Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Die gewerblichen Schutzrechte bei Arzneimitteln in der Europäischen Union und den USA – Arzneimittel und Patente

Dr. Karl Zimmermann (Abschlußjahr: 2010)

The conflict of interests between the research based pharmaceutical industry and the concern of the public for a supply with medicinal products as inexpensive as possible is dominating the debate on both sides of the Atlantic regarding the intellectual property rights for pharmaceuticals. The obtainable legal options are virtually the same. That comprises the patent including its extension, the data for marketing authorization being exclusive for protection and as a special form the particular protection for rare diseases as well as for children.

With respect to the patent protection to be granted both legal entities d not differ. A deep difference however is the fractured granting of patents in the Member States of the European Union as well as the nationally dominated legal protection. The consequence is an extra effort and cost by granting as well as prosecution.

The subsequent, on both sides possible extension of the patent protection precipitates uniformity in Europe. In terms of content they differ pertaining the term of the extension only marginally. Because of the varying in Europe there remains the issue when the extension period actually begins. The same is true for the selection of the medicinal product launching the term as well as the particular requirements for his marketing authorisation.

With respect to the exclusivity of the data for marketing authorisation the notably longer protection period in the EU with ten versus five years is apparent. The benefit however is not clear, since the main profit margin for most of the medicinal product is during the fist years after entering the market. In the US in contrast, the protection period for advances of for already approved products is much longer, three versus one year. In comparison here the temporarily longer protection applies only for the newly generated data, not, as in Europe, for the entire product.

Defining for the United States is the indication of potential patent infringements already when submitting the request for approval. In addition, the second applicant has the option to attack still ongoing patent protection. If he succeeds it would reward him with a 180 day period of exclusive rights of market protection.

In Europe, the often unclear begin of the deadline as well as the uncertain selection of the reference product and its status of approval have a disadvantageous effect. The reason are the not yet consistently fulfilled advanced requirements pursuant to the European provisions. It should be emphasized that due to the long transition periods no practical experience has been achieved so far.

The protection of data for medicinal products submitted for rare diseases is similar, although the period in Europe is longer with ten versus seven years. Nevertheless, only in Europe the product could be reclassifies and loose its Orphan status due to an unexpectedly high profit margin.

In both legal entities occurs in two steps, with an initial designation and a subsequent approval. Each time the requirements pursuant to the law for a competing product pertaining clinical superiority are exceptionally high.

On both sides exist incentives to proceed research for the application in children. They lead to an extension of the patent term for six month. In the United States, that extension could also link to the protected data submitted for marketing approval. Pediatric research is already mandatory in the approval period. Nevertheless, only in the EU remuneration exists. In the US, a written request would be necessary. In both legal entities, the option for waivers and deferrals exists. However, the proceeding in the US appears to be more flexible.

In terms of clinical research widely harmonized exceptions for patent infringements exist. However, in Europe acts such as allocation and supply are exempted from infringement only vague.

In Europe, the option for legal protection in case of patent infringement carries the problem of the inhomogeneous, nationally driven legislation. In case of protection of the data for approval the emphasis is indistinctive on the triangle between authority, originator searching for protection and generic manufacturer. Decisive is the only limited right for judicial review of the originator.

Pages: 123