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Microsoft powerpoint - vpm_09_2011_mei_last

Patent Attorneys Attorneys-at-Law München Basel Berlin 5th International VPM Days
Prolongation of Patent Term ???
Dr. Jürgen Meier
2011 Vossius & Partner 1. Claims in Medicine
• Examples of claim structure• Scope of protection 1. Beer, comprising at least 20% EtOH.
2. Pharmaceutical composition comprising beer as characterized in claim 1.
3. Beer as characterized in claim 1 for use in a method of treating stress release, nervous disorders and/or myogelosis. [EPC2000] 4. The pharmaceutical composition of claim 2 or the use of claim 3, wherein the beer is to be administered after sunset.
YES.he can! G2/08
!Dosage or Treatment Regimen Are Allowable!
His Patent will run for 20 years (Filing Date)
IP Protection for Factual Uncertainties • patents filed at a very early stage of • only vague anticipation of product to be developed/marketed • no anticipation of potentially infringing embodiments of IP Protection for Biologics (etc) Legal Uncertainties First approval of originator Biosimilar/ 20-year patent term Data marketing exclusivity 2. SPCs IN A NUTSHELL.
Supplementary Protection Certificates COUNCIL REGULATION (EEC) No. 1768/92 of 18 June 1992 concerning the creation of a Supplementary Protection Certificate for medicinal products (now codified under Regulation (EC) 469/2009) Regulation (EC) No. 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a Supplementary Protection Certificate for plant protection products Regulation (EC) No. 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use 29 EFTA states and CH/LI Swiss national SPC Regulation (EC) 469/2009 What is an SPC?
the SPC provides up to 5 years of additional proprietary protection + 6 month paediatric extension Grant of M.A.
Filing date of patent Actual exploitation of the patent but only in respect of a product which has received a M.A. in the particular Member State it DOES NOT (!!) extend the term of the patent itself Patent Term Restoration and SPCs SPC Regulation
• max. 14 years from 1st MA • max. 15 years from 1st MA • max. 5 years from patent • max. 5 years from patent (+ ½ -year paediatric • only 1 restoration per • multiple SPCs per patent • affiliation to MA holder • no affiliation to MA holder • limited to approved • limited to approved 3. THE PROTECTION CONFERRED
"Whereas all the interests at stake, including those of public health … the protection granted should be strictly
confined to the product
which obtained authori-
zation to be placed on the
market as a medicinal pro- Art. 4 - Subject-matter of protection:
"Within the limits of the protection conferred by the basic patent, the protection conferred by a certificate shall
extend only to the product covered by the authorization
to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorized before the expiry of the certificate." Art. 5 - Effects of the certificate:
"Subject to the provisions of Article 4, the certificate shall
confer the same rights as conferred by the basic patent
and shall be subject to the same limitations and the same The Objective of the SPC … to provide a guaranteed period of 15 years "adequate protection" from the time the medicinal product in question first obtains authorization to be placed on the market to "cover the investment put into the research" … Conditions for Obtaining a Certificate Article 3 SPC
A certificate shall be granted in the Member State if…(a) the product is protected by a basic patent in force; a valid authorization to place the product on the market as a medicinal product has been granted in accordance with Directive .; the product has not already been the subject of a the authorization referred to in (b) is the (EP) first authorization to place the product on the market as a medicinal product.
Idarubicin hydrochloride Claims of basic patent:
Idarubicin (free base only) Description of basic patent:
only Idarubicin hydrochloride Request for the grant of the SPC:
"Idarubicin and salts thereof, including Idarubicin Art. 3(a) and (b)
The approved product must be
protected by a basic patent
• approved product must be covered by the scope of protection of the basic patent, i.e.,
literal wording and scope of equivalence • definition of the product should not extend beyond the scope of the patent "19. If the certificate did not cover the actual medicinal product, as protected by the basic patent and one of the possible forms of which is the subject-matter of a marketing authorisation, the fundamental objective of Regulation would "22. Where a product in the form referred to in the marketing authorisation is protected by a basic patent in force, the certificate is capable of covering that product, as a medicinal product, in any of the forms enjoying the protection of the Adalimumab/Yeda Research Dutch Council of State
Farmitalia
Supplementary Protection Certificates covering biological substances SPC application:
"human monoclonal antibodies
against tumor necrosis factor-alfa" Adalimumab/Yeda Research "The assumption that related biological drugs, [like small molecules] … have the same therapeutic value can not be made. It has not been made plausible that, in the case of "adalimumab" and other monoclonal antibodies against "tumor necrosis factor alpha", such an equivalence can in principle be assumed. "Adalimumab" has been attributed as an INN to a monoclonal antibody consisting of a sequence of 1330 amino acids by the WHO. For such a tremendously complicated structure it is troublesome to foresee the precise effects induced by every of the possible variants of the monoclonal antibody." 4. COMBINATION OF ACTIVE
The "Disclosure Test" vs. the 1. The "Disclosure Test":
The combination must be disclosed or
identifiable in the basic patent (GB, FR, DE,
2. The "Infringement Test"
The combination must infringe the patent
pursuant to Article 69 EPC (CH, NO, CZ) Combination of Active Ingredients Approved Product: combination of salmeterol
and flucticasone
Basic Patent: combination of salmeterol and
flucticasone
Combination of Active Ingredients Approved Product: fosinopril + hydrochlorothiazide
Basic Patent: fosinopril
"Für ein als Arzneimittel zugelassenes Erzeugnis, das aus zwei Wirkstoffen zusammengesetzt ist, kann auch dann ein ergänzendes Schutzzertifikat beansprucht werden, wenn das Grundpatent nur einen der beiden Wirkstoffe nennt und beschreibt." [mBGE 124 III 375] Combination of Active Ingredients Approved Product: combination of
lansoprazole and clarithromycin Basic Patent: only lansoprazole
SPC refused: The so-called "combination" of lansoprazole
and an antibiotic would only infringe because of the presence of the lansoprazole. In truth, the combination is not as such "protected by a basic patent in force". What is protected is only the lansoprazole element of that combination. (Jacob J, para. 10[2004], RPC, 3) Basic patent: Method claim for the preparation of
an acellular B. pertussis vaccine Approved Product (Government Health Policy):
Multi-vaccine against: • Whooping cough Questions referred to the ECJ:
What is meant in Article 3(a) of the Regulation by "the product is protected by a basic patent in force" and what are the criteria for deciding this? • 4. Is a multi-disease vaccine "protected by a basic patent" if one antigen of the vaccine
is covered by the patent?
• 5. Is a multi-disease vaccine "protected by a basic patent" if all antigen of the vaccine
is covered by the patent? (i.e. : …are there different criteria in respect of a medicinal product comprising more than one activeingredient or for a multi-disease vaccine…?????) C-322/10 / C-422/10 Medeva and Georgetown University and Others Opinion AG Trstenjak 1 Handed down on July 13th, 2011 Answer from Attorney General: ????? "SPC for compound X should be granted" "Said SPC would also cover X +Y" "However, only one SPC (for "X") should be allowed" CONTRADICTION!!!!!! How will the European Court of Justice now react? 5. MULTIPLE SPCs?
"The product has not already been the subject of a certificate." On face value Article 3(c) seems to imply that for any one product only a single certificate may be C-181/95 Biogen/SmithKline Beecham 1. Where a medicinal product is covered by several basic patents, the SPC Regulation No. 1768/92 "does not preclude the grant of a Supplementary Protection Certificate to each holder of a basic patent".
Conditions for Obtaining a Certificate Article 3 (2) EC 1610/96
The holder of more than one patent for the same
product shall not be granted more than one certificate for that product. However, where two or more applications concerning the same product and emanating from two or more holders of different patents are pending, one certificate for this product may be issued to each of these holders.
Recital 17 of the preamble of EC 1610/96
Whereas the detailed rules in … Articles 3 (2). of this
Regulation are also valid, mutatis mutandis, for the interpretation . of 3 of Council Regulation (EEC) No.
Prior approval: Citalopram
Marketing approval: S–Citalopram
Basic patent: S-Citalopram
FSC (BGH):
Prior approval of racemic compound is no bar to the issue of an SPC for an enantiomer of the compound if it is the subject-matter of a later marketing authorisation and a substance patent of its own.
C-258/99
Different ratios of active ingredient:
impurities are regarded as the same
• Implantable wafer comprising carmustine for the treatment of brain tumours.
• Carmustine is embedded in a matrix wafer, controlling the local release of the toxic chemotherapeutic agent • Well-tolerated, low toxicity• Significant prolongation of life expectancy "combination of active ingredients of a medicinal product" should only include substances which have a therapeutic effect of their own for a specific indication" 7. SPC INFRINGEMENT CASE LAW
BE: Combination Does • SPC/Paediatric extention• Lorsartan Generic product:
• Lorsartan + HCZ
• SPC/Paediatric extention• Lorsartan Generic product:
• Lorsartan + HCZ
• Injunctive relief granted
Generic product: Valsartan + HCZ
• Injunctive relief granted, confirmed by higher regional court • Valsartan +HTZ • Court Settlement Patent Attorneys Attorneys-at-Law München Basel Berlin Thank you for your attention!

Source: http://vaccine-manager.eu/en/resources/5.-VPM-Tage-Presentations/Juergen_Meier.pdf