ENLI on HCP's as consultants

ENLI clarifies the rules on the use of HCPs as consultants
Just before Christmas, following debate in the Danish media on the Industry's use of HCPs as consultants, the Danish Industry Board, ENLI, clarified the rules on the Industry's use of HCPs as consultants.

ENLI underlined that compliance with the Code will always be the pharmaceutical company's responsibility, regardless of whether the activity has been handled by a consultant.

Further, ENLI emphasized that payment for the HCP's services only can be paid in cash, which means that gift cards or the like are not considered compliant modes of payment, and that cooperation with HCPs requires prior permission from the Danish Medicinal Agency. It was also noted that if the activity is considered advertising, notification should be given to ENLI in accordance with the rules in the Code.

Update of the Advertising Code and the Guidelines
1 January 2012 ENLI launched a modified and updated version of the Industry Code of advertising practice and the Guideline on the Code.

Overview of changes in the Code: 

• Samples of medicinal products can only be distributed within the first two years of launch
• Medical devices defined as medicine under the law are now also included in the definition of medicine in terms of the Code.

Overview of most important changes in the Guideline: 

• Special words: The appeal board has now confirmed that the word "effective" is to be used only if 100% cure can be documented. The word "safety" should never be used.
• Sponsorship of participation in conferences etc.: Until a final programme is set only non-binding invitations can be sent out.
• Notification: of sponsorships of conferences etc. are to be given 10 working days ahead of the departure date.

The Code and the Guideline can be found in Danish at ENLI's homepage, unfortunately no English version is available. There is a modification log at pages 21 and 43, respectively.

The CJEU on Supplementary Protection Certificates for combination products
- The CJEU decisions in Medeva (C-322/10), Georgetown (C-422/10), Yeda (C-518/10), Queensland (C-630/10) and Daiichi (C-6/11)

The CJEU rendered in late November 2011 its decision in a number of cases referred by the English courts regarding the possibility of obtaining a Supplementary Protection Certificate for combination products. The CJEU stated that Supplementary Protection Certificates are only to be granted in accordance with the wording of the patent claim.

What is an SPC?
The purpose of obtaining a Supplementary Protection Certificate (SPC) for a medicinal product is to prolong the patent protection for a period of up to five years. The conditions for obtaining an SPC are laid down in Regulation no. 469/2009, article 3, which among other things requires that the product is protected by a basic patent in force, cf. article 3 (a), and that a marketing authorization (MA) has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate, cf. article 3 (b).

Background
All the referred cases relate to SPC applications where either the patent claims consisted of a combination of two or more active ingredients or the MA was granted for a product consisting of two or more active ingredients. The question before the CJEU was whether it is possible to obtain an SPC for a combination product, when the active ingredients according to the patent claims are not identical to the active ingredients in the product covered by the MA.
 
Wording of the patent claim
The Court stated in the Medeva case that article 3 (a) precludes the granting of an SPC for active ingredients which are not specified in the wording of the claims of the basic patent. This means that if the patent claims consist of A+B and the product covered by the MA consists of A+B+C there can be no SPC granted for A+B+C. This was confirmed in both the Queensland and Daiichi cases.

Similarly, the Court stated in the Medeva case that if a patent claims that a product is composed of two (or more) active ingredients, but makes no claim in relation to one of those active ingredients individually, there can be no SPC granted on the basis of such a patent for the one active ingredient considered in isolation. This means that if the patent claims consist of A+B and the product covered by the MA of only A, there can be no SPC granted for A in isolation according to article 3 (a). This was confirmed in the Yada case.

Marketing Authorization
Contrary, the Court stated that article 3 (b) does not preclude the granting of an SPC for a combination of two active ingredients, corresponding to that specified in the wording of the patent claims in cases where the medicinal product covered by the MA combines not only those two active ingredients but others as well. This means, where the patent consists of A+B and the medicinal product covered by the MA of A+B+C, an SPC can be granted for A+B.

Conclusion
On this basis we note:

• The CJEU's judgement leaves open the question of what "specified in the wording of the claim" means. Is, for example, a Markush claim (i.e. a single patent claim defining alternatives) sufficient to obtain an SPC for a product?
• On this basis we assess that it will only be a matter of time before we see a new referral regarding SPCs for combination products.

The CJEU enables negative term SPC

The CJEU rendered its judgement in Merck (C-125/10) in December 2011, stating that it is possible to obtain a negative term Supplementary Protection Certificate.

The term of an SPC
The term of an SPC is laid down in Regulation 469/2009, article 13 (1), which states that the duration of an SPC is equal to the period elapsed between the date on which the application for a basic patent was lodged and the date of the first Marketing Authorization (MA) in the Community, reduced by a period of five years.

The facts
Merck's application for an SPC was rejected by the German authorities on the ground that only four years eight months and sixteen days had elapsed between the date on which the patent application was lodged and the date on which the first MA was issued.

Enabling paediatric extension - without going all in
Merck submitted that even if the SPC cannot result in a positive duration, it can nevertheless have a zero or negative duration, emphasizing that an SPC is a requirement for obtaining a paediatric extension. A paediatric extension is prolonging the patent protection period by 6 months and can be obtained by conducting paediatric studies and submitting the results thereof.

Accepting Merck's reasoning, the CJEU stated that a negative term SPC can be granted. However, the CJEU further stated that the patent holder will not be entitled to the full 6-month paediatric extension running from the expiry day of the basic patent (zero-term SPC).

The paediatric extension starts on a date to be determined by deducting from the patent expiry date the difference between five years and the duration of the period elapsed between the lodging of the patent application and the grant of the first MA. In this case a paediatric extension would thus start to run 3 months and 14 days prior to the expiry date of the patent, thus prolonging the patent protection period by only 2 months and 14 days.

Conclusion
Provided the negative duration is not more than 6 months, the patent holder will benefit from a paediatric extension. The possibility of having a negative-term SPC is thus clearly good news for the pharmaceutical industry and may encourage companies to undertake paediatric research and development to a greater extent.

News on apps - Check your medicine on your phone

Who
The Danish Medicinal Agency has launched an app for smartphones, providing information about medicinal products on the Danish market.

What
The app gathers all information from the webpages medicinpriser.dk, medicinkombination.dk, indlaegsseddel.dk and laegemiddelstyrelsen.dk, all run by the Danish Medicines Agency.

Why
Allowing users easy access to the newest information, by searching the product name or scanning the barcode, and providing users with information about substitutes containing the same active ingredients.

How
The app is free and can be downloaded from App Store and Android market, search for "Medicintjek".

Danish government: Securing closer cooperation between health care professionals and the industry

Following public debate and the media's intense focus on questionable independency cases, the Danish government now strikes a blow for the cooperation between health care professionals and the industry, claiming the cooperation to be necessary and important as health care professionals possess useful knowledge for the industry.

The Minister for Health states that the rules need to be clearer - and the cooperation closer, emphasizing that the media's focus leads not only to insecurity for consumers and patients, but also to reluctance to deal with clinical trials among health care professionals.

In order to enhance clinical research in Denmark and stop the recent years' decrease in the number of clinical trials in Denmark, the Minister has appointed a Committee consisting of, among others, members from the various Danish industry boards, the Danish Patient Association and the Danish Medicinal Agency.

The committee will look into the needs for regulation and provide the Minister with suggestions for concrete initiatives on how to strike the balance on the cooperation between health care professionals and the industry by the summer of 2012.

It will be interesting to follow the work of the Committee and we welcome the initiatives by the Danish government to not only focus on the downsides of the cooperation between health care professionals and the industry.

Merger between the Danish National Board of Health and The Danish Medicines Agency

From 1 March 2012 the Danish Medicines Agency will no longer exist as an independent agency.

As part of a larger cost-cutting and restructuring program, the Danish government has decided to merge the Danish Medicines Agency with the Danish National Board of Health. The effects of this merger and creation of a new health board of course remains to be seen, but it is stressed that the merger shall take place with respect for the professional core services that is currently provided by the two institutions.

Along with the new health board, another agency is established with responsibility for disease spread emergency preparedness and monitoring as well as for health documentation. This new agency gathers the present Danish State Serum Institute, Danish National e-Health and the documentation tasks of the Danish National Board of Health and the Danish Medicines Agency and Diagnosis Related Grouping (DRG) from the department of the Ministry of Health.

Further information on laegemiddelstyrelsen.dk 

New decision by the Maritime and Commercial Court regarding parallel-imported medicinal products
By Julie Sikker Hansen, attorney-at-law
 
In late November 2011, the Danish Maritime and Commercial Court rendered a decision in a case regarding the main condition of legal parallel import: The condition of necessity. In accordance with existing case law, the result was a strict interpretation of the condition to the benefit of trademark proprietors.

Facts of the case
Three companies in the Merck group (hereinafter "Merck") claimed i.a. that the parallel importer Orifarm was unentitled to market Merck's medicinal product in Denmark under the trademark of COZAAR. The Maritime and Commercial Court assessed whether circumstances on the Danish marked prevented Orifarm from marketing the product under the name of LOORTAN, which was the name applied to the product by Merck in the export state. Thus, the court assessed whether Orifarm's relabeling from LOORTAN to COZAAR was legitimate.

The facts of the case showed that the product was marketed and sold on the Danish market under both the Danish trademark COZAAR and the Italian trademark LORTAAN. Furthermore, the data showed that the sale of the product under non-Danish trademarks in numbers was nearly as large as the sale under the Danish trademark COZAAR. Consequently, the Court found that relabeling was not objectively necessary for Orifarm's effective access to the Danish market and relabeling was, therefore, an infringement of Merck's trademark rights.

Consequences
The consequence of the decision is that a parallel importer cannot invoke the condition of necessity in support of relabeling a parallel-imported medicinal product if the actual sales show that it has actually been possible in the import state to market the product under a trademark other than that of the manufacturer's.

Due to the facts in the case, including the evidence relating to the actual sale, the Maritime and Commercial Court did not get the opportunity to rule on whether the relabeling could have been deemed objectively necessary for the effective access to the market if no actual sale had occurred in Denmark under another trademark than the manufacturer's.

In principle, a parallel importer might successfully claim objective necessity where the patient group and the doctors are reluctant to purchase, ingest and/or prescribe the medicinal product under a trademark other than the one used by the original manufacturer in Denmark.