patent term extension statute) does not expressly reference terminal disclaimers; Hatch-Waxman extensions run from the patent expiration date (as adjusted under 35 U.S.C. § 154(b) to make up for specific USPTO delays); “[t]he legislative history of § 156 indicates that Congress was aware of concerns over the effects of extending related patents—at least as to parent, continuation, and continuation-in-part patents—and chose to provide the patentee with the option to select to extend the term of only one of either the parent patent or a continuation patent”; court held that a patent term extension under
35 U.S.C. § 156 may be applied to a patent subject to a terminal disclaimer

AFG Industries, Inc., et al. v. Cardinal IG Company, Inc., et al. (03/30/2007, non-precedential): appeal of decision on remand for infringement of patent (affirmed as to some products but not others, so remanded to district court); discussion of patent relating to transparent electrically conductive laminated products (U.S. Patent No. 4,859,532 “Transparent laminated product”); product claims “generally are not limited by how the product is produced” but “exceptions may arise when the product's distinction from the prior art depends on how it was produced, for when the validity of the patent depends on use of a particular process, the claims are construed in the manner that will sustain their validity, when such construction is supported by the record”; judgment of infringement affirmed as to products whose central zinc oxide core is produced by a single sputter deposit, but not to products produced from at least two sputtering deposits, based upon claim construction

Teva Pharmaceuticals USA, Inc. v. Novartis Pharmaceuticals Corporation, et al. (03/30/2007): appeal of dismissal of declaratory judgment action because no reasonable apprehension of imminent suit established (reversed because declaratory judgment test for non-infringement or invalidity conflicts with the recent MedImmune v. Genentech decision); discussion of five patents relating to the active ingredient in Famvir® (Novartis product) and methods of therapeutic use (U.S. Patent Nos. 5,246,937, 5,840,763, 5,866,581, 5,916,893 and 6,124,304); declaratory judgment action under 35 U.S.C. § 271(e)(5) and 21 U.S.C. § 355(j)(5)(C) to establish “patent certainty” brought by Abbreviated New Drug Application (“ANDA”) applicant; “in a declaratory judgment action, “all the circumstances” must demonstrate that a justiciable Article III “controversy” exists”; discussion of three standing requirements under Article III; discussion of two-part test to determine if an “actual controversy” exists in a general declaratory judgment action for patent non-infringement or invalidity; discussion of five circumstances contributing to Teva’s justiciable controversy is Novartis’ pending infringement litigation; reversal of district court’s decision to dismiss the declaratory judgment action because “Teva has experienced real and actual injury”


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Mark Reichel
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I am a patent attorney with Reichel IP LLC, where I concentrate my practice on patent drafting and prosecution, trademarks, and general intellectual property matters. I currently focus on the preparation and prosecution of medical device and other life sciences patent applications, and being actively involved in a number of local not-for-profit organizations.

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