A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here
Tuesday, 27 April 2010
The medicinal product in question was a combination of antigen + adjuvant, and SPCs were granted to both the adjuvant per se and to the (antigen + adjuvant) as a combination of active substances.
All of this must be considered within the context of the decision in the ECJ Case C-431/04 (MIT) which related to a combination of an active plus a bioerodible matrix that enabled the active to be administered in a therapeutically relevant way. The ECJ decided that:
Article 1(b) of Council Regulation No 1768/92 of 18 June 1992 ...must be interpreted so as not to include in the concept of ‘combination of active ingredients of a medicinal product’ a combination of two substances, only one of which has therapeutic effects of its own for a specific indication.
Does a vaccine adjuvant have a therapeutic effect of its own for a specific indication? A vaccine adjuvant, which itself has some immunological/ physiological effect on a host, might at least be considered to be more of an active substance than a matrix to allow slow release.
Let's throw into the mix (not literally) that some adjuvants for vaccines are being considered as monotherapies in their own right, such as CpG for cancer ...
Moreover, it's an interesting one for patent attorneys and their regulatory teams. Do you argue that an adjuvant is an active, which may be necessary if trying to obtain an SPC on a combination of an old active with new adjuvant, for example. Or do you argue that the adjuvant is a mere excipient to assist in the regulatory process?
If anyone has any other SPC related information on SPCs granted or refused on adjuvants, please do share them with us.
"The newly added point 6 provides that the official fee for the examination of a request for a 6-month extension of the supplementary protection certificate for medicinal products for pediatric use is EUR 500 (USD 682), the same as for the examination of a request for granting an SPC for other medicinal products.
The newly added point 7 provides that the official fee for the 6-month extension of an SPC for medicinal products for pediatric use, as per the provisions of Council Regulation (EEC) No. 1768/92 with further amendments, is EUR 1,400 (USD 1,913).
On the same date ... the Romanian PTO issued Regulation No. 112, which establishes the standard form to be used for requesting the extension of an SPC for medicinal products for pediatric use.
These two new regulations establish formal rules for practices regarding the SPCs that were not formerly regulated by the PTO".
Monday, 19 April 2010
"For the purpose of the application of Article 3(1)(b) of 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, must account be taken exclusively of a marketing authorisation under Article 4 of Directive 91/414/EEC, or can a certificate also be issued pursuant to a marketing authorisation which has been granted on the basis of Article 8(1) of Directive 91/414/EEC?".The hearing before the Court takes place this Thursday, 22 April at 11.00am.
Thursday, 15 April 2010
By way of background, the issue is as follows.
Article 2 of SPC Regulation EC 469/2009 stipulates that:
"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 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 may, under the terms and conditions provided for in this Regulation, be the subject of a certificate."
[A product according to Article 1 of the SPC regulation is any active ingredient or combination of active ingredients of a medicinal product].
What does the underlined text mean? Does it mean that only a product specifically approved under Directive 2001/83/EC or 2001/82/EC may be subject of an SPC, or does it allow for an SPC to be granted for an active approved under some other EC legislation, and where the active component has undergone the same level of scrutiny as required by in Directive 2001/83/EC or 2001/82/EC.
The latter situation may arise in the medicinal devices Directives 93/42/EC (for Medicinal Devices) and 90/385/EEC (for implantable medicinal devices).
For example, Article 1(3) of Directive 93/42/EC indicates that medical devices containing actives are generally covered by the medicinal device directive and would not be authorised under Directive 2001/83/EC or 2001/82/EC. [The exception is where the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, in which case Directives 2001/83/EC or 2001/82/EC apply].
Directive 93/42/EC specifies, in paragraph 7.4 of Annex 1,that:
"Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 65/65/EEC and which is liable to act upon the body with action ancillary to that of the device, the safety, quality and usefulness of the substance must be verified, taking account of the intended purpose of the device, by analogy with the appropriate methods specified in Directive 75/318/EEC [now Directive 2001/83/EC]. Similar language is found in Article 1(3) and paragraph 10 of Annex 1 of Directive 93/385/EEC.
Thus it would appear that an active component of a medicinal product whose approval is governed by the medicinal devices Directives should to be assessed at the same level of rigour as an active agent covered by Directives 2001/83/EC or 2001/82/EC. The need for equally stringent testing of active ingredients approved under different directives makes perfect sense, but does that fact alone open the door to SPC protection for the product?
Arguably it should. It appears to be unfair that SPC protection would only be available to actives that have been approved under Directives 2001/82/EC or 2001/83/EC, and that a new active specifically delivered by a device but approved under the medicinal devices Directive 93/42/EC (for example), could not take advantage of the SPC provisions.
The German Federal Patent Court in the Yttrium-90 Glass Microspheres case considered the level of testing required by the medicinal devices Directives allowed the product to conform to the administrative authorisation requirement of Article 2 of SPC Regulation EC 469/2009.
A similar conclusion was arrived at by the Court of The Hague in 2004 in Genzyme Biosurgery v. BIE (if anyone has an English translation of this decision we'd love to see it).
However, a court might consider that it was not able to interpret Article 2 of the SPC regulation more broadly than approval under Directives 2001/82/EC and 2001/83/EC per se. It might also be argued – at a stretch - that assessment of safety "by analogy" with Directive 2001/83/EC is not necessarily assessment at the same standard as under by Directive 2001/83/EC.
If you have other examples in the device area we would be interested to find out.
You can post any thought as a Comment below.
Wednesday, 14 April 2010
"In an eagerly anticipated ruling, the European Court of Justice ("ECJ") finally made it clear that the European SPC Regulations for Medicinal products and Plant protection products aim to protect the interests of each holder of a different basic patent by enabling the grant of SPCs to each holder of a different basic patent. SPC applications do not need to be pending simultaneously. The article provides an overview of the relevant legal framework for SPC protection within Europe as well as giving inside in what role the underlying objectives of the European legal framework play when interpreting the law.
Through reviewing the case from a national and European perspective, this article describes the ruling by the ECJ and the interest the case holds for patent life management".As this suggests, this is an analysis of the ruling in Case C -482/07 AHP Manufacturing BV v Bureau voor de Industriële Eigendom (noted on The SPC Blog here). The 6-page piece concludes that the ruling's clear statement that the underlying objective of the SPC Regulations are more important for the grant of an SPC is "positive news" for the innovative pharmaceutical industry, providing the possibility of extending patent protection and improving the management of the life of a patent.
Thursday, 8 April 2010
Thursday, 1 April 2010
The Committee's report will be debated in Parliament before a decision is made to amend the Patents Bill.
Source: Adrian Evans (Henry Hughes Patent & Trade Mark Attorneys).