recent biotech case law stephen walsh, ph.d., j.d. associate solicitor prepared for...
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RECENT BIOTECH CASE LAW
Stephen Walsh, Ph.D., J.D. Stephen Walsh, Ph.D., J.D. Associate SolicitorAssociate Solicitor
Prepared for Biotech/Chem/Pharm CustomerPrepared for Biotech/Chem/Pharm Customer
Partnership Meeting, November 10, 2005Partnership Meeting, November 10, 2005
Today’s topics
WRITTEN DESCRIPTIONWRITTEN DESCRIPTION UTILITYUTILITY DISCLOSING INFORMATION TO THE DISCLOSING INFORMATION TO THE
PTOPTO OBVIOUSNESSOBVIOUSNESS CLAIM CONSTRUCTIONCLAIM CONSTRUCTION
WRITTEN DESCRIPTION
Case law includes several tests for Case law includes several tests for written description, including written description, including possession, but two themes are re-possession, but two themes are re-emerging in recent decisions. emerging in recent decisions.
Is the Federal Circuit’s written Is the Federal Circuit’s written description jurisprudence converging?description jurisprudence converging?
Possession Tests
Variety of ways disclosure could show Variety of ways disclosure could show possession such as:possession such as:
Described an actual reduction to practiceDescribed an actual reduction to practice Showed the invention was ready for Showed the invention was ready for
patenting such as by the disclosure of patenting such as by the disclosure of drawings or structural chemical formulas drawings or structural chemical formulas showing the invention was completeshowing the invention was complete
Described distinguishing identifying Described distinguishing identifying characteristics sufficient to show possessioncharacteristics sufficient to show possession
Other….Other….
What Are Distinguishing Identifying Characteristics?
Complete or partial structureComplete or partial structure Other physical and/or chemical propertiesOther physical and/or chemical properties Functional characteristics when coupled Functional characteristics when coupled
with a known or disclosed correlation with a known or disclosed correlation between function and structurebetween function and structure
Some combination of such characteristicsSome combination of such characteristics
Themes Re-emerging In Recent Written Description Cases
MPEP 2163 II.A.2:MPEP 2163 II.A.2:Inverse correlation between level of skill and Inverse correlation between level of skill and knowledge in the art and the amount of knowledge in the art and the amount of description needed – what is already known does description needed – what is already known does not have to be repeated in the specificationnot have to be repeated in the specification
MPEP 2163 II.A.3.ii:MPEP 2163 II.A.3.ii:Predictability in genus/species cases – Predictability in genus/species cases – representative number inverse function of level representative number inverse function of level of skill and knowledge in the artof skill and knowledge in the art
First re-emergent theme: credit for what is already known
Capon v. Eshhar,Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005)418 F.3d 1349 (Fed. Cir. 2005) old DNAs fused to make chimeric genesold DNAs fused to make chimeric genes
Amgen v. Hoecsht Marion RousellAmgen v. Hoecsht Marion Rousell, 314 F.3d 1313 , 314 F.3d 1313 (Fed. Cir. 2003)(Fed. Cir. 2003) mammalian and vertebrate cellsmammalian and vertebrate cells
Union Oil Co. of Cal. v. Atlantic RichfieldUnion Oil Co. of Cal. v. Atlantic Richfield, 208 F.3d , 208 F.3d 989 (Fed. Cir. 2000)989 (Fed. Cir. 2000) gasoline formulationsgasoline formulations
Ralston Purina Co. v. Far-Mar-Co, Inc.Ralston Purina Co. v. Far-Mar-Co, Inc., 772 F.2d , 772 F.2d 1570 (Fed. Cir. 1985)1570 (Fed. Cir. 1985) food productfood product
Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005)
Claims directed to chimeric genes to be Claims directed to chimeric genes to be made from known DNA sequences of made from known DNA sequences of known function using known proceduresknown function using known procedures
The Board found that “persons having The Board found that “persons having ordinary skill would not have been able to ordinary skill would not have been able to visualize and recognize the identity of the visualize and recognize the identity of the claimed genetic material without claimed genetic material without considering additional knowledge in the considering additional knowledge in the art, performing additional art, performing additional experimentation, and testing to confirm experimentation, and testing to confirm results”results”
Capon (cont.)
The Court explained:The Court explained: ““descriptive text needed . . . varies with the descriptive text needed . . . varies with the
nature and scope of the invention at issue, nature and scope of the invention at issue, and and with the scientific and technologic with the scientific and technologic knowledge already in existenceknowledge already in existence””
““as each field evolves, the balance also as each field evolves, the balance also evolves between what is known and what is evolves between what is known and what is added by each inventive contribution”added by each inventive contribution”
““Board’s rule . . . is an inappropriate Board’s rule . . . is an inappropriate generalization” generalization”
A very old theme
Loom Co. v. HigginsLoom Co. v. Higgins, 105 U.S. 580, 586 , 105 U.S. 580, 586 (1881)(1881)
The inventor “may begin at the point The inventor “may begin at the point where his invention begins, and describe where his invention begins, and describe what he has made that is new, and what what he has made that is new, and what it replaces of the old. it replaces of the old. That which is That which is common and well known is as if it common and well known is as if it were written out in the patentwere written out in the patent and and delineated in the drawings.”delineated in the drawings.”
Second re-emergent theme: predictability in genus claims
In re LukachIn re Lukach, 442 F.2d 967, 968 (CCPA , 442 F.2d 967, 968 (CCPA 1971)1971)
““[W]here an applicant claims, as here, a [W]here an applicant claims, as here, a class of compositions, he must class of compositions, he must describe that class in order to meet describe that class in order to meet the description requirement of the the description requirement of the statute.”statute.”
Really an old theme: predictability in the art
Holland Furniture Co. v. Perkins Glue Holland Furniture Co. v. Perkins Glue Co.Co., 277 U.S. 245, 256 (1928) , 277 U.S. 245, 256 (1928)
““an inventor may not describe a an inventor may not describe a particular starch glue which will particular starch glue which will perform the function of animal glue perform the function of animal glue and then claim all starch glues which and then claim all starch glues which have those functions”have those functions”
Univ. Of Rochester v. G.D. Searle & Co., 358 F.3d 916 (Fed. Cir. 2004)
Paraphrased claim:Paraphrased claim: A method of selectively inhibiting an A method of selectively inhibiting an enzyme comprising administering a selective inhibitor.enzyme comprising administering a selective inhibitor.
District court found no disclosure of selective inhibitor District court found no disclosure of selective inhibitor structure or physical properties, and selective inhibitor structure or physical properties, and selective inhibitor structure could not be deduced from any known structure could not be deduced from any known structure.structure.
The claimed method was not adequately described.The claimed method was not adequately described. A “reach through” claim?A “reach through” claim?
In re Curtis, 354 F.3d 1347 (Fed. Cir. 2004)
Claim:Claim: Dental floss “having a coating of at least one Dental floss “having a coating of at least one material capable of increasing the coefficient of material capable of increasing the coefficient of friction.”friction.”
Generic claim was not supported by parent application Generic claim was not supported by parent application disclosing one microcrystalline wax coating.disclosing one microcrystalline wax coating.
““[A] patentee will not be deemed to have invented [A] patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of species sufficient to constitute the genus by virtue of having disclosed a single species when . . . the having disclosed a single species when . . . the evidence indicates ordinary artisans could not predict evidence indicates ordinary artisans could not predict the operability . . . of any other species.”the operability . . . of any other species.”
In re Wallach,378 F.3d 1330 (Fed. Cir. 2004)
Claim:Claim: Isolated DNA encoding TBP-II. Isolated DNA encoding TBP-II. Inventor described the purified protein TBP-II by its Inventor described the purified protein TBP-II by its
molecular weight, biological activity, and a partial molecular weight, biological activity, and a partial amino acid sequence listing ten amino acids.amino acid sequence listing ten amino acids.
Credited with possession of the genus of DNA Credited with possession of the genus of DNA molecules encoding the partial protein structure, molecules encoding the partial protein structure, but not DNA encoding the entire protein.but not DNA encoding the entire protein.
No evidence that there is any known or disclosed No evidence that there is any known or disclosed correlation between the combination of a partial correlation between the combination of a partial structure of a protein, the protein’s biological structure of a protein, the protein’s biological activity, and the structure of the DNA encoding the activity, and the structure of the DNA encoding the protein.protein.
Bilstad v. Wakalopulos, 386 F.3d 1116 (Fed. Cir. 2004)
sterilizing apparatussterilizing apparatus
““if the art is unpredictable, then disclosure if the art is unpredictable, then disclosure of more species is necessary to adequately of more species is necessary to adequately show possession of the entire genus”show possession of the entire genus”
Remanded for further fact finding on the Remanded for further fact finding on the understanding of predictability in this art 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)digital image transform process (DWT) Specification described a particular Specification described a particular
seamless DWT algorithm, but claim also seamless DWT algorithm, but claim also covered a covered a nonnonseamless algorithmseamless algorithm
Person of skill in the art would not have Person of skill in the art would not have understood LizardTech to have invented a understood LizardTech to have invented a method for DWT except by the particular method for DWT except by the particular disclosed methoddisclosed method
Time out for a tip about a process described in a provisional application Provisional applications don’t have claimsProvisional applications don’t have claims A spec that describes only one order of A spec that describes only one order of
steps might not cover another ordersteps might not cover another order Process claims are construed to cover any Process claims are construed to cover any
order, but specs are notorder, but specs are not Be alert to unintended process limitationsBe alert to unintended process limitations In re HolcombIn re Holcomb, No. 04-1550 (Fed. Cir. , No. 04-1550 (Fed. Cir.
April 14, 2004)April 14, 2004)
UTILITY
Section 101: Section 101: “any new and “any new and usefuluseful . . . .” . . . .”
““Useful” means that a Useful” means that a specificspecific and and substantialsubstantial utility is utility is currently availablecurrently available..
In re Fisher, 421 F.3d 1365 (Fed. Cir. 2005)
Nucleic acid comprising any of SEQ ID NO:1 Nucleic acid comprising any of SEQ ID NO:1 to 5to 5
SEQ ID NO:1 to 5 are ESTs characterized as SEQ ID NO:1 to 5 are ESTs characterized as being from corn leavesbeing from corn leaves
Proposed uses: chromosome marker, Proposed uses: chromosome marker, measure mRNA levels, primers, find measure mRNA levels, primers, find polymorphisms, isolate promoters, control polymorphisms, isolate promoters, control expression, locate other organism moleculesexpression, locate other organism molecules
Fisher (cont.)
Board found no specific and substantial Board found no specific and substantial utility, CAFC affirmedutility, CAFC affirmed
Board’s reasoning tracked guidelinesBoard’s reasoning tracked guidelines CAFC agreed that CAFC agreed that Brenner v. MansonBrenner v. Manson, 383 , 383
U.S. 519 (1966), is controlling precedentU.S. 519 (1966), is controlling precedent CAFC agreed that Fisher’s proposed uses CAFC agreed that Fisher’s proposed uses
were the sort of “use-testing” that fails were the sort of “use-testing” that fails under the under the MansonManson standard standard
DISCLOSING INFORMATION TO THE PTO
Star Fruits v. USAStar Fruits v. USA, 293 F.3d 1277 (Fed. Cir. 2005), 293 F.3d 1277 (Fed. Cir. 2005) Rule 105: Applicant must disclose nonfrivolous Rule 105: Applicant must disclose nonfrivolous
information if examiner asks for itinformation if examiner asks for it Purdue Pharma L.P. v. Endo Pharmaceuticals Inc.Purdue Pharma L.P. v. Endo Pharmaceuticals Inc., 410 , 410
F.3d 690 (Fed. Cir. 2005)F.3d 690 (Fed. Cir. 2005) Rule 56: Applicant must disclose material information Rule 56: Applicant must disclose material information
without being asked for itwithout being asked for it past tense for prophetic example violated duty of past tense for prophetic example violated duty of
candorcandor Novo Nordisk v. BioTechnology Gen.Novo Nordisk v. BioTechnology Gen., ___ F.3d ____, 2005 , ___ F.3d ____, 2005
WL 2443857 (Fed. Cir. Oct. 5, 2005)WL 2443857 (Fed. Cir. Oct. 5, 2005) past tense for prophetic example violated duty of past tense for prophetic example violated duty of
candorcandor
Star Fruits v. USA,393 F.3d 1277 (Fed. Cir. 2005)
37 C.F.R. 37 C.F.R. § 1.105 (§ 1.105 (Rule 105): Rule 105):
Office may require applicant to submit Office may require applicant to submit information information reasonably necessaryreasonably necessary to examine or treat a matterto examine or treat a matter
Star Fruits (cont.)
Rule 105 authorizes PTO to require Rule 105 authorizes PTO to require applicants to provide:applicants to provide:
information relevant to examination information relevant to examination procedurally or substantivelyprocedurally or substantively
information that supports a rejectioninformation that supports a rejection information that might not support a information that might not support a
rejection (materiality is not the rejection (materiality is not the standard)standard)
information relevant to patentability information relevant to patentability under any nonfrivolous legal theoryunder any nonfrivolous legal theory
Purdue Pharma v. Endo Pharms.,
410 F.3d 690 (Fed. Cir. 2005) District court’s inequitable conduct finding District court’s inequitable conduct finding
affirmedaffirmed Purdue repeatedly told the examiner what Purdue repeatedly told the examiner what
it had “discovered,” and its surprising it had “discovered,” and its surprising “result”“result”
Statements were made to overcome Statements were made to overcome obviousness rejectionobviousness rejection
Failure to disclose that the discovery was Failure to disclose that the discovery was an insight, not a result, was materialan insight, not a result, was material
Purdue intentionally misled the PTO 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: District court found inequitable conduct based on: Examiner relied on Example 1 to support enablementExaminer relied on Example 1 to support enablement Board relied on Novo’s expert testimony about Example 1 to support Board relied on Novo’s expert testimony about Example 1 to support
enablement in an interference proceedingenablement in an interference proceeding Novo failed to disclose that Example 1 had never been performedNovo failed to disclose that Example 1 had never been performed Novo failed to disclose that it had not been able to perform Example Novo failed to disclose that it had not been able to perform Example
1 successfully1 successfully Novo argued that district court erred because:Novo argued that district court erred because:
It did not make a finding that anyone had It did not make a finding that anyone had actual knowledgeactual knowledge that that Example 1 was propheticExample 1 was prophetic
It did not make a finding that anyone had It did not make a finding that anyone had actual knowledgeactual knowledge that that Example 1 never workedExample 1 never worked
It did not make a finding that the author of Example 1 had It did not make a finding that the author of Example 1 had actual actual knowledgeknowledge that a prophetic example in the past tense is not good that a prophetic example in the past tense is not good procedureprocedure
Federal Circuit rejected Novo’s “circular logic”Federal Circuit rejected Novo’s “circular logic”
OBVIOUSNESS Range overlapping prior art range Range overlapping prior art range prima prima
faciefacie obvious obvious In re HarrisIn re Harris, , 409 F.3d 1339 (Fed. Cir. 2005)409 F.3d 1339 (Fed. Cir. 2005) HarrisHarris sharply distinguishes, and may sharply distinguishes, and may
limit, dictum in limit, dictum in In re PetersonIn re Peterson, , 315 F.3d 315 F.3d 1325 (Fed. Cir. 2003)1325 (Fed. Cir. 2003)
Case to watch: Case to watch: Teleflex, Inc. v. KSR Int’l Teleflex, Inc. v. KSR Int’l Co.Co., 119 Fed. Appx. 282 (Fed. Cir. 2005) , 119 Fed. Appx. 282 (Fed. Cir. 2005) (non-precedential), (non-precedential), cert.cert. petition pending at petition pending at the Supreme Courtthe Supreme Court
In re Harris,, 409 F.3d 1339 (Fed. Cir. 2005)
(nickel-base superalloy comprising nickel plus (nickel-base superalloy comprising nickel plus percentages of 12 other elements)percentages of 12 other elements)
Reaffirms Reaffirms prima facieprima facie obviousness if obviousness if prior art discloses overlapping rangesprior art discloses overlapping ranges
Distinguishes dictum in earlier opinion Distinguishes dictum in earlier opinion about “broad” ranges in prior artabout “broad” ranges in prior art
CLAIM CONSTRUCTION
PTO applies the broadest PTO applies the broadest reasonable interpretation in light of reasonable interpretation in light of the specificationthe specification
Do dictionaries trump the Do dictionaries trump the specification?specification?
Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005)
Issue:Issue: extent to which specification is used for extent to which specification is used for finding proper scope of claimsfinding proper scope of claims
person of ordinary skill reads the claim in person of ordinary skill reads the claim in context of entire patent context of entire patent specification: the single best guide to the specification: the single best guide to the
meaning of a disputed term, note 37 CFR meaning of a disputed term, note 37 CFR 1.75(d)(1)1.75(d)(1)
prosecution history: created by patentee in prosecution history: created by patentee in attempting to explain the inventionattempting to explain the invention
extrinsic evidence less reliable than patent and extrinsic evidence less reliable than patent and prosecution historyprosecution history
Phillips (cont.)
Why extrinsic evidence is less reliable than Why extrinsic evidence is less reliable than intrinsic evidence:intrinsic evidence:
Not part of the patentNot part of the patent Extrinsic pubs may not be written by or for Extrinsic pubs may not be written by or for
skilled artisansskilled artisans Bias not present in intrinsic evidenceBias not present in intrinsic evidence Unbounded universe of marginally relevant Unbounded universe of marginally relevant
extrinsic evidenceextrinsic evidence Undue reliance on extrinsic evidence risks Undue reliance on extrinsic evidence risks
changing the meaning of claimschanging the meaning of claims
Phillips (cont.)
Problems arise if a dictionary is given Problems arise if a dictionary is given more weight than the specification:more weight than the specification:
focus on the focus on the abstractabstract meaning of words meaning of words rather than on the meaning of claim rather than on the meaning of claim terms within the terms within the contextcontext of the patent of the patent
collection of multiple definitions from collection of multiple definitions from common to obscure may extend patent common to obscure may extend patent protection beyond what should properly protection beyond what should properly be affordedbe afforded
Nystrom v. Trex, ___ F.3d ___, 2005 WL 2218631 (Fed. Cir. Sept. 14, 2005)
Pre-Pre-PhillipsPhillips decision (dictionary meaning + no scope decision (dictionary meaning + no scope disclaimer) disclaimer) withdrawnwithdrawn ! !
““board” not limited to boards of woodboard” not limited to boards of wood ““manufactured” not limited to processes of manufactured” not limited to processes of
woodworking techniqueswoodworking techniques finding of non-infringement finding of non-infringement reversedreversedPost-Post-PhillipsPhillips decision turns on context of written decision turns on context of written
description and prosecution historydescription and prosecution history ““board” is limited to boards of woodboard” is limited to boards of wood ““manufactured” is limited to processes of woodworking manufactured” is limited to processes of woodworking
techniquestechniques finding of non-infringement finding of non-infringement affirmedaffirmed
