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Presenting a live 90-minute webinar with interactive Q&A
Labeling and Induced Infringement
in Pharma Patent Litigation and
Protecting IP Rights
Today’s faculty features:
1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific
THURSDAY, JULY 13, 2017
Thomas L. Irving, Partner, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.
Barbara R. Rudolph, Ph.D., Partner, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.
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Outline
I. Implications of Lilly for induced infringement
II. Other Federal Circuit induced infringement decisions post-
Commil
A. Takeda Pharma U.S.A. v. Hikma Am Inc. (Fed. Cir. May 6, 2015)
B. Braintree Labs Inc. v. Breckenridge Pharm. Inc. (Fed. Cir. May 5,
2017)
III. How do Novo v. Caraco and use codes fit in?
IV. Strategic considerations of label language for induced
infringement
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35 U.S.C. § 271
a) Except as otherwise provided in this title, whoever
without authority makes, uses, offers to sell, or sells
any patented invention, within the United States, or
imports into the United States any patented invention
during the term of the patent therefor, infringes the
patent.
b) Whoever actively induces infringement of a patent shall
be liable as an infringer.
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Inducement: Basic Requirements
• To prove induced infringement, the patent owner
must show that:
(i) there is direct infringement;
(ii) the accused infringer induced the infringement; and
(iii) the accused infringer knew or should have known
that its actions would induce actual infringement.
– The required knowledge/scienter can be satisfied by
either (i) actual knowledge of a patent or (ii) willful
blindness to the existence of a patent. Global-Tech
Appliances, Inc. v. SEB S.A., 131 S. Ct. 2060, 2068
(2011).
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Global-Tech Appliances, Inc. v. SEB S.A., 131 S.Ct.
2060 (May 31, 2011)
•Holding: “[I]nduced infringement under §271(b)
requires knowledge that the induced acts constitute
patent infringement. . . .
•Deliberate indifference to a known risk that a patent
exists is not the appropriate standard under §271(b)– but
Supreme Court nevertheless affirmed the judgment of the
Court of Appeals because the evidence supported a finding
of Pentalpha’s knowledge under the doctrine of willful
blindness.”
Induced Infringement
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Global-Tech v. SEB
• Supreme Court:
– Elements of “willful blindness:
(1) defendant must subjectively believe that there is
a high probability that a fact exists;
(2) defendant must take deliberate actions to avoid
learning of that fact
Induced Infringement
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Induced Infringement: Intent
Commil USA, LLC v. Cisco Systems, Inc.,
135 S.Ct. 752 (U.S. Dec. 5, 2014)
• Held: A reasonable belief of noninfringement is a
defense to claims of inducement, but a good
faith belief that a patent is invalid is not a
defense to a charge of induced or contributory
infringement.
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Induced Infringement
Hatch Waxman Act cases
• First prong of Global-Tech is easily shown by the
patents listed in the Orange Book and the
generic manufacturer’s paragraph IV
certification.
• Second prong of specific intent to induce
infringement may be proven by the instructions
and information in a drug label.
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Induced Infringement
Limelight Networks, Inc. v. Akamai Techs., Inc.,
134 S. Ct. 2111 (2014)
• Supreme Court: Liability for induced
infringement can only be found if the patent has
been directly infringed, meaning directly
infringed by a single party.
– Found no reason to interpret the statutory
requirements for induced and direct infringement
differently.
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Divided Infringement
• Infringement of a method claim where its steps
are performed by more than one actor.
• Supreme Court – A defendant may not be liable for infringing a patent
under §271(b) when no one has directly infringed the
patent under §271(a) or any other statutory provision.
– Acknowledged that a would-be infringer could evade
liability by dividing performance of a method patent's
steps with another whom the defendant neither directs
nor controls.
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Divided Infringement
Akamai Techs., Inc. v. Limelight Networks, Inc.,
797 F.3d 1020 (Fed. Cir. 2015)
• Federal Circuit: In cases of divided infringement, one
entity could be liable for direct infringement under two
circumstances:
– Entity directs or controls another entity’s
performance.
• Acts through agency or contractual relationship
• Conditions participation in an activity or receipt of a benefit
upon performance of a step or steps of a patented method and
establishes the manner or timing of that performance
– Entities form a joint enterprise.
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Divided Infringement
Akamai Techs., Inc. v. Limelight Networks, Inc.,
797 F.3d 1020 (Fed. Cir. 2015)
• Entity directs or controls another entity’s
performance
• Key concept: third party’s actions are attributed to
the alleged infringer such that the alleged infringer
becomes the single actor chargeable with direct
infringement.
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Divided Infringement
Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., 845 F.3d
1357 (Fed. Cir. 2017)
Claim 12. An improved method for administering
pemetrexed disodium to a patient in need of
chemotherapeutic treatment, wherein the improvement
comprises:
a) administration of … folic acid prior to the first administration
of pemetrexed disodium;
b) administration of … vitamin B12, prior to the first
administration of pemetrexed disodium; and
c) administration of pemetrexed disodium.
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Eli Lilly & Co. v. Teva Parenteral Medicines
Physician Administers B12 & pemetrexed
Patient
Self-administers folic acid
Teva
Supplies the pemetrexed
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Divided Infringement
Eli Lilly & Co. v. Teva Parenteral Medicines
• District Court: Claims valid and infringed.
– No single actor performs all steps of the asserted
claims -- actions of both physicians and patients are
required.
– But all steps of the asserted claims are attributable to
physicians.
– Defendants liable for inducing that infringement .
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Divided Infringement
Eli Lilly & Co. v. Teva Parenteral Medicines
• Federal Circuit: Affirmed.
– Single actor who directly infringes: Product labeling
and testimony provide sufficient evidence that
physicians condition patient participation in an
activity or receipt of a benefit (pemetrexed
treatment) on folic acid administration and also
establish the manner or timing of performance.”
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Divided Infringement
Eli Lilly v. Teva Parenteral
– Physician Prescribing Information:
• ‘Instruct patients to initiate folic acid 400 [mg] to
1000 [mg] orally once daily beginning 7 days before
the first dose of [pemetrexed]”
• “Instruct patients on the need for folic acid and
vitamin B12 supplementation to reduce treatment-
related hematologic and gastrointestinal toxicity”
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Divided Infringement
Eli Lilly v. Teva Parenteral
– Patient Information:
• “To lower your chances of side effects of
[pemetrexed], you must also take folic acid …prior
to and during your treatment with [pemetrexed].’’
• “It is very important to take folic acid and vitamin
B12 during your treatment with [pemetrexed] to
lower your chances of harmful side effects. You
must start taking 400–1000 micrograms of folic acid
every day for at least 5 days out of the 7 days
before your first dose of [pemetrexed]”
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Divided Infringement
Eli Lilly v. Teva Parenteral
• Single actor who directly infringes: Did physicians direct
or control their patients’ administration of folic acid?
– Condition the patient’s participation: Based on the product
labeling, taking folic acid in the manner specified is a condition of
the patient’s participation in pemetrexed treatment.
– Manner and timing of performance: Physicians would prescribe
an exact dose of folic acid and direct that it be ingested daily.
– The performance of all steps of the asserted claims were
attributable to physicians.
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Induced Divided Infringement
Eli Lilly v. Teva Parenteral
• Intent to induce: Must show Teva has specific
intent to induce.
– “[T]he intent for inducement must be with respect to the actions
of the underlying direct infringer, here physicians.”
– The label must encourage, recommend, or promote infringement.
For purposes of inducement, it is irrelevant that some users may
ignore the warnings in the proposed label.
– In this case, “[t]he instructions are unambiguous on their face and
encourage or recommend infringement.”
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35 U.S.C. § 271(e)(2)
35 U.S.C. § 271(e)(2)
It shall be an act of infringement to submit [ ] an application under section 505(j) of the [FDA Act] or described in section 505(b)(2) of that Act for a drug claimed in a patent or the use of which is claimed in a patent . . . if the purpose of such submission is to obtain approval under such Act to engage in the commercial manufacture, use or sale of a drug . . . claimed in a patent before the expiration of such patent.
Requirement 1: an application:
directed to an FDA approved
use
Requirement 2: a patent
claiming a use
of the drug
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Method of Use Patents
• A viable Hatch-Waxman Act claim of
inducement of method claims
– Accused use must be an approved use.
– Accused use must also be a claimed use.
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Method of Use Patents Takeda Pharmaceuticals U.S.A., Inc. v. West-ward
Pharmaceutical Corp., 785 F.3d 625 (Fed. Cir. 2015)
– Takeda patents cover several methods of administering colchicine
products but not colchicine itself.
– Hikma did not file a Para. IV certification with respect to Takeda’s
patents because it did not seek FDA approval of Mitigare for a use
covered by Takeda’s patents.
– Federal Circuit: No preliminary injunction to stop West-Ward
from continuing its launch of Mitigare and from launching an
authorized generic version of Mitigare.
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Method of Use Patents
Takeda v. West-ward
• Label language: “[i]f you have a gout flare while taking
[Mitigare], tell your healthcare provider.”
• Takeda argued that statement induced infringement
because, in the case of the patient taking Mitigare for
prophylaxis, the physician would likely tell the patient to
use the Mitigare product to treat the acute flare.
• DC: Instruction insufficient to establish induced
infringement.
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Method of Use Patents
Takeda v. West-ward
• Federal Circuit: Agreed. Instructions need to
evidence an intent to encourage infringement.
– “Mere knowledge of off-label infringing uses of
Mitigare’s product would not establish inducement.”
– “The label must encourage, recommend, or promote
infringement. …The mere existence of direct
infringement by physicians, while necessary to find
liability for induced infringement, is not sufficient for
inducement.
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Section 4.2a Instructions
• FDA revised the instructions on identifying labeling
information regarding method of use claims.
Form
Section
October 2010
November 2013
Form FDA 3542
Method of Use
(4.2a)
Specify the part of
the approved
drug labeling that
is claimed by the
patent.
Identify the
precise words of
the approval
labeling that
describe with
specificity the
patented method
of use.
Align the method of
use patent claims with
direct, verbatim text in
the proposed or final
drug labeling?
Focus on label as a whole supports concept of looking beyond the
Indications and Usage section for “approved methods”
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Section 4.2b
• If the answer to 4.2 is "Yes," also provide the
information on the indication or method of use
for the Orange Book "Use Code" description.
• Use: (Submit the description of the approved
indication or method of use that you propose FDA
include as the "Use Code" in the Orange Book,
using no more than 240 total characters including
spaces.) _____________________________
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Section 4.2b Instructions
• Section 4.2b Information and Instructions
– “The answer to this question will be what FDA uses to
create a ‘use-code’ for Orange Book publication. The
use code designates a method of use patent that claims
an approved method of using a drug product. Each
approved method of use claimed by the patent should
be separately and specifically identified in this section
and the use code created should contain adequate
detail to assist 505(b)(2) and ANDA applicants in
determining whether a listed method of use patent
claims a method of use for which the 505(b)(2) or
ANDA applicant is not seeking approval. Use a
maximum of 240 characters for each ‘use code.’”
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“USE CODES”
• U-279: METHOD OF USE OF THE APPROVED PRODUCT
• U-308: CLAIMS A SOLID ORAL FORMULATION
INCLUDING TABLETS AND GRANULES OF OLANZAPINE
USEFUL FOR TREATING ANY NUMBER OF LISTED
CONDITIONS, INCLUDING SPECIFIC PSYCHOLES,
EMPLOYING OLANZAPINE AS PER THE INDICATIONS OF
THIS NDA
• U-362: USE OF APPROVED FORMULATIONS TO TREAT
ALL APPROVED DISEASE INDICATIONS
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The Prandin® Case
• Prandin® (repaglinide) was originally approved as an
adjunct to diet and exercise to improve glycemic control
in adults with Type 2 Diabetes Mellitus – (1) alone, (2) in
combination with metformin, and (3) in combination with
thiazolidinediones (TZDs).
• In 2004, Novo submitted the ‘358 patent to FDA with the
following use codes:
– U-546: USE OF REPAGLINIDE IN COMBINATION WITH
METFORMIN TO LOWER BLOOD GLUCOSE
• In 2005, Caraco submitted an ANDA for repaglinide with a
section viii statement carving out the metformin
combination use.
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FDA
• In 2008, at FDA’s request, Novo adopted the indication
statement: – “PRANDIN is indicated as an adjunct to diet and exercise to
improve glycemic control in adults with type 2 diabetes mellitus”
• Novo then revised its use code to track the new indication: – U-968: A METHOD FOR IMPROVING GLYCEMIC CONTROL IN ADULTS
WITH TYPE 2 DIABETES MELLITUS
• This forced FDA to disallow Caraco’s section viii
statement, because the use code now read entirely on the
indication statement.
• Caraco immediately sought relief in the courts, claiming
the use code was unlawful.
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District Court • Caraco brought a counterclaim in its patent suit with Novo
– In a patent infringement action against the ANDA applicant, “the
applicant may assert a counterclaim seeking an order requiring the
holder to correct or delete the patent information submitted by
the holder . . . on the ground that the patent does not claim
either (aa) the drug for which the application was approved; or
(bb) an approved method of using the drug.” 21 USC
355(j)(5)(C)(ii) (emphasis added)
• District Court granted Caraco’s motion and ordered Novo
to amend its use code.
• Novo appealed to the Federal Circuit.
– Does “patent information” include use codes?
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Federal Circuit
• April 2010, the Federal Circuit reversed and later declined
en banc review:
– “Patent Information” is a term of art under 21 USC 355(b)(1),
referring to the patent number and date of expiration only.
– Caraco’s “real complaint” was with FDA, whose actions in 2008
prompted the use code change. • “This court recognizes that a broad use code covering all uses of a
pharmaceutical could require generic manufacturers to prove
specifically that their use will not overlap with and infringe the
patented use. This proof, under Hatch-Waxman procedures, will take
the form of a Paragraph IV lawsuit. In the context, the generic may
provide proof that their use will not cause infringement of the
patented use . . . Thus, the Act again facilitates efficient resolution
of disputes concerning potential overlapping of protected and
unprotected uses.” (emphasis added).
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Supreme Court • Supreme Court held that a generic drug
manufacturer may employ the counterclaim
provision of the Hatch-Waxman Act to force
correction of a use code that inaccurately
describes the brand’s patent as covering a
particular method of using a drug.
• Dicta in Caraco regarding content of use code – Footnote 7: Novo claims that a use code may sweep
more broadly than the patent. But that is
incorrect.
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More From Caraco
• From the concurrence – FDA’s guidance as to what is required of brand
manufacturers in use codes remarkably opaque.
• Novo argued that the regulations permit a brand manufacturer
to submit for publication in the Orange Book a description of
either the patented method of use or the indication (which
refers to “what a drug does”)
• [The regulations and the form] at the least suggest (as Novo
thought) that a method of use here is distinct from an
indication and that either suffices as a use code.
• For the reasons explained by the Court, Novo is mistaken. But
the company can hardly be faulted for so thinking.
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Final Rules: Use Codes For Method Of Use Patents
• Goal: Address “overbroad or ambiguous use codes that may delay
approval of generic drugs”
• Use Code must:
– “describe only the specific approved method of use claimed by the patent
for which a claim of infringement could reasonably be asserted”
– “identify with specificity the section(s) and subsection(s) of the approved
labeling that describes the method(s) of use claimed by the patent”
• Contents of patent submission
– Before approval - identify the patent, method, and labeling sections
– Upon and after approval - same, plus description of use
• For Final Rules, see 81 Fed. Reg. 69580-69658 (Oct. 6, 2016).
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Scope Of The Use Code
• FDA’s Guiding Principles:
1. Claimed use is broader than approved indication
• Use code must describe only the specific patented method of
use described in the approved label
2. Claimed use is narrower than approved indication
• Use code must describe only the specific approved method
claimed by the patent
3. Claimed use is co-extensive with approved indication
• Use code must describe only the specific approved method of
use claimed by the patent
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Use Code Submission
• No duty for current NDA holders to
resubmit patent information for all
currently listed patents.
– But others can submit a patent listing dispute.
• NDA holders required to submit new patent
information only prospectively, after
December 5, 2016.
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Why Do We Care?
• Better to force para. IV than allow section 8.
– 30-month stay.
– Notice to NDA holder.
• Downside of improper use code
– Generics request change at FDA.
– Generics present counterclaim under Caraco.
– Possible patent misuse / antitrust suit if branded loses
ANDA lawsuit?
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Rapamune® • FDA approved sNDA related to cyclosporine withdrawal procedures in
patients at low to moderate risk for rejection.
– 3 years of marketing exclusivity.
• Label: Indications and Usage
– It is recommended that Rapamune be used initially in a regimen with cyclosporine and corticosteroids. In patients at low to moderate immunologic risk cyclosporine should be withdrawn 2 to 4 months after transplantation. . . .
• Wyeth filed Citizen’s Petition requesting FDA to refrain from approving generic versions of Rapamune before expiration of exclusivity period.
• FDA agreed.
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Farxiga®
• Approved indication:
– An adjunct to diet and exercise to improve glycemic
control in adults with type 2 diabetes mellitus
• Patent claim:
– A method of treating Type II diabetes in a mammal
comprising administering to the mammal a
therapeutically-effective amount of the
pharmaceutical composition according to claim 1.
• Use code:
– TREATMENT OF TYPE 2 DIABETES MELLITUS
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Dalvance®
• Patent claim:
– A method for treating a bacterial infection in a human in need
thereof, the method comprising: administering initial and
subsequent therapeutically effective doses of dalbavancin in a
pharmaceutically acceptable carrier to the patient, wherein each
dose is separated by five to ten days and wherein the amount of
the initial dose is about 100 mg to about 5000 mg, and wherein
the amount of the initial dose is at least about two times the
amount of dalbavancin contained in the subsequent dose.
• Use code:
– TREATMENT OF BACTERIAL INFECTIONS USING A TWO-DOSE
REGIMEN OF DALBAVANCIN.
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Zontivity®
• Approved Indication:
– Reduction of thrombotic cardiovascular events in patients with a
history of myocardial infarction (MI) or with peripheral arterial
disease (PAD). ZONTIVITY has been shown to reduce the rate of a
combined endpoint of cardiovascular death, MI, stroke, and urgent
coronary revascularization (UCR).
• Patent claim:
– A method of treating thrombosis, atherosclerosis, restenosis,
hypertension, angina pectoris, arrhythmia, heart failure,
myocardial infarction, glomerulonephritis, thrombotic stroke,
thromboembolic stroke, peripheral vascular diseases, or cerebral
ischemia comprising administering….
• Use code:
– REDUCTION OF THROMBOTIC CARDIOVASCULAR EVENTS 53
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Relistor®
• Approved Indication:
– RELISTOR is indicated for the treatment of opioid-induced constipation in
patients with advanced illness who are receiving palliative care, when
response to laxative therapy has not been sufficient.
• Patent claim:
– 11. A method comprising the steps of:
• (i) providing a packaged composition, substantially free from
tungsten, comprising a unit dosage of a liquid composition comprising
8 mg or 12 mg of a compound of formula III-1…in 0.4 mL or 0.6 mL
water, and a compound of formula II-1 …wherein the compound of
formula II-1 is present in an amount of less than about 190 ppm; and
• (ii) administering the unit dosage to a subject via subcutaneous
injection.
• Use code:
– TREATMENT OF OPIOID-INDUCED CONSTIPATION
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Vimpat®
• Patent claim:
– 11. A method of treating central nervous system disorders in an
animal comprising administering to said animal in need thereof an
anticonvulsant effective amount of a compound according to any
one of claims 1-9.
• Use codes: – METHOD OF TREATING, AS MONOTHERAPY OR ADJUNCTIVE
THERAPY, PARTIAL-ONSET SEIZURES IN A PATIENT WITH EPILEPSY
AGED 17 YEARS AND OLDER
– METHOD OF TREATING, AS INTITIAL LOADING DOSE FOR
MONOTHERAPY OR ADJUNCTIVE THERAPY, PARITAL ONSET-
SEIZURES IN A PATIENT WITH EPILEPSY AGED 17 YEARS OR OLDER
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Hypothetical Example
• Indicated Use: Drug X for treating
disease A.
• Patented Use: A method for causing
pharmacologic effect.
• Expert: Drug X treats disease A via
pharmacologic effect.
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Hypothetical Example
• Indicated Use: Drug X for treating disease A.
• Patented Use: A method for treating class of
diseases.
• Expert: Disease A is member of patented class.
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Label Construction Example
• What evidence determines the scope of
the approved use?
• Under Bayer, “the label, taken in its entirety,
[must] recommend or suggest to a physician
that [the drug] is safe and effective for inducing
the claimed [effect].”
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Impact of recent decisions on label language.
Strategic considerations to keep in mind when
labeling drugs.
Summary
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Drafting and Prosecution Tips for Pharma Patents
• Coordinate patent, regulatory and clinical
personnel early.
• Maintain consistency between claims and likely or
actual label language.
• Maintain the coordination referenced above
throughout the U.S. patent prosecution and label
negotiation with FDA.
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• Consider drafting claims so that one party infringes claims
(e.g., one party performs all recited steps).
• Consider obtaining a noninfringement opinion to show
good-faith belief of noninfringement.
– Opinion of counsel concluding that the patent in question is invalid will
not be relevant to induced infringement allegation.
• Consider explicitly pleading indirect infringement and
knowledge of the patent prior to the complaint.
Drafting and Prosecution Tips for Pharma Patents
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