SPCs on adjuvants??

The SPC blog has found out that a couple of patent offices, Italy and Slovenia, have granted SPCs on vaccine adjuvants (generally vaccine components that modify the immune response to an antigen). We recall from the SPC blog event in January that France had refused such claims, and it wasn't looking too good elsewhere for those seeking this sort of protection.

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.

Romania's SPC fees and forms

On 31 March 2010 the Romanian Patent and Trade Mark Office issued Regulation No. 111. This Regulation adds two new points to Article 6 of Regulation No. 146 on Supplementary Protection Certificates for Medicinal and Plant Protection Products from December 28, 2006. According to a news item from Balkan-based IP practice Petosevic:

"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".

Genzyme Biosurgery v BIE: English translation

Following on from our post on Thursday 15th April concerning medical devices, attached is an English language version of the Genzyme Biosurgery v BIE decision. Many thanks to Kathryn Nicholls at Mewburn Ellis LLP for this.

Jodosulfuron dispute: hearing this Thursday

In June last year The SPC Blog reported on a German reference for a preliminary ruling from the Bundespatengericht to the Court of Justice of the European Union on the interpretation of Art. 3(1)(b) of Council Regulation 1610/96 regarding the creation of a supplementary protection certificate for plant protection products. This reference is Case C-229/09 Rechtsanwaltssozietät Lovells v Bayer CropScience AG (jodosulfuron) and the single question referred for a ruling is this:

"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.

SPCs, actives and medical devices

Recently, we posted a German Federal Patent Court decision which overruled a decision of the German Patent and Trademark Office, and granted an SPC to an implantable medicinal device (see link - Yttrium-90 Glass Microspheres). In light of questions we have received on this issue the SPC Blog asks whether any of its readers is aware of further decisions on SPCs involving medicinal devices.

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.

Latest AHP analysis now in print

Volume 10, issue 5 of the Bio-Science Law Review, published six times a year by Lawtext Publishing, carries another article on SPCs. This is "SPC Entitlement: ECJ Rules in Favour of Drug Innovators in Interpreting the SPC Regulations for Medicinal and Plant Protection Products", by Klaas Bisschop and Kersti Schrijvers (both of Lovells, Amsterdam). According to the abstract,

"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.

Full translation of German Sitagliptin Referral Available

The SPC Blog kindly thanks Monica Heinemann (Abitz & Partner) and Miriam Gundt (Lovells)for providing a full translation of the German Federal Patent Court's Sitaglipin referral decision (see here for previous post on this matter).

New Zealand: extensions unlikely?

New Zealand's Patents Bill, to replace that country's current legislation which dates from 1953, was referred last year to the Commerce Select Committee for public submissions. The Select Committee released its report on the Patents Bill this past Tuesday. The Committee recommended the introduction of various amendments before the Bill goes through the normal legislative process. A version of the report, together with a marked-up version of the Bill showing the proposed amendments, can be viewed here.

Among the topics that have been mooted for the reforms is the possible introduction of patent term extensions where the commercial exploitation of a pharmaceutical or agrochemical product is delayed due to the need to obtain regulatory approval. It has been noted that the Select Committee makes no recommendation in this regard. This omission is particularly disappointing for patentees because the Bill contains two 'spring-boarding' provisions. These are clause 136, which will grant an exemption from infringement for an act done for experimental purposes, and clause 138, which will govern the development and submission of information required to obtain regulatory approval.

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).