Paedriatric extensions: note on Merck

Writing in the Oxford University Press monthly Journal of Intellectual Property Law & Practice 2009 4: 457-459, Professor Dr Ulrich M. Gassner has produced a helpful note, "Paediatric extensions: the requirement of a compliance statement", on the decision in Merck and Co., Inc. [2008] BL O/035/08, UK IPO, 6 February 2009 (see also the posting on The SPC Blog here). According to the abstract,

"Taking a narrow interpretation of what is meant by a statement indicating compliance with an agreed completed paediatric investigation plan (PIP), the UK Intellectual Property Office has held that a valid application for a paediatric extension must include an authorization containing such a statement and that therefore a positive opinion of the Paediatric Committee of the EMEA, as such, is not suitable as a means to meet this requirement".

The SPC Blog is taking steps to get permission from the publishers to make this note available to its readers.

Reverse payments: (how) do they affect SPCs?

While discussing possible subjects for discussion at The SPC Blog's second annual seminar this coming January, one of the topics that was raised was that of "reverse payments". The idea of a patent owner "buying off" a generic competitor in order to ensure a longer period of exclusivity and avoiding a legal challenge is one that has become well enshrined in US patent practice -- and although concern has been expressed by antitrust regulators, consumer groups and others, the Supreme Court has yet to agree to hear an appeal on this issue.

Have reverse payments become part of European practice and, if so, to what extent? There is certainly some support for the proposition that they are illegal in their basic form. But would they especially nuanced where the right which the proprietor seeks to protect lies in the realm of supplementary protection? I've not been able to find a literature on this subject, but would like to consider it as a seminar topic if there's enough substance to it.

Please let me know your thoughts, either by posting them below so that everyone can see them, or by emailing them here. If there are other topics that appeal to you, please let me know about those too.

Another ECJ referral - this time sprouting out of Germany

Via Klemens Stratmann of Hoffmann Eitle (Munich) comes this piece of news: the German Federal Patent Court has recently, and for the first time in its history, referred a question to the ECJ concerning the interpretation of Art. 3(1)(b) of Council Regulation 1610/96 regarding the creation of a supplementary protection certificate for plant protection products:

"Is the existence of an authorisation to place the product on the market in accordance with Art. 4 of Directive 91/414/EEC exclusively decisive for the application of Art. 3(1) b of the Regulation or can a certificate also be granted based on an authorisation to place the product on the market in accordance with Art. 8(1) of Directive 91/414/EEC."

Klemens has kindly provided a summary of the case, available here. However, here are some extracts:

"In the Jodosulfuron case, the IP firm Lovells, Düsseldorf, lodged a nullity action against Bayer CropScience AG concerning the supplementary protection certificate DE 100 75 026 which extends the duration of EP 0 574 418. The unusual role of an IP firm as plaintiff may indicate that plaintiff and defendant cooperate and have selected this case for the clarification of various questions by the courts. The underlying facts are as follows.

Bayer CropScience is the owner of EP 0 574 418 relating to arylsulphonyl urea compounds, a method of preparing them and their use as herbicides. The patent protects, inter alia, the chemical compound 4-iodo-2-[3-(4-methoxy-6-methyl-1,3,5-triazin-2-yl) ureidosulfonyl] benzoic acid also known as jodosulfuron.

On 9 March 2000, a provisional marketing authorisation with effect for Germany was issued by "Biologische Bundesanstalt für Land- und Forstwirtschaft" in accordance with Sec. 15 c of the German Plant Protection Act. This provisional marketing authorisation was granted for 3 years and, upon the request of the defendant, extended until May 21, 2005. Jodosulfuron was included in Annex I of Directive 91/414/EEC in accordance with Directive 2003/84/EC[1] which entered into force on 1 January 2004. On 13 January 2005, a regular marketing authorisation in accordance with Sec. 15 of the German Plant Protection Act was granted to the defendant for the plant protection product Husar including jodosulfuron.

Based on the provisional marketing authorisation of 9 March 2000, the defendant applied on 8 September 2000 for an SPC of EP 0 574 418 at the GPTO. This SPC (DE 100 75 026) was granted on 17 July 2003 by the Federal Patent Court[2].

In 2006 the German Patent Office started to change its practice of allowing SPC applications based on provisional authorisations under Sec.15c of the Plant Protection Act. Between 1999 and 2006, the German Patent and Trademark Office (“GPTO”) has been regularly issuing applications for SPCs (about 20) on the basis of the provisional authorisation under Sec. 15c of the Plant Protection Act. These applications were now objected to.

According to the most recent opinion of the GPTO, the 6-month period of Art. 7(1) of Regulation for submitting the SPC application is to be calculated starting from the date of the regular authorisation pursuant to Sec. 15 or 15b of the Plant Protection Act and only SPC applications based on these regular applications can be allowed.

Having noted the changed practice of the GPTO, the defendant lodged a second SPC application for jodosulfuron on 7 August 2006, this time based on the regular marketing authorisation issued on 13 January 2005.

To substantiate the nullity action, plaintiff primarily argued that, contrary to the requirements of Art. 3(1) b of the Regulation, the marketing authorisation of 9 March 2000 does not represent a valid authorisation to place the product on the market
which was granted in accordance with Art. 4 of Directive 91/414/EEC or an equivalent provision of national law.

The Federal Patent Court agreed with plaintiff. It held that the requirements of Art. 4 of Directive 91/414/EEC are not met. Art. 4 of Directive 91/414/EEC requires that the active substance of the plant protection product is listed in Annex I of Council Directive 91/414/EEC. On the other hand, provisional authorisations are issued pursuant to Sec. 15c of the Plant Protection Act if the inclusion of in Annex I has not yet been decided as it was the case for iodosulfuron when Bayer CropScience applied for the first SPC.

The Federal Patent Court also denied that the marketing authorisation was granted in accordance with an equivalent provision of national law [...] The Federal Patent Court also addressed the question of whether the later issuance of a regular marketing authorisation according to Sec. 15 of the German Plant Protection Act is to be considered for the validity of an SPC granted on the basis of a provisional marketing authorisation according to Sec. 15 c Plant Protection Act. In this respect, the court saw no reason to derogate from the wording of Art. 3 of the Regulation which requires that the condition of Sec. 1(b) is met at the date of the application. Accordingly, it was irrelevant in the view of the court, whether after the date of filing the SPC application this condition was met by the grant of the regular authorisation dated 13 January 2005.

The Federal Patent Court also considered whether it matters that SPC applicants had relied on a long-standing practice of the GPTO since 1999. In fact, the SPC application forms and guidelines available over this time period suggested that the SPC application shall be filed within six months from the provisional marketing authorisation according to Sec. 15c of the German Plant Protection Act.

In this connection, the Federal Patent Court held that the general principle of protection of confidence in a long-standing practice of the GPTO can be considered if the nullification of the SPC would lead to a final and unjust loss of the IP right and moreover outbalancing interests of the public do not oppose the maintenance of the SPC. In the specific circumstances of the Jodosulfuron case, the Federal Patent Court referred the defendant to the possibilty of obtaining an SPC for jodosulfuron based on the 2nd SPC application of 7 August 2006 which relied on the regular marketing authorisation according to Sec. 15 of the German Plant Protection Act.

This, in turn, raises the question of whether the grant of the 1st SPC for jodosulfuron on 17 July 2003 opposes the grant of the 2nd SPC application in light of Art. 3(1) c of the Regulation. This subsection of Art. 3 requires as a pre-condition for SPC grant that an SPC has not yet been granted for the same product.

In the opinion of the Federal Patent Court, Art. 3(1) c of the Regulation would be nno obstacle to the grant of further SPCs for the same product if the 1st SPC is declared null and void, since this nullification is effective ex tunc.

It has also become apparent from the decision that the Federal Patent Court sympathised with the defendant with regard to the difficult situation which the change of practice by the GPTO had created. The Court took the view that, despite the clear wording of Art. 3(1) b of the Regulation, the following reasons speak for allowing SPC applications filed within six months of the date of the provisional application.

§ The inclusion of the product into Annex I of Directive 91/414/EEC does not require any additional testing by the owner of the provisional marketing authorisation which indicates that both provisional and regular marketing authorisations furnish the same protection for humans, animals and the environment.

§ As a rule, provisional marketing authorisations are transformed into regular marketing authorisations after 3 years.

§ The issuance of the provisional marketing authorisation represents the beginning of the actual commercial use of the plant protection product. It is therefore also taken into account when calculating the duration of the SPC according to Art. 13(3) of the regulation.

§ Delays in the inclusion of products into Annex I can be beyond the control of SPC applicants and may deprive them of their legitimate right to have time losses compensated by SPC protection, especially if the rgular marketing authorisation is issued after the expiration of the basic patent. This risk seems to be incompatible with the aim of the Regulation (see Recitals 5 and 10).

§ The new legal opinion of the GPTO is not consistent with the handling practice of ost EU Member States in which the Directive 91/141/EEC has been implemented. For instance, according to the the Section “Supplementary Protection Certificates for Plant Protection Products” of the British "Manual of Patent Practice", subsection SPP 13.01 under reference to SPP 3.02, both the provisional and the final (unlimited) marketing authorisations are accepted with regard to Art. 3(1) b) of the Regulation[3].

The Federal Patent Court thus decided to refer the above-cited question to the European Court of Justice. "

[1] Directive 2003/84/EC of the European Commission dated 25 September 2003, Official Journal No L 247 of 30 September 2003
[2] 15 W (Pat) 11/02

[3] The IPO offices in France, Belgium, Italy, Portugal and Austria also seem to accept provisional authorizations.

Adopted codifed version of Council Regulation 1768/92 now published

Last year, we posted a short piece on the proposed codification of the Council Regulation 1768/92 concerning supplementary protection certificates for medicinal products. The proposed text was finally adopted by the European Parliament on 21 October 2008 and the full codified Regulation was recently published in the Official Journal of the European Union.

Readers can get a copy of the codifed regulation here.

Thanks to Martijn de Lang for pointing this out.

strategic use of supplementary protection certificates - a recent article

Recently, we reported that Leighton Howard was preparing an article on the strategic use of supplementary protection certificates. This has now published online in the May 2009 issue of the Journal of Generic Medicine.

In this article, Leighton reviews the circumstances that may give rise to the grant of multiple SPCs applied for/granted per International Nonproprietary Name (INN), focussing particularly on cases in the UK.



The full electronic text is available here for $30 + tax.

Australian Patent Office allows patent term extension for a drug delivery system for two or more active substances

The Australian Patent Office has recently handed down a case, N. V. Organon [2009] APO 8 (298 May 2009) which impacts the type of subject matter which is eligible for a patent term extension in Australia, particularly relating to formulations and delivery devices. The test for whether a product qualifies for a patent term extension now appears to be whether there is "integration" between the active ingredient and the other feature.

The Intellectual Property Laws Amendment Act (1998) amended the Australian Patents Act 1990 to provide, inter alia, for an extension of term for pharmaceutical patents. The scheme allows patentees to apply for an extension of term of up to 5 years for a standard patent that claims a pharmaceutical substance.

In order for a patent to be eligible for an extension, it must satisfy the criteria set out in section 70(2) of the Australian Patent Act:

• one or more pharmaceutical substances per se must be in substance disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification, or
• one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology, must in substance be disclosed in the complete specification of the patent and in substance falls within the scope of the claim or claims of that specification.

Pharmaceutical substance in the Australian Act is defined in Schedule 1 as a substance (including a mixture or compound of substances) for therapeutic use whose application (or one of whose applications) involves:

• (a) a chemical interaction, or physico-chemical interaction, with a human physiological system; or
• (b) action on an infectious agent, or on a toxin or other poison, in a human body;
  but does not include a substance that is solely for use in in vitro diagnosis or in in vitro testing.

In the case in question, the patentee applied for an extension of term of the patent based on its patent relating to a drug delivery system adapted to the slow release of particular steroidal mixtures such as for the purpose of contraception or hormone replacement therapy. A key aspect of the invention is that the steroidal mixture is contained in a thermoplastic polymer core over which is laid a permeable thermoplastic skin. It was considered whether the product as claimed in the patent was a pharmaceutical substance within the meaning of the Act and more particularly whether it was a substance for therapeutic use as provided in the definition given in Schedule 1.

The Commissioner held that

"the definition of a pharmaceutical substance encompasses a compound with a controlled spatial configuration if, as a whole, it can still be considered a “pharmaceutical substance”, but the combination of such a substance with what would reasonably be considered a separate physical device, layer or structure is excluded. It may be difficult to determine whether a particular feature of a product is correctly considered part of a “substance” rather than a separate physical integer but in the present case the steroidal components are mixed with and necessarily diffuse through the thermoplastic materials in the core and skin regions and as such the product as a whole exhibits a level of integration or interaction between the component parts that was considered more characteristic of a pharmaceutical substance in itself rather than a substance combined with another element or thing.
Consequently the application to extend the term of the patent was allowed. "

In its decision, the Australian Patent Office followed a line of reasoning similar to that expressed by Advocate General Leger in the ECJ MIT case.

Losartan Decision in the Netherlands

On 2 June 2009, the Netherlands Patent Office granted the extension to the SPC for Losartan (while being fully aware of the recent UK Patent Court Decision). You can access the decision here.

The decision can be summarized as follows:

"First of all Dupont introduced into the Dutch proceedings two key pieces of evidence: A compliance statement from by the Dutch Medicinal Evaluation Board which forms part of the market authorization dated 16th April 2009 and a so-called end-of-procedure notification also from the Dutch Medicinal Evaluation Board, acting as Reference Member State, dated 6th April 2009 which positively concludes the Mutual Recognition Procedure and instructs all Member States to vary the market authorisation within 30 days. This material apparently was not brought forward in the proceedings before the Patents Court.

Secondly we disagree for several reasons with the opinion of the English judge that article 10.3 cannot in all cases be used to put the application in order. Therefore we accepted the aforementioned pieces introduced after the filing date and within the period that was set under article 10.3 in our first communication to the applicant."

Thanks to Martijn de Lange from the Netherlands Patent Office informing us on this decision.

Losartan Appeal Heard in UK High Court

The High Court has upheld the Intellectual Property Office's decision of not granting an extension to the term of an SPC for Losartan (for the IPO decision, here - for our previous report on the IPO's decision, here) in In the Matter of E I Du Pont Nemours & Co [2009] EWHC 1112 (Ch), not yet available on BAILII but on LexisNexis Butterworth's subscription service.

John Baldwin QC, sitting as deputy judge of the Chancery Division, held the IPO had correctly identified the requirements of the Paediatric Regulation (EC Regulation 1901/2006) with regards to the availability of rewards of an extension to an existing SPC: Article 36 of the Paediatric Regulation must be considered as a whole. The first paragraph of Art. 36(1) cannot be considered in isolation. The second paragraph of Art. 36(1) clearly requires a completed marketing authorisation before a reward is available. Additionally, the second substantive requirement indicated in Art. 36(2) calls for the statement of compliance referred to in Art. 28(3) be included in the marketing authorisation used for applying for the extension. The third substantive requirement (Art. 36(3)) is that if the mutual recognition procedure was used , the extension shall only be granted if the product is authorised in all Member States. Therefore, an application for an extension of an SPC which does not satisfy all the requirements of Art. 36 is a defective application.

At the time of Du Pont's application for an extension, the procedure for obtaining a marketing authorisation in the Netherlands (the reference Member State) was not complete and accordingly, there was no entitlement to the extension.

It may seem unfortunate that applicants will need to rely on the relevant authority to grant a marketing authorisation in order to apply for an extension to an existing SPC, and that the timing of the grant of the marketing approval is not within the applicant's control. Unless of course the applicant chooses to test the medicine simultaneously in the paediatric and adult populations...

Public health and the preservation of competitiveness: article now available

Our previous post informed readers of this weblog of the publication of Diane Delcourt's article, "Public health and the preservation of economic competitiveness: the European supplementary protection certificate for medicinal products", in the June 2009 issue of the Journal of Intellectual Property Law and Practice (JIPLP, published monthly by Oxford University Press). 

I'm pleased to say that the publishers have kindly agreed to allow readers to access it for free. You can read it in PDF format here.

In my capacity as editor of the Journal. I should like to hear from any readers of this weblog who are considering writing articles or case notes on supplementary protection certificate law and practice (please email me here).