The Ministry of Health and Care has recently issued a hearing letter proposing stringent restrictions on import of medicinal products for personal use. Among the actions proposed, is a general ban on the import of prescription drugs, and access for Customs to seize and destroy falsified or illegal medicinal products.

On 17th July 2012, the Norwegian Medicines Agency (NMA) announced a change in their practice regarding disclosure of information for applications of marketing authorisations for medicinal products.

A new Act on the Patent Office and Industrial Property Rights Appeals Commission (the Patent Office Act) will be enacted and come into effect on 1st January 2013. The current Act on the Industrial Property Protection Board was enacted in 1910, and time for a complete reform had come.

"Sunset clause" is a common term for the provision which could lead to the cessation of the validity of the marketing authorisation of a medicinal product.

Questions on pensions have long had a large political focus in Norway, in connection with pension reforms such as obligatory occupational pension and changes in the National Insurance Scheme.

In 2011 it was expected that new provisions for competition clauses, customer clauses and non-recruitment clauses would come into force. As early as June 2010, the Department of Employment sent a proposal on new provisions in the Working Environment Act for comments.

Earlier this year, EU Commission Regulation No 1217/2010 was implemented in Norwegian law.

In accordance with the provisions of the Act on Medicines and the appurtenant Regulation on Medicinal Products, pre-approved reimbursement for use of a medicinal product outside the approved indications of the marketing authorization is not allowed.

Questions on pensions have long had a large political focus in Norway, in connection with pension reforms such as obligatory occupational pension and changes in the National Insurance Scheme.

pharmaceutical products

The Ministry of Health and Care has issued a hearing regarding the removal of the requirement for wholesalers of medicinal products to be able to supply all medicinal products that are requested in the Norwegian market.

Earlier this year the Competition Law Reform Commission, appointed by the Norwegian Government, delivered its proposal on a new competition act.

The Government is at present working on a proposal for the inclusion of EU’s directive on temporary staff recruitment agencies (2008/104/EF) into Norwegian law. The directive regulates, i.a., the member countries’ possibilities to limit companies’ access to hire staff, and rules on which working conditions employees of recruitment agencies are entitled to during their period of hire.

On 16th May this year the European Commission approved 222 health claims which are allowed in advertising and labelling of food products.

Advertising of medicinal products is governed by the Act on Medicinal Products of 4th December 1992 and by the appurtenant Regulation on medicinal products of 18th December 2009.

In April 2011, the Norwegian Ministry of Justice (MoJ) issued a proposal for the strengthening of the legislation concerning the enforcement of intellectual property rights (IPR).

Eight years after Norway implemented the Patent Directive (Directive 98/44/EC), and four years after the Patents Act underwent some further changes when Norway acceded to the EPC, the Norwegian Ministry of Justice (MoJ) has issued a consultation paper in which some of the implemented measures are reviewed and some amendments and adjustments are proposed.

In a judgement of 12 April 2012 Oslo District Court ruled that Krka’s marketing of Esomeprazol Krka infringed AstraZeneca’s patent NO 307308.

According to Norwegian law, preliminary injunctions are available for the patentee in order to preliminarily stop an infringement. The motion for a preliminary injunction should be filed with the District Court where the alleged infringer has its place of business, or, where the infringing activities take place.

Regulation (EU) 1235/2010 and Directive 2010/84/EU amending the legal framework regarding pharmacovigilance for medicinal products will enter into force in the European Union in July 2012.

Paediatric Investigation Plans

The European Ombudsman has recommended that the European Medicines Agency (EMA) ensures adequate transparency in its decisions regarding the Paediatric Regulation. 

(Case C-457/10 P): Appeal from AZ should be dismissed

The Advocate General Jàn Mazák today delivered his opinion in the AstraZeneca case. AstraZeneca (AstraZeneca AB and AstraZeneca plc) had appealed the judgment from the General Court of the European Union of July 2010 where the European Commission’s fine for i.a. abusing the patent system was upheld, although it was reduced to 52,5 mill EURO. The Advocate General’s opinion is in support of the former court decision. The opinion of the Advocate General is not binding on the Court of Justice, which will decide on the case later. 

On 3rd May 2012, Advocate General Verica Trstenjak issued her opinion in case C-130/11, also known as the Neurim case. Should the Court of Justice choose to accept the findings of the opinion, it will improve the possibility for the pharmaceutical industry in Europe to obtain SPCs for medicinal products.

Norway is on the verge of involuntarily allowing the advertising of alcoholic beverages on television, contrary to the country’s strict alcohol policy. This change, which may take place as a result of pressure from the EU Commission, would have a significant impact for owners of alcohol brands.

Ruling by ECJ November 24th 2011.

On 24th November 2011 the Court of Justice of the European Union released its important decisions in the two cases Medeva (Case C-322/10) and Georgetown (Case C-422/10). 

New media world = stronger protection of source

ISDA Master Agreement - changes in the way? Flawed assets, the provision under pressure

Småkraftutbygging i elver og fossefall er en langvarig prosess, hvor det går flere år fra den første planleggingen til første spadetak. Mange prosjekter ser heller aldri dagens lys – enten på grunn av manglende konsesjon, uklare rettighetsforhold, svikt i økonomien eller manglende finansiering.

Small Hydro AS murmur - anonymous companies are self-made traps

Small Hydro Development in the rivers and waterfalls is a lengthy process, which is several years from the initial planning to break ground. Many projects never see the light of day - either because of lack of licensing, unclear right conditions, failure of the economy or lack of funding.

Uavhengig av bransje, er det mange firmaer som vegrer seg mot å ta rettslige skritt overfor konkurrenter som ikke følger spillereglene.

When the competition gets too aggressive - what do you do?

Regardless of industry, many companies are reluctant to take legal action against competitors that do not follow the rules.

Stortinget har denne uken vedtatt elsertifikatloven i samsvar med forslaget til lovvedtak fremsatt i Prop. 101 L. Lovforslaget ble ferdigbehandlet onsdag 15. juni.

Act on electricity certificates passed in Parliament

Parliament has this week adopted green certificates in accordance with the proposed legislation set forth in Prop. 101 L. The bill was finalized Wednesday 15 June.

A practical cross-border insight into pharmaceutical advertising.

Det vises til høringsdokumenter vedrørende prNS 8407 Alminnelige kontraktsbestemmelser for totalentrepriser, med høringsfrist 1. mars 2011. Advokatfirmaet Grette har gjennomgått forslaget, og kommenterer allerede innledningsvis at standarden fremstår som en vellykket utvikling av kontraktsbestemmelser for totalentrepriser, på en form som står seg godt i forhold til NS 8405

Consultation - prNS 8407 General conditions of contract for the turnkey contracts

Reference is made to the consultation documents concerning prNS 8407 General contract provisions for turnkey contracts, with a deadline 1 March 2011. Law firm Grette have undergone the proposal and comment at the outset that the standard is emerging as a successful development of contractual provisions for turnkey contracts, in a form that stands up well compared to 8405.

Konkurslovgivningen er utformet med tanke på kreditorene, som gjerne er flere enn de øvrige aktørene på prosjektet og som alle ønsker en størst mulig del av skyldnerens verdier. Konkurslovgivningen baserer seg på at verdiene skal fordeles tilnærmet likt mellom de ulike kreditorene, og tar ikke nødvendigvis det samme hensynet til balansen i kontraktsforholdet mellom skyldneren og medkontrahenten. I og med at konkurslovgivningen ikke kan fravikes ved avtale, kan man komme opp i utfordrende situasjoner med hensyn til prosjektets videre gjennomføring.

Insolvency in small hydro power projects - what happens if one of those involved goes bankrupt?

Bankruptcy law is designed to creditors, which is often more than the other players on the project and that everyone wants as much as possible of the debtor's assets. Bankruptcy law is based on the values ​​to be distributed almost equally between the various creditors, and does not necessarily the same concern for balance in the contractual relationship between the debtor and the co-contractor. Since the bankruptcy laws can not be waived by agreement, one may come up in challenging situations with regard to the project's future implementation.

Kraftsituasjonen har økt norske industribedrifters behov for å sikre seg langsiktige og forutberegnelige kraftleveranser. En ny garantiordning er opprettet for norsk kraftintensiv industris kraftkjøp og Regjeringen synes å mene at denne vil stimulere til flere langsiktige kraftavtaler. Senest denne uken sto Statsministeren frem og mente at norske industribedrifter har mye å lære av Norske Skog på Skogn, som nylig inngikk en langsiktig kraftavtale med Statkraft. Det er imidlertid grunn til å reise spørsmål ved hvilken betydning ordningen har med sikte på inngåelse av flere kraftavtaler.

Amendment relating to safety at entry into long-term power contracts - an appropriate instrument?

The power situation has increased the Norwegian industrial companies' needs to secure long-term and provided calculable power supplies. A new guarantee is created for the Norwegian energy-intensive industry's power purchases and the Government seem to think that this will encourage more long-term power contracts. Last week the Prime Minister stood up and said that Norwegian industry has a lot to learn from the Norwegian Forest Skogn, who recently signed a long-term power agreement with Statkraft. However, there is reason to question the impact the scheme has the purpose of entering into force of several agreements. 

On 10 February 2011 Supreme Court ruling in a case where a minority shareholder had been forcibly exercised by a triangle fission. The case raised important questions about how such a process can take place.

Minoritetsvern ved trekantfisjoner

Den 10. februar 2011 avsa Høyesterett dom i en sak hvor en minoritetsaksjonær var blitt tvangsinnløst etter en trekantfisjon. Saken reiste et viktig spørsmål om hvordan en slik prosess kan foregå.  

Wind power is among the most expensive production facilities for renewable energy and will in most cases require external funding - even if Enova has pledged. Complex projects means that the bank can sit with a false sense of security in the form of worthless collateral.

Lånefinansiering av vindkraftprosjekter - uklare grensesnitt for bankens sikkerhet

Vindkraftprosjekter er blant de dyreste produksjonsanleggene for fornybar energi og vil i de aller fleste tilfeller kreve ekstern finansiering - selv om Enova har gitt tilsagn. Komplekse prosjekter gjør at banken kan sitte med en falsk trygghet i form av verdiløst pant.

Kun få måneder etter at EU-domstolen konkluderte med at skyld ikke kunne oppstilles som vilkår for erstatning ved brudd på anskaffelsesregelverket, sak C-314/09 (Strabag) – se tidligere artikkel på grette.no), understreker EU-domstolen i en annen avgjørelse at EU-retten ikke inneholder bestemte kriterier for erstatningsspørsmålet, sak C-568/08 (Spijker).

Ved spørsmål om hvem som har risikoen for uforutsette grunnforhold i entreprise, ligger svaret i standardkontrakten.

ITV Studios Ltd (ITV S) and its affiliate ITV Global Entertainment Ltd (ITV G), an international distributor and licensor of television formats, together with Viasat and Swedish production and distribution company Silverback AB, held rights to the television format for programme Come Dine with Me.The first programme was broadcast on Channel 4 in the United Kingdom in 2005 and was followed by nine seasons on Channel 4 until 2009.

Picking the correct court to handle a case first time can save time and money. Norwegian company Marin Alpin AS sued Swiss company Würth International AG in the district court where it had its main offices for alleged violation of the unfair competition rules set out in the Marketing Control Act. Marin claimed that Würth was liable for damages after copying a sports jacket.

At present, security interests may only be created in IPR which forms part of the equipment of a business, and only all of the equipment of a business may be used as security, not only individual assets.

Ringnes AS, a subsidiary of Danish drinks giant Carlsberg, sued Water of Norway AS claiming that it should be prohibited from manufacturing and using its Polaris water bottles. Ringnes also claimed damages for trademark infringement and acts of unfair competition. The court dismissed all of Ringnes’s claims.

Picking the correct court to handle a case first time can save time and money. Norwegian company Marin Alpin AS sued Swiss company Würth International AG in the district court where it had its main offices for alleged violation of the unfair competition rules set out in the Marketing Control Act.

Oslo tingrett avsa den 29. oktober 2010 dom i tvisten mellom Kraft Foods og Juritzen Forlag vedrørende Juritzen Forlags bruk av bokomslag på boken PÅSKE KRIM i 2009, og mulig bruk av lignende bokomslag på en tilsvarende bok i 2011. Saken reiser flere spørsmål, blant annet KVIKK LUNSJ-emballasjens beskyttelsesomfang og forholdet til afrikanske statsflagg.

On September 7th 2009 Norway and Sweden signed an agreement on the principles for a common market for electricity certificates. A proposal for a bill is expected in the spring of 2011 and the market start-up is planned for January 1st 2012. In the 2011 national budget the electricity certificate initiative has been allocated funds.

The Ministry of Finance has proposed that the value of waterfall rights should not be deductible in the special tax base for resource rent tax on production of hydroelectric power. The Ministry refers to this as a “clarification”, but based on case law from the tax authorities, the proposal will de facto deny deductibility for many hydro power plants.

The EU Renewable Energy Directive (EU Directive 2009/28/EC) sets a target of increasing the share of renewable energy used in the EU to 20 % by 2020. The intention is for all EU-countries to contribute a given percentage, however, countries with a high GDP will be contributing the most.

Mr Bjarte Baasland used various internet based betting services for a number of years, and in the end he had accumulated a total loss of approximately 7,5 million Euros. Centrebet was one of two services he used the most, and in 2009 he initiated legal proceedings against the Australian company.

The use of open source code is growing every day, and in some sectors the use of such code has exceeded all reasonable expectations. As always, such “new” phenomena provide both opportunities and challenges. The latter includes the many pitfalls that open source code generates in business takeover situations. 

A practical cross-border insightinto pharmaceutical advertising 

It is a well known fact that the Norwegian authorities do not prioritize criminal prosecutions of individuals that infringe copyright legislation by making movies, music, software etc available through various file sharing services on the Internet. It also seems to be a widespread conception that users anonymity is absolute in regard to other civilians, and that such user therefore are safely outside the reach of the copyright holders. The latter is now confirmed to be a misconception.

The Commission’s Reflection Group on Digitisation, established in April 2010, has now launched its consultation and seeks views on how to boost the online presence of Europe’s cultural heritage. The purpose is to speed up the online accessibility and preservation of cultural works across Europe.

Å ha hytte kan være dyrt. Å leie ut hytten kan derfor være lurt og lønnsomt. Det gjelder imidlertid å vite hvilke skatte- og avgiftsregler som gjelder.

Åsne Seierstad’s international bestseller, The Bookseller of Kabul, portrays an Afghan bookseller and his family, and tells the story of a patriarch society were men are considered superior to women. In 2002 Seierstad was invited to live with the bookseller and his family. During a family dinner Seierstad said to herself “This is Afghanistan. How interesting it would be to write a book about this family”. This dinner and the emerging idea are described in the book’s opening. From a legal point of view it is of course relevant that Seierstad claimed to be portraying an actual family. The book was based on Seierstad’s many conversations and discussions with the bookseller and his family during her stay.

The Norwegian market offers great business opportunities for foreign enterprises, both within the oil and gas sector, which is one of Norway’s major areas of business, and also within various other areas of business and industry.

On 25th March 2010 the Supreme Court ruled against NRK, the Norwegian state broadcaster NRK, in a lawsuit initiated by Norwegian actress Gørild Mauseth.Supreme Court finds something fishy in nudity scene broadcast

Patents in Europe 2010" is published bi-annually by Intellectual Asset Management Magazine in association with the European Patent Office.

"Courts lead the way in IP rights enforcement" summarizes some important decisions and developments within IP in Norway in 2008-2009.

Den 26. februar oppnevnte Kulturdepartementet en referansegruppe om ulovlig fildeling. Gruppen skal fungere som en referanse for departementets arbeid med den pågående revisjonen av åndsverkloven, og skal ta stilling til mulige tiltak som kan begrense den ulovlige fildelingen og samtidig stimulere til økt bruk av lovlige tjenester.

Høyesterett har i en nylig avsagt dom (9. februar 2010) innskjerpet mangelsvurderingen og reklamasjonstiden i forhold til tidligere underrettspraksis.

ISDA (International Swaps and Derivatives Association) er en sammenslutning av mange internasjonale finansinstitusjoner. Et av formålene til ISDA er å legge til rette for en standardisering av unoterte derivattransaksjoner, vanligvis referert til som OTC (Over-The-Counter) derivater. Dette har ISDA gjort ved å publisere standardisert derivatdokumentasjon som 1992 ISDA Master Agreement samt 2002 ISDA Master Agreement.

Fra og med 1. januar 2010 hefter entreprenører som setter ut arbeid eller leier inn arbeidstakere, solidarisk for lønn til arbeidstakere i kontraktkjeden under seg. Dette gjelder uavhengig av om byggherren er forbruker eller næringsdrivende.

Forordning (EF) nr. 1901/2006 om legemidler til barn ble vedtatt i EU i desember 2006 og trådte i kraft i EU 26. januar 2007. Høringsfristen for forslaget fra Helse- og omsorgsdepartementet om gjennomføring i norsk rett gikk ut 9. oktober 2009. Forslaget omfatter endring av legemiddelforskriften og patentloven. Departementet har til hensikt å fremme lovproposisjon med de nødvendige endringer så snart som mulig, men avventer vedtak i EØS-komiteen, med de nødvendige tilpasningstekster (overgangsregler), som tar forordningen inn i EØS-avtalen.

Med virkning fra inntektsåret 2009 skal faste tekniske installasjoner i avskrivbare bygg skilles ut i en egen saldogruppe "Fast teknisk installasjon i bygninger". Driftsmidler i denne gruppen avskrives med inntil 10 % av saldoverdien årlig. Det skal være en samlesaldo for hvert bygg som inkluderer alle faste tekniske installasjoner i bygget.

EF-domstolen har nylig avsagt en avgjørelse (Cartesio - C-210/06, 16. desember 2008) hvor det konkluderes med at den enkelte EF-medlemsstat kan forhindre at selskaper som er stiftet etter denne statens rett, flytter til en annen EF-medlemsstat. Dommen er basert på EF-traktaten art. 43 og art. 48 som tilsvarer EØS-avtalen art. 31 og art. 34. Dommen skal derfor etterleves også i Norge. Dette innebærer at dagens rettsoppfatning, om at norske selskaper ikke kan flytte til andre EF- og EFTA-medlemsstater uten å oppløses og avvikles, ikke er i strid med europeisk rett.

Geschäfte mit Norwegen sind für deutsche Unternehmen interessant. Dabei können verschiedene Rechtsprobleme auftreten, die zur erfolgreichen Geschäftsdurchführung bereits im Vorfeld beachtet werden sollten. In dem Artikel wird aufgezeigt, worin diese Probleme bestehen und wie sie gelöst werden können.

Når man skal håndtere masseoppsigelser er det viktig å holde på den gode dialogen. Ifølge arbeidsmiljøloven er det snakk om masseoppsigelse når ti arbeidstakere mister jobben innenfor et tidsrom på 30 dager og oppsigelsene ikke er begrunnet i de enkelte arbeidstakere, men i stedet i selve virksomhetens forhold.

Mit Urteil vom 29. Januar 2009 hatte das Landgericht Borgarting (Borgarting lagmansrett) entschieden, dass die Mitglieder des Verwaltungsrats (styre) einer norwegischen GmbH (aksjeselskap, abgekürzt: AS) gesamtschuldnerisch für nicht ordnungsgemäß eingezahlte Einlagen haften (wir berichteten im Newsletter Nr. 1-2009).

A supplier company working as a contractor towards an oil company may face the situation where the oil company, without using the formalities under the provisions of the contract, instructs the performance of a specific piece of work. How does the contractor react to such an instruction?

1. Introduction

All cases are heard by the ordinary courts, except those decided by other authorities and those very few which because of their specific nature are referred to special courts.

Background
Foreign investors looking at investment opportunities in Norway will often be faced with the choice of acquiring operating business undertakings. Norway's leftist government, in office since October, are looking into the re-introduction of a piece of regulatory legislation that was abolished in 2002. The Ministry of Industry and Trade is working on a project on state ownership. The project also includes enacting legislation regulating the acquisition of businesses. The issue came on the political agenda just before the September 2005 parliamentary election, after one of the biggest Norwegian corporations, Norske Skog, decided to shut down one of its largest and state of the art paper mills, Union in Skien, laying off several hundred workers. The shut-down occurred in spite of the operation of the mill being profitable, the reasons given by the management being that it was not profitable enough, and that there was surplus production capacity in Europe. It should be added that it is debatable whether anything could have been done with this even if the old act had still been in force.

Customer bankruptcy generally generates unpleasant surprises for suppliers. Use of consignment stock located at the customer?s premises may constitute one. Is the bankruptcy estate of the customer storing the goods entitled to confiscate these goods because they have been delivered ? or is the supplier entitled to have the goods released since they have not been paid for?

Customer bankruptcy generally generates unpleasant surprises for suppliers. Use of consignment stock located at the customer?s premises may constitute one. Is the bankruptcy estate of the customer storing the goods entitled to confiscate these goods because they have been delivered ? or is the supplier entitled to have the goods released since they have not been paid for?

1. Introduction
There is an ongoing debate in the Norwegian legal community regarding the right to link to and make copies of copyrighted works made available to the public on the Internet. The debate was sparked by the Norwegian Supreme Court’s recent ruling in the so-called Napster.no case (published in Rt 2005 p41), and by the discussions in the preparatory works to the amendment of the Norwegian Copyright Act, which entered into force on 1 July 2005.

A new act that is supposed to replace present ?Norwegian Working Environment Act? of 1977 was ratified in June 2005, and it was planned to have it enter into force on 1st January 2006. The new act is mainly a codification of the unwritten law, but it also introduces some substantive changes compared to present law. Some of the changes concern temporary engagements.

Earlier this year, the Norwegian Parliament (Stortinget) decided that a mandatory occupational pension scheme would be introduced and become effective from 1st January 2006. A proposal including more detailed regulations was drafted by The Banking Law Commission and The Norwegian Ministry of Finance. This article explains the main features of the prosed mandatory pension scheme.

1. INTRODUCTION

On the 3rd of September 2004 the European Commission released its Statement of Objections against Tomra. The Commission is of the opinion that Tomra has exploited its dominant market position in several European markets. The alleged abuse is partly due to having entered into exclusive purchase agreements with customers and partly due to use of loyalty rebates. The alleged violations shall have taken place in different time periods during the last ten years in the various markets.

Effective 1 March 2004, the former Act on Exclusive Rights to Trade Names and other Trade Designations (Trade Names Act) of 1985 was replaced by the Act on Exclusive Rights to Enterprise Names and other Trade Designations (Enterprise Names Act).

Introduction

In almost all construction projects, the contractor enters into agreements with subcontractors, such as electricians, painters, plumbers etc. In lager projects, the use of subcontractors can be quite extensive, and relate to almost every aspect of the construction process. It is in such cases it is not unusual that also the subcontractors enters into agreements with other suppliers in order to be able to fulfill their own contractual obligations. This article focuses on the need for coordination of the agreements on the various levels of a construction project, and the so-called "back to back" principle as a remedy for obtaining this. The intention is to point out both advantages and risks by employing this technique.

during implementation of a competitive tender within public and private sector in Norway

1. Introduction

If the current regulations and principles the tender is based upon do not abide by the rules, the purchaser can be subject to a claim of compensation from the competitors.

The claim can be based upon loss of non-performance contractual interest or loss from reliance on promise contractual interest. The term loss from non-performance contractual interest means that the tenderer shall be in the position as if he obtained the contract (full compensation for costs and loss of profit). The term loss from reliance on promise contractual interest means that the tender is in a position as if he had not participated in the competitive tender (full compensation for all costs.)

On the website of the Ministry of Agriculture you will find an invitation reading 'Buy your own small farm'. The statement refers to the new acreage limits stated in the new Concession Act of 1 January 2004. The Act states that concession is not required for acquisition of developed property up to 100 decares provided that not more than 20 decares of the property is cultivated.

Introduction
Under Norwegian law, there is a clear distinction between the statutory provisions involving only professional parties on the one hand, and, on the other, contracts involving consumers. In general there is full freedom of contract between professional parties, while contracts with consumers are regulated by law.