Newsletter Life Sciences and Healthcare

Newsletter 1/2018
Life Sciences and Healthcare

1. Clinical trials: Biogen's rituximab patent found invalid due to a clinical trial started before the priority date

Celltrion and Sandoz have raised invalidity proceedings against Biogen's Norwegian patent on the use of rituximab in a particular treatment regimen for low-grade follicular B-cell non-Hodgkin's lymphoma. The patented treatment regime consists of providing a specified dose of rituximab as a maintenance therapy in patients having responded to previous treatment with CVP therapy.

Oslo District Court was presented with several alternative grounds supporting Sandoz and Biogen's claim for invalidity, herein lack of novelty, lack of inventive step, added matter and insufficiency.

On 7 February 2018 the Oslo District Court revoked the patent due to lack of novelty. The Court based its assessment in particular on a clinical trial started by the Eastern Cooperative Oncology Group (E1496) prior to the filing date of the patent application. The Court concluded that the study was novelty destroying as the doctors and patients, who had access to the study protocol and a consent form describing all the features of the invention, had to be considered as members of the general public in relation to the patent holder. The novelty requirement for a patent was therefore not met.

The case has been appealed by Biogen. The appeal court will have to assess whether there exists such a (third) possible exception from what is considered obstructive to novelty. 

The appeal proceedings will probably be held early 2019, but no dates have yet been fixed. (Oslo County Court, Case no. 16-206868TVI-OTIR/05)

Kvale represents Sandoz.

2. Public Procurement – Price no longer the solitary criterion

Suppliers of medicines that take responsibility for environmentally friendly production, will now be rewarded by gaining an advantage in public tenders in Norway.

Sykehusinnkjøp HF, which is responsible for public procurement of medicines for specialist health services in Norway, has announced that it as of second part of 2018 is set to evaluate and weigh environmental impact when purchasing medicines and medical equipment. This means that the lowest price will no longer be the sole criterion. Environmental aspects shall also be a weighted criterion. Representatives from the industry, has for a long time requested for such a change and has thus been heard.  The new environmental criterion will most likely mean that the suppliers will have to document a risk assessment and strategy for environmental impact throughout the value chain - including subcontractors and active substance production. The suppliers that can produce such will have a competitive advantage. Thus, price will no longer be weighted with the customary 100%. The weighting of the environment criterion versus price, will not be fixed but announced with each tender. However, according to the Norwegian Regulation on Public Procurement an environmental criterion ought to weighted with at least 30 %.

Suppliers should therefor prepare for new assessments and tasks related to the procurements this upcoming autumn. 

3. Pharmacies: Norway joins in on the pan European logo for online sales of medicines

Since 2015, there has been an EU requirement that websites and apps selling medicines shall have a visible logo to show for legitimate and authorised operations. As from April 2, 2018 this requirement also applies for Norwegian online- and app based pharmacies. The Norwegian Medicines Agency (NOMA) is responsible for implementing the logo in Norway. Before using the logo, the acting entity must be approved by- and registered with- and also enter into a license agreement with NOMA. The logo provides for a link to NOMA's list of pharmacies authorised to sell medicines over the internet.

4. The Norwegian Food Safety Authority is working on new regulations

Additive of substances other than vitamins and minerals in food supplements is not specifically regulated in the EU. Many countries have therefore developed national rules on such additives. The Norwegian Food Safety Authority has now taken steps for a Norwegian regulation on food supplements easier and more transparent. As part of the development of new regulation, the Norwegian Food Safety Authority has had the risk associated with 44 different substances and microorganisms often used in dietary and energy drinks assessed. Potential negative consequences have been investigated, - not potential positive health effects.

Amongst the substances that have been assessed are ia.: betaalanine, D-Glukurono-γ-lakton, D-ribose, eicosapentaenoic acid (EPA), docosapentaenoic acid (DPA), docosahexaenoic acid (DHA), glycine, inositol, inulin, isoflavone, coenzyme Q10, caffeine, collagen from fish skin, conjugated linoleic acids, creatine and many more.

For further information, click here.

5. No right to appeal: Manufacturers cannot appeal gainst the Special Helthcare Service's decisions and priorities on medical use

The Ombudsman concludes in a recent decision that public priorities within the field of medication shall be regarded as exercise of private autonomy rather than exercise of public authority, and is therefore not subject to the right of appeal.

Decision Forum for New Methods (hereinafter "the Forum"), decides whether a new type of medicine shall be introduced to - and implemented in Norwegian public hospitals and the public specialist healthcare services. This after a period of assessments and negotiations carried out amongst the relevant authorities.

Following two negative decisions by the Forum in 2016, concerning methods for treatment of two different indications of cancer, two manufacturers (Abbvie and Roche) filed complaints with the Ministry of Health and Care. 

The Ministry rejected the complaints on the grounds that the Forum's decisions do not constitute "individual decisions" in relation to  the Norwegian Public Administration Act and therefore cannot be appealed. In an opinion published 4, April 2018, The Ombudsman agrees with the Ministry's legal considerations when rejecting the two complaints. The Ombudsman expresses that the legal assessment had been difficult and without any apparent conclusion, but that the Forum decisions  more resemble exercises of private authority, rather than involving exercise of public interests of the state. This implies that the decisions cannot be appealed.

 © 2018 Kvale Advokatfirma DA