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Supreme Court is skeptical of patent standards

By Christopher Rugaber
THE ASSOCIATED PRESS
11/29/2006

WASHINGTON — Supreme Court justices expressed skepticism Tuesday about the current legal standard for granting patents and signaled a willingness to make patents harder to obtain.

The justices heard oral arguments in KSR International v. Teleflex Inc., a case that focuses on whether an invention is obvious and therefore ineligible for a patent.

Teleflex Inc. sued KSR in 2002 for infringing its patent on a gas pedal it makes for Ford Motor Co. Teleflex combined a gas pedal that can be adjusted for the height of the driver with one that controls acceleration electronically, rather than through a mechanical cable. KSR subsequently made a similar pedal for General Motors.

KSR fought back, arguing that the combination of the two features was an obvious one and as a result the patent was invalid.

Justice Anthony Kennedy seemed to agree.

"Why is (it) such a big deal" to combine the adjustable and electronic pedals? Kennedy asked. "Certainly this inventor would not be the only one to think that the two could and should be combined."

Justice Stephen Breyer added a down-to-earth note, wondering if he would be entitled to a patent for moving his electric garage-door opener from the bottom of the door, where it had been chewed on by squirrels, to the top.

The case is one of several focused on patents on the Supreme Court's docket this term, as the justices wade back into an area of law they largely have avoided since the Court of Appeals for the Federal Circuit was created in 1982 to handle patents.

Legal experts interpret the court's interest as a sign the justices are willing to make changes to patent law. However, the justices voiced concern Tuesday over whether any changes to patent law might unleash a new wave of patent litigation.

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Impax Labs., Inc. v. Aventis Pharm. Inc.

Impax Laboratories, Inc. (“Impax”) sued Aventis Pharmaceuticals Inc. (“Aventis”) in the United States District Court for the District of Delaware for a declaratory judgment that Impax did not infringe, induce infringement of, or contribute to the infringement of, U.S. Patent No. 5,527,814 (“the ’814 patent”) under 35 U.S.C. § 271(e)(2) by filing an Abbreviated New Drug Application (“ANDA”). In its suit, Impax alleged, inter alia, that the ’814 patent was invalid and unenforceable. Impax filed its ANDA under the provisions of the Patent Laws and Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984), codified at 21 U.S.C. §§ 355, 360(c) (2000), 35 U.S.C. §§ 156, 271, and 282 (2000) (commonly referred to as the “Hatch-Waxman Act”). In its ANDA, Impax sought the approval of the United States Food and Drug Administration (“FDA”) to engage in the commercial manufacture and/or sale of riluzole tablets for the treatment of patients with amyotrophic lateral sclerosis (“ALS”).

Impax now appeals from the decision of the district court, following a bench trial, that it failed to prove (1) that the ’814 patent is unenforceable due to inequitable conduct and (2) that claims 1-5 of the ’814 patent are invalid as anticipated. See Impax Labs., Inc. v. Aventis Pharms., Inc., 333 F. Supp. 2d 265 (D. Del. 2004) (“Validity and Enforceability Order”). We see no error in the decision of the district court on the inequitable conduct issue. However, as far as the anticipation issue is concerned, we conclude that the court erred in its determination that one of the alleged two items of invalidating prior art did not enable a method of using riluzole to treat ALS and, therefore, could not serve as an anticipatory reference under 35 U.S.C. § 102(b). Accordingly, we affirm-in-part, vacate-in-part, and remand.

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Depuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.

DePuy Spine, Inc. (formerly DePuy AcroMed, Inc.) and Biedermann Motech GmbH (collectively “DePuy”) appeal from grants of summary judgment that the Vertex® and bottom-loaded types of devices marketed by Medtronic Sofamor Danek, Inc. and Medtronic Sofamor Danek USA, Inc. (collectively “Medtronic”) do not infringe U.S. Patent No. 5,207,678 (’678 patent). DePuy Acromed, Inc. v. Medtronic Sofamor Danek, Inc., No. 01-10165-EFH (D. Mass. Apr. 14, 2003) (“All Models Order”); DePuy Acromed, Inc. v. Medtronic Sofamor Danek, Inc., No. 01-10165-EFH (D. Mass. Feb. 24, 2004) (“Vertex Order”). Medtronic cross-appeals from the denial of its motion for judgment as a matter of law (JMOL) and the final judgment entered after a jury verdict finding that Medtronic’s MAS polyaxial pedicle screws infringe the ’678 patent by equivalents and awarding lost profit damages. DePuy Acromed, Inc. v. Medtronic Sofamor Danek, Inc., No. 01-10165-EFH (D. Mass. Feb. 10, 2005). We conclude that the district court erred in granting summary judgment of non-infringement on the Vertex® model. We also conclude that district court’s judgment of non-infringement for the bottom-loaded screw devices was proper and that it correctly determined that Medtronic was not entitled to judgment as a matter of law on the issues of non-infringement or lost profit damages for the MAS polyaxial pedicle screws and correctly entered judgment of infringement as to the MAS device. Thus, we affirm-in-part, reverse-in-part, and remand.

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Ranbaxy Labs. Ltd. v. Leavitt

The Hatch-Waxman Amendments to the Food, Drug, & Cosmetic Act provide a period of marketing exclusivity to the first drug manufacturer that either successfully challenges a patent listed by the Food and Drug Administration for an approved, branded drug and markets an approved generic version of that drug or prevails in litigation establishing that the patent is valid or not infringed. Ranbaxy Laboratories Limited and Ivax Pharmaceuticals, Inc., the latter since acquired by Teva Pharmaceuticals, USA, Inc., applied for approval of drugs to compete with an approved drug manufactured by Merck & Co. and challenged two patents covering it. Thereafter, at Merck’s request, the FDA removed the challenged patents from the “Orange Book,” its listing of patents covering approved drugs, thereby depriving the generic manufacturers of an opportunity to have a period of marketing exclusivity.

Ranbaxy and Teva each filed a “citizen petition” asking the FDA to relist the two patents. The FDA denied the petitions because Merck had not sued Ranbaxy or Teva for patent infringement. Ranbaxy and Teva then repaired to the district court, which entered a summary judgment for the plaintiffs, and the FDA appealed.

We hold the FDA’s requirement that a generic manufacturer’s patent challenge give rise to litigation as a condition of retaining exclusivity when a patent is delisted is inconsistent with the Act, which provides that the first generic manufacturer to file an approved application is entitled to exclusivity when it either begins commercially to market its generic drug or is successful in patent litigation. Accordingly, we affirm the judgment of the district court.

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02 Micro Int'l Ltd. v. Monolithic Power Sys., Inc.

Appellants 02 Micro International Limited and 02 Micro, Inc. (collectively “02 Micro”) appeal the district court’s grant of summary judgment of non-infringement in favor of appellee Monolithic Power Systems, Inc. (“MPS”). Specifically, 02 Micro contends that the district court erred in denying it leave to amend its infringement contentions and refusing to allow supplementation of its expert report. Because we find no error in the district court’s denial of leave to amend the infringement contentions, refusal to allow amendment of the expert report, or grant of summary judgment, we affirm.

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Abraxis Bioscience, Inc. v. Mayne Pharma (USA) Inc.

Mayne Pharma (USA), Inc. (“Mayne”) appeals from the decision of the United States District Court for the Southern District of New York granting judgment of infringement of U.S. Patents 5,714,520 (“the ’520 patent”), 5,731,355 (“the ’355 patent”), and 5,731,356 (“the ’356 patent”), both literally and under the doctrine of equivalents, in favor of AstraZeneca Pharmaceuticals LP and AstraZeneca UK Ltd. (collectively “AstraZeneca”). AstraZeneca Pharms. LP v. Mayne Pharma (USA) Inc., No. 02-7936, 03-6487 (S.D.N.Y. Nov. 2, 2005) (“Nov. 2, 2005 Opinion”). Because the district court erred in its construction of “edetate,” which was the basis upon which it found literal infringement, we reverse the court’s claim construction and the court’s finding of literal infringement. However, because the court did not clearly err in determining that the accused product infringes under the doctrine of equivalents, we affirm the district court’s judgment.

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PHG Techs., LLC v. St. John Cos., Inc.

Defendant-Appellant, St. John Companies, Inc. (“St. John”), appeals the decision of the United States District Court for the Middle District of Tennessee granting a preliminary injunction in favor of Plaintiff-Appellee, PHG Technologies, L.L.C. (“PHG”). Because we find that St. John has raised a substantial question of the validity of the two patents at issue, the district court abused its discretion by granting PHG’s motion for a preliminary injunction. Therefore, we vacate the preliminary injunction.

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Abbot Labs. v. Baxter Pharm. Prods., Inc.

Plaintiffs Abbott Laboratories and Central Glass Company (collectively “Abbott”) appeal from a judgment of noninfringement of U.S. Patent No. 5,990,176 (“the ’176 patent”) by the United States District Court for the Northern District of Illinois. Defendants Baxter Pharmaceutical Products, Inc. and Baxter Healthcare Corp. (collectively “Baxter”) cross-appeal the district court’s determination that the asserted claims are valid and its refusal to find unenforceability due to inequitable conduct. This is our second hearing of this case; following our first, we reversed the district court’s claim construction and remanded for trial. Abbott Labs. v. Baxter Pharm. Prods., Inc., 334 F.3d 1274 (Fed. Cir. 2003). The district court conducted a bench trial, then further construed the claims at issue and found them valid and enforceable but not infringed. Abbott Labs v. Baxter Pharm. Prods., Inc., No. 01-CV-1867 (N.D. Ill. Sept. 26, 2005). This appeal timely followed.

Because we hold the asserted claims of the ’176 patent to be anticipated by the disclosure in U.S. Patent No. 5,684,211 (“the ’211 patent”), we reverse the district court’s validity judgment.

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Blue Cross & Blue Shield Ass'n v. Am. Express Co.

There is one possible way to show reliance, at which the district judge hinted. If the Association had alerted American Express in 2000 or 2001 to its view that the alphanumeric phone number violated the agreement, then perhaps American Express would not have filed it away but would instead have ensured that its legal department vetted the “Blue Cash” slogan before new cards were issued. The judge did not find, however, that this chain of “ifs” would have come to pass. Nor did the court discuss whether, if such attenuated causation and reliance can be established, delay wipes out the Association’s rights, as opposed to limiting enforcement to prospective relief. Further proceedings
therefore are essential.

The judgment is vacated. On remand the district court must promptly enter a consent decree that complies with Rule 65(d) and then address the question of detrimental reliance and the appropriate remedy, if necessary after a further hearing.

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Waterloo Furniture Components, Ltd. v. Haworth, Inc.

Before FLAUM, Chief Judge, and KANNE and SYKES,
Circuit Judges.
FLAUM, Chief Judge. On October 29, 1992, Haworth, Inc. (“Haworth”) entered into an agreement with Waterloo Furniture Components, Ltd. (“Waterloo”), granting Waterloo a license to Haworth’s Patent No. 4,616,798 (“the ‘798 patent”). The agreement included a “most favored nations” provision that required Haworth to give Waterloo the benefit of any more favorable royalty rates that
Haworth might grant to another licensee under the ‘798 patent. Haworth’s patent expired on October 14, 2003. On March 24, 2004, Haworth executed a settlement agreement with a third party, SoftView Computer Products Corporation (“SoftView”), for past infringement of the ‘798 patent. Waterloo learned of the settlement agreement and brought suit against Haworth alleging breach of contract. The district court stayed discovery in the case and granted Haworth’s motion for summary judgment holding that Waterloo’s rights under the “most favored nations” clause ended on the day the parties’ agreement expired, October 14, 2003. For the following reasons, we affirm the judgment of the district court.

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