ariad and written description

1

The Implications of the Federal Circuit Reaffirming the Written

Description Doctrine in the Ariad v. Eli Lilly Decision

Paul M. Rivard

John P. Iwanicki

May 6, 2010

2

Overview

• Introduction

• Federal Circuit written description jurisprudence and “possession” test

• Questions presented and discussion of Ariad en banc decision

• Practice tips

3

Introduction

“The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.” [35 U.S.C. § 112, First Paragraph]

4

Introduction

“The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.” [35 U.S.C. § 112, First Paragraph]

5

Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991)

• At issue was whether priority design application contained a “written description” of double lumen catheter claimed in later utility patents

6


• Challenger Vas-Cath conceded design drawings provided an enabling disclosure

• District court: no “written description” in design application; summary judgment of invalidity based on intervening prior art

• Federal Circuit reversed; drawings alone may provide adequate written description in utility

7


• Federal Circuit: statute “requires a ‘written description of the invention’ which is separate and distinct from the enablement requirement.”

• “The purpose of the ‘written description’ requirement is broader than to merely explain how to ‘make and use’; the applicant must also convey with reasonable clarity to those skilled in the art that . . . he or she was in possession of the invention.”

8

Fiers v. Revel, 984 F.2d 1164, 1169 (Fed. Cir. 1993)

• “[I]rrespective of the complexity or simplicity of the method of isolation employed, conception of DNA, like conception of any chemical substance, requires a definition of that substance other than by its functional utility.”

9

University of California v. Eli Lilly Co., 119 F.3d 1559 (Fed. Cir. 1997)

• Patents relating to recombinant DNA, particularly recombinant plasmids and microorganisms that produce human insulin

• Patents contained example of rat cDNA, but only a general method of producing human insulin cDNA

• District court found invalidity on written description• Federal Circuit affirmed: specification does not

describe human “cDNA's relevant structural or physical characteristics . . . in other words, it thus does not describe human insulin cDNA.”

10

University of California v. Eli Lilly Co., 119 F.3d 1559 (Fed. Cir. 1997)

• Satisfaction of enablement requirement alone insufficient

• “The ‘written description’ requirement implements the principle that a patent must describe the technology that is sought to be patented . . . and . . . demonstrate that the patentee was in possession of the invention that is claimed.”

11

University of Rochester v. G.D. Searle & Co., 358 F.3d 916 (Fed. Cir. 2004)

• U of R patent claimed methods of selectively inhibiting COX-II enzyme (PGHS-2) to treat inflammation while avoiding gastrointestinal side effects associated with COX-I

• Patent disclosed assay for determining whether compound is a selective inhibitor, but did not identify any actual compounds

• Searle’s (Pfizer’s) commercial product Celebrex is selective COX-II inhibitor

12

University of Rochester v. G.D. Searle & Co., 358 F.3d 916 (Fed. Cir. 2004)

• District court held claims invalid for lack of written description; Federal Circuit affirmed

• “A compound that selectively inhibits PGHS-2 activity was hypothetical, for it is clear that the inventors had neither possession nor knowledge of such a compound.”

• Four judges dissented from denial of rehearing en banc

13

“Possession” Test

“Possession is nine-tenths of the law.”

-Anonymous

14


• In Enzo, patentee argued biological deposit showed per se possession of invention

• “[T]he written description requirement . . . is not subsumed by the ‘possession’ inquiry . . . a showing of possession alone does not cure the lack of written description in the specification . . .”

Enzo Biochem v. Gen-Probe (“Enzo II”), 323 F.3d 956 (Fed. Cir. 2002)

15


• Deposit of the probes sufficient to meet written description requirement

• Deposit referred to in the specification• Effort to determine the exact nucleotide

sequences was difficult• PHOSITA could sequence the deposited

materialEnzo Biochem v. Gen-Probe (“Enzo II”), 323 F.3d 956

(Fed. Cir. 2002)

16

The Enzo (II) Lesson

• No strict need to claim genetic material by sequence

• No strict need to describe genetic material by sequence

• Deposit can meet written description

• But what about mutants, variants, subsequences, mixtures?

17


• Specification needs to describe a representative number of species sufficient to evidence that the Applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus.

Guidelines for Examination of Patent Applications under the 35 U.S.C. Sec. 112(1) Written Description Requirement, 66 Fed. Reg. 1099 (2001).

18

Ariad Pharm. Inc. v. Eli Lilly & Co., No. 2008-1248 (Fed. Cir. March 22, 2010)

• Patent claimed methods of treating diseases by regulating a protein in human cells

• Inventors were the first to identify the protein (NF-κB) and uncover the mechanism by which it activates gene expression underlying the body’s immune responses to infection

19


• Genus claims encompassing the use of all substances that achieve the desired result of reducing the binding of NF-kB to NF-kB recognition sites

• Application only hypothesized three classes of molecules capable of reducing NF-kB activity: Specific inhibitors, dominantly interfering molecules and decoy molecules

• No written description of the molecules that reduce the binding of NF-kB to NF-kB recognition sites.

20


• Original Federal Circuit panel overturned jury verdict favorable to patentees, and held claims invalid for lack of written description– Patent contains no working (or even

prophetic) examples of reducing protein activity, or a description of the synthesis of hypothetical molecules that could be used for that purpose

21

Ariad: Questions Presented

• Federal Circuit granted petition for rehearing en banc to address two questions:– “Whether 35 U.S.C. § 112, ¶1, contains a

written description requirement separate from an enablement requirement” and

– “If so, what is the scope and purpose of the written description requirement?”

22


• Ariad argued for reading the statute as: The specification shall contain [A] a written description

[i] of the invention, and [ii] of the manner and process of making and using it,

[B] in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same . . .

23


• Lilly argued for reading the statute as: (1) “The specification shall contain a written description of the invention, and” (2) “The specification shall contain a written description . . . of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same . . .”

24


• Federal Circuit agreed with Lilly’s construction of statute

• Under Ariad’s construction, the phrase “of the manner and process of making and using it” would be superfluous

25


• Legislative history– 1793 Act: specification “to enable” the

invention and “to distinguish” it from all things previously known

– 1836 Act added requirement for claims but maintained requirement of “written description”

26


• Supreme Court treated post-1836 statute as containing separate written description requirement – Schriber-Schroth Co. v. Cleveland Trust Co., 305

U.S. 47 (1938) – O’Reilly v. Morse, 56 U.S. (15 How.) 62 (1853)

– Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722 (2002)

27


• “The term ‘possession’ . . . has never been very enlightening.”

• Inquiry must focus on "the four corners of the specification from the perspective of a person of ordinary skill in the art.”

• “The specification must describe an invention understandable to that skilled artisan and show that the inventor actually invented the invention claimed.”

28


• Court contrasted purposes of claims and written description:– “Claims define and circumscribe, the

written description discloses and teaches.”

• Court rejected arguments that written description doctrine should be limited to priority disputes

29


• Federal Circuit rebuffed criticism that written description amounts to “super enablement” standard for chemical and biotechnology inventions– “The doctrine never created a heightened

requirement to provide a nucleotide-by-nucleotide recitation of the entire genus of claimed genetic material; it has always expressly permitted the disclosure of structural features common to the members of the genus.”

30


• “Patents are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others. ‘[A] patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.’”

31

Implications of Ariad

• Reaffirms written description and enablement are separate requirements

• Maintains “possession” test but emphasizes focus on four corners of specification (objective inquiry)

• Method claims susceptible to attack based on lack of description of molecules needed to perform method

32

Practice Strategies

• Describe species structure/formula actually reduced to practice

• Describe generic structure/formula• Describe sequence portions required

for function• Describe relationship between

structure and functional properties

33

Practice Strategies

• Use prophetic examples of varying scope• Use exemplary methods of making and using

of varying scope• Describe standard practices for PHOSITA• Disclose that which is known or conventional• Use differing claim scope and make sure the

claim language is expressly in the specification

34

Practice Strategies

• Use provisional applications to add new developments over the course of a year and develop PREDICTABILITY

• Use Markush groups, but dedicate originally filed dependent claims to specific members

35

Practice Strategies

• Be your own lexicographer – Undefined terms will be construed by

PHOSITA at the time of filing

• Defining terms broadly may allow for scientific advancement

• Multiple definitions may broaden scope• Alternate and equivalent terms may

broaden scope

36

Questions?

ariad and written description

Documents

written description

adequate written description

description jurisprudence

human insulin patents

challenger vascath

design drawings

person skilled

later utility patents