Building and Managing Patent Portfolios in the Life Sciences

A Henry Stewart Workshop

Building and Managing
Patent Portfolios
in the Life Sciences

• Pharmaceuticals
• Biotechnology Products
• Medical Devices

Workshop Leaders:

Barton W. Giddings, Ph.D.
Senior Patent Counsel, NPS Pharmaceuticals

Kevin B. Laurence
Partner, Stoel Rives LLP

Preparing specifications based on a progressive interpretation of U.S. case law
• How to ensure that applications directed to inventions in the life sciences satisfy the written description, enablement and best mode requirements of 35 USC §112, para. 1.
• Strategies for planning and limiting the specification to essentially the detailed description and the list of drawings to avoid interpretations such as Hoffer v. Microsoft Corp., (Fed. Cir. 2005)
• Strategic selection of the words and phrases to prevent unnecessarily narrow claim interpretations as occurred in Rhodia Chimie v. PPG Industries Inc., (Fed. Cir. 2005), AstraZeneca AB v. Mutual Pharmaceutical Co. (Fed. Cir. 2004), etc.

Claim drafting tips for the U.S.
• Drafting various types of claims including: “reach through” compounds, intermediate products, metabolites, protein fragments, uses, treatment methods, etc.
• Drafting claims of varying breadth
• Effective use of functional terms, relative terms and terms of approximation which are definite under 35 USC §112, para. 2. Recent cases will be examined such as Medrad, Inc. v. Medical Devices Corp., (Fed. Cir. 2005), Playtex Products, Inc. v. Procter & Gamble Co., 04-1200 (Fed. Cir. 2005) and Howmedica Osteonics v. Tranquil Prospects (Fed. Cir. 2005)
• Markush groups in light of Abbott Laboratories v. Baxter Pharmaceutical Products, 334 F.3d 1274 (Fed. Cir. 2003) and Gillette Co. v. Energizer Holdings Co. (Fed. Cir. 2005)
• Reciting ranges to avoid coverage lacunas. Recent cases will be discussed including nonprecedential decisions such as In re Harris (Fed. Cir. 2005) and Janssen Pharmaceutica v. Eon Labs (Fed. Cir. 2005)
• Claiming salts in pharmaceutical applications. Analysis of cases such as Merck v. Teva, 347 F.3d 1367 (Fed. Cir. 2003)

Preparing patent applications for successful prosecution in Europe and Japan
• Consider the requirements of other countries when drafting original applications
- What types of claims are permissible?
- How different are the standards for finding support of claim elements such as ranges?
- Include “Swiss-type” claims in the specification of U.S. applications for subsequent use abroad
• How are functional claims handled and interpreted in Europe?
• Procedural tactics such as early requests for examination in Japan

Case studies of the factors considered by a company’s patent team in foreign filing decisions
• Where to file patent applications
• Industry filing trends

Case studies of the claim strategies used for blockbuster drugs and their value as corporate assets
• Building the fence: what to claim
• Which claims fare best in litigation

Potential impact of patent reform legislation for life sciences
• When to file - there will be an emphasis on filing applications as soon as an invention is complete even for very early stage technologies
• Elimination of the best mode requirement removes a key tool in invalidating patents in the unpredictable arts. Without the best mode requirement and in the rush to file an application in a first-to-file system, the quality of specifications may decrease
• Will patent attorneys cease being “jackals” representing “knaves” as referenced in the Judge Newman’s dissent of Hoffman-La Roche v. Promega Corporation?

Update regarding the PTO’s “green paper” on reforming restriction practice
• Analysis of the 4 options proposed in the green paper
• Discussion of the Restriction Training Materials for TC 1600

Managing patent term
• Filing for Hatch-Waxman patent term extensions in the U.S.
• Using Supplemental Protection Certificates to maximize patent term outside the U.S.

Enforcing drug/device patents

Discussion of recent Supreme Court and Federal Circuit decisions
• Implications of Merck v. Integra
• Development of inherent anticipation case law up through SmithKline Beecham Corp. (SKB) v. Apotex Corp. (Fed. Cir. 2005)
• What things under the sun are made by man? The Supreme Court considers the patentability of “laws of nature, natural phenomena, and abstract ideas” in relation to a medical diagnosis method patent in Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc., Supreme Court No. 04-607, 125 S.Ct. 1413 (2005)

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