Biopharma Patent

8/6/2019 Biopharma Patent

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Copyright 2003 Schwegman, Lundberg, Woessner & Kluth, P.A.

Claim Drafting:

Bio/Pharma

Presented by:

Jan Embretson Patti Jurkovich

Brad Forrest Gary Speier Katy Jackson Leif Stordal


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Hot Topics

Presented by:Brad Forrest


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Hot Topics

Unity of InventionProposal in USPTO

Importing prescription drugsPatent fees update

Minton, on sale bar (lease)EZ Doc


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Preambles

Presented by:Leif Stordal


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Preambles

Preamble statements that limit structure

are treated as claim limitations

Pac-Tec Inc. v. Amerace Corp., 14

U.S.P.Q.2d 1871 (Fed. Cir. 1990). The court in Pac-Tec opined that

structural limitations recited within the

preamble of a claim are structural

limitations to the claim. Pac-Tec at 1876.


6/87Copyright 2003 Schwegman, Lundberg, Woessner & Kluth, P.A.

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Preamble terms that provide antecedent

basis may be treated as claim limitations Rappoport v. Dement, 254 F.3d 1053; 59 U.S.P.Q.2d 1215 (Fed. Cir.

2001).

This case was an appeal challenging the award of priority by the Boardof Patent Appeals and Interferences regarding an interference count.The count reads as follows:

"A method for treatment of sleep apneas comprising administration of atherapeutically effective amount of a Formula I azapirone compound ora pharmaceutically effective acid addition salt thereof to a patient in

need of such treatment ...." Id. at 1057. The Appellant (Rappoport) asserts that "treatment of sleep apneas" in

the interference count includes treatment of underlying disorder andthe symptomatology associated with the occurrence of sleep apneas.Id. at 1060.

The court opined, "[There is no dispute in this case that the phraseshould be treated as a claim limitation. Moreover, without treating thephrase "treatment of sleep apneas" as a claim limitation, the phrase "toa patient in need of such treatment" would not have a properantecedent basis." Id. at 1060. The court further stated, "We thereforeconclude that the Board was correct in interpreting "treatment of sleep

apneas" as being limited to treatment of the underlying sleep apneadisorder, i.e., reducing the frequency and severity of the apneaepisodes during sleep." Id. at 1060.



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Preamble terms that provide utility to

claimed methods may be limiting

Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 65U.S.P.Q.2d 1961 (Fed. Cir. 2003) The term "isolating" as used within claim 1 came into issue in this case.

Claim 1 refers to a method of growing and isolating swine infertility andrespiratory syndrome virus, ATCC-VR2332, which comprisesinoculating the virus on a full or partial sheet of simian cells in the

presence of serum in a suitable growth medium and incubating theinoculated cell sheet at about 34oC. to 37oC. until CPE (cytopathiceffect) is observed. (U.S. Patent No: 5,476,778).

In this case, the term "isolating" was determined to be a limitation of theclaim because it was recognized as being part of the definition of theclaimed subject matter. As stated by the court, "Divorced from theprocess of growing and isolating virus, the claimed method reduces tonothing more than a process for producing cytopathic effects in sheetsof cultured MA-104 cells - a process whose absence of fathomableutility rather suggests the academic exercise."

Accordingly, a preamble term that provides a utility for a claimed

method will likely be limiting.



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Preamble statements that recite an intended purpose

or use are generally not considered claim limitations

C.R. Bard, Inc. v. M3 Systems, Inc., 48 USPQ2d 1225 (Fed. Cir.1998), rehearing denied & suggestion for rehearing in bancdeclined, 161 F.3d 1380 (Fed. Cir 1998). "A preamble may serve a variety of purposes, depending on its

content. It may limit the scope of the claim, for example whenpatentability depends on limitations stated in the preamble, asin In re Stencel, 828 F.2d 751, 754, 4 USPQ2d 1071, 1073(Fed. Cir. 1987), or when the preamble contributes to thedefinition of the claimed invention, as in Bell CommunicationsResearch, Inc. v. Vitalink Communications Corp., 55 F.3d 615,620, 34 USPQ2d 1816, 1820 (Fed. Cir. 1995). In this case,however, the preamble simply states the intended use or

purpose of the invention, as in Loctite Corp. v. Ultraseal Ltd.,781 F.2d 861, 868, 228 USPQ 90, 94 (Fed. Cir. 1985). Such apreamble usually does not limit the scope of the claim unlessthe preamble provides anticedents for ensuing claim terms andlimits the claims accordingly." Bard at 1230-1231.



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Practice Tip Terms found in the preamble that provide a utility for the claimed

invention will likely limit the claim Examples of such terms include: isolate, purify, and detect

Define utility providing terms within the specification broadly toavoid severely limiting claim

Terms found in the preamble that define structure will likely limit

the claim Define such terms broadly within the specification

Draft claims to define structure within the body of the claim toavoid limitation by preamble

Terms found in the preamble that provide antecedent basis willlikely limit the claim Use terms in the preamble that do not provide antecedent basis

for claim

Use antecedent providing terms in the preamble that have a

broad scope to avoid severely limiting the claim


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Process Claims



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Process Claims

35 U.S.C. 271(g)

"Whoever without authority imports into the

United States or offers to sell, sells, or uses

within the United States a product which is

made by a process patented in the United

States shall be liable as an infringer, if the

importation, offer to sell, sale, or use of the

product occurs during the term of such

process patent."



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Application toward Biotechnology

Include claims to processes used to create

biological materials to protect those materialsunder 35 U.S.C. 271(g)

Examples: Claim processes used to produce antibodies,

express polypeptides, create transgenic plants

and animals, and create claimed cells.


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Product-by-Process Claims



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Product-by-Process Claims A "product-by-process" claim defines a product by the process

used to make the product.

Representative Historical Cases In re Brown, 173 USPQ 685 (CCPA 1972)

"It must be admitted, however, that the lack of physicaldescription in a product-by-process claim makes determinationof the patentability of the claim more difficult, since in spite ofthe fact that the claim may recite only process limitations, it isthe patentability of the product claims and not of the recitedprocess steps which must be established." Brown at 688.

In re Marosi, 218 USPQ 289 (Fed.Cir. 1983).

"Where a product-by-process claim is rejected over a prior artproduct that appears to be identical, although produced by adifferent process, the burden is upon the applicants to comeforward with evidence establishing an unobvious differencebetween the claimed product and the prior art product."(citations omitted). Marosi at 293.



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In re Thorpe, 227 USPQ 964 (Fed. Cir.

1985). "Product-by-process claims are not specifically discussed in the

patent statute. The practice and governing law have developed

in response to the need to enable an applicant to claim anotherwise patentable product that resists definition by other thanthe process by which it is made. For this reason, even thoughproduct-by-process claims are limited by and defined by theprocess, determination of patentability is based on the product

itself." (citing In re Brown, 173 USPQ 685 (CCPA 1972 ); In rePilkington, 162 USPQ 145 (CCPA 1969); Buono v. Yankee MaidDress Corp., 26 USPQ 57 (2d Cir. 1935). Thorpe at 966.

The Court went on to say that, "The patentability of a productdoes not depend on its method of production." (citationsomitted). "If the product in a product-by-process claim is thesame as or obvious from a product of the prior art, the claim isunpatentable even thought the prior product was made by adifferent process." (citations omitted). Thorpe at 966.



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Product-by-process claims addressed by two

panels of the United States Court of Appeals for

the Federal Circuit Scripps Clinic & Research Foundation v. Genentech, Inc., 927

F.2d 1565, 18 U.S.P.Q. 1001 (Fed. Cir. 1991)

In Scripps, a panel composed of Judges Markey, Newman andBeer ruled that, "In determining patentability we construe theproduct as not limited by the process stated in the claims.Since claims must be construed the same way for validity andfor infringement, the correct reading of product-by-process

claims is that they are not limited to product prepared by theprocess set forth in the claims." Scripps at 1583.

Atlantic Thermoplastics Co. v. Faytex Corp., 970 F.2d 834, 23U.S.P.Q.2d 1481 (Fed. Cir. 1992) In Atlantic, a panel composed of Judges Archer, Michel and

Rader ruled that, "In light of Supreme Court caselaw and thehistory of product-by-process claims, this court acknowledgesthat infringement analysis proceeds with reference to the patentclaims. Thus, process terms in product-by-process claimsserve as limitations in determining infringement." Atlantic at

846-847.


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Representative Federal Circuit Cases

Dealing with Product-by-Process Claims Mentor Corp. v. Coloplast, Inc., 998 F.2d 992, 27 U.S.P.Q.2d

1521 (Fed. Cir. 1993).

In Mentor, the plaintiff argued that their claims to a malecondom catheter in which an adhesive was transferred from anouter surface to an inner surface were product-by-processclaims. The Federal Circuit declined to classify the claims asproduct by process claims. "The claims in issue here are not in

fact product-by-process claims; product-by-process claimsrecite how a product is made, not how it is used." Mentor at997. The Federal Circuit ruled that the defendants device"excludes the transfer of adhesive from the outer to innersurface" and therefore did not infringe the claims. Mentor at

997. Stryker Corp. v. Davol Inc., 234 F.3d 1252, 1258, 57 U.S.P.Q.2d

1133 (Fed. Cir. 2000). In Stryker, the Federal Circuit declined to impute functional

limitations from the specification into a claim term when the

claim term was defined structurally and not functionally in theclaims.


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Vanguard Products Corp. v. Parker Hannifin

Corp., 234 F.3d 1370, 57 U.S.P.Q.2d 1087 (Fed.

Cir. 2000).

The defendant argued that the accused product did not infringethe claims because it was made by a different process than theclaimed product, even though it was conceded that the accusedproduct had the same properties as the claimed product. TheFederal Circuit declined to limit the scope of the claims to

include the method of manufacture and affirmed the finding ofinfringement.

"The method of manufacture, even when cited asadvantageous, does not of itself convert product claims intoclaims limited to a particular process. We agree with the district

court that the word "integral" describes the relationship betweenthe elastomeric layers, not the means of joining them. Thisword did not limit the claim to the manufacturing process setforth in the specification. A novel product that meets the criteriaof patentability is not limited to the process by which it wasmade." Vanguard at 1372.


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Representative District Court Cases

Dealing with Product-by-Process Claims

Tropix, Inc. v. Lumigen, Inc., 825 F.Supp. 7, 10; 27

U.S.P.Q.2d 1475 (D. Mass. 1993). The District Court for the District of Massachusetts

applied Atlantic to limit the scope of a product-by-processclaim to the process used to produce a product, and notthe product itself. The basis of the decision was that it

appeared from the record "that a majority of the judges ofthe Federal Circuit would rule that Atlantic states thecontrolling law." In a later grant of partial summary

judgment for noninfringement, process steps used within

the product-by-process claim at issue were consideredduring the infringement analysis. The district courtgranted partial summary judgment for noninfringementbased on a different process step being used by thedefendant to produce the product. Thus, process steps

were read into the product-by-process claim as elementsto be used during the infringement analysis.

T t f C l bi U i R h


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Trustees of Columbia Univ. v. Roche

Diagnostics Gmbh, 126 F.Supp.2d 16, 57

U.S.P.Q.2d 1825 (D. Mass. 2000).

The District Court for the District of Massachusetts has

also applied Scripps to interpret product-by-processclaims as not being limited to the product prepared by theprocess set forth in the claims. The district court inColumbia noted the direct conflict in the law concerning

product-by-process claims as put forth by Atlantic andScripps. In deciding the case, the district court applied thedirect conflict rule to determine which law to apply. "Whenconfronted with two panel opinions in direct conflict, the

earlier decision is controlling." Columbia at 48 (citationsomitted). "Accordingly, the product by process claims shallbe interpreted so that "they are not limited to productprepared by the process set forth in the claims.""

Columbia at 49 (quoting Scripps, 927 F.2d 1565, 1583).

D K lb G i C N h Ki C


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DeKalb Genetics Corp. v. Northrup King Co.,

1997 U.S. Dist. LEXIS 14275 (N.D. Ill. Aug. 14,

1997)

The District Court for the Northern District of Illinois,

Western Division applied Scripps to deny a motionfor partial summary judgment for patent infringement.

Union Carbide Chems. & Plastics Tech. Corp. v.Shell Oil Co., 163 F.Supp.2d 426 (D. Del. 2001).

Atlantic was applied to case transferred to the DistrictCourt for the District of Delaware to limit a product-by-process claim based on a process step in the claim.

Smithkline Beecham Corp. v. Geneva Pharms., 2002

U.S. Dist. LEXIS 25275 (E.D. Penn. 2002). Scripps was applied to find product-by-process claims

invalidate for anticipation based on prior art product.


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Practice Tip

Include Product-by-Process claims in current

applications

Don't lose anything if court includes process

limitations during claim interpretation

Obtain product claim to product if court does

not include process limitations


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Restriction Practice

Presented by:

Katy Jackson


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Restriction Practice

35 U.S.C. 121 : "if two or more independent

and distinct inventions are claimed in oneapplication, the Director may require the

application to be restricted to one of the

inventions. MPEP 802.01


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Independent and Distinct Inventions

(MPEP 802.01)

no disclosed relationship between inventions

unconnected in design, operation and effect

Examples

species under a genus which are not usabletogether as discloses

process and apparatus incapable of being

used in practicing the process


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Distinct Inventions

related as disclosed

capable of separate manufacture, use, or

sale

Example DNA, protein and transfected cell


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Serious burden of search must be

shown by the Examiner (MPEP 803)

separate classification

separate status in the art

different field of search


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Examiner divides inventions

requires election of a single disclosed species

only one sequence examined, unless a core

sequence relating sequences structurally to

others is identified (MPEP 803.04)


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The Unity of Invention Standard the application shall relate to one invention or

a group of inventions linked to form a singleinventive concept

common feature (special technical feature orfeatures that define a contribution over the

art) (PCT Rule 13)


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only independent claims are considered

claims are analyzed for a technical

relationship (common structural element) or

single inventive concept Nucleotide sequences that encode the same

protein will be examined together

see Fed. Reg., Vol. 68, No. 97, Tuesday, May20, 2003 Notices

The Unity of Invention Standard


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Examples a process, and the apparatus for carrying out

the process;

a process for making product and the product

made; an apparatus, and the product made by the

apparatus

a product, and the process of using theprocess


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Strategies to minimize the number of groups

talk with examiner and supervisor

use linking claims if possible

rejoinder (MPEP 821.04)

petition


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Linking claim strategy (MPEP 809)

"one or more claims inseparable from claims

to two or more otherwise properly divisibleinventions"

Impact connects claims to otherwise divisible

inventions

if allowed, linked claims are rejoined


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Types of Linking Claims genus claims linking species claims

process of making a product linking proper

process and product claims

"means" for practicing a process linkingproper apparatus and process claims

claim to the product linking a process of

making and a process of using


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Example A composition for reducing HIV viral load in an

HIV-infected patient, comprising an agent thatinhibits viral replication and a pharmaceutically

acceptable carrier.

The composition of claim 1, wherein the agent isa polypeptide having the amino acid sequence of

SEQ ID NO:2.

The composition of claim 1, wherein the agent is

a polynucleotide having the sequence of SEQ ID

NO:5.


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In re Ochiai Rejoinder Practice

(MPEP 821.04)

Proper restriction between product and

process claims

Applies only where product claims are

elected Requires allowable product claim

Applies only to process claims that depend

from or include all the limitations of theallowable product claim


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Practice tips draft application with linking claims keeping

the likely restriction groups in mind

call the Examiner to discuss linking claim

options

draft claims in more of a EP style to

emphasize the core invention


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Definitions


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Canons of claim construction intrinsic evidence of record controls

the patent itself

claims

specification prosecution history

dictionaries, encyclopedias and treatises Texas Digital Systems, Inc. v. Telegenix Inc., 308 F.3d 1193,

64 USPQ 2d 1812 (Fed. Cir. 2002);

Intellectual Property Development v. UA-Columbia Cablevision

of Westchester, No. 02-124 (Fed.Cir. July 21, 2003).


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Common and Relative Terms treat common words as carefully as technical

terms Examples

on and onto Inverness Medical Switzerland GmbH v. Warner Lambert

Co., 309 F.3d 1373 (Fed. Cir. 2002)

or Abbot Laboratories and Central Glass Company, Inc. v.

Baxter Pharmaceutical Products, Inc. and BexterHealthcare Corp., Lexis 13507 (Fed. Cir. July 3. 2003).


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About"

Jeneric/Pentron, Inc. v. Dillon Co., Inc., 205 F.3d

1377, 54 U.S.P.Q.2d 1087 (Fed. Cir. 2000)


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Transition Terms

comprising

Invitrogen Corp. v. Biocrest Mfg., L.P., 66

U.S.P.Q.2D 1631 (Fed. Cir., 2003)

"consisting essentially of" "comprising the steps of"

is it necessary that the steps be performed

separately and sequentially?


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Isolating

Boehringer Ingelheim Vetmedica, Inc. v.Schering-Plough Corp. and Schering Corp., 320

F.3d 1339, 65 U.S.P.Q.2d 1961 (Fed. Cir. 2003)

Purifying

Detecting

Example


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Drafting tips

Specify which definition is intendedmultiple common definitions special definition as well as an ordinary

meaning

define and consistently use termsuse equivalent and alternative terms in

the description to broaden the inventionEliminate unnecessary words

see, e.g., Karsten Mfg. Corp. v. Cleveland Golf Co., 242 F.3d 1376, 58U.S.P.Q.2d 1286 (Fed. Cir. 2001)


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Written Description and

EnablementPresented by:

Jan Embretson


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112, First Paragraph

The specification shall contain a written

description of the invention and of the mannerand process of making and using it, in suchfull, clear, concise, and exact terms as to

enable any person skilled in the art to which itpertainsto make and use the same, andshall set forth the best mode contemplated by

the inventor of carrying out his invention.


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Written Description

To satisfy the written description requirement, a

patent specification must describe an invention insufficient detail that one skilled in the art can clearly

conclude that the inventor invented the claimed

subject matter, i.e., that the inventor had possessionof the claimed invention. (Vas-Cath, Inc. v.

Mahurkar, 935 F2d at 1563 (Fed. Cir. 1991).


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Specification & Claims

A vertebrate insulin cDNA

A mammalian insulin cDNA

A human insulin DNA

Method to isolate human

insulin cDNA; Complete

cDNA sequence for rat++

insulin

DNA that codes for humanfibroblast interferon-beta

Method to isolate sequencefor interferon-beta+;

Interferon DNA or a fragment

thereof

ClaimSpecification

+Fiers v. Sugano, 25 USPQ2d 1601 (Fed. Cir. 1993)

++UCa v. Eli Lilly, 43 USPQ2d 1398 (Fed. Cir. 1997)


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In Fiers v. Revel, the Fed. Cir. held in dicta that

product-by-process claims would adequatelydescribe DNA if the disclosed process is enabling:

Our statement in Amgen that conception may occur

inter alia, when one is able to define a chemical by itsmethod of preparation requires that the DNA be

claimed by its method of preparation (25 USPQ2d at

1604-1605)


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Possession can be shown by

I. actual reduction to practice

II. reduction to drawings

III. describe sufficient relevant identifying characteristics

a) complete or partial structure

b) functional characteristics, provided there is a

correlation between structure and function

c) physical characteristicsd) chemical characteristics

e) combination of above

Possession

In re Lundak, 773 F2d 1216 (Fed. Cir. 1985); Pfaff v. Wells Electronics, Inc., 525 US 55 (1998); Regents of UCa v. EliLilly, 119 F3d 1568 (Fed. Cir. 1997); Amgen v. Chugai Pharma., 927 F2d 1200 (Fed. Cir. 1991); Guidelines forExamination of Patent Applications under 35 USC 112(1) Written Description Requirement, Fed. Reg., 66, 1099(2001)


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Satisfactory disclosure of a representative number of

species depends on whether one skilled in the artwould recognize that Applicant was in possession of

the necessary common attributes or features of the

elements possessed by members of the genus.Guidelines for Examination of Patent Applications

under the 35 U.S.C. 112(1) Written Description

Requirement, Fed. Reg., 66, 1099 (2001).


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Examples

Method to detect expression of gene X;

sequence of 2 oligos useful to amplify cDNAof gene X; data that 2 oligos specificallyamplify gene X and not gene Y

Method to identify patients having or at risk ofhaving disease W; sequence of 2 oligosuseful to amplify cDNA of gene Z; data that

overexpression of gene Z correlates withdisease W

E Bi h I G P b I


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Enzo Biochem. Inc. v. Gen-Probe Inc.

et al., 296 F3d 1316 (Fed. Cir. 2002) U.S. Patent No. 4,900,659

A composition of matter that is specific for Neisseria gonorrhoeaecomprising at least one nucleotide sequence for which the ratio of theamount of said sequence which hybridizes to chromosomal DNA ofNeisseria gonorrhoeae to the amount of said sequence whichhybridizes to chromosomal DNA of Neisseria meningitidis is greater

than about five, said ratio being obtained by a method comprising thefollowing steps:

a) providing a radioactively labeled form of said nucleotide sequence;

b) providing a serial dilution series of purified chromosomal DNA fromeach of the N. gonorrhoeae strains; (1) ATCC 53420, (2) ATCC53421, (3) ATCC 54322, (4) STCC 53423, (5) ATCC 53424, (6)ATCC 53425

c) providing a serial dilution series of purified nucleotide sequencesfrom each of the N. meningitidis strains: (1) ATCC 53414, (2) ATCC

53415, (3) ATCC 53416, (4) ATCC 53417, (5) ATCC 53418, (6)ATCC 53419


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4. The composition of claim 1 wherein said

nucleotide sequences are selected from the group

consisting of:

the Neisseria gonorroheae DNA insert of ATCC

53409, ATCC 53410 and ATCC 53411, and discrete

nucleotide subsequences thereof,

mutated discrete nucleotide sequences of any of the

foregoing inserts that are within said hybridization

ratio and subsequences thereof; and mixtures thereof.


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reference in the specification to a deposit in a public depository,

which makes its contents accessible to the public when it is nototherwise available in written form

for biological inventions for which providing a description in

written form is not practicable, patentees may comply with thewritten description requirement by publicly depositing thebiological material

as with possession, proof of a reduction to practice may showpriority of invention or allow one to antedate a reference, but itdoes not by itself provide a written description


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claim a method of growing and isolating

swine infertility and respiratory syndromevirus in simian cells.

claim a method of growing and isolatingattenuated swine infertility and respiratory

syndrome virus in mammalian cells.

Examples

Amgen v Hoechst 314 F3d 1313


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U.S. Patent No. 5,955,422

A pharmaceutical composition comprising a

therapeutically effective amount of human EPO and

a pharmaceutically acceptable diluent, adjuvant or

carrier, wherein said EPO is purified from

mammalian cells grown in culture

Fed. Cir. held that disclosure of 2 types of cells

enabled all mammalian cells, including human cells,and was sufficient written description to support a

product claim. (See Cellpro, 152 F3d at 1361).

Amgen v. Hoechst, 314 F3d 1313,

65 USPQ2d 1391 (Fed. Cir. 2003)


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Both Eli Lilly and Enzo Biochem are inapposite to this

case because the claim terms at issue here are not newor unknown biological materials that ordinarily skilledartisans would easily miscomprehend.

Instead, the claims of Amgens patents refer to types ofcells that can be used to produce recombinant humanEPO. Thus, TKT can only challenge the adequacy ofdisclosure of the vertebrate or mammalian host cell -- notthe human DNA itself. This difference alone sufficientlydistinguishes Eli Lilly, because when used, as here,

merely to identify types of cells (instead of undescribed,previously unknown DNA sequences), the wordsvertebrate and mammalian readily conveydistinguishing information concerning [their] identity suchthat one of ordinary skill in the art could visualize orrecognize the identity of the members of the genus.


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Vertebrate cells which can be propagated in vitro andwhich are capable upon growth in culture of

producing erythropoietin in the medium of their

growth in excess of 100 u of erythropoietin per 106

cells in 48 hours as determined by

radioimmunoassay, said cells comprising non-human

DNA sequences that control transcription of DNA

encoding human erythropoietin.


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The enablement question thus posed is this: havingdisclosed one way to make the claimed EPO-producing

cell, is Amgen entitled to claim all such cells that can bepropagated in vitro, comprise non-human DNAsequences that control transcription, transcribe DNAencoding human erythropoietin, and produce the claimedamount of EPO? While our precedent does hold thatdisclosure of one or two species may not enable a broadgenus, e.g., In re Vaeck, 947 F.2d at 495-96, 20 USPQ2dat 1444-45, the district court made several fact-findingsindicating that any gaps between the disclosures and the

claim breadth could be easily bridged. See, e.g., Amgen,126 F. Supp. 2d at 149, 57 USPQ2d at 1514.


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The district court found that a skilled artisan could readily have

used various cultured vertebrate and mammalian cells toproduce human EPO, and this fact was buttressed by numerouspost-filing publications that demonstrated the extent of theenabling disclosure.

The court also found that for those skilled in the art it was arelatively simple matter to determine whether a certain promoterwould work within a specific vertebrate cell, whether a particular

vertebrate cell would produce human EPO in culture, andwhether a particular promoter could be operatively linked tocontrol the transcription of the human EPO DNA.


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Wands Factors (In re Wands, 858 F2d 731 (Fed.Cir. 1988))

1. Nature of the invention

2. State of the Prior Art

3. Level of Ordinary Skill in the Art

4. Level of Predictability

5. Amount of Direction

6. Presence of a Working Example

7. Breadth of Claims8. Quantity of Experimentation

Post-filing date evidence

Enablement

Plant Genetics Sys v DeKalb Genetics


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Plant Genetics Sys. v. DeKalb Genetics

Corp.,315 F3d 1335 (Fed. Cir. 2003)


A plant cell having a heterologous DNA stablyintegrated into its genome; said DNA comprising a

heterologous DNA fragment encoding a protein

having an acetyl transferase activity whichinactivates a glutamine synthetase inhibitor in said

cell.


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The district court looked into post-1987 reports to

determine whether monocot cells were readilytransformable in 1987 not to show that monocot cells

could be successfully transformed in 1990. A report

of a first success after 1987 is indicative of a failure

or difficulty in or before 1987. Thus, the district courtproperly used later reports as evidence of the state of

the art existing in 1987.

Bristol-Myers Squibb v Rhone-Poulenc


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Bristol Myers Squibb v. Rhone Poulenc

Rorer Inc., 326 F3d 1226 (Fed. Cir. 2003)

U.S. Patent No. 4,924,011; RE 34,277

A method of making 10-deacetylbaccatin III (10-DAB) with an acetyl group, later adding a 3-phenylisoserine side chain to yield taxol.

The district court did not clearly err in concluding thatthe limiting statements in the JACS article withregard to the unsuccessful use of TMS and MOM in

producing taxol would have raised an importantissue in a reasonable examiners mind as to whetherthe inventors had broadened the patent beyond thatlegally permissible based on the examiners reviewof the application for enablement.


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Practice Tips

Written Description

Consider how to structurally and functionally

describe claim elements Disclose relationship(s) between structure and

function

Disclose sources of claim elements with biological

component (representative species) or argueknown or conventional

Differing claim scope (product by process claims)and specification tailored to each

Enablement

Detailed prophetic examples

Differing claim scope

Logical/reasonable extrapolations


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Patentability of Reach-

Through ClaimsPresented by:

Gary Speier


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Exemplary Reach Through Situations

Small moleculeper se claim, where the molecule is definedas binding to target but not yet identified (e.g. A receptor[X] agonist).

Method of screening claim: how effectively does this claim

protect a small molecule identified in the screen? Functional use claim: claim is to a method of treating a

disease by a compound defined not by its structure butrather by its ability to bind to a target (e.g. A method of

treating disease [Y] by administering a compound which isa receptor [X] agonist.


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Major Patentability Issues

Utility (35 U.S.C. 101)

See Utility Examination Guidelines 66 Fed. Reg. 1092 (Jan. 5, 2001)

Written Description (35 U.S.C. 112, 1st para.)

See Written Description Examination Guidelines

66 Fed. Reg. 1099 (Jan. 5, 2001)

Enablement (35 U.S.C. 112, 1st para.)

Novelty (35 U.S.C. 102)

Nonobviousness (35 U.S.C. 103)


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Receptor Agonist Claims

Types of Claims at Issue:

A receptor [X] agonist.

A method of treating disease [Y] by

administering a compound which is a receptor

[X] agonist.


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Major Patentability Issue Written Description

Generic claim to A receptor [X] agonist unlikelyto comply with written description requirement: No description of structure of representative number of

claimed compounds

No description of chemical or physical characteristics ofrepresentative number of claimed compounds or offunction of representative number of claimed compounds(other than binding to identified receptor)

Analogous to Regents of the Univ. of Cal. v. Eli Lilly &

Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997)(description of how to obtain compounds not sufficientwithout description of what the compounds are) See also Flers v. Revel, 984 F.2d 1164, 25 USPQ2d 1601

(Fed. Cir. 1993); In re Ruschig, 379 F.2d 990, 154 USPQ

118 (CCPA 1967)


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Major Patentability Issue Enablement

Specification must teach how to make and use thefull scope of the claimed invention without undueexperimentation.

Apply factors set forth in In re Wands, 858 F.2d

731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) Breadth of the claims

Nature of the invention

State of the prior art

Relative skill of those in the art Level of predictability in the art

Amount of direction provided by the inventor(s)

Existence of any working examples

Quantity of experimentation needed


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Generic claim to A receptor [X] agonist unlikely tocomply with enablement requirement:

The specification does not usually teach how to make

and use the full scope of agonists or antagonists within

that genus without undue experimentation.

Specification usually teaches how to identify

compounds, rather than how to make them;

specification does not usually teach how to use the fullscope of the compounds within the genus without

undue experimentation.


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If a claim to A receptor [X] agonist meets theutility, enablement and written descriptionrequirements, a claim to A method of treating

disease [Y] by administering a compoundwhich is a receptor [X] agonist must still besupported by an enabling disclosure.

Will compound operate as intended withoutundue experimentation?


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Methods of Screening

Major Patentability Issue Utility Requirement met if screening method

identifies a ligand which acts upon a receptor

so as to effect a specific, substantial, andcredible use


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Methods of Screening

Scope of Protection

Claim prevents others from making, using,selling, or offering for sale the claimedscreening method.

A product identified by a screening method isnot a product made by a patented process.

35 U.S.C. 271(g) includes use, sale, orimportation of a product made by a patentedprocess as an act of infringement.

Products Identified by Methods of


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Screening Major Patentability Issue Written Description

Generic claim to A receptor [X] agonist identified

by the screening method unlikely to comply withwritten description requirement: No description of structure of representative number of

claimed compounds

No description of chemical or physical characteristics ofrepresentative number of claimed compounds or offunction of representative number of claimed compounds(other than binding to identified receptor)

Analogous to Regents of the Univ. of Cal. v. Eli Lilly &

Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997)(description of how to obtain compounds not sufficientwithout descriptions of what the compounds are) See also Flers v. Revel, 984 F.2d 1164, 25 USPQ2d 1601

(Fed. Cir. 1993); In re Ruschig, 379 F.2d 990, 154 USPQ118 (CCPA 1967)



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Screening Major Patentability Issue Enablement

Specification must teach how to make and use thefull scope of the claimed invention without undueexperimentation.

Apply factors set forth in In re Wands, 858 F.2d

731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) Breadth of the claims

Nature of the invention

State of the prior art

Relative skill of those in the art Level of predictability in the art

Amount of direction provided by the inventor(s)

Existence of any working examples

Quality of experimentation needed


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International

Considerations

Presented by:Patti J. Jurkovich

Statutory Requirements for


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Statutory Requirements for

Patentability in Foreign Jurisdictions

Common requirements:

1. Novelty

- Europe: absolute novelty

- Grace periods2. Inventive Step

- must identify problem & solution

3. Industrial Applicability


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Patentable Subject Matter

For Europe, Japan and Canada:

Methods of Medical Treatment claims areprohibited.

Composition of matter, process of making a

composition, first medical use of a knowncompound, second medical indication, and kitclaims.

Example: Swiss-form claims (i.e., The use ofcompound X in the manufacture of amedicament effective against disease Y.)


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Patentable Subject Matter

Transgenic plants

Europe yes Canada no

Japan - yes

Transgenic animals

Europe yes Canada no

Japan yes

Genetically engineered microorganisms Europe yes

Canada yes

Japan yes


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Practice Tips

Consider including language in the specification to

address potential environmental issues. If control features are known which can

reduce/eliminate impact or harm to public orenvironment, include this information in the

specification. Be well advised: Peculiarities in patentable subject

matter arise on a country-by-country basis.

For example, bacterial strains that have beenmutantized via chemical mutagenesis may not bepatentable in some countries.


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Deposits

Requirements vary widely

Practice tip: prior to filing, consider whetherto do a deposit in light of the strictest

countrys requirements. Some countries

require a deposit PRIOR to filing.


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Claiming and Unity of Invention

Depth of claim set

A variety of claims gives flexibility

No penalty for multiply dependent claims

Omnibus claims

The Claim Set and Unity of Invention: Multiple independent claims in Europe applications must

relate to a common inventive concept

If an application has more than 1 independent claim in any

one category (i.e., device, system, method, use), it will beobjected to either because the claims relate to more thanone invention (unity) or the claims are not concise.


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Final Comments

For more information about Schwegman,

Lundberg, Woessner & Kluth, P.A., pleasecontact Catherine Klima at 612-359-3276 or

[email protected].

Thank you!

Biopharma Patent

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