Examples of using Basic patent in English and their translations into Slovak
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As noted by the United Kingdom Government, the order in Yissum(72)had previously also concerned a situation in which the basic patent protected the second therapeutic use of a known active ingredient.
It is apparent from paragraph 5 of that order that the basic patent at issue protected a combination which contained a previously authorised active ingredient and was intended for use in connection with a new therapeutic indication.
In my opinion, from that perspective that it is necessary to understand recital 14 of Regulation No 1610/96,which Abraxis relies upon in order to establish the validity of the scope of protection of the basic patent test.
The certificate referred to in paragraph 1 shallnot confer protection against certain acts against which the basic patent conferred protection if, with respect to those particular acts, the following conditions are met.
Paragraph 6 of that judgment reveals that the basic patent relied upon in the SPC application protected the alliance, for the treatment of brain tumours, of an excipient and an active ingredient already authorised for such use.
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In that situation, as has been emphasised by Abraxis and by the United Kingdom Government,the application of the scope of protection of the basic patent test would in any event lead to the rejection of the SPC application.
Even if the composition of matter(the basic patent on the new chemical entity and its molecular structure), has expired, originators can extend exclusivity by generating new evidence and extending a medicine's indications or developing new formulations.
In the alternative, and in the event that the Court does not wish to adopt such an approach, I shall examine below the options which mightallow it to limit the application of the scope of protection of the basic patent test to specific situations.
That finding leads me to propose the abandonment of the scope of protection of the basic patent test and a return to a literal interpretation of Article 3(d) of Regulation No 469/2009, in the light of Article 1(b) of that regulation.
It might also lead to the unequal treatment of economic operators, since the combined application of Regulation No 1768/92 and the Paediatric Regulation would no longer have theeffect of making the monopoly on exploitation exercised by basic patent holders subject to the same maximum duration.
In the same vein,the fourth subparagraph of paragraph 28 of the Explanatory Memorandum states that the basic patent may cover‘the active ingredient, the process by which the medicinal product is obtained, or an application or use of the medicinal product'.
On the basis of that basic patent and MAs granted on 27 August 1997 in respect of the medicinal product Aprovel, which contains irbesartan as its single active ingredient and is used principally to treat primary hypertension, Sanofi obtained its first SPC for that active ingredient on 8 February 1999.
Any product which, on the date on which this regulation enters into force,is protected by a valid basic patent and for which the first[marketing authorisation] in the Community was obtained after 1 January 1985 may be granted a certificate.
(vi) the basic patent is revoked or limited to the extent that the active ingredient(s) for which the SPC was granted would no longer be protected by the patent, or after expiry of the basic patent grounds for revocation exist which would have justified such revocation or limitation.
Notwithstanding paragraph 1,where the authorization to place the product on the market is granted before the basic patent is granted, the application for a certificate shall be lodged within six months of the date on which the patent is granted.
(c) the basic patent is revoked or limited to the extent that the product for which the certificate was granted would no longer be protected by the claims of the basic patent or, after the basic patent has expired, grounds for revocation exist which would have justified such revocation or limitation.
Any product which, on the date on which this Regulation enters into force,is protected by a valid basic patent and for which the first[MA for the product] as a medicinal product in the Community was obtained after 1 January 1985 may be granted a certificate.
That formulation is protected by the basic patent relied upon by Abraxis in support of its SPC application, it being understood that the protection conferred by that patent does not extend to paclitaxel as such.
Notwithstanding paragraph 1,where the authorization to place the product on the market is granted before the basic patent is granted, the application for a certificate shall be lodged within six months of the date on which the patent is granted.
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 authorizations to place the corresponding plant protection product on the market and for any use of the product as a plant protection product that has been authorized before the expiry of the certificate.".
The application for a certificate shall be lodged with the competent industrialproperty office of the Member State which granted the basic patent or on whose behalf it was granted and in which the authorization referred to in Article 3(b) to place the product on the market was obtained, unless the Member State designates another authority for the purpose.
If that solution were adopted, this would mean that the basic patent holder would be eligible for the six-month extension provided for by the Paediatric Regulation only if the period that elapsed between the date of the patent application and the date on which the first MA was granted exceeds four years and six months.
The application for a certificate shall be lodged with the competent industrialproperty office of the Member State which granted the basic patent or on whose behalf it was granted and in which the authorisation referred to in Article 3(b) to place the product on the market was obtained, unless the Member State designates another authority for the purpose.
In a situation in which multiple products are protected by a basic patent in force, does the Regulation, and in particular Article 3(c), preclude the proprietor of the patent being issued a certificate for each of the products protected?
In the situation brought to the attention of the Court,the new use protected by the basic patent concerned a therapeutic indication in human medicine of a product already covered by an earlier marketing authorisation for a therapeutic indication in a separate therapeutic area as a veterinary medicinal product.
In the light of those considerations, I propose that the Court, in the alternative,hold that the scope of protection of the basic patent test applies only where a product previously authorised pursuant to Directive 2001/82 for a therapeutic indication in veterinary medicine is subsequently granted a marketing authorisation under Directive 2001/83 for a new therapeutic indication in human medicine.