Viagra in shape despite close shave

pharmafile | October 8, 2003 | Feature | Sales and Marketing EU, patents, viagra 

The success this year of Remington Consumer Products in the European Court of Justice (ECJ) in a long running dispute with Philips has finally provided clarification on many of these questions of European trademark law, particularly in relation to its application to trademarks, which protect shapes.

Philips has long held a monopoly in the production of triple-headed rotary shavers and, after the expiry of its patent for this design, sought to exclude competitors from the market by registering the shape of the head of this particular type of shaver as a trademark. Unlike the protection provided by a patent, which is finite, trademark protection lasts indefinitely, subject to the payment of renewal fees, and Philips trademark registration for the shape of the head of its shaver therefore had the aim of maintaining its monopoly in this area of the market in perpetuity.

When Remington introduced its own triple-headed rotary shaver onto the market in the mid-1990s, Philips brought an action against it for trademark infringement. Remington, however, counterclaimed that Philips trademark registration was invalid. Following successes against Philips in the High Court and the Court of Appeal, the Court of Appeal referred a number of questions on the interpretation of the directive to the ECJ.

Article 3(1)(e) of the Directive states that "signs which consist exclusively of the shape of goods which is necessary to obtain a technical result cannot be validly registered as a trademark." Philips argued that the purpose of this provision in the Directive is to prevent a monopoly being granted in a particular technical result by means of trademark protection. However, it went on to argue that if the registration of a mark consisting of a shape that has a technical result does not prevent competitors from achieving the same technical result by other shapes then there is nothing to prevent trademark protection for that shape. Philips claimed that there are many alternatives to its triple-headed rotary shavers shape that achieve the same technical result in shaving terms at an equivalent cost and therefore, on the basis of this argument, its trademark was valid.

The ECJ held that Article 3(1)(e) is intended to prevent the protection conferred by the trademark right from being extended, beyond signs that serve to distinguish a product or service from those offered by competitors. This is so it does not form an obstacle that would prevent competitors from freely offering for sale products incorporating such technical solutions or functional characteristics in competition with the owner of the trademark.

The Court made it clear that where the essential functional characteristics of the shape of a product are attributable solely to the technical result, Article 3(1)(e) prevents registration of that shape even if the same technical result can be achieved by other shapes. This decision does not affect the validity of shape trademark registrations per se, such as the classic Coca-Cola bottle, which protects the packaging used by one undertaking to distinguish its product from others. This shape does not contain essential functional features attributable to a technical result.

For the pharma industry, the significance of shape marks is not just limited to the shape of packaging and medicine bottles. Companies are also looking at opportunities to protect the shape and colour of the drugs themselves. A notable example is Pfizer's Viagra.

Extremely successful in a very short space of time after entering the marketplace, Pfizer applied to register Viagras shape and colour as a trademark. This mark consists of a three dimensional shape with the colour blue, Pantone No 284U, applied to the whole of the outside surface. Applications for non-functional shape trademarks, like that for Viagra, will still be granted in the future; however, businesses ought to bear in mind that shape trademarks are not easy to obtain and often what is effectively required is for the shape to acquire distinctiveness in the market that distinguishes it from competing products before applying to register new shape marks.

Functional shape marks, would by contrast, now appear to be dead in the water.

Viagra has also been in the news recently in Pfizer's ultimately unsuccessful attempts to protect its patent for a second medical use of its compound. Pfizer had earlier patented the medical use of phosphodiesterase (PDE) inhibitors including sildenafil citrate, the active ingredient in Viagra, for the treatment of various cardiovascular disorders such as angina and hypertension. However, in 1994 it applied for the Viagra patent covering these PDE inhibitors in the treatment of impotence.

In order to patent an invention, it must involve an inventive step. This is possible if it is not obvious to a person skilled in the art, having regard to any matter that forms part of the state of the art. The state of the art is taken to include all matter (whether a product, a process, information about either, or anything else) that has at any time before the priority date of that invention been made available to the public (prior art).

In February 1999, Lilly Icos started proceedings for the revocation of Pfizer's patent primarily on the grounds that the invention was obvious. In the High Court, the case came before Mr Justice Laddie in October 2000 and in his judgment it was held that the patent was obvious and should therefore be revoked. Pfizer appealed but was again unsuccessful. Its final hope of an appeal to the House of Lords was refused on 17 June 2002, effectively upholding the earlier Court of Appeal judgment.

Applying the test from Windsurfing (see box) the court considered the difference between the invention and the disclosed prior art and whether the invention was therefore obvious. The Court of Appeal agreed with the High Court that the invention was obvious and consequently Pfizers Viagra patent was held invalid.

The judgement, however, has no bearing on Pfizer's patent for Viagra's active ingredient for treating impotency, sildenafil citrate, which will remain in force in the UK until 2013. The impact of the judgement on Pfizer is therefore not quite as bad as the headlines have implied. What it suggests is that in addition to ensuring that they have carried out thorough prior art searches, patentees should put themselves in the position of the person in the Windsurfing test and take an objective view of whether there has been an inventive step, particularly in cases of second medical use. If, after this, and on the basis of their conclusions from exercising this approach, they believe the invention was obvious, they should then consider whether the economics of pursuing such applications or defending these patents is worthwhile.

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