Press Release

GlaxoSmithKline AS ("GSK") owns the drug, which it launched in 1999 as a first of its kind combination drug formula for asthma and chronic obstructive pulmonary disease ("COPD"). Patients inhale the drug via a dry-powder inhaler (named Diskus) or an aerosol spray. The patent protecting Seretide expired in 2014, after which competing drug manufacturers were free to produce and sell their own generic versions of the drug.

One such producer of generic drugs is the Danish company Sandoz A/S, who together with Novartis Norge AS (together referred to as "Sandoz"), launched the competing asthma and COPD inhaler Airfusal Forspiro on the Norwegian market in March-April 2014. Airfusal is Sandoz' generic version of GSK's Seretide. Forspiro is the name of Sandoz' dry-powder inhaler, and is Sandoz' own version of GSK's Diskus.

The Diskus and the Forspiro differ in both function and design; both inhalers are, however, colored purple. Sandoz' primary reasoning behind its choice was to conform with industry practices, which has an established informal coloring scheme to differentiate between the various types of inhaler drug formulas for treating asthma and COPD. Traditionally, producers would color inhalers blue for seizure drugs, orange/brown for inflammation suppressants, green for preventative use, and more recently purple for combinations of said treatments.

Shortly after launching Airfusal Forspiro, GSK filed a motion for a preliminary injunction against Sandoz alleging unfair competition and a breach of the Norwegian Marketing Act provisions on product imitation and good business practice (§§ 30 and 25). Oslo Office of the City Recorder dismissed the motion, and GSK ultimately dropped its appeal. Shortly thereafter, on October 28, 2014, it filed a suit to Oslo District Court claiming, among other things, a prohibition against Sandoz' marketing and sale of purple colored Airfusal Forspiros. The court dismissed the claim, the appellate court affirmed. In its appeal to the Supreme Court, GSK revised its acquired distinctiveness claim from covering the purple color in general, to two specific purple nuances: Pantone 2587C ("dark purple") and Pantone 2573C ("Sandoz purple").

In its decision, the Supreme Court concludes that Sandoz purple could not have acquired distinctiveness for GSK, as GSK never had utilized that specific color in its product range. There were, however, no fundamental obstacles in acquiring trademark rights in specific colors. A requisite for acquiring such distinctiveness according to Section 3 of the Norwegian Trademark Act is that the color must be something more than a generally known mark. The relevant public must recognize it as someone's particular mark. Section 14 of the Trademark Act, which regulates trademark registrability, is also relevant in this determination. The mark is ineligible for registration if exclusively consisting of characters indicating the nature, amount, or other characteristics relating to the product or service. The only exception to this limitation is if the intensiveness of the marketing is sufficient to change the mark's characteristics, giving it an alternative connotation to its generic definition.

In extension of this, the Supreme Court confirmed its previous statements in Yellow Pages (Rt-2005-1601) and Pangea (HR-2016-1993-A) regarding the relevancy of decisions from Court of Justice of the European Union ("CJEU") and other EU agencies such as the European Union Intellectual Property Office ("EUIPO") when determining Norwegian trademark issues. Indeed, in the absence of explicit Norwegian regulation, Norwegian courts will adhere to EU jurisprudence. This is particularly interesting as the Trade Mark Directive (Section 5 of the preamble, 2008/95/EC) does not implement rules for determining acquired distinctiveness (or secondary meaning).

The level of acquired distinctiveness depends on how the relevant public perceives the trademark usage. In this connection, the Supreme Court first had to determine whether the purple color was a descriptive color for the relevant combination drug. The parties presented several arguments, most notably of which were proof of industry usage of color schemes for asthma drugs since the 1970's to differentiate visually product purpose, function and strength. This includes several actual examples of use, including several publications, which refers use of color schemes. The pertinent colors were blue for seizure drugs, and red, orange and brown for anti-inflammatory steroids. GSK started using the color purple with the introduction of their combination drug in 1999. Today, GSK delivers Seretide Diskus in several colors including blue, orange/brown, green, and purple to differentiate between purpose and function.

The Supreme Court reasoned that GSK's color usage indicates that "with the introduction of Seretide [GSK] did not have as a primary aim to establish purple as a color for identifying the enterprise, but that it was used with aim to expand the color code to encompass purple as a color for combination drugs."* As "use of color codes may serve as an important function to guide consumers, this will contribute to strengthen the consideration" for keeping it available for use by others in the specific sector. The fact that GSK previously had used several purple nuances contributed in solidifying the impression of GSK not consciously attempting to acquire distinctiveness for Seretide.

When determining the conflicting interests between GSK's accrued goodwill and the consideration for keeping the color available for the public, less weight is attributed the former where the mark "only will have a limited significance for the purchaser's decision making process" (our emphasis).

So who was the purchaser, or the relevant public? GSK submitted several market surveys directed primarily towards physicians and pharmacists, but also to some degree patients, containing questions relevant to the assessment of purple as a distinctive trademark for GSK's Seretide. GSK argued that physicians and pharmacists had to be the relevant public, reasoning that these actors are the ones who prescribe drugs. In Norway, it is illegal to market prescription drugs towards patients. On the other side, Sandoz argued that patients indeed participate in deciding what drugs to use in the particular area.

The Supreme Court reasoned that the questions becomes "who directly or indirectly are able to influence each individual purchase decision." Seeing that the drugs are "essentially used by patients with chronic conditions [who undoubtedly will] have a particular interest in choice of drugs," the patients must be considered as a natural part of the relevant public. This is rooted in two CJEU decisions (C-371/02 Björnekulla and C-412/05 Travatan). Furthermore, physicians, pharmacists, and patients are not to be considered different relevant public, seeing that these are actors in the same market which are not geographically demarcated, "granting a special right to one group [will] practically act as a special right for all marketing towards the" relevant public.

Instead of discussing the particular knowledge measured in the surveys, the Supreme Court merely holds these likely to be insufficient for acquiring distinctiveness. The surveys say nothing about to what "extent the participants have perceived the color usage as a particular trademark for one producer. The surveys do say something about the number of persons who associate purple inhalers with a particular producer, but this, as the case is, does not provide a basis for concluding that purple is perceived as someone's particular trademark." None of the presented proof gave clear indication that the survey participants would have concluded from the fact that the product is purple, that GSK is the particular producer.

To associate purple with Seretide or Diskus is not the same as concluding that purple is perceived as someone's particular trademark for the specific drug. In extension of this, the Supreme Court states that the particular survey methodology was unsuitable. The results could "just as well be due to a knowledge regarding the color use and about which company that produces the specific medication." In general, it is unproblematic to map knowledge regarding the use of a mark, but it will be "more problematic to determine if the person who possess such knowledge about the mark usage and that the mark might be connected to one producer, will also perceive the mark as someone's particular trademark".

Specific market surveys, such as the German three-prong test, will not necessarily be of primary relevance unless said method gives specific answers to the particular questions raised in the case. The fact that GSK relied on the test, which was successfully applied in the Yellow Pages decision, is not relevant, as the court did not find it satisfactory in this particular case. In all instances, marketing surveys will only be one part of the overall evidence assessment.

The case illustrates the importance of establishing a clear trademark strategy early in the commercialization process. It also highlights the importance of continuous monitoring of possible infringement and other misuse. In this instance, it might have been easier to acquire distinctiveness for one specific color, which did not consist of a "natural" combination of the colors used for the different types of individual drugs. The same could apply if GSK had used one specific color nuance, instead of a range of nuances during the product's history. Market surveys play a major role in determining trademark distinctiveness. It is paramount to follow established test methodology, but as made evident by this case, it is also important to tailor each survey, taking into account (among other things) the particular type of trademark in question and its relevant public.