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PLI Update: Pharmaceutical and Biotech Patent Law


In this release, the authors (Kaye Scholer LLP’s Patent Group) update and expand Pharmaceutical and Biotech Patent Law with new discussion of many topics, including double patenting, inequitable conduct, product by process claims, attorneys fees under Hatch-Waxman and more.

Table of Contents

Table of Authorities

Below is a synopsis of the significant updates provided for the Fall of 2009.

  • Anticipation and obviousness: Both anticipation and obviousness require a comparison to the prior art, but Cohesive Technology, Inc. notes that novelty and nonobviousness are separate requirements and give rise to separate defenses in an infringement actions. See § 5:2, at note 22.1.
  • Double patenting—use of post-filing-date art: Federal Circuit’s Takeda Pharmaceutical Co. v. Doll states that “later developments in the art may inform the ‘patentably distinct’ determination for double patenting . . . but only to the extent that the subsequent developments predate the secondary application that triggers a double patenting rejection.” See new § 5:8.5[C][4], at note 861.1.
  • Inequitable conduct—balancing intent and materiality: To assess inequitable conduct, the Federal Circuit says the courts must balance levels of materiality and intent, a formulation that raises some questions—including the meaning of “levels” with respect to intent. See § 5:9.2[B], at note 915.1.
  • Inequitable conduct—retreat from Ferring? The intent element of inequitable conduct may be inferred from the materiality of undisclosed information, where there is a lack of explanation for the nondisclosure, under a three-pronged test applied in Ferring B.V. v. Barr Laboratories, Inc. But the cases allowing this inference have been in tension with other cases emphasizing that materiality and intent are separate elements, and that one cannot infer intent from materiality. At least some panels of the Federal Circuit have been retreating from the Ferring approach of inferring intent to deceive from an unexplained failure to disclose material information. See new § 5:9.4[C][2][b], at note 959.1.
  • Patentability of chemical compounds: Chapter 7 is extensively revised and reorganized to present up-to-date coverage of this fundamental topic, including novelty of a claim to a chemical compound over the prior art, obviousness and the impact of KSR, and genus and species inventions. See §§ 7:2.1—7:2.3.
  • Product-by-process claims: With respect to the issue of construction of product-by-process claims in infringement litigation, the Federal Circuit’s 2009 Abbott Laboratories v. Sandoz Corp. resolves the long-standing conflict between Scripps and Atlantic Thermoplastics, adopting the Atlantic approach and holding that in patent infringement litigation, “process terms limit product-by-process claims.” See § 7:5.2.
  • Attorney fees—Hatch-Waxman “exceptional case” litigation: In Takeda Chemical Industries, Ltd. v. Mylan Laboratories, Inc., the Federal Circuit upheld a district court’s determination that the case was “exceptional” based on its findings that both ANDA filers had filed baseless certification letters and then engaged in bad faith litigation misconduct. The conduct was sufficient to justify an award of $16.8 million for attorney fees, expenses, and expert fees plus interest. In light of Takeda and the 2000 Yamanouchi case, it now appears settled that abandoning arguments made in an ANDA certification can be evidence supporting an award of attorney fees. See § 8:1.7[D][3][a], at note 217.1.
  • Hatch-Waxman safe harbor: Prior to the 2008 Proveris decision, it was unclear whether the statutory safe harbor (35 U.S.C. § 271(e)(1)) exempts the infringing use of patented research tools to develop data to be submitted in seeking FDA approval of a drug or device other than the research tool. The Federal Circuit, however, held in Proveris that the safe harbor did not apply to an optical spray analyzer because it was “not subject to FDA premarket approval, and therefore faces no regulatory barriers to market entry upon patent expiration.” See § 8:1.8[J], at note 313.1. See also § 8:1.8[C], at note 248.1; § 7:1.3, at note 22.
  • Claim construction as a matter of law: If the parties dispute the meaning of a proposed construction, the court may need to construe the construction to avoid giving claim construction disputes to the jury. (To support this point in O2 Micro Int’l Ltd., the Federal Circuit quoted Jacques Derrida, who was quoting Montaigne.) See § 9:1.2, at note 5.2.
  • Transition—“consists essentially of”: Although the phrase has a standard interpretation when used as the transition, a patentee can alter the meaning of “consists essentially of” by statements in the specification or prosecution history (Ecolab, Inc. v. FMC Corp.). See § 9:3.2[C], at note 50.1.

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