Stanford Ppt

The Stanford Law School Conference on Intellectual Property Law and Biosciences

Friday, September 15, 2006

Patent Litigation in the Biosciences: A View from the BenchModerator:

William F. Lee, Wilmer Cutler Pickering Hale and Dorr LLP

Panel:

Hon. Susan Illston, United States District Judge, Northern District of California

Hon. Elizabeth LaPorte, United States Magistrate Judge, Northern District of California

Hon. Pauline Newman, Circuit Judge, United States Court of Appeals for the Federal Circuit

Hon. Ronald M. Whyte, United States District Judge, Northern District of California

Reach-Through Claims and Reach-Through Royalties: The Evolving Legal Landscape Relating to Reach-Through Rights

Moderator:Alfred C. Server, Wilmer Cutler Pickering Hale and Dorr LLP

Panel:Rebecca S. Eisenberg, University of Michigan Law School

Robin C. Feldman, UC Hastings College of the Law

Robert P. Merges, Boalt Hall School of Law, University of California at Berkeley

Introduction

Alfred C. Server

Wilmer Cutler Pickering Hale and Dorr LLP

Timeline for Drug Discovery and Development

Drug Discovery

Pre-clinical Studies

INDClinical Studies NDA

MARKET

Transmembrane Receptor: The Drug Target

Screening Assay

High-Throughput Screening: Finding a Hit

Discovery Effort Success: A Hit Is Found

Target-Based Drug DiscoveryA Summary

Reach-Through Claim

A claim that “reaches-through” the drug discovery

screening tool to cover a yet-to-be-discovered compound

that may be found through the use of such tool, and/or a

method of treating disease using such a compound.

Limit on Enforcement of Patent Right

Common-Law Experimental Use Exception

Statutory (Drug Development) Exemption(35 U.S.C. §271(e)(1))

Target-Based Drug DiscoveryA Summary

Reach-Through Royalty

A royalty that is paid on the sale of a drug discovered by

a licensee using a licensed patented drug discovery tool

where the licensed tool patent does not cover the drug.

Panel Presentation Overview

Reach-Through Claim

The Issue ofClaim Scope

Professor Merges

Enforceability of Patent Right

Statutory and Common Law Exceptions

Professor Eisenberg


A Question of Patent Misuse

Professor Feldman

Reach-Through Claims: Issues of Patent Scope

Robert P. MergesBoalt Hall School of Law,

University of California at Berkeley

Doctrines Relevant to Scope

• Enablement

• Written description

• Utility?

Enablement

Traditional “undue experimentation” standard

Query: Does it require “undue experimentation” to go

from disclosure in spec. of screening tool, to a claim that

covers any successful candidate screened for by the

tool?

Sawyer and Mann Patent

Claimed: “All Fibrous and textile material” (6,000-plus embodiments)

Enabled: Carbonized paper, plus?

The Incandescent Lamp Patent, 159 US 465 (1895)

Incandescing conductor

Bamboo discovered as an incandescing conductor.

Query: Does it require “undue experimentation” to go from disclosure in spec. of screening tool, to a claim that covers any successful candidate screened for by the tool?

Written Description:

• What is it?

• Relationship to enablement

Enabled

Described

Claim 1

Enabled subject matter: everything the inventor teaches to one of skill in the art.

Described embodiments of the invention: everything the inventor “adequately describes” to one in the art; everything the inventor shows she is in “possession of” or contemplates as embraced by her invention

Specification

Patent Specification

Application to Reach-Through Type of Claims?

Univ. of Rochester v. GD Searle & Co.,358 F.3d 916 (Fed. Cir. 2004) –application of the written description requirement

Patent for a method of treating inflammation using inhibitors of prostaglandin H synthase-2 (PGHS-2) enzyme activity, also known as “COX-2”

Claimed method of using a compoundacting upon a polypeptide did not comply with the written description requirement where such a compound was not disclosed.

Spec. did not disclose which, if any, compounds selectively inhibit PGHS-2

Enforceability of Patent Right

Rebecca S. EisenbergUniversity of Michigan Law School

35 U.S.C. § 271(e)(1)“It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United State a patented invention (other than a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4, 1913) which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques) solely for uses reasonable related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.”


Robin FeldmanUC Hastings College of the Law

The Stanford Law School Conference on Intellectual Property Law and Biosciences

Lunch

John M. Whealan

Deputy General Counsel for Intellectual Property and Solicitor, United States Patent and Trademark Office

ANDA Patent Challenges under Hatch-Waxman: Reconciling Antitrust, FDA and Patent Interests

Moderator:

James C. Burling, Wilmer Cutler Pickering Hale and Dorr LLP

Panel:

Donald O. Beers, Arnold and Porter LLP

Thomas B. Leary, Hogan & Hartson LLP

Marc Schildkraut, Heller Ehrman LLP

Carl Shapiro, Walter A. Haas School of Business, University of California at Berkeley

Hatch-Waxman Act Issues Raising Antitrust Concerns

Donald O. BeersArnold & Porter LLP

Hatch-Waxman and Market AccessHatch-Waxman amendments to Federal Food, Drug and Cosmetic Act control market access for generic drugs

• Requirement that the generic match the innovator

• Non-patent market exclusivity

• Linkage between FDA drug approval and patent

rights

Hatch-Waxman Issues Raising Potential Antitrust Concerns

• Patent listing decision• Petitioning FDA• Successive improvements in products, delaying effective

generic erosion• Authorized generics• Settlement of pharmaceutical patent litigation

Patent Listing (1)

• An innovator must provide information concerning certain types of patents to FDA as part of its new drug application

• FDA lists those patents in the “Orange Book”• A generic applicant must either wait until those patents

expire, or challenge them

Patent Listing (2)

• To argue that a listed patent is invalid or not infringed, the generic applicant submits a “paragraph IV” certification in its application.

• The generic applicant then sends notice to NDA and patent holder.

• The patent holder can then sue, and in some circumstances, gets a 30-month stay of the generic approval by doing so.

Patent Listing (3)

• It is not always clear whether a patent meets the criteria for listing.

• It is argued that listing a patent inappropriately, and thus delaying or discouraging generic competition, violates the antitrust laws.

Petitioning FDA (1)

An innovator concerned that FDA will approve a generic that

– does not match the innovator– will otherwise be unsafe or ineffective– will violate exclusivity rights may file a “citizen petition” with FDA asking FDA not to approve the generic.

Petitioning FDA (2)• FDA is not required to hold up approval of a generic

application until it responds to a citizen petition.• Nevertheless, FDA will generally respond to the petition

on the same day as the approval, suggesting a delay.• While petitioning is protected activity, sham petitioning,

which may be an antitrust violation, is sometimes alleged.

Extending the Franchise (1)• Generic companies do little marketing of their products.

Instead, they count on substitution of their product when the innovator is prescribed.

• Once a new chemical entity is approved, most pharmaceutical companies look for ways to improve the product, e.g.;:– a more convenient dosage form– a formulation that does not have a food effect.

Extending the Franchise (2)• If, when the generic version of the product is approved,

physicians no longer prescribe the copied product because they now prescribe the improved version, the generic market is diminished.

• In the Abbott v. Teva decision, the court declined to dismiss an antitrust case based on successive improvements.

Authorized Generics• The first ANDA applicant to challenge a patent may earn

a 180-day head start over any generic competitor. • NDA applicants can launch their own “authorized

generics,” marketed pursuant to NDA, to compete during that 180-day period.

• This has been challenged on antitrust grounds.

Patent Settlements• There are obvious economic incentives to settle:

because generic competition will be at a lower price, both parties may make more money sharing the innovator’s profits.

• If the patent holder settles a patent case against the first ANDA applicant to challenge a patent, and the agreement permits eventual market entry near patent expiration,180-day exclusivity may prevent all other ANDA applicants from coming to the market until patent expiration.

Donald O. BeersArnold & Porter LLP

[email protected]

The Antitrust Challenge to Patent Settlements

Marc G. SchildkrautHeller Erhman LLP

The Reasons That Courts Have Been Rejecting Patent Settlements

The Big Reasons

• Court want to encourage settlements

• Courts do not believe that litigants must act in the public interest when settling litigation

• Accepting the theory of the challengers would require rejection of settlements where damages were compromised

• Risk aversion: insurance against catastrophic results

More Reasons• Difficult to reconcile condemnation of reverse

payments with the right of patent holders to exclude

• Cannot be reconciled with the Guidelines on Intellectual Property, which permits patent holders to exclude if it is more likely than not that the patent is valid and infringed

• Focuses on intent evidence rather than effect evidence

• Ignores the reduction in output that might be caused by generic entry

The Growing Role of the Supreme Court in Patent CasesModerator:

John F. Duffy, George Washington University Law School

Panel:

Barbara A. Caulfield, Affymetrix

Mark A. Lemley, Stanford Law School

The Return of the Supreme Court to the Bar of Patents

John F. Duffy George Washington University Law School

S.Ct. Patent Cases: Five Term Running Average (1810-Current)

0

2

4

6

8

10

12

14

16

18

Feb

1810

Feb

1818

Feb

1825

Jan

1832

Jan

1839

Jan

1846

Dec

185

2D

ec 1

859

Dec

186

6O

ct 1

873

Oct

188

0O

ct 1

887

Oct

189

4O

ct 1

901

Oct

190

8O

ct 1

915

Oct

192

2O

ct 1

929

Oct

193

6O

ct 1

943

Oct

195

0O

ct 1

957

Oct

196

4O

ct 1

971

Oct

197

8O

ct 1

985

Oct

199

2O

ct 1

999

Oct

200

6

Three Periods in the Supreme Court’s Patent Jurisprudence

1. Before 1891: S.Ct. is the appellate patent court –

mandatory appellate jurisdiction from trials in all patent

cases.

2. 1891-1982: Certiorari power over regional circuits.

3. After 1982: Certiorari over the CAFC.

S.Ct. Patent Cases: Five Term Running Average (1952-Current)

0

0.5

1

1.5

2

2.5

3

Oct 19

52Oct

1955

Oct 19

58Oct

1961

Oct 19

64Oct

1967

Oct 19

70Oct

1973

Oct 19

76Oct

1979

Oct 19

82Oct

1985

Oct 19

88Oct

1991

Oct 19

94Oct

1997

Oct 20

00Oct

2003

Oct 20

06

S.Ct. Patent Cases: Ten Year Running Average (1952-Current)

0

0.5

1

1.5

2

2.5

3

3.5

Oct 19

52Oct

1955

Oct 19

58Oct

1961

Oct 19

64Oct

1967

Oct 19

70Oct

1973

Oct 19

76Oct

1979

Oct 19

82Oct

1985

Oct 19

88Oct

1991

Oct 19

94Oct

1997

Oct 20

00Oct

2003

Oct 20

06

October 2006 Term: Patent Cases Granted Certiorari 1. MedImmune v. Genentech – Licensor Estoppel &

Declaratory Judgment Act

2. KSR v. Teleflex – Nonobviousness

October 2006 Term: Patent Cases Pending on “CVSG”

1. Microsoft v. AT&T – Section 271(f) / International

Infringement

2. Apotex v. Pfizer – Declaratory Judgment Act

Note: Increasingly, the Court is asking the Solicitor

General for an opinion at the certiorari stage (Calling

for the Views of the Solicitor General – CVSG).

CVSG's in Federal Cases vs. Patent Cases 2000-2005 Terms

Patent CVSG's:17 cases

(20%)

Non-patent CVSG's: 68 cases

(80%)

CVSG's in Federal Cases vs. CAFC "Core" Patent Cases 2000-2005 Terms

Non-patent CVSG's:

70 cases (82%)

CAFC Patent CVSG's:

15 cases (18%)

CVSG's in Federal Cases vs. Patent Cases 1994-1999 Terms

Patent CVSG's:

1 case (1.7%)

Non-patent CVSG's:

57 cases (98.3%)

CVSGs per Term (all cases)

0

5

10

15

20

25

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

Term

CVS

Gs

Patent CVSGs Per Term

0

1

2

3

4

5

619

99

2000

2001

2002

2003

2004

2005

Term

CVS

Gs

The Growing Role of the Supreme Court in Patent Cases

Moderator:

John F. Duffy, George Washington University Law School

Panel:

Barbara A. Caulfield, Affymetrix

Mark A. Lemley, Stanford Law School

Thank You

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