Pharma Session 1: The endgame: patent term extensions and …Patent Term Extension is provided under...

Pharma Session 1: The endgame:

patent term extensions and SPCs

Tuesday, September 2509:00-10:30

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2018 AIPPI World Congress – Cancun

September 23 - 26, 2018

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Alexa von Uexkuell, Vossius & Partner (Moderator)

MaryAnne Armstrong, BSKB LLP

Makoto Ono, Anderson Mori & Tomotsune

John Todaro, Merck & Co, Inc., Kenilworth, New Jersey

(USA)


September 23 - 26, 2018

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Topics to be discussed

1. One Patent – one patent term extension?

2. Patent term extensions for combination products

3. The level of disclosure required – to what extent must a patent disclose or claim the active ingredient(s)?

4. Best practices for complying with Patent Term Extension/SPC Filing Deadlines

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(1) U.S. - One Patent – One patent term extension?

Patent Term Extension is provided under 35 U.S.C. 154 –

“(a) The term of a patent which claims a product, a method of using a product, or a method ofmanufacturing a product shall be extended in accordance with this section from the originalexpiration date of the patent, which shall include any patent term adjustment granted undersection 154(b) …” 35 U.S.C. 154(a)

Under 35 U.S.C. 154 (f) –

(1) The term “product” means:

(A) A drug product.

(B) Any medical device, food additive, or color additive subject to regulation under theFederal Food, Drug, and Cosmetic Act.

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Under 35 U.S.C. 154(d)(5)(F) –

(F) The rights derived from any patent the term of which is extended under this paragraph shall, during the period of interim extension—

(i) in the case of a patent which claims a product, be limited to any use then under regulatory review;

(ii) in the case of a patent which claims a method of using a product, be limited to any use claimed by the patent then under regulatory review; and

(iii) in the case of a patent which claims a method of manufacturing a product, be limited to the method of manufacturing as used to make the product then under regulatory review.

However, under 37 C.F.R. 1.720 - The term of a patent may be extended if:

(b) The term of the patent has never been previously extended, except for extensions issued pursuant to §§ 1.701, 1.760, or § 1.790

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Thus, under U.S. rules there can only be one extension per patent –

If there is more than one potential API in a patent, it may be desirable to file a continuation application and split the compounds into separate patent applications.

Other limitations:

Only for first commercial marketing of the product - Fisons PLC v Quigg, (Fed. Cir. 1989) – new formulations of cromolyn sodium not eligible for PTE because it was not the first commercial marketing of the active cromolyn sodium.

One patent for a single regulatory period (37 C.F.R. 1.720(h))

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2018 AIPPI World Congress – CancunSeptember 23 - 26, 2018

(1) U.S. - One Patent – One patent term extension?• US Prohibition on Double Patenting: a judicially created doctrine that

“prohibits an inventor from obtaining a second patent for claims that are not patentably distinct from the claims of the first patent” (UCB,. Inc. v. Accord Health Care, Inc. (Fed. Cir. 2018)

• Quote from Gilead Sciences, Inc. v. Natco Pharma Ltd. (Fed. Cir. 2014):

– “[I]t is a bedrock principle of our patent system that when a patent expires, the public is free to use not only the same invention claimed in the expired patent but also obvious or patentably indistinct modifications of that invention. . . . And that principle is violated when a patent expires and the pubic is nevertheless barred from practicing obvious modifications of the invention claimed in that patent because the inventor holds another later-expiring patent with claims for obvious modifications of the invention.”

• Double Patenting can be overcome by filing a “terminal disclaimer” up until expiration of the later-expiring patent Boehringer Ingelhim Int’l GmBH v. Barr Labs, Inc. (Fed. Cir. 2010)

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• Double Patenting Scenarios:

– Two patents, with different filing dates, claiming subject matter that is not patentably distinct

– But does Double Patenting apply to patents from the same family, with the same filing date?

• Patent Term Adjustment: extension of patent term due to patent office delay during prosecution

• Quote from Gilead Sciences, Inc. v. Natco Pharma Ltd. (Fed. Cir. 2014):

– “Patents claiming overlapping subject matter that were filed at the same time can still have different patent terms due to examination delays at the PTO.”

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• Why is this important for PTE? What if the patent which is to be extended is subject to a Double Patenting scenario?

• Potential Double Patenting Scenarios

– Species Claims/Genus Claims

– Compound Claims/Composition of Matter Claims

– First Species Claims/Second Species Claim

• Some PTE applicants file terminal disclaimers during the PTE process to avoid potential double patenting issues

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(1) JP One Patent – One PTE?

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Conditions for obtaining a PTE

Examination Guidelines in JPO

A PTE application may be granted:1. if all the claimed elements are found in a newly approved drug product;

and 2. when there is another drug already on the market, if the newly approved

drug is different from the previously approved drug in any of components (ingredients and quantities thereof), dosage and administration (dosing amount, dosing schedule and administration route), or indication (effect and efficacy).

Condition 1: The patent claims can be read on the approved drug.

Condition 2: This is the first approval for any of the components, dosage

and administration, or indication.

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How many patents? How many times?

Accordingly, if the above conditions are met:

• Multiple PTEs may be granted for a single patent based on multiple

regulatory approvals; and

• Multiple patents may be extended based on a single regulatory approval

for a product.

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Hypothetical ExamplesConditions

1. The patent claims can be read on the approved drug. 2. This is the first approval for any of the components, dosage and

administration, or indication.

Patent Approvals Extendable? Remarks

(Basic Patent)

A pharmaceutical composition comprising compound A.

1st API: compound AAdmin.: 5 mg/kg dailyIndication: psoriasis

Yes

Conditions 1 and 2 are met.

2nd API: compound AAdmin.: 25 mg/kg weeklyIndication: psoriasis

Yes

3rd API: compound AAdmin.: 5 mg/kg dailyIndication: IBD

Yes

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Hypothetical Examples (continued)


(Dosage Patent)

A pharmaceutical composition comprising compound A wherein said composition is administered to patients at a dose of 25 mg/kg weekly.

1st API: compound AAdmin.: 5 mg/kg dailyIndication: psoriasis

NoCondition 1 is not met.

2nd API: compound AAdmin.: 25 mg/kg weeklyIndication: psoriasis

YesConditions 1 and 2 are met.

3rd API: compound AAdmin.: 5 mg/kg dailyIndication: IBD

NoCondition 1 is not met.

4th API: compound AAdmin.: 25 mg/kg weeklyIndication: IBD

YesConditions 1 and 2 are met.

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(1) EU One Patent – One SPC?

REGULATION (EC) No 469/2009 (the SPC Regulation for Medicinal Products)

Regulation (EC) No 1610/96 (the SPC Regulation for Plant Protection Products)

no statutory provision in the SPC Regulations that one patent may give rise to only one SPC

the only statutory limitation is that only one SPC should issue per product per patentee

CJEU C-181/95 (Biogen) of 23 Jan 1997, para. 28:

“Under Article 3 (c) of the regulation, however, only one certificate may be granted for each basic patent”

Article 3 (c):

“ the product has not already been the subject of a certificate”

only one certificate per product, rather than only one SPC per patent

Standing Practice of the national patent offices to grant multiple SPC on the basis of a single patent, if different products are involved

PDL EP 451 216 “Humanized Immunoglobulins” 7SPCs

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CJEU C-322/10 (Medeva) of 24 November 2011, para. 41

“Second, where a patent protects a product, in accordance with Article 3(c) of Regulation No 469/2009, only one certificate may be granted for that basic patent”

“Medeva and its Progeny”

(see also CJEU Georgetown (C-422/10), as well as the reasoned orders Yeda (C-518/10), Queensland (C-630/10) and Daiichi (C-6/11)).

Some patent offices adopted the interpretation of Medeva to the effect that it prohibits the grant of more than one SPC per patent.

This controversy has triggered multiple further referrals to the CJEU for clarification.

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CJEU C-443/12 (Actavis v Sanofi) of 12 December 2013

CJEU C-577/13 (Actavis v Boehringer Ingelheim) of 12 March 2015)

Facts:

Basic Patent: “Ibersartan” and “Irbesartan + a diuretic” /“Telmisartan” and “Telmisartan + HCTZ”

First SPC: “Ibersartan “/“Telmisartan”

Second SPC: “Irbesartan +HCTZ”/ “Telmisartan + HCTZ”

It is possible, on the basis of a patent which protects several different ‘products’, to obtain several SPCs in relation to each of those different products, provided, that each of those products is ‘protected’ as such by that ‘basic patent’ within the meaning of Article 3(a).

No second SPC available for combination of the API protected as such by the basic patent and which constitutes

“the core inventive advance” (CJEU C-443/12)

“the sole subject-matter of the invention (CJEU C-577/13)

and another API which is not protected by the basic patent

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(1) EU One Patent – One PTE?

CJEU C-484/12 (Georgetown II) of 12 December 2013

Basic patent: a vaccine for the prevention of papillomavirus infection, comprising at least one of the antigens A, B, C or D

First SPC: Papillomavirus vaccine composition comprising A+B+C+D

Second SPC: Papillomavirus vaccine composition comprising C+D

Further SPCs were filed for in respect of A, B, C, and D individually. All SPC applications relied on the first marketing authorization (MA1) that covered the combination product (A+B+C+D).

Multiple SPCs per patent available if each API is protected per se

SPCs available for combinations of APIs, as well as individual API, based on same MA

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(2) U.S. - Patent term extensions for combination products

Combination products are only eligible for PTE if one of the actives is has not been previously marketed.

– The Arnold Partnership v Dudas (Fed. Cir. 2004) – new combination product of hydrocodone and ibuprofen not eligible for PTE, even if synergistic effects are demonstrated, because both actives had been previously approved as separate drugs.

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(2) U.S. - Patent term extensions for combination products

However:

– New enantiomers may be eligible for PTE as a “new product” – Ortho-McNeil v Lupin, (Fed. Cir. 2010) – Levofloxacin (S(-) enantiomer of the racemate ofloxacinheld to be a new product compared to the racemate.

– Esters may be considered “new products” from previously approved salts –Photocure v. Kappos, (Fed. Cir. 2010) – methyl aminolevulinate hydrochloride (MAL HCl), which is a methyl ester of previously approved aminolevulinic acid (ALA) held to be a new product. Glaxo v. Quigg, (Fed. Cir. 1990) – cefuroximeaxetil, which is an acid ester of previously approved cefuroxime salts held to be a new product.

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(2) JP Patent term extensions for combination products

Is a PTE available for a new combination of previously approved products?

Yes, if the following Conditions are met:

1. The patent claims can be read on the approved drug.

2. This is the first approval for any of the components, dosage and administration, or indication.

Scenario 1: Patent Claim: A / Approved Product A + B

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(Basic Patent)

A pharmaceutical composition comprising compound A.

1st API: compound AIndication: psoriasis

Yes

Conditions 1 and 2 are met.

2nd API: compounds A + BIndication: psoriasis

Yes

3rd API: compounds A + BIndication: IBD

Yes

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(2) JP Patent term extensions for combination products

Scenario 2: Patent Claim: A + B / Approved Product A only

No PTE will be granted because Condition 1 is not met.

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Claim language Extendable? Remarks

A pharmaceutical composition comprisingcompounds A and B.

(probably) NoCondition 1 is notmet.

A pharmaceutical composition comprising compound A for use in combination withcompound B.

YesCondition 1 is met (if Condition 2 is also met).

Scenario 2.1: Patent Claim : A + B / Approved Product A, but according to the

label must be used in combination with B

It may depend on the claim language:

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(2) EU Patent term extensions for combination products

Is an SPC available for a new combination of previously approved products?

Article 1 Definitions:

(b) ‘product’ means the active ingredient or combination of active ingredients of a medicinal product;

Article 3(d) - the autorization… is the first authorization to place the product on the market…

As a product comprising active ingredient A+B differs from a product comprising A or B, SPC protection is available, provided the conditions of Article 3 are fulfilled.

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(2) EU Patent term extensions for combination productsMust the Patent claim match the active ingredients of the approved product?

Article 3: Conditions for obtaining a certificate

A certificate shall be granted if, in the Member State if … at the date of that application:

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

(b) a valid authorisation to place the product on the market as a medicinal product has been granted …

It has been the general consensus that the term “product” as used in the SPC Regulation must always have the same meaning.

As a consequence, it was assumed that the SPC product definition must correspond to the active ingredient(s) of the approved product.

Patent Claim: A+B / Approved product: A+B no problem

But what if there is a mismatch between patent claim and the approved product?

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Medeva and its Progeny

Infringement test not applicable

SPC for combinations of APIs only if they are "specified" in the wording of the claims

The SPC product definition must be commensurate with the claims

An SPC is availabe for API(s) "specified" in the wording of claims, even if MA contains additional API(s)

if patent only claims combination, no SPC for individual API

SPC for single API will be infringed by combination comprising this API

See also C-422/10 Georgetown, C-630/10 Queensland,

C-6/11 Daiichi, C-518/10 Yeda (all of 24/25 November 2011)

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CJEU in Medeva and its Progeny - a Teleological approach

A strict approach to Article 3(a) (i.e. the API having to be ‘specified’ or identified’ in the claims of thebasic patent) necessitates a balanced, more purposive or ‘teleological’ approach to interpreting Article3(b).

Otherwise no SPC extension would be available for manufacturers of medicinal products who areobliged, for legal or practical reasons, to market an active ingredient as a fixed combination with otheractive ingredients. Such an interpretation of the Regulation would run counter to its very aims.

Article 3

A certificate shall be granted if, in the Member State if … at the date of that application:

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

(b) a valid authorisation to place the product on the market as a medicinal product has been granted …

The product in accordance with Art.3(a) does not have to be identical with the product of Art. 3(b).

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Must the Patent claim match the active ingredients of the approved product?

Scenario 2: Patent Claim: A + B / Approved Product A only

As Product A per se is not protected by the patent no SPC (confirmed by CJEU in Medeva and its Progeny)

Scenario 2.1: Patent Claim: A + B / Approved Product A, but according to the label must be used in

combination with B

National courts, prior to Medeva (High Court CH2010 APP 0137 Yedas, CH2010 APP 0137 of 12 July 2010 and Bundesgerichtshof Pantoprazole, X ZB1/08 of 8 July 2008) have rejected the issue of an SPC under these circumstances.

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Scope of protection Medeva/ Georgetown (C-322/10 & C-422/10)

Scope

SPC for "A" will be infringed by product comprising A+B

SPC for "A+B" will be infringed by product comprising A+B+C

(confirmed by CJEU in C-442/11 Valsartan of 9 December 2012)

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CJEU case Claims API of MA SPC product definition

Medeva A+B A+B+C+D A+B

Georgetown A A+B A

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(3) U.S. - The level of disclosure required – to what extent must a patent disclose or claim the active ingredient(s)?

37 CFR 1.710 Patents subject to extension of the patent term(a) A patent is eligible for extension of the patent term if the patent claims a productas defined in paragraph (b) of this section, either alone or in combination with other ingredients that read on a composition that received permission for commercial marketing or use, or a method of using such a product, or a method of manufacturing such a product….

(b) The term product referred to in paragraph (a) of this section means —

(1) The active ingredient of a new human drug, antibiotic drug, or human biological product…including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient; or

(2) The active ingredient of a new animal drug or veterinary biological product… that is not primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes including site specific genetic manipulation techniques, including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient; or

(3) Any medical device, food additive, or color additive…

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(3) U.S. - The level of disclosure required – to what extent must a patent disclose or claim the active ingredient(s)?

Hoechst-Roussel v. Lehman, (Fed. Cir. 1997) – Claims were directed to 1-hydroxy-tacrineand a method of treating a patient with 1-hydroxy-tacrine. The approved product wastacrine hydrochloride, which is metabolized into 1-hydroxy-tacrine by the body. Patentdid not claim tacrine hydrochloride or methods of using tacrine hydrochloride,therefore the claims were not entitled to patent term extension.

Merck v. Teva, (Fed. Cir. 2003) – Claims that recited 4-amino-1-hydroxybutane 1, 1-bisphosphonic acid (i.e. acid form) were held to encompass the approved product of 4-amino-1-hydroxybutane 1, 1-bisphosphonic acid monosodium salt trihydrate (i.e. saltform) because the specification was clear that “acids” encompassed salts forms.

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(3) JP The level of disclosure required – to what extent must a patent disclose or claim the active ingredient(s)?

• Generally, the JPO requires that the active ingredient(s) be defined in the claims as follows:

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Chemical Compounds Antibodies

Regarding compound claims, the compound must be defied by thestructural formula; orconventional or IUPAC nomenclature.

Rrgarding antibody claims, the antibody must be defied by the amino acid sequence (full or at least six CDRs).

Functional/ generic definitionmay be allowed if the patent is principally directed to an inventive compound, i.e. additional compounds in the sebsequent claims may be defined functionally or generically.

Functional /generic definition may be allowed in use claims, e.g. "A pharmaceutical composition for treating cancer comprising an antibody specifically binds to antigen X."

Markush formula is allowed.

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(3) JP The level of disclosure required – to what extent must a patent disclose or claim the active ingredient(s)?

Is it necessary that each active ingredient is identified in the claims?Case 1:

• Patent is principally directed to compound A and subsequently claims a combination of compound A and e.g. a diuretic.

• Approved Product is a combination of compound A and HCTZ. PTE may be granted because Condition 1 is met (and if Condition 2 is also met) even though

HCTZ is neither explicitly claimed nor described in the specification.

Case 2:

• Patent is directed to an inventive combination.

The JPO is very unlikely to allow claims only broadly reciting, e.g. compound A and a diuretic, and would probably require that the diuretic be defined by the chemical structure.

Case 3:

• Patent is directed to a therapeutic use of an antibody that is defined functionally, e.g. specifically binds to antigen X.

• Approved Product is Antibody A that specifically binds to antigen X.

PTE may be granted for the use patent because Condition 1 is met (and if Condition 2 is also met) even though Antibody A is neither explicitly claimed nor described in the specification.

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(3) EU The level of disclosure required – to what extent must a patent disclose or claim the active ingredient(s)?

Medeva and its Progeny

Question referred:

“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?

CJEU:

In the absence of EU harmonization of patent law, the extent of patent protection can only be determined by the non-European Patent rules

Infringement test (Art. 69 EPC) is not sufficient SPC are not available for active ingredients which arenot "specified/ identified" in the wording of the claims

What are these non-European Patent rules ?

“Medeva and its Progeny”

(see also CJEU Georgetown (C-422/10), as well as the reasoned orders Yeda (C-518/10), Queensland (C-630/10) and Daiichi (C-6/11))

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Multiple further referrals to CJEU

1. CJEU C-493/12 Eli Lilly (Functional definition of an antibody)

2. CJEU C-121/17 Gilead (Truvada) (Generic definition of active ingredient)

3. UK Court of Appeal [2017] EWHC 987 (Pat) Searle (Markush-type Formula)

4. German Federal Patent Court 14 W (pat) 12/17 Sitagliptin ( C-650/17)(Functional definition of active ingredient)

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Chemical Compounds Antibodies

INN, IUPAC INN

Functional/ generic definition? Functional /generic definition ?

Markush formula

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CJEU in C-493/12 Eli Lilly of 12 December 2013 – Functional definition of an antibody

Facts:

Patent claims very broadly antibodies that bind specifically to Neutrokine alpha.

Question referred:

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

"… in order for an active ingredient to be regarded as 'protected by a basic patent in force', it is not necessary for theactive ingredient to be identified in the claims of the patent by a structural formula.“

Departure from Medeva ?

Where the active ingredient is covered by a functional formula in the claims, Art. 3(a) does not preclude the grant of anSPC on condition that it is possible to reach the conclusion on the basis of the claims, interpreted inter alia in the lightof the description of the invention, as required by Article 69 [EPC]… that the claims relate, implicitly but necessarilyand specifically, to the active ingredient in question, which is a matter to be determined by the referring court.“

The Rt Hon. Professor Sir Robin Jacob: ‘This is close to gibberish’R. Jacob, IP and Other Things (Hart Publishing, ISBN-10: 1849465959).

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CJEU in C-121/17 Truvada (Teva v Gilead) of 25 July 2018

Recap:Gilead Truvada (tenofovir)

Approved Product: Tenofovir + Emtricitabine

Basic Patent (filing date 1997): Tenofovir + "compound of claim 1 together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients"

Application as filed does not disclose Emtricitabine, which was only approved as an anti-HIV agent in 2003.

J Arnold: The Court of justice [in Eli Lilly] 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?

What are the criteria for deciding whether “the product is protected by a basic patent in force”?

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CJEU in C-121/17 Truvada (Teva v Gilead) of 25 July 2018

A product composed of several APIs is ‘protected by a basic patent in force’ within themeaning of that provision, even if the combination of APIs is not expressly mentioned in theclaims, provided that the claims relate necessarily and specifically to that combination. For thatpurpose, from the point of view of a person skilled in the art and on the basis of the prior art atthe filing date or priority date of the basic patent.

the combination of those active ingredients must necessarily, in the light of the description anddrawings of that patent, fall under the invention covered by that patent, and each of those activeingredients must be specifically identifiable, in the light of all the information disclosed by thatpatent.

SPC revoked in Germany (4 Ni 12/17 of 15 May 2018) Pending cases in the UK, FR and ES are likely to be rejected

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Swiss Federal Patent Court in O2017_001 Truvada (Teva v Gilead) of 3 October 2017

Recap:

Swiss Patent Court in BGE 124 III 375 Fosinopril of 10 July 1998

Infringement Test

Swiss SPC provisions are based on and should mirror EU provisions

Strive for harmonization

Swiss Federal Patent Court in O2017_001 Truvada (Gilead) of 3 October 2017

“The guidance provided by the CJEU [in Medeva and its Progeny] is a‘terminological mess’; as such harmonization of Swiss case law is premature, aslong as the CJEU does not provide clear and implementable guidance.”

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Swiss Federal patent Court (O2017_001) Truvada of 3 October 2017

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CJEU Decision Core message

Medeva which are not specified in the claims

Yeda is not the subject of any claims relating to that activeingredient

Actavis v Sanofi core inventive advance that is subject matter of the basicpatent

Queensland andDaiichi

which are not identified in the wording of the claims of thebasic patent

Eli Lilly the claims relate, implicitly but necessarily and specificallyto the active ingredient in question

Actavis v Boehringer the subject matter of the invention which constitutes thesole subject matter of the invention

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Swiss Federal Supreme Court in 4A_576/2017 Truvada ( Teva v Gilead) of 11 June 2018

The need for strive for harmonization implies that the Swiss authorities cannot ignore the case law and practice of the EU

Infringement Test no longer applicable

Medeva case law applicable also in CH as of June 2018

No retroactive effect

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(4) Best Practices for Pharma Companies in Complying with Patent Term Extension Deadlines

• Patent Term Extension Countries: (US, EU, Japan, Korea, Canada, Australia, Russia, Eurasian Patent Office, Israel, Chile, Taiwan, Central American countries)

• Timing of Filing for Patent Term Extension– Based on Date of Marketing Approval (assuming that the relevant patent has granted – for

example, 6 months in Australia, 3 months in Korea, Taiwan; 60 days in the US, Dominican Republic), or

– Based on Patent Grant Date

• Communication with the Internal Regulatory Groups

• Communication with Internal Business Groups in PTE Countries

• Role of Outside Patent Counsel

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Thanks for your attention!

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Pharma Session 1: The endgame: patent term extensions and …Patent Term Extension is provided under...

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