Supplementary Protection Certificates - The Waiver Regulation

Jane Lambert

On 1 July 2019 Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products (Text with EEA relevance.) OJ L 153, 11.6.2019, p. 1–10 came into force.  It consists of 30 paragraphs of recitals but only 2 articles. Art 1 amends Regulation (EC) No 469/2009 of the Europea Parliament and of the Council f 6 May 2009concerning the supplementary protection certificate for medicinal products OJ 16.6.2009 L 152 p1-9 so as to enable generic and biosimilar manufacturers to make products that are protected by supplementary protection certificates ("SPC") for export to third countries or to stockpile them for distribution from the moment the SPC expires.  Art 2 provided for Regulation 2019/933 to enter into force on the 20th day following its publication in the Official Journal.

What is an SPC?

An SPC is an intellectual property right akin to a patent.   The intellectual asset that an SPC protects is the active ingredient of a previously patented pharmaceutical or plant protection product.  An SPC extends the monopoly in relation to such ingredient for up to 5 years after the expiry of the patent.  In the case of a medicine for children, it can extend the monopoly for a further 6 months.  SPCs are granted for pharmaceutical and plant protection products because the marketing of such products is delayed until after they obtain regulatory approval which can take a very long time,  The extension of the monopoly is intended to compensate for such delay.

Regulation 469/2009

Regulation 469/2009 is the legislation that provides for SPC for pharmaceutical products.  It consists of 11 recitals and 23 articles. The key article is art 2:

"Any product protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure as laid down in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (2) or Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (3) may, under the terms and conditions provided for in this Regulation, be the subject of a certificate."

For the purposes of this Regulation, "product" means  "the active ingredient or combination of active ingredients of a medicinal product", "medicinal product" means "any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals" and "a certificate" means an SPC.

Art 5 provides that the SPC confers the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations. subject to art 4.  That article limits the protection afforded by the SPC 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 had been authorized before the expiry of the SPC within the limits of the protection conferred by the basic patent.  "The basic patent" is defined as a patent which protects:
  • a product as such, 
  • a process to obtain a product or 
  • an application of a product, 
and which is designated by its holder for the purpose of the procedure for grant of an SPC. The person entitled to an SPC is the holder of the basic patent or his or her successor in title.

The conditions for the grant of an SPC are as follows:

(a) the product must be protected by a basic patent in force;
(b) a valid authorization to place the product on the market as a medicinal product must have been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate;
(c) the product may not already be the subject of an SPC;
(d) the authorization referred to in paragraph (b) should be the first authorization to place the product on the market as a medicinal product.

Art 7 (1) requires the application for an SPC to be lodged within 6 months of the date on which the authorization to place the product on the market as a medicinal product was granted. Other articles provide for the content of the application and where it should be lodged,  If the conditions for the grant of an SPC are met the application should be granted but if not it should be refused. There is also provision in the Regulation for charging fees, the duration of SPCs, challenges to their validity and appeals.

Regulation 2019/933

Paragraph (3) of the recitals to Regulation 2019/933 noted that since the adoption in 1992 of the legislation providing for SPCs, markets have evolved significantly and there has been huge growth in the making of generics and especially of biosimilars, and in the making of their active ingredients, in particular in countries outside the EU in which protection does not exist or has expired. According to the next paragraph, the absence of any exception to the protection conferred by the SPC has had the unintended consequence of preventing makers of generics and biosimilars in the EU from making generics and biosimilars in the EU, even for the purpose of export to third-country markets in which protection does not exist or has expired. Likewise, makers are prevented from making generics and biosimilars for the purpose of storing them for a limited period before the expiry of the SPC.

Those circumstances make it more difficult for those makers, in contrast to makers located in third countries where protection does not exist or has expired, to enter the EU market immediately after expiry of the SPC, given that they are not in a position to build up production capacity for the purpose of export or for the purpose of entering the market of a member state until the protection provided by that SPC had expired. The 5th paragraph recited that those circumstances put makers of generics and biosimilars established in the EU at a significant competitive disadvantage in comparison with makers based in third countries that offer less or no protection. Without intervention, the 6th paragraph warned, the viability of makers of generics and biosimilars established in the EU could be threatened, with consequences for the EU's pharmaceutical industrial base as a whole. 

To promote the competitiveness of the EU, thereby enhancing growth and job creation in the internal market and contributing to a wider supply of products under uniform conditions, by allowing makers of generics and biosimilars established in the Union to make in the Union products, or medicinal products containing those products, for the purpose of export to third-country markets or stockpiling, the Council and European Parliament adopted Regulation 2019/933.

The main change was the insertion of 9 new paragraphs into art 5 of Regulation 406/2009 by art 1 (2) of Regulation 2019/933:

"2. By way of derogation from paragraph 1, the certificate referred to in paragraph 1 shall not confer protection against certain acts which would otherwise require the consent of the holder of the certificate (“the certificate holder”), if the following conditions are met:
(a) the acts comprise:
(i) the making of a product, or a medicinal product containing that product, for the purpose of export to third countries; or
(ii) any related act that is strictly necessary for the making, in the Union, referred to in point (i), or for the actual export; or
(iii) the making, no earlier than six months before the expiry of the certificate, of a product, or a medicinal product containing that product, for the purpose of storing it in the Member State of making, in order to place that product, or a medicinal product containing that product, on the market of Member States after the expiry of the corresponding certificate; or
(iv) any related act that is strictly necessary for the making, in the Union, referred to in point (iii), or for the actual storing, provided that such related act is carried out no earlier than six months before the expiry of the certificate.
(b) the maker, through appropriate and documented means, notifies the authority referred to in Article 9 (1) in the Member State in which that making is to take place, and informs the certificate holder, of the information listed in paragraph 5 of this Article no later than three months before the start date of the making in that Member State, or no later than three months before the first related act, prior to that making, that would otherwise be prohibited by the protection conferred by a certificate, whichever is the earlier;
(c) if the information listed in paragraph 5 of this Article changes, the maker notifies the authority referred to in Article 9(1) and informs the certificate holder, before those changes take effect;
(d) in the case of products, or medicinal products containing those products, made for the purpose of export to third countries, the maker ensures that a logo, in the form set out in Annex -I, is affixed to the outer packaging of the product, or the medicinal product containing that product, referred to in point (a)(i) of this paragraph, and, where feasible, to its immediate packaging;
(e)  the maker complies with paragraph 9 of this Article and, if applicable, with Article 12 (2).
3. The exception referred to in paragraph 2 shall not apply to any act or activity carried out for the import of products, or medicinal products containing those products, into the Union merely for the purpose of repackaging, re-exporting or storing.
4. The information provided to the certificate holder for the purposes of points (b) and (c) of paragraph 2 shall be used exclusively for the purposes of verifying whether the requirements of this Regulation have been met and, where applicable, initiating legal proceedings for non-compliance.
5. The information to be provided by the maker for the purposes of point (b) of paragraph 2 shall be as follows:
(a) the name and address of the maker;
(b) an indication of whether the making is for the purpose of export, for the purpose of storing, or for the purpose of both export and storing;
(c) the Member State in which the making and, if applicable, also the storing is to take place, and the Member State in which the first related act, if any, prior to that making is to take place;
(d) the number of the certificate granted in the Member State of making, and the number of the certificate granted in the Member State of the first related act, if any, prior to that making; and
(e) for medicinal products to be exported to third countries, the reference number of the marketing authorisation, or the equivalent of such authorisation, in each third country of export, as soon as it is publicly available.
6. For the purposes of notification to the authority under points (b) and (c) of paragraph 2, the maker shall use the standard form for notification contained in Annex Ia.
7. Failure to comply with the requirements of point (e) of paragraph 5 with regard to a third country shall only affect exports to that country, and those exports shall, therefore, not benefit from the exception.
8. The maker shall ensure that medicinal products made pursuant to point (a) (i) of paragraph 2 do not bear an active unique identifier within the meaning of Commission Delegated Regulation (EU) 2016/161 
9. The maker shall ensure, through appropriate and documented means, that any person in a contractual relationship with the maker who performs acts falling under point (a) of paragraph 2 is fully informed and aware of the following:
(a) that those acts are subject to paragraph 2;
(b) that the placing on the market, import or re-import of the product, or the medicinal product containing that product, referred to in point (a)(i) of paragraph 2 or the placing on the market of the product, or the medicinal product containing that product, referred to in point (a)(iii) of paragraph 2 could infringe the certificate referred to in paragraph 2 where, and for as long as, that certificate applies.
10. Paragraph 2 shall apply to certificates that are applied for on or after 1 July 2019.
Paragraph 2 shall also apply to certificates that have been applied for before 1 July 2019 and that take effect on or after that date. Paragraph 2 shall only apply to such certificates from 2 July 2022.
Paragraph 2 shall not apply to certificates that take effect before 1 July 2019."

Art 1 (1) of 2019/933 inserted a new point (4) into art 1 of Regulation 406/2009 which defined "maker" as

"the person, established in the Union, on whose behalf the making of a product, or a medicinal product containing that product, for the purpose of export to third countries or for the purpose of storing, is carried out".

The logo referred to in the new art 5 (2) (d) is the one shown at the top of this article.

Art 1 (3) of Regulation 2019/933 requires the intellectual property office that has granted the SPC to publish the information specified by the new art 5 (5).  Art 1 (4) entitles such intellectual property offices to charge fees for notifications under these new provisions.  Art 1 (5) inserts a new art 21a providing for a review and evaluation of the new legislation every 5 years.  Finally, art 1 (6) inserts a new Annex -1 and a new Annex -1a.   Annex -1 contains the logo mentioned above and Annex -1a the notification form.

Brexit

As the UK did not leave the EU on 29 March 2019 it is bound by Regulation 2019/933.  In a consultation document entitled Draft legislation: supplementary protection certificate manufacturing waiver in a 'no deal' outcome. the government indicated that the new Regulation would be incorporated into the laws of England and Wales, Scotland and Northern Ireland by s.3 (1) of the European Union (Withdrawal) Act 2018.  It would, however, amend the Regulation mutatis mutandis by a new statutory instrument to be known as The Patents (Amendment) (No.2) (EU Exit) Regulations 2019.  A consultation was held on the terms of the draft regulations in July and August 2019 and the government is evaluating respondents' feedback.

Anyone wishing to discuss this article or SPC, in general, should call me on 020 7404 5252 during office hours or send me a message through my contact form.

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