Transcript Recent Developments in the Law

RECENT BIOTECH CASE LAW
Stephen Walsh, Ph.D., J.D.
Associate Solicitor
Prepared for Biotech/Chem/Pharm Customer
Partnership Meeting, November 10, 2005
Today’s topics
WRITTEN DESCRIPTION
 UTILITY
 DISCLOSING INFORMATION TO THE
PTO
 OBVIOUSNESS
 CLAIM CONSTRUCTION

WRITTEN DESCRIPTION
Case law includes several tests for written
description, including possession, but two
themes are re-emerging in recent
decisions.
Is the Federal Circuit’s written description
jurisprudence converging?
Possession Tests
Variety of ways disclosure could show possession
such as:
 Described an actual reduction to practice
 Showed the invention was ready for patenting
such as by the disclosure of drawings or
structural chemical formulas showing the
invention was complete
 Described distinguishing identifying
characteristics sufficient to show possession
 Other….
What Are Distinguishing Identifying
Characteristics?
Complete or partial structure
 Other physical and/or chemical properties
 Functional characteristics when coupled
with a known or disclosed correlation
between function and structure
 Some combination of such characteristics

Themes Re-emerging In Recent Written
Description Cases


MPEP 2163 II.A.2:
Inverse correlation between level of skill and
knowledge in the art and the amount of
description needed – what is already known does
not have to be repeated in the specification
MPEP 2163 II.A.3.ii:
Predictability in genus/species cases –
representative number inverse function of level of
skill and knowledge in the art
First re-emergent theme:
credit for what is already known

Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005)


old DNAs fused to make chimeric genes
Amgen v. Hoecsht Marion Rousell, 314 F.3d 1313
(Fed. Cir. 2003)


Union Oil Co. of Cal. v. Atlantic Richfield, 208 F.3d 989
(Fed. Cir. 2000)


mammalian and vertebrate cells
gasoline formulations
Ralston Purina Co. v. Far-Mar-Co, Inc., 772 F.2d 1570
(Fed. Cir. 1985)

food product
Capon v. Eshhar,
418 F.3d 1349 (Fed. Cir. 2005)
Claims directed to chimeric genes to be made
from known DNA sequences of known
function using known procedures
The Board found that “persons having ordinary
skill would not have been able to visualize
and recognize the identity of the claimed
genetic material without considering
additional knowledge in the art, performing
additional experimentation, and testing to
confirm results”
Capon (cont.)
The Court explained:
 “descriptive text needed . . . varies with the
nature and scope of the invention at issue,
and with the scientific and technologic
knowledge already in existence”
 “as each field evolves, the balance also
evolves between what is known and what is
added by each inventive contribution”
 “Board’s rule . . . is an inappropriate
generalization”
A very old theme
Loom Co. v. Higgins, 105 U.S. 580, 586
(1881)
The inventor “may begin at the point where
his invention begins, and describe what
he has made that is new, and what it
replaces of the old. That which is
common and well known is as if it
were written out in the patent and
delineated in the drawings.”
Second re-emergent theme:
predictability in genus claims
In re Lukach, 442 F.2d 967, 968 (CCPA
1971)
“[W]here an applicant claims, as here, a
class of compositions, he must describe
that class in order to meet the description
requirement of the statute.”
Really an old theme:
predictability in the art
Holland Furniture Co. v. Perkins Glue Co.,
277 U.S. 245, 256 (1928)
“an inventor may not describe a particular
starch glue which will perform the function
of animal glue and then claim all starch
glues which have those functions”
Univ. Of Rochester v. G.D. Searle &
Co., 358 F.3d 916 (Fed. Cir. 2004)
Paraphrased claim: A method of selectively inhibiting an
enzyme comprising administering a selective inhibitor.

District court found no disclosure of selective inhibitor
structure or physical properties, and selective inhibitor
structure could not be deduced from any known structure.

The claimed method was not adequately described.
A “reach through” claim?

In re Curtis,
354 F.3d 1347 (Fed. Cir. 2004)
Claim: Dental floss “having a coating of at least one
material capable of increasing the coefficient of friction.”


Generic claim was not supported by parent application
disclosing one microcrystalline wax coating.
“[A] patentee will not be deemed to have invented
species sufficient to constitute the genus by virtue of
having disclosed a single species when . . . the evidence
indicates ordinary artisans could not predict the
operability . . . of any other species.”
In re Wallach,
378 F.3d 1330 (Fed. Cir. 2004)
Claim: Isolated DNA encoding TBP-II.
 Inventor described the purified protein TBP-II by its
molecular weight, biological activity, and a partial amino
acid sequence listing ten amino acids.
 Credited with possession of the genus of DNA molecules
encoding the partial protein structure, but not DNA
encoding the entire protein.
 No evidence that there is any known or disclosed
correlation between the combination of a partial structure
of a protein, the protein’s biological activity, and the
structure of the DNA encoding the protein.
Bilstad v. Wakalopulos,
386 F.3d 1116 (Fed. Cir. 2004)

sterilizing apparatus

“if the art is unpredictable, then disclosure of
more species is necessary to adequately show
possession of the entire genus”

Remanded for further fact finding on the
understanding of predictability in this art
LizardTech v. Earth Resources
Mapping, ___ F.3d ___, 2005 WL
2429824 (Fed. Cir. Oct. 4, 2005)



digital image transform process (DWT)
Specification described a particular seamless DWT
algorithm, but claim also covered a nonseamless
algorithm
Person of skill in the art would not have
understood LizardTech to have invented a method
for DWT except by the particular disclosed
method
Time out for a tip about a process
described in a provisional application
Provisional applications don’t have claims
 A spec that describes only one order of
steps might not cover another order
 Process claims are construed to cover any
order, but specs are not
 Be alert to unintended process limitations
 In re Holcomb, No. 04-1550 (Fed. Cir.
April 14, 2004)

UTILITY
Section 101:
“any new and useful . . . .”
“Useful” means that a specific and
substantial utility is currently
available.
In re Fisher, 421 F.3d 1365 (Fed. Cir. 2005)

Nucleic acid comprising any of SEQ ID NO:1 to 5

SEQ ID NO:1 to 5 are ESTs characterized as
being from corn leaves

Proposed uses: chromosome marker, measure
mRNA levels, primers, find polymorphisms,
isolate promoters, control expression, locate
other organism molecules
Fisher (cont.)




Board found no specific and substantial utility,
CAFC affirmed
Board’s reasoning tracked guidelines
CAFC agreed that Brenner v. Manson, 383 U.S.
519 (1966), is controlling precedent
CAFC agreed that Fisher’s proposed uses were
the sort of “use-testing” that fails under the
Manson standard
DISCLOSING INFORMATION TO
THE PTO

Star Fruits v. USA, 293 F.3d 1277 (Fed. Cir. 2005)
Rule 105: Applicant must disclose nonfrivolous
information if examiner asks for it
Purdue Pharma L.P. v. Endo Pharmaceuticals Inc., 410
F.3d 690 (Fed. Cir. 2005)
 Rule 56: Applicant must disclose material information
without being asked for it
 past tense for prophetic example violated duty of
candor
Novo Nordisk v. BioTechnology Gen., ___ F.3d ____, 2005
WL 2443857 (Fed. Cir. Oct. 5, 2005)
 past tense for prophetic example violated duty of
candor



Star Fruits v. USA,
393 F.3d 1277 (Fed. Cir. 2005)

37 C.F.R. § 1.105 (Rule 105):
Office may require applicant to submit
information reasonably necessary to
examine or treat a matter
Star Fruits (cont.)
Rule 105 authorizes PTO to require applicants
to provide:
 information relevant to examination
procedurally or substantively
 information that supports a rejection
 information that might not support a rejection
(materiality is not the standard)
 information relevant to patentability under
any nonfrivolous legal theory
Purdue Pharma v. Endo Pharms.,
410 F.3d 690 (Fed. Cir. 2005)





District court’s inequitable conduct finding
affirmed
Purdue repeatedly told the examiner what it had
“discovered,” and its surprising “result”
Statements were made to overcome obviousness
rejection
Failure to disclose that the discovery was an
insight, not a result, was material
Purdue intentionally misled the PTO
Novo Nordisk Pharms. v. BioTechnology Gen., ___ F.3d ____, 2005 WL
2443857 (Fed. Cir. Oct. 5, 2005)



District court found inequitable conduct based on:
 Examiner relied on Example 1 to support enablement
 Board relied on Novo’s expert testimony about Example 1 to support
enablement in an interference proceeding
 Novo failed to disclose that Example 1 had never been performed
 Novo failed to disclose that it had not been able to perform Example 1
successfully
Novo argued that district court erred because:
 It did not make a finding that anyone had actual knowledge that
Example 1 was prophetic
 It did not make a finding that anyone had actual knowledge that
Example 1 never worked
 It did not make a finding that the author of Example 1 had actual
knowledge that a prophetic example in the past tense is not good
procedure
Federal Circuit rejected Novo’s “circular logic”
OBVIOUSNESS

Range overlapping prior art range prima facie
obvious
 In re Harris, 409 F.3d 1339 (Fed. Cir. 2005)
 Harris sharply distinguishes, and may limit,
dictum in In re Peterson, 315 F.3d 1325 (Fed.
Cir. 2003)

Case to watch: Teleflex, Inc. v. KSR Int’l Co.,
119 Fed. Appx. 282 (Fed. Cir. 2005) (nonprecedential), cert. petition pending at the
Supreme Court
In re Harris,,
409 F.3d 1339 (Fed. Cir. 2005)
(nickel-base superalloy comprising nickel plus
percentages of 12 other elements)


Reaffirms prima facie obviousness if prior
art discloses overlapping ranges
Distinguishes dictum in earlier opinion
about “broad” ranges in prior art
CLAIM CONSTRUCTION

PTO applies the broadest reasonable
interpretation in light of the
specification

Do dictionaries trump the specification?
Phillips v. AWH Corp.,
415 F.3d 1303 (Fed. Cir. 2005)
Issue: extent to which specification is used for
finding proper scope of claims
 person of ordinary skill reads the claim in context
of entire patent
 specification: the single best guide to the
meaning of a disputed term, note 37 CFR
1.75(d)(1)
 prosecution history: created by patentee in
attempting to explain the invention
 extrinsic evidence less reliable than patent and
prosecution history
Phillips (cont.)
Why extrinsic evidence is less reliable than intrinsic
evidence:
 Not part of the patent
 Extrinsic pubs may not be written by or for
skilled artisans
 Bias not present in intrinsic evidence
 Unbounded universe of marginally relevant
extrinsic evidence
 Undue reliance on extrinsic evidence risks
changing the meaning of claims
Phillips (cont.)
Problems arise if a dictionary is given more
weight than the specification:
 focus on the abstract meaning of words
rather than on the meaning of claim terms
within the context of the patent
 collection of multiple definitions from
common to obscure may extend patent
protection beyond what should properly be
afforded
Nystrom v. Trex, ___ F.3d ___, 2005
WL 2218631 (Fed. Cir. Sept. 14, 2005)
Pre-Phillips decision (dictionary meaning + no scope
disclaimer) withdrawn !
 “board” not limited to boards of wood
 “manufactured” not limited to processes of woodworking
techniques
 finding of non-infringement reversed
Post-Phillips decision turns on context of written description
and prosecution history
 “board” is limited to boards of wood
 “manufactured” is limited to processes of woodworking
techniques
 finding of non-infringement affirmed
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