"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.
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
Monday, 29 June 2009
Friday, 26 June 2009
Wednesday, 24 June 2009
"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 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.
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.
The Federal Patent Court thus decided to refer the above-cited question to the European Court of Justice. "
 Directive 2003/84/EC of the European Commission dated 25 September 2003, Official Journal No L 247 of 30 September 2003
 15 W (Pat) 11/02
 The IPO offices in France, Belgium, Italy, Portugal and Austria also seem to accept provisional authorizations.
Monday, 22 June 2009
Friday, 19 June 2009
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.
Wednesday, 17 June 2009
Australian Patent Office allows patent term extension for a drug delivery system for two or more active substances
- 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.
- (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.
"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. "
Monday, 8 June 2009
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.