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U.S. Patent Term Extension

1

U.S. Patent Term Extension(35 U.S.C. §156)

Courtenay C. Brinckerhoff

Foley & Lardner LLP

July 2017

Patent Term Extension (PTE) vs.Patent Term Adjustment (PTA)

Patent Term Extension extends patent term to compensate for commercialization delays due to regulatory review

– Patent holder must calculate and apply for PTE within strict time frame after regulatory approval

– Extended patent rights are limited

– PTE is not printed on the patent, but determination should be in prosecution history and Orange Book listing


2

Patent Term Extension (PTE) vs.Patent Term Adjustment (PTA)

Patent Term Adjustment adjusts patent term to compensate for PTO delays in examination

– PTO calculates and awards PTA automatically

– PTA applies to full scope of all claims

– PTA printed on patent (or in Certificate of Correction)

Hatch-Waxman Act (1984)

The Drug Price Competition and Patent Term Restoration Act of 1984

Policy Objectives:

– Enable generic competitors to bring cheaper generic drugs to market more quickly (Drug Price Competition)

– Encourage new drug research by restoring patent term lost to regulatory delays (Patent Term Restoration)


3

Prior to Hatch-Waxman

A generic company could not begin the approval process until after the patent expired, because use of the patented drug to obtain comparative data would infringe the patent (Roche v. Bolar)

– Because of the length of the approval process, this delay effectively lengthened patent term

17 year patent term

Brand name drug approval

Generic testing begins

Roche v. Bolar

Generic approval

Effective lengtheningof patent term

Prior to Hatch-Waxman

A patent holder might not obtain FDA approval to market its drug until years after the patent is granted

– Because of the length of the approval process, this delay effectively shortened patent term


4

Patent Term Extension

FileIND

NDA approval

File NDA

Safety and efficacy testing

Approval phase

½ days All daysDrug Development

Patent

File Issue

Effective patent term

Original Expiration

PTE

Expiration

Basic Limitations of PTE

One patent extension per product

One product per patent extension

One patent extension per patent


5

Basic Requirements Under §156

Product has been subject to a regulatory review period

Regulatory approval results in first commercial marketing/use of product

Patent has not previously been granted PTE

Patent “claims” the approved product, method of using, or method of manufacturing

PTE application filed within 60 days of approval

PTE application filed before patent expires(can apply for “interim” extension after NDA is filed if patent is about to expire)

Definition of “Product” in §156(f)

“Product" means “drug product” which means the “active ingredient” of

– A new drug, antibiotic drug, or human biological product or

– A new animal drug or veterinary biological product which is not primarily manufactured using recombinant DNA/RNA/hybridoma technology or other specific genetic manipulation techniques

– Includes salt or ester of the active ingredient, as a single entity or in combination with another active ingredient

“Product” also means a medical device, food additive, or color additive subject to regulation under the Federal Food, Drug, and Cosmetic Act


6

“Product” Requirements under §156(a) §156 (a)(5)(A) requires that the regulatory review

period must be for the first commercial marketing/use of the product New NDA does not always qualify for PTE

– Fisons v. Quigg, 876 F.2d 99 (Fed. Cir. 1989)

– Approval of new use of old drug does not qualify

– Approval of new formulation or new dosage form does not qualify

– Approval of new combination of old drugs does not qualify

The Arnold Partnership v. Dudas, 362 F.3d 1338 (Fed. Cir. 2004)

Per USPTO, Fed. Cir. dicta, synergy does not support PTE

In re Patent Term Extension for Patent No. 5,674,860

Examples of “Product” Requirements

Glaxo Operations UK Ltd. V. Quigg, 894 F.2d 392 (Fed. Cir. 1990)

– Old product: cefuroxime (an acid)

– New product: cefuroxime axetil (an ester of cefuroxime)

– Court rejected PTO’s “active moiety” argument

– Because cefuroxime axetil had never been the “active ingredient” of an approved drug, PTE was available


7


Photocure v. Kappos, 603 F.3d 1372 (Fed. Cir. 2010)

– Old product: ALA hydrochloride (a salt of aminolevulinicacid)

– New product: MAL hydrochloride (a salt of an ester of aminolevulinic acid)

– Court rejected PTO’s “active moiety” argument

– PTE was available


Ortho-McNeil Pharmaceutical v. Lupin, 603 F.3d1377 (Fed. Cir. 2010)

– Old product: ofloxacin (racemate)

– New product: levofloxican (single enantiomer)

– PTO granted PTE, was challenged by ANDA applicant

– An “enantiomer is a different drug product from the racemate” (long-standing policy?)


8

“Patent” Requirements Under §156(a)

At least one claim of the patent must claim:

– The approved product

– Method of using the approved product, OR

– Method of manufacturing the approved product

Claims in question should read directly on the product


Hoechst-Roussel Pharm., Inc. v. Lehman, 109 F.3d756 (Fed. Cir. 1997)

– Patent claimed 1-hydroxy tacrine

– FDA approval for tacrine hydrochloride (a prodrug of 1-hydroxy tacrine)

– No PTE


9


Merck v. Teva, 347 F.3d 1367 (Fed. Cir. 2003)

– Patent claimed method of using alendronic acid

– FDA approval for an alendronate salt

– PTE is available because “product” includes salt or ester

– Fed. Cir. used “active moiety” language in justifying conclusion

Scope of Rights Extended Under §156(b) Extended rights are limited

Patent claims product: rights limited to any use approved for the product

Patent claims method of using product: rights limited to any use claimed by patent and approved for the product

Patent claims method of manufacturing product: rights limited to the method of manufacturing as used to make the approved product

Scope of extended rights can expand if same product is approved for additional formulations, dosage forms, methods of uses, etc.

Scope of extended rights CANNOT expand original scope of patent


10

Examples: Scope of Extended Rights

PTE for approved drug extends to drug and any salt or ester of the drug

Pfizer v. Dr. Reddy’s, 359 F.3d 1361 (Fed. Cir. 2004)

– Patent claimed drug or salt thereof

– FDA approval for besylate salt

– ANDA for maleate salt

– Extended rights encompassed maleate salt

– “Active ingredient is amlopidine... whether administered as maleate or besylate salt”

Examples: Scope of Extended Rights

Although the scope of extended rights is limited by §156(b), the patent as a whole is deemed to be extended and pending during the extended term

– Genetics Inst., LLC v. Novartis Vaccines & Diagnostics, Inc., 655 F.3d 1291 (Fed. Cir. 2011)


11

Interaction of PTE and Terminal Disclaimers

PTE can be added to a patent with a Terminal Disclaimer

– Merck v. Hi-Tech Pharmacal Co., 482 F.3d 1317 (Fed. Cir. 2007)

Length of Extension under §156(c)

Extension is generally based on the length of the regulatory review period that occurred after patent grant

– Credit for ½ days between IND and NDA

– Credit for full days between NDA and approval

Deductions taken for any period during which the applicant did not act with due diligence

Maximum of five years extension

Extended patent term cannot exceed 14 years from date of FDA approval


12

Strategies: Multiple Patents Eligible Which patent has the latest expiration date?

Which patent has the broadest claims that could cover potential subsequent approvals of the same product?

Which patent is strongest on validity?

Which patent will be easiest to enforce?

– Off-label uses of method claims

– Proving infringement of manufacturing claims

Product claims > method of use claims > method of manufacture claims

File multiple PTE applications and pick one?

One Product, Two Patents

Before PTE, Patent A expires > 14 years from FDA approval

Patent A not eligible for PTE

Patent B expires earlier

PTE can extend Patent B up to 14 years from FDA approval

Product X Product X

Patent A B

Priority Date

20 yr term

5/30/2004

5/30/2024

5/30/2000

5/30/2020

Issue Date 5/30/2007 5/30/2003

FDA Approval 11/30/2009 11/30/2009

PTE 0 days

(14 yr cut-off)

5yrs max w/ 14 yr cut-off

Latest Patent Expiration

5/30/2024 11/30/2023 (14 yr cut-off)


13

Two Products, One Patent

First product approved when patent term still has 14+ years

Approval can’t extend term

When second product is approved, patent term has < 14 years

Approval can extend term

Vasotec

(enalaprilmaleate)

Prinivil

(lisinopril)

Patent 4,374,829 4,374,829

Priority Date 12/11/1978 (pre-GATT)

12/11/1978 (pre-GATT)

Issue Date

17 yr term

02/22/1983

02/22/2000

02/22/1983

02/22/2000

Approval Date

12/24/1985 12/29/1987

PTE 0 days

(14 yr cut-off)

676 days

Latest Patent Expiration

02/22/2000 12/29/2001

(14 yr cut-off)

Strategic Considerations

Interplay of other forms of exclusivity:

– Orphan drug exclusivity (seven years)

– New chemical entity (data exclusivity)

Usually five years

Three years for enantiomer when racemate previously approved

– Pediatric exclusivity (six months)


14

PTE Application under §156(d)

To obtain an extension the owner of record of the patent or its agent shall submit an application to the Director

[S]uch an application may only be submitted within the 60 period beginning on the date the product received permission for commercial marketing or use


The date of the FDA approval letter is day one of the 60 day period, not day 0!

– Unimed, Inc. v. Quigg, 888 F.2d 826 (Fed. Cir. 1989)

– (FDA approval, not DEA authorization, was critical date)

The date of FDA approval can be counted as the first of the 60 day period for filing a PTE application as long as the application is approved during business hours.

– Meds. Co. v. Kappos, 731 F. Supp. 2d 470, 482 (E.D. Va. 2010).


15


Tremendous costs of miscalculating this deadline:

– In re Patent Term Extension for Patent No. 5,674,860 PTEdenied for Symbicort - application was 1 day late

Global Symbicort sales were $1.6 billion in 2007 (approx $4.4 million/day)

– PTE denied for The Medicines Company’s Angiomaxsubmitted 62 days after approval

Angiomax accounts for 95% of company revenues


Key parts of PTE application:

– Identify approved product(chemical structure and formulation)

– Confirm that approval is first approval for product

– Identify each qualifying patent claim

– Calculate extension period

– Summarize activities of regulatory review period(appendix with chronology of events between IND and approval)

The Duty of Disclosure applies during PTE process


16


PTO receives, reviews PTE application

PTO sends letter to FDA with request to review, confirm “first approval” and regulatory review period

FDA publishes determination in Federal Register

“Any interested person” can request hearing on applicant’s diligence during the review period within 60 days of Fed. Reg. notice

FDA provides its determinations to PTO

PTO grants or denies patent term extension

Can take years to complete this process

ATTORNEY ADVERTISEMENT. The contents of this document, current at the date of publication, are for reference purposes only and do not constitute legal advice. Where previous cases are included, prior results do not guarantee a similar outcome. Images of people may not be Foley personnel.© 2017 Foley & Lardner LLP

Thank You!

Courtenay C. Brinckerhoff

Foley & Lardner LLP

Washington, D.C. Office

[email protected]

Questions? Please contact:

Patent Term Extension (PTE) in Japan

1

Dr. Hisatoshi SHINAGAWA Ms.Harumi KOJO

Patent Term Extension (PTE) in Japan - Scope of the Extended Patent Under the IP High Court

Decision of Jan. 20, 2017

July 10, 2017

Requirements for Patent Term Extension Products eligible for PTE Patents eligible for PTE PTE on 2nd and subsequent approvals

Scope of the extended Patent Term IP High Court Decision on Jan. 20, 2017

****************************** Relevant Information

Re-Examination Period Requirements for Biosimilars

2


2

A Brief Overview

January 1987

Introduced Patent Term Extension system (PTE)

Article 67, 67ter : Requirements for PTE. Article 68bis: Scope of the extended patent.

Requirements for PTE: There has been much discussions

and changes in interpretation, until the Supreme Court decision of 2015/11/7in the JPO vs. Genentech, Inc. case (Avastin®(bevacizumab) case).

Scope of the extended Patent: IP High Court Grand Bench

Decision of 2017/1/20 in the Debiopharm vs. Towa case (oxalyplatine case)being reviewed by the Supreme Court

3

Requirements for Patent Term Extension

4


3

Patent Law Art. 67(2)

Where there is a period during which the patented invention is unable to be implemented because approvals prescribed by relevant Acts ………or any other disposition designated by Cabinet Order ……… (=Marketing Approval) is necessary to implement the patented invention, the duration of the patent right may be extended, upon the filing of a request for the registration of extension of the duration, by a period not exceeding 5 years.

Patent Term Extension (PTE)

5


Restore the term required for the marketing approval

Original Patent Term20 years from filing

PTEup to 5 years

Marketing Approval

unable to implement the patented invention

6


4

Extension Period (Examination Guidelines)time from later of patent registration/start of clinical trial (INDA)up to date of Marketing Approval (max 5 years)


Case 1

Case 2

Case 3

Start of INDA

Marketing Approval

7

Requirements for PTE -Product-

Products that are eligible for PTE are limited to

Drugs for human and animals

Agrochemicals

In vitro Diagnostics

Regenerative Medicine Products

(Cabinet Order for Enforcement of the Patent Law Art. 2 )

Need Marketing Approval before manufacturing/selling/importing the product

8


5

Requirements for PTE -Product-

Products not eligible for PTE include

Medical Devices Food Additives, Color Additives Cosmetics

9

Patent Law Art 67ter (1)

Where an application for the registration of extension of the duration of a patent right falls under any of the following items, the examiner shall refuse the PET application:

(i) where the disposition designated by Cabinet Order under Article 67(2) (=Marketing Approval on the basis of which patent term extension is requested) is not deemed to have been necessary to implement the patented invention

Requirements for Patent Term Extension (PTE)

Key Question: Was the marketing approval necessary to implement the patented invention? 10


6

Examination Guidelines

(No change since the implementation of the law on the following points)

• Multiple patents can be extended based on one Marketing approval.

• Multiple extensions based on the 2nd and subsequent approvals per one patent are possible


11

Requirement 1

The marketing of the approved product is covered by the patented invention.

Requirement 2

The approved product is not covered by any of previously approved product(s).


Examination Guidelines

Was the marketing approval necessary to implement the patented invention?

12


7

Requirement 1

The marketing of the approved product is covered by the patented invention.

→No statutory limitation on patents eligible for PTE.

Requirements for PTE -Patent-

13

All types of patents that cover the approved product are eligible, for example


Product

– compound– composition– formulation

Process

– manufacturing Active Pharmaceutical Ingredient

– manufacturing the formulation

Product with limitation of

– medical use – dosage regimen

14


8

Patent to Medical Device

When a drug product in combination with a specific medical device is approved, a patent that cover the medical device only can also be eligible for PTE


15

Patent to

intermediate of the active ingredientcatalyst for producing the active ingredientapparatus for manufacturing the product

Do not cover the product per se

⇒ Not Eligible for PTE


16


9

Requirement 2

The approved product based on which a PTE is requested is not covered by any of previously approved product(s).

Comes from Supreme Court Decision on November 17, 2015 the JPO vs. Genentech, Inc. Supreme Court, No. 2014(gyo hi)356

Before the decision, there has been much discussions and changes in interpretation

Requirements for PTE –vs. prior approval(s)-

17

Supreme Court Decision on Nov. 17, 2015 the JPO vs. Genentech, Inc. Supreme Court, No. 2014(gyo hi)356

(Avastin® (bevacizumab) case)

PTE based on 2nd and subsequent approvals

• when the newly approved drug is covered by the previous approval(s) in terms of items directly influencing the substantial identity of drugs, it is determined that the inventionhas already been implemented by the previous approval(s) and therefore, the approval was not necessary to implement the invention

• items directly influencing the substantial identity of drugs are: ingredients, quantity, dosage, administration, and indication


18


10

Supreme Court Decision on Nov. 17, 2015 the JPO vs. Genentech, Inc. Supreme Court, No. 2014(gyo hi)356


A

B

A

B

Approval B was not necessary for drug B→PTE based on B is Rejected

Approval B was necessary for drug B→PTE based on B is Allowed

Drug B was approved after approval of Drug A

scope of the patented invention

19

Requirement 2

The marketing approval (approved product) based on which a PTE is requested is not covered by any of previous approvals (approved products).

Compare Product vs. Product

when the products are drugs, compare them in terms of

ingredients, quantity, dosage, administration, and indication


20


11


appeared for the first time

Hypothetical Example

Approvals 1st 2nd 3rd 4th 5th

API* A A A A A

indicationhepaticcancer

hepatic cancer

hepatic cancer

stomachcancer

hepatic cancer

dosage form injection injection tablet tabletDDS

capsule

dosageregimen

10mgdaily

20mgdaily

10mgdaily

10mgdaily

50mg weekly

Pat1compound A

Pat2 hepaticcancer use

Pat3tablet

Pat4 somatic cancer use

Pat5 DDS capsule 50 mg weekly

*API: Active Pharmaceutical Ingredient 21

appeared for the first time

patent covers the approved product



API A A A A A


hepatic cancer

hepatic cancer

somatic cancer

hepatic cancer


capsule

dosageregimen

10mgdaily

20mgdaily

10mgdaily

10mgdaily

50mg weekly

Pat1compound A

Pat2 hepatic cancer use

Pat3tablet



22


12

Compare product vs. previously approved product(s) in terms ofingredients, quantity, dosage, administration and indication



API A A A A A


hepatic cancer

hepatic cancer

somatic cancer

hepatic cancer


capsule

dosageregimen

10mgdaily

20mgdaily

10mgdaily

10mgdaily

50mg weekly

Pat1compound A Yes Yes Yes Yes Yes

Pat2 hepatic cancer use

Yes Yes Yes Yes

Pat3tablet Yes Yes


Yes


Yes

23

Pharmaceutical Companies should consider filing a PTE

based on every single approval

for all patents that cover the

approved product

24


13

SCOPE OF THE EXTENDED PATENT

25

Patent Law Art. 68bis

Where the duration of a patent right is extended (・・・・・・・), such patent right shall not be effective against any act other than the working of the patented invention for the product which was the subject of the marketing approval (where the specific use of the product is prescribed by the marketing approval, the product for such use) which constituted the reason for the registration of extension.

Scope of the Extended Patent

The law defines the scope of extended patent by the product and use prescribed by the marketing approval which constituted the ground for the extension.

26


14


IP High Court Decision on Jan.20, 2017Debiopharm vs. Towa, IP High Court Grand Bench, No. 2017- (Ne)10046.

The first case wherein the IP High Court in an infringement casedecided on the issue of scope of extended patent

(Factual backgrounds)

- Patent Invention concerned “pharmaceutically stable preparationof oxaliplatin and water”, while oxaliplatin was a known API at thetime of the patent application.

- The term of the Patent was extended based on the approval of“ELPLAT” (a drug for treatment of certain type of cancer), whichconsists of oxaliplatin and water (without stabilizing agent or anyother additives.)

27


IP High Court Decision on Jan.20, 2017

- The accused product was almost identical with “ELPLAT”, exceptthat it contained as stabilizing agent substantial amount of"concentrated glycerin".

(Issues)

- Scope of the Extended Patent

- Underlining question: Does the claim of the original patent cover aproduct which contains ingredients other than “oxaliplatin andwater” ?

28


15



Held:

Accused Product does not fall within the scope of the ExtendedPatent, because it is not “substantially identical” with the“product subject to the marketing approval” (=approved drug)on the basis of which the patent term extension was allowed.

29



(Statement of the Court)

General Rule

-A term extended patent is effective not only against products

identical with the product subject to the marketing approval(“approved product”) but also against those products that aresubstantially identical with such product as medicine.

30


16



General Rule (continued)

- Among the elements prescribed by the marketing approval, the elements that directly relates to substantial identity of the “approved product (and use)” are

“ingredients, quantity, dosage, administration, and indication” (Genentech, S.Ct. decision of 2015/11/7) .

➡therefore, those elements should be used in the comparison of the approved products and the accused product

31



General Rule (continued)

- In the case where the difference between the approved product and the accused product is merely a slight difference or a formal difference as a whole as medicine, the accused product is deemed “substantially identical” and falls within the scope of the extended patent.

-The standard for “substantial identity” is distinct from that of the “doctrine of equivalent”. The standard established by the Supreme Court (judgement of February 24, 1998) for application of “doctrine of equivalent” cannot be applied, or applied by analogy in the determination of the scope of extended patent.

32


17

Criteria for determining “substantial identity” or “a slight or merely formal difference”

Court stated:

In the limited case where the patent is “a product patent addressed to ingredient(s) of medicine” and the accused product differs in any one of the “ingredients”, “quantity”, “dosage”, “administration” and “indication” as specified by the marketing approval of the approved product (and no other differences), the determination should be made

- based on and in relation to the contents of the patented invention （such as whether the invention is one that is characterized solely by active ingredient(s) of a medicine or one that is characterized by dosage form or pharmaceutical stability, technical features, function/effects and so on.)

- taking into account common technical knowledge of those skilled in the art.


33

(continued):In the limited cases as referred to above, there are 4 types of cases wherein the accused product is considered “substantially identical” with the approved product:

Type 1

-In the case where the patented invention is characterized solely by the active ingredient(s) of a medicine,

-the accused product has added to, or substituted the non-active ingredient of the approved drug, such addition or substitution of ingredient(s) being made by applying well-known or commonly used art as of the time of the filing of the application for the marketing approval.


34


18

Type 2

-In the case where the patented invention concerns the stability

or dosage form, etc. of a medicine of known active ingredients,

-the accused product has added to, or substituted some ingredientof the approved product, such addition or substitution of ingredient(s) being made by applying well-known or commonly used art as of the time of the filing of an application for the marketing approval, and

-the accused product and the approved product are recognized as being identical with each other in the technical features and function and effect in light of the content of the patented invention.


35

Type 3

In the case where there is only a quantitatively meaningless difference between the accused product and the approved product in terms of "quantity" or "dosage and administration" prescribed by the marketing approval.

Type 4

In the case where the accused product differ from the approved product in terms of the "quantity" prescribed by the marketing approval but both products are recognized as identical in consideration of the "dosage and administration” .


36


19

(continued)

In contrast, in the case other than the above mentioned limited cases, the above criteria are not applicable.

This is because, for example, where differences other than quantitative difference exists in "dosage and administration“ due to a difference in dosage form (e.g. spray and injection), it is necessary to examine the difference from multiple points of view in light of the specific contents of the difference. In addition, if "efficacy, and effects" of the accused product differ from the approved product due to a difference in the subject diseases, it is important to examine the difference from medical perspectives, such as the similarity of diseases.


37

Application of the criteria to the present case

The court stated: The accused product is neither “identical” nor “substantially identical” with the approved product.

because:

- Ingredient differs(*“ingredients” are not limited to API)

- One of the main technical features of the patented invention is the omission of additives in the aquatic solution of oxaliplatin.

- Glycerin (the third ingredient) gives new effect

- In light of the specific feature of the patent invention, the difference cannot be seen as merely a slight difference or a formal difference as a whole as medicine.


38


20

Summary of the current status

The patent right of a term extended patent extends to products that are identical or substantially identical with the “product subject to market approval ” (=approved product)

product vs. product

Note: An approved product is defined by “ingredients

(including non-active ingredients), quantity, dosage, administration, and indication”.


39

Scope of the Original Patent

Ex 1

Ex 2

Ex 3

Ex 4


PTE max 5yearsOriginal Patent Term (20 years from filing)

The scope of each extension is defined by “ingredients (including non-active ingredients), quantity, dosage, administration, and indication” of the approved product.

40


21

Summary of the current status (continued)

•Criteria for determining “substantial identity”- may differ depending upon the types of patented inventions and the

types of medicines

- the Court referred to several examples of “substantially identical” product as guidance, but they are limited to specific types of invention and medicine.

• The court prudently noted “limited cases”, and left the issues of scope under other situations to the determined by future courts dealing with infringement cases.

However, in light of the holdings of the IP High Court in Debiopham, it seems more likely that future courts will give relatively narrow construction to “substantial identity” requirement.


41

Pharmaceutical Companies should consider filing a PTE based on every single approval

for all patents that cover the approved product,

because-the scope of a PTE is determined with

reference to the approved product, -and the court is more likely to give a narrow

construction to the requirement of “substantially identical with the approved product”.

Here again:

42


22

RE-EXAMNATIONPERIOD/DATA EXCLUSIVITY PERIOD

Generic drugs are not approved during this period

43

APPENDIX 1

RE-EXAMINATION PERIOD

• Period for carrying out post-marketing examination to ensure efficacy and safety of the drug.

• No marketing application for generic drugs is approved during this period

Re-examination Period

=Substantial Data Exclusivity Period

44


23

Re-examination (RE) Period

Type of Drug for marketing approval Re-examination Period

Drug for orphan diseases10 years

Drug necessary to epidemiologically investigate for long-term

Drug comprising a new active ingredient 8 years

New pharmaceutical combinationDrug to be administered via new route

6 years

Drug for new indication4-6 years

Drug for new dose

45

Re-examination (RE) Period

new indication is added during the original RE period

existing indicationnew

indication

RE for the new

indication

non-orphanRE period8 years

RE period remainsmore than 4 years

non-orphanremainingRE period

RE period remainsless than 4 years

non-orphan 4 years

non-orphan(RE period 8 years） orphan 10 years

orphan（RE period 10 years） non-orphan5 years10 months

orphan（RE period 10 years） orphan 10 years

46


24

47Japan Pharmaceutical Manufacturers Association

REQUREIMENETS FOR BIOSIMILARS

48

APPENDIX 2


25

Regulatory requirements of data-package for NDA application in Japan

Requirements for Biosimilars

49NAI: new active ingredient, GE: Generic, BS: Biosimilar, ○ mandatory, △ depends the case, ×: not required

Requirements for Biosimilars (continued)

50


26

Requirements for Biosimilars (continued)

51

Matsui et al., RSMP vol.5 no.3, 181−194, Sep 2015

Thank You!

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Obtaining Supplementary Protection Certificates in Europe

1

Boston, July 10, 2017

Dr. Thorsten BauschDr. Bianca-Lucia Vos

Obtaining Supplementary ProtectionCertificates in Europe – Summary for discussion

2

1 Introduction

2 Art. 3(a) – Protection by the basic patent

3 Art. 3(b) – Valid Authorization

4 Art. 3(c) – One SPC per product

5 Art. 3(d) – First Marketing Authorization

Boston July 10 th 2017


2

3

Introduction

Extension of patent protection available via Supplementary Protection Certificates

(SPCs) in Europe

Separate Right – no “patent term extension”


4

Introduction – Requirements for obtaining SPCs in Europe

Art 3 of the SPC Regulation No. (EU) 469/09:

A certificate shall be granted if…

a) the product is protected by a basic patent in force;

b) a valid authorization to place the product on the market(as a medicinal product or plant protection product) has been granted;

c) the product has not already been the subject of a certificate;

d) the authorization referred to in point (b) is the first authorization to place the product on the market as a medicinal product.

Requirements for obtaining SPCs in Europe



3

5 Boston July 10 th 2017

1 Introduction





6

Art. 3(a) – Protection by the basic patent

The „product“ means the active ingredient or the combination of activeingredients of a medicinal product or plant protection product (Art. 1(b))

CJEU in Farmitalia (C-392/97):

SPC covers product in all forms protected by the basic patent, e.g. salts and esters thereof

Protection can be determined only in the light of the non-European Union rules governing patents




4

7

Practice of many PTOs:

If the product infringes a claim, the product is “protected”

But then…



8

Art. 3(a)

Medeva, C-322/10

Georgetown University, C-422/10

Daiichi Sankyo, C-6/11

C-322/10 Medeva and C-6/11 Daiichi Sankyo:

Art. 3(a) must be interpreted as precluding the grant of SPCs relating to active ingredients which are not specified / identified in the wording of the claims of the basic patent.




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10

C-493/12 Eli Lilly

Claim 13:

"An isolated antibody or portion thereof that binds specifically to:

(a) the full length Neutrokine-� polypeptide (amino acid sequence of residues 1 to 285 of SEQ ID NO:2)…“

UK High Court - Questions referred to the CJEU:

1) What are the criteria for deciding whether “the product is protected by a basic patent in force” in Art. 3(a) of the Regulation?

2) […]

3) In the case of a claimed antibody or a class of antibodies, is it […] necessary to provide a structural definition of the antibody or the antibodies […]?

Recent CJEU case law regarding Art. 3(a)



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Art. 3(a) – CJEU Eli Lil ly

C-493/12 Eli Lilly (continued)

Decision of the CJEU:

Article 3(a) does not require that the active ingredient is defined in the claims of the patent by a structural formula.

Where the active ingredient is covered by a functional formula, the claims must relate, implicitly but necessarily and specifically, to the active ingredient in question, which is a matter to be determined by the referring court.





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13

What did the UK High Court do with that?

Warren, J.:

The product is protected, if

1. it falls within the extent of protection provided by the claims, and

2. represents the focus of the claims (as opposed to falling within the scope of the claims merely due to the use of extending, general words) – modified “extent of protection test”

Decision: Antibody Tabalumab – although not specificallymentioned in the patent – considered to be protected by thebasic patent

Art. 3(a) – Application of CJEU Eli Lil ly by UK High Court


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Sandoz v Searle

Patent – Claim 1:

MA (Janssen): Prezista (darunavir) – HIV treatment

SPC (held by Searle): Darunavir (..and salts thereof)




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Sandoz v Searle (continued)

Patent did not concretely disclose darunavir

Sandoz’ position:

Claim includes 8 x 10 36 possibilities, hence darunavir not “identified/specified” in the claim.



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Sandoz v Searle (continued)

Arnold, J.

Clear from CJEU Eli Lilly (“relate implicitly..”) that identification by means of structural formula is permissible

Markush claim embodies inventive advance

Claimant’s objection as to excessive breadth is an objection to the validity of the patent (insufficiency, Agrevo)

Not the function of IPO to assess claim breadth in SPC cases

Darunavir is “protected” in the sense of Art. 3(a).




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Teva v Gilead

Background:

MA for Truvada, i.e. combo of Tenofovir disoproxil (TD)

and Emtricitabine

Patent:

Claim 25 = compound claim to TD

Claim 27 = Pharmaceutical composition comprising TD together with optionally other therapeutic ingredients

Emtricitabine not mentioned in patent

Product of SPC:

Combination of Tenofovir disoproxil and Emtricitabine


New Referral to CJEU by UK High Court - Teva v Gilead - Art. 3(a)

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Teva v Gilead (cont.)

Warren J. struggles with CJEU Eli Lilly:

The Court of Justice has “once again” (sic) failed to give national authorities clear guidance as to the proper interpretation of Art. 3a

What does “relate implicitly but necessarily and specifically” mean?

Therefore asks the same question again (as already referred to the CJEU in Eli Lilly)

What are the criteria for deciding whether “the product is protected by a basic patent in force” in Article 3(a) of the SPC Regulation?



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Basic Patent claims

MA granted for SPC requested for SPC possible?

A A + B A + B NO

A + B A + B + C A + B + C NO

A + B A + B A NO

A + B A + B B NO

A A A YES

A + B A + B A + B YES

A + B + C A + B + C A + B + C YES


Art. 3(a) – “if the product is protected by a basic patent in force” - Summary


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Consequences resulting from Medeva and Eli Lilly decisions (in light of UK judgments)

Basic patents includes claim to… Product of the SPC application

Deemed “protected by the basic patent”?

Markush formula that comprises A A Yes (UK)

Pharmaceutical composition comprising A

A + B No (CJEU Boehringer)

Pharmaceutical composition comprising A and a “further active substance”

A + B CJEU Referral

Pharmaceutical composition comprising A and a further functionally defined active substance (e.g. diuretic)

A + B (B is a diuretic)

Probably yes (if J. Warren test is used)

Pharmaceutical composition comprising A + B

A + B Yes

Art. 3(a) – „…if the product is protected by a basic patent in force“



1 Introduction






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Art. 3(b) – “if a valid authorization to place the product on the market has been granted”

Art. 3(b) – Valid authorization

Marketing Authorization (MA) for a medicinal product may be granted by

− National Authority

− Decentralized Procedure

− European Medicines Agency (EMA)

SPC filing term:

6 months from the date of the MA in the member state where the SPC application is filed (Art. 7.1) or

if the patent is granted after the MA, 6 months after the date on which the patent is granted (Art. 7.2).


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Basic Patent protects

MA granted for SPC requested for SPC possible?

A A A YES

A + B A A + B NO

A A + B A YES

A + B A + B + C A + B YES

A + B A + B + C + D A + B YES

A + B + C A + B + C + D A + B + C YES


Art. 3(b) – “if a valid authorization to place the product on the market has been granted”


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Art. 3(b) - Third party SPCs

Art 3(b) – SPCs may be based on MA by third party

Art 3(b): “a valid authorization to place the product on the market (as a medicinal product or plant protection product) has been granted”

Allows the holder of a patent which protects an authorisedproduct to apply for an SPC.

Patent holder need not be the authorised party: Possibility for unrelated third party to obtain SPC based on MA (Biogen v SKB, C-181/95)


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Art. 3(b) – SPC relying on Third Party MA – What’s the problem?



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Art. 3(b) – SPCs based on Third Party MA

Art 3(b) – Isn’t that “MA squatting”?

Are such SPCs in line with the aim of the SPC Regulation?

Company A owns EP patent protecting API X

Company A grants license to Company B under this patent

Company B develops X and obtains MA

Company A requests SPC for X based on B’s MA

Company B must pay royalties for up to 5 more years.

Company A owns EP patent protecting API X

Company B wants to market X after expiry of EP patent

Company B develops X and obtains MA

Company A requests SPC for X based on B’s MA

Company B cannot market X during SPC duration (absent license).


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Art. 3(b) – SPCs based on Third Party MA

Art 3(b) – Isn’t that “MA squatting”?

Are such SPCs in line with the aim of the SPC Regulation?

CJEU in C-493/12 HGS v Eli Lilly:

… if an SPC were granted to the patent holder, even though […] that patent holder had not made any investment in research relating to that aspect of his original invention, that would undermine the objective of Regulation No. 469/2009, […]

UK High Court (Eli Lilly v. HGS):

SPC could be granted

Lilly (also) relied on HGS’ work in developing tabalumab

Subsequent research is often conducted by third party (licensee)

An approach which discriminated between different stages of the research leading to an MA would be almost impossible of practical implementation.



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1 Introduction





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Art. 3(c) – One SPC per product

Art. 3(c):

A certificate shall be granted if the product has not already been the subject of a certificate.

One SPC per product and patentee

New case law regarding Art. 3(c) using the „different innovation test“



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CJEU C-484/12 Georgetown University


On the basis of the same basic patent, a patentee may obtain an SPC for a combination of several active ingredients as well as an SPC for each of those active ingredients provided that the active ingredients are protected as such by the basic patent.

Patent with claims for A, B and A+B → B protected as such

SPC for A, B and A+B possible!


Art. 3(c) – SPCs for combination products – CJEU Georgetwon II

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CJEU - C-443/12 Actavis v Sanofi


If an SPC has been granted for an active ingredient (A) for a basic patent, Article 3(c) precludes that an SPC is granted on the basis of the same basic patent for the combination of the active ingredient (A) and another active ingredient (B) which is not protected as such.

A is protected by the basic patent

SPC has been granted for A

Claim to A+B does not protect B as such

SPC for A+ B on the basis of the same basic patent not possible


Art. 3(c) – SPCs for combination products – CJEU Actavis I


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UK High Court in Teva v MSD

MA:

• Atripla (efavirenz, emtricitabine and tenofovir disoproxil)

SPC:

• Composition of efavirenz, embricitabine and tenofovir (..and salts thereof)

Patent:

• Focus on efavirenz

• emtricitabine and tenofovir are not mentioned

• Claim 16 = a combination of efavirenz .. with a nucleoside analog having biological activity against HIV reverse transcriptase

Earlier SPC (“035”) for efavirenz


Art. 3(c) – SPCs for combination products – the „different innovation“ test

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Arnold J. in Teva et al. v MSD

In order to determine for a given combination product whether the requirements of Art. 3(c) are met in view of CJEU Actavis I, the “different innovation” test needs to be applied by the IPOs.

Is the combination of claim 16 a “different innovation”?

NO:

The combination does not represent a distinct invention such that it could in principle form the subject-matter of a separate patent.




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UKIPO decision BL O/117/16 in MSD v Comptroller

MA and SPC:

• ATOZET – combination of ezetimibe and atorvastatin

Patent:

• Claim 1: Markush formula covering ezetimibe

• Claim 16/17 = pharmaceutical composition for the treatment of atherosclerosis …comprising ezetimibe in combination with a cholesterol biosynthesis inhibitor selected from atorvastatin

Earlier SPC (2003) for ezetimibe based on claim 1 of the patent



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UKIPO decision BL O/117/16 in MSD v Comptroller (cont.)

Question under Art. 3(c):

Is the combination of ezetimibe and atorvastin a “different innovation”?

UKIPO decision based on witness statements: YES

Not well known to use statins in combination therapy

Combination represents a significant technical advance over claim 1




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Art. 3(c): One SPC per product and patentee – and patent?

Recent case law:

Combination of two active ingredients represents a newproduct only if the combination represents a separate invention.

Recommendations:

Use different basic patents for an SPC for A and an SPC forA+B or for a derivative.

Include separate claims in pharmaceutical patents for combinations or derivatives, ideally accompanied with information on unexpected advantageous effects.

Art. 3(c) – Summary



1 Introduction






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Art. 3(d) – First MA

Article 3 (d) – First MA

A certificate shall be granted if the authorization referred to in point b) is the first authorization to place the product on the market.

An SPC application should be filed based on the first MA for a product

Before the CJEU decision Neurim C-130/11 in 2012, only theearliest MA granted for a product was considered to represent thefirst MA


40

Art. 3(d) – First MA

Headnote 1 of CJEU Neurim, C-130/11:

Articles 3 and 4 of [the SPC Regulation] must be interpreted as meaning that, in a case such as that of the main proceedings, the mere existence of an earlier MA for a veterinary product does not preclude the grant of a SPC for a different application of the same product for which a MA has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application of the SPC.

Art. 3(d) and its interpretation by the CJEU



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Art. 3(d) – Neurim

Case underlying Neurim

Earlier MA (NL), 1992 Basic patent for Neurim‘s SPC request:Melatonin formulation for use in correctingmelatonin deficiency (filed 1992)

Melatonin for enhancingfur growth in mink

Earlier MA (UK), 1999Melatonin for initiating an early

breeding season in sheep

Circadin MA (EU), 2007Melatonin as a medicine forinsomnia

NLMA

UKMA


EUMA

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How broadly is the term “different application of the same product” as used by the CJEU in the Neurim decision to be interpreted?

New indication (treatment of new disease) only?

Same disease, but new patient group?

Same disease, but new therapeutic dosage regimen such as once monthly administration instead of once daily?

Same disease, but new administration form, e.g. oral, topical, injection?

New formulation for a known administration form, e.g. new excipients in an oral dosage form?

Art. 3(d) - CJEU Neurim



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Can CJEU Neurim be applied to new formulations of known actives?

Decision of UK High Court of Justice [2017] EWHC 14(Pat) dated January 13, 2017 asking for a CJEU referral(Abraxis Bioscience LLC v. Comptroller):

Is Article 3(d) of the SPC Regulation to be interpreted as permitting the grant of an SPC where the marketing authorisation referred to in article 3(b) is the first authorisationwithin the scope of the basic patent to place the product on the market as a medicinal product and where the product is a new formulation of an old active ingredient?

Art. 3(d) - Referral to CJEU – Application of CJEU Neurim to formulation patents?


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CJEU referral in Abraxis Bioscience LLC

Question:

Will the answer be limited to new formulations or also providefurther direction as regards basic patents protecting:

- a new dosage regime,

- a new patient group,

- a new administration form?

Art. 3(d) - Referral to CJEU – the application of CJEU Neurim to formulation patents



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The CJEU‘s decision Neurim established a link between the scope of the selected basic patent and the marketing authorization.

Recommendations

If a patent protects a new application of a known active ingredient, consider the possibility of obtaining SPCs if a marketing authorization is granted for a medicinal product and an application falling within the limits of the patent even if earlier MAs for the active ingredient exist.

Art. 3(d) – Summary first MA



1 Introduction





6 Data Exclusivity and Marketing Protection in Europe


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Data Exclusivity and Market Protection in Europe


8 years

Data Exclusivity

2 years

Market Protection

+1 year

Other companiesmay not refer tothe MA

Genericcannot beplaced on the market

Extra marketprotection*

*if new indication is granted within first 8 years +

signif icant clinical benefit over existing therapies

Dr. Thorsten Bausch | [email protected]

Dr. Bianca-Lucia Vos | [email protected]

Thank you for your attention

u.s. patent term extension - m.foley.com · u.s. patent term extension 3 prior to hatch-waxman a...

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