Recent Developments in the Law - Impact on Biotechnology

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5 Δεκ 2012 (πριν από 4 χρόνια και 11 μήνες)

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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)


mammalian and vertebrate cells


Union Oil Co. of Cal. v. Atlantic Richfield
, 208 F.3d 989
(Fed. Cir. 2000)


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
non
seamless
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. Bio
-
Technology 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) (non
-
precedential),
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

THANK YOU

stephen.walsh@uspto.gov

(571) 272
-
9035