Ariad v. Eli Lilly

1
Ariad v. Eli Lilly 560 F.3d 1366 (Fed. Cir.
2009) Written Description as a Function of
Enablement
N. Scott Pierce, Esq. Suffolk University Law
SchoolNovember 4, 2009
2
Claim

• A method of modifying effects of external
  influences on an eukaryotic cell, which external
  influences induce NF-kB-mediated intracellular
  signaling, the method comprising reducing NF-kB
  activity in cells such that NF-kB-mediated
  effects of external influences are modified.
• Extracellular NF-kB
  Expression of Some Harmful
• Influence Activation
  Protective Proteins Effects

3
Candidates

• Specific Inhibitors
• Dominantly Interfering Molecules
• Hypothesized examples only
• Decoy Molecules
• Examples

4
Holding by CAFC

• Issue "Whether there is substantial evidence
  to support the jury's verdict that the written
  description evidenced that the inventor possessed
  the claimed invention."
• Holding "The jury lacked substantial evidence
  for its verdict that the asserted claims were
  supported by adequate written description, and
  thus hold the asserted claims invalid."

5
Statute

• 35 U.S.C. 112 first paragraph
• 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

6
Ariad v. Eli LillyEn Banc Questions on Rehearing

• Whether 35 U.S.C. 112, paragraph 1, contains a
  written description requirement separate from an
  enablement requirement?
• If a separate written description requirement is
  set forth in the statute, what is the scope and
  purpose of the requirement?

7
1790 Statute

• The grantee or grantees of each patent shall,
  at the time of granting the same, deliver to the
  Secretary of State a specification in writing,
  containing a description, accompanied with drafts
  or models, and explanations and models . . . of
  the thing or things, by him or them invented or
  discovered . . . .
• The specification shall be so particular, and
  said models so exact, as not only to distinguish
  the invention or discovery from other things
  before known and used, but also to enable a
  workman or other person skilled in the art or
  manufacture, whereof it is a branch, or wherewith
  it may be nearest connected, to make, construct,
  or use the same, to the end that the public may
  have the full benefit thereof, after the
  expiration of the patent term . . . .

8
1793 Statute
Sec. 3 Sec. 3
Every inventor . . . shall deliver a written description of his invention, and of the manner of using, or process of compounding the same, in such full, clear and exact terms, as to distinguish the same from all other things before known, and to enable any person skilled in the art or science, of which it is a branch, or with which it is most nearly connected, to make, compound, and use the same.



9
Statute of 1793
Sec. 2 "Any person, who shall have discovered
an improvement in the principle of any machine,
or in the process of any composition of matter
which shall, have been patented,he shall not be
at liberty to make use or read the original
discovery And it is hereby enacted and
declared, that simply changing the form or
proportion of any machine, or composition of
matter, in any degree, shall not be deemed a
discovery." Sec. 3 "And in the case of any
machine, he shall fully explain the principle,
and the several modes in which he has
contemplated the application of that principle or
character, by which it may be distinguished from
other inventions"


10
Odiorne v. Winkley 18 F. Cas. 581 (C.C.D.
Mass.1814) Infringement/Patentability

• Infringement
• "Mere colorable alterations of a machine are not
  sufficient to protect the defendant."
• Patentability
• "Mere colorable differences, or slight
  improvements, cannot shake the right of the
  original inventor."

11
Evans v. Eaton20 U.S. (7 Wheat.) 356 (1822)Two
Objects Linked to Statute

• "to enable artisans to make and use it, and
  this give to the
• public the full benefit of the discovery."
• "to put the public in possession of what the
  party claims as
• his own invention, so as to ascertain if he
  claim anything
• that is in common use."

12
1836 Statute

• He shall deliver a written description of his
  invention or discovery, and of the manner and
  process of making, constructing, using, and
  compounding the same, in such full, clear, and
  exact terms, avoiding unnecessary prolixity, as
  to enable any person skilled in the art or
  science to which it appertains, or with which it
  is most nearly connected, to make, construct,
  compound and use the same....
• He shall particularly specify and point out the
  part, improvement, or combination, which he
  claims as his own invention or discovery.

13
1836 Statute (cont.)

• "He shall fully explain the principle and the
  several modes in which he has contemplated the
  application of that principle or character by
  which it may be distinguished from other
  inventions."

14
Winans v. Adams, 56 U.S. (15 How.) 330 (1853)
Infringement/Patentability

• Whether defendants had "constructed cars which,
  substantially, on the same principle and on the
  same mode of operation, accomplished the same
  result."
• Court "Under our law a patent cannot be granted
  merely for a change of form.To employ other
  mechanical principles or natural powers, such is
  the basis on which the plaintiff's patent rests."
• Thereby equating tests for patentability and
  infringement.

15
1870 Statute

• That before any inventor or discoverer shall
  receive a patent for his invention or discovery,
  he shall...file in the patent office a written
  description of the same, and of the manner and
  process of making, constructing, compounding, and
  using it, in such full, clear, concise, and exact
  terms as to enable any person skilled in the art
  or science to which it appertains, or with which
  it is most nearly connected, to make, construct,
  compound, and use the same...."
• Said specification and claims shall be signed
  by the inventor and attested by two witnesses.

16
White v. Dunbar, 119 U.S. 47 (1886)
Patentability/Infringement

• "Textile fabric" vs. "enveloping material"
• "We see nothing to imply that the patentees
  were the inventors."
• "When their claim is confined to a lining of
  textile fabric, it is tantamount to a declaration
  that they claimed nothing else. "

17
Graver Tank v. Linde Air Products, Co. 339 U.S.
605 (1950)

• "A patentee may invoke this doctrine to proceed
  against the producer of a device 'if it performs
  substantially the same function in substantially
  the same way to obtain the same result.'"
• "Thus, where a device is so far changed in
  principlethe doctrine may be used to restrict
  the claim."

18
Eng. Dev. Labs v. Radio Corp. of America, 153
F.2d 523 (2d Cir.1946)

• "Same result in substantially the same wayany
  patent is entitled to some range of equivalents."
• "The doctrine of intervening rights...certainly
  does not prevent amendments which go no further
  than to make express what would have been
  regarded as an equivalent of an original."

19
Summary Pre-1952 Patent Act

• Partition of meaning of possession by public
• Particularity claim language and equivalents
• Scope specification and equivalents
• as a function of enablement

20
1952 Patent Act

• 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.

21
Early InterpretationIn re Gay, 309 F.2d 769
(CCPA 1962)

• Enablement "A The specification shall contain
  a written description of the inventionas to
  enable."
• Best Mode "B set forth the best mode."

22
In re Ruschig, 379 F.2d 990 (CCPA 1967)

• "Appellants are pointing to trees. We are
  looking for blaze marks which single out
  particular trees. We see none."
• "Does the specification convey clearly to those
  skilled in the art, to whom it is addressed, in
  any way the information that appellants invented
  the specific compound."

23
In re DiLeone, 436 F.2d 1404 (CCPA 1971)
Enablement
A B C D
Description
"The first paragraph of 112 requires both
description and enablement."
24
In re Wertheim, 541 F.2d 257 (CCPA 1976)

• The function of the description requirement is
  to ensure that the inventor had possession, as of
  the filing date of the application relied on, of
  the specific subject matter later claimed by
  him.

25

• 35 U.S.C. 112 first paragraph
• 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.
• In re Barker, 559 F.2d 588 (CCPA 1977)
• Dissent

What
How and for whom
26

• 35 U.S.C. 112 first paragraph
• The specification shall contain
• a 1 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.
• In re Barker, 559 F.2d 588 (CCPA 1977)
• Dissent
• Majority 1

What
How and for whom
27

• 35 U.S.C. 112 first paragraph
• The specification shall contain
• a 1 written description
• of the invention,
• 2 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.
• In re Barker, 559 F.2d 588 (CCPA 1977)
• Dissent
• Majority 1 2

What
How and for whom
28
Summary Post-1952 Patent Act

• Change in judicial interpretation of 35 U.S.C.
  112, 1st
• Shift in emphasis by caselaw from possession by
  public to possession by inventor.

29

• Biotechnology

30
Fiers v. Revel 984 F.2d 1164 (Fed. Cir. 1993)

• "The issue here, however, is conception of the
  DNA of the count, not enablement."
• "To paraphrase the Board, one cannot describe
  what one has not conceived."
• "Because the countpurports to cover all DNAs
  that code for ß-IF, it is analogous to a single
  means claim.It is an attempt to pre-empt the
  future before it has arrived.

Fiers
Revel
31
The Regents of the Univ. of Cal. v. Eli Lilly
and Co., 119 F.3d 1559 (Fed. Cir. 1997)

• Enabling method and sequence for rat only
• Example 6 prophetic method for obtaining human
  sequence was insufficient.
• "Whether or not it provides an enabling
  disclosure, it does not provide a written
  description."
• " A description of a genus of cDNAs may be
  achieved by means of a recitation of a
  representative number of cDNAs,.This is
  analogous to enablement of the genus under 112,
  1."

32
Enzo Biochem, Inc. v. Gen-Probe, 323 F.3d 956
(Fed. Cir. 2002)

• Deposit of sequences that selectively hybridize
• "We hold that reference in the specification to
  a deposit in a public depository, . sufficient
  to comply with the written description
  requirement of 112, 1."

33

Judge Rader Introduces "Priority Policeman" Idea

• "In any event, the WD Written Description
  doctrine, at its inception, had a very clear
  function--preventing new matter from creeping
  into claim amendments."

34
Moba v. Diamond Automation Inc., 325 F.3d 1306
(Fed. Cir. 2003)

• "The Lilly disclosure rule does not require a
  particular form of disclosure because one of
  skill could determine from the specification that
  the inventor possessed the invention at the time
  of filing."

35
Rader's Concurrence

• "In 1997, this court inexplicably wrote a new
  disclosure requirement, found nowhere in title
  35."
• "After all, to enable is to show possession, and
  to show possession is to enable."

36
Bryson

• "The real question raised by Judge Rader's
  statutory analysis is not whether Lilly was an
  unwarranted departure from the Ruschig line of
  cases, but whether that entire line of cases is
  based on a fundamentally flawed construction of
  35 U.S.C. 112, paragraph 1."

37
University of Rochester v. G.D. Searle, 358 F.3d
916 (Fed. Cir. 2004)

• Method claimed selective inhibition of "PGHS-2"
  or "COX-2"
• No compounds actually disclosed in specification

38
Majority Opinion (Lourie)

• Written Description and Enablement Distinct
• Relied on DiLeone (CCPA 1971)

39
Rader - Theory

• Critical of DiLeone hypothetical
• "In the first place, the hypothetical rarely, if
  ever, happens."

40

Rader's Analogy

• Described radio
• Claimed receiver
• Scope of claim TV?
• Rader No
• According to Rader, Lilly court would invalidate
• "Lack of disclosure is a dead give-away for
  enablement problems."

41
Two Problems with Rader's TheoryPre-Ruschig

• Prutton v. Fuller, 230 F.2d 459 (CCPA 1956)
• The determining factor is whether the
  application would fairly suggest to the skilled
  worker in the art the particular composition
  claimed.
• In re Gay, 309 F.2d 769 (CCPA 1962)
• "Appellants' specification would have indicated
  to one skilled in the art that all suggested
  container materials were to be substantially
  nonporous."
• In re Rainer, 347 F.2d 574 (CCPA 1965)
• "the specification discloses nothing to guide
  such a person in making the selection of such
  specific materials from the rather extensive
  catalog of materials recited."

42
Post-Ruschig

• In re Robins, 429 F.2d 452 (CCPA 1970)
• "mention of representative compounds may provide
  an implicit description upon which to base
  generic claim language. . . ."
• In re Smythe, 480 F.2d 1376 (CCPA 1973)
• "The question which must be answered is whether
  the application originally filedconveyedthe
  information that appellants invented the analysis
  system with an inert fluid as the segmentizing
  medium."
• Amgen v. Hoechst (Fed. Cir. 2003)
• "Moreover, the specification can fairly be read
  to, if not expressly, disclose the use of human
  DNA in human host cells in culture."

43
Chiron Corp. v. Genetech, 363 F.3d 1247 (Fed.
Cir. 2004)

• Monoclonal antibodies that bind to human breast
  cancer antigen (c-erb-2, or HER2)
• Original claim language in CIP at issue
• No description of later-developed chimeric and
  humanized technology.

44
Summary

• Pre-1952 Patent Act
• Bifurcation of requirement to put public in
  possession.
• Particularity claim language and equivalents
• Scope specification and equivalents
• Post-1952 Patent Act
• Change in judicial interpretation of 35 U.S.C.
  112, 1st
• Left no standard for description of the
  invention.
• Shift in focus of "possession" from public to
  inventor.
• Result Requirement of more than literal
  description of invention as claimed.

45
A written description
46
A written description
of the invention
Literal Description (or "fair reading")
Time of filing
47
A written description
of the manner and process of making and using it
of the invention
Literal Description (or "fair reading")
Description of Enablement
Time of filing
Time of filing
48
A written description
of the manner and process of making and using it
of the invention
Literal Description (or "fair reading")
Description of Enablement
Time of filing
Time of filing
49
A written description
of the manner and process of making and using it
of the invention
Literal Description (or "fair reading")
Description of Enablement
Possession by inventor (e.g., demonstration)
Time of filing
Time of filing
50
A written description
of the manner and process of making and using it
of the invention
Literal Description (or "fair reading")
Description of Enablement
Possession by inventor (e.g., demonstration)
Possession by inventor (e.g., embodiment)
Time of filing
Time of filing
51
A written description
of the manner and process of making and using it
of the invention
Literal Description (or "fair reading")
Description of Enablement
Possession by inventor (e.g., demonstration)
Possession by inventor (e.g., embodiment)
Time of filing
Time of filing
Future Point
52
A written description
of the manner and process of making and using it
of the invention
Literal Description (or "fair reading")
Description of Enablement
Possession by inventor (e.g., demonstration)
Possession by inventor (e.g., embodiment)
Time of filing
Time of filing
Future Point
53
A written description
of the manner and process of making and using it
of the invention
Literal Description (or "fair reading")
Description of Enablement
Possession by inventor (e.g., demonstration)
Possession by inventor (e.g., embodiment)
Time of filing
Time of filing
Future Point
54
A written description
of the manner and process of making and using it
of the invention
Literal Description (or "fair reading")
Description of Enablement
Possession by inventor (e.g., demonstration)
Possession by inventor (e.g., embodiment)
Time of filing
Time of filing
Future Point
55
A written description
of the manner and process of making and using it
of the invention
Literal Description (or "fair reading")
Description of Enablement
Possession by inventor (e.g., demonstration)
Possession by inventor (e.g., embodiment)
Time of filing
Time of filing
Future Point
Ariad
Literal Description Inhibitor Jointly
interfering Decoy