Medtronic Navigation, Inc. v. BrainLAB Medizinische Computersysteme GMBH, 603 F.3d 943, CPLRG0056 (Fed. Cir. 2010) (BRYSON & Newman; LOURIE, concurring)Medtronic04262010

MAJOR ISSUES:  attorney fee award to prevailing accused infringer;  “exceptional case” determination under 35 U.S.C. § 285; continuing infringement suit after adverse claim construction ruling; theory on doctrine of equivalents and prosecution history estoppel; denial of summary judgment; litigation misconduct; arguments to jury allegedly undermining court’s claim construction Read CPLRG™ 0056

Microsoft Corp. v. i4i Limited Partnership, — U.S. —- (June 9, 2011) (SOTOMAYOR, Scalia, Kennedy, Ginsburg, Breyer, Alito, & Kagan; BREYER, Scalia & Alito, concurring; THOMAS, concurring judgment) Microsofti4i.ussc

MAJOR ISSUES: invalidity defenses; clear and convincing evidence standard of proof; Section 282 as codification of common-law heightened proof standard; jury instruction when accused infringer relies on new evidence not considered by PTO during examination

COMMENTS: The Court, in a well-crafted opinion by Justice Sotomayor, confirms the Federal Circuit’s position, consistently maintained for almost 30 years, that one challenging the validity of a patent claim bears a proof burden of clear and convincing evidence and not the general civil burden of a preponderance of the evidence. This heightened standard is not lowered even when the challenger relies on “new” evidence, that is, evidence that was not presented to or considered by the PTO during examination of the claim. However, the Court, like the Federal Circuit, cautioned that a challenger may more easily carry the heightened burden by relying on new evidence. And the Court directed that a cautionary instruction to a jury on new evidence will be proper.

Cross References: For a discussion of the proof burden, as applied to obviousness invalidity defenses, see Chisum on Patents § 5.06[2]. See also Chisum on Patents § 19.02. For cases on the presumption of validity, see Chisum Patent Law Digest § 1562, § 5663.

For a summary of the Court’s decision, see below. Read CPLRG™ 0069

Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd., 601 F.3d 1359 (Fed. Cir. 2010) (RADER; CLEVENGER,, concurring; DYK, dissenting) NovoNordisk04142010

MAJOR ISSUES:  listing method-of-use claims with Food and Drug Administration; FDA approved uses; labeling of generic drugs; Hatch-Waxman Act; 2003 counterclaim amendment Read CPLRG™ 0050

Optium Corp. v. Emcore Corp., 603 F.3d 1313, CPLRG 0063 (Fed. Cir. 2010) (NEWMAN & Mayer; PROST, concurring in the result)OptiumEmcore05052010

MAJOR ISSUES:  inequitable conduct; intent to deceive the PTO; no presumption from high materiality and lack of credible explanation for nondisclosure Read CPLRG™ 0063

Ortho-McNeil Pharmaceutical, Inc. v. Lupin Pharmaceuticals, Inc., 603 F.3d 1377, CPLRG 0065 (Fed. Cir. 2010) (NEWMAN, Rader & Linn) OrthoLupin05102010

MAJOR ISSUES: patent term extension for drugs, Hatch-Waxman Act; first commercial marketing of “drug product”; active ingredient of drug product; enantiomer distinct from racemate Read CPLRG™ 0065