(2003; 82 pages)
Barth R. Patent protection of biotechnology, pharmaceutical and chemical inventions in Eastern Europe. Patent World, December 1993/January 1994, 27-29.
The disintegration of the former Soviet Union and Yugoslavia resulted in changes in the patent laws of the Newly Independent States. In 1994, most of the new States set up their own patent offices. This article provides an overview of the legal situation in Eastern Europe. It includes a table showing whether the various jurisdictions protect biotechnology, pharmaceutical and chemical inventions.
Challu PM. Effects of the monopolistic patenting of medicine in Italy since 1978. International Journal of Technology Management (special issue on the management of international intellectual property), 1995, 10(2/3): 237-251.
The paper discusses the effect that the patenting of medicine in Italy has had since the current legislation was passed in 1978. Comments focus on four areas: the influence of patents on prices, the attitude of the national laboratories and the consequences for national production, the effect of monopolistic patents on the capacity for innovation, and the influence of patents on Italy's balance of trade in pharmaceuticals.
Cook TM. Pharmaceutical patents and the generic sector in Europe. Patent World, February 1997, 36-40.
The strategies adopted by the research-based companies in the pharmaceutical industry to hamper generic competition after patent expiry are many and varied. In some cases, they will take the form of further patents with later expiry than the original one protecting the product, but relating for example to formulations or processes. However, the research-based company can also make the most of its original patents, as discussed in this article, which seeks to summarize developments in Europe over recent years in the underlying legal framework affecting the balance between the generic sector and the research-based sector of this industry.
Darbà J, Rovira J. Parallel import of pharmaceuticals in the European Union. Paper presented at the Symposium on Dynamics of the International Pharmaceutical Marketplace: Major Forces in the Late 1990s, Talloires, France, 24-25 July 1997.
Differences among EU Member States in political, social, economic, legal and regulatory regimes cause differences in pharmaceutical prices, which in turn create opportunities for parallel trade. This paper looks at the current state of parallel trade of prescription medicines in the EU, with a particular focus on Spain as a source of parallel exports. It also analyses some policy implications derived from parallel trade. Finally, it develops a simple microeconomic model for assessing the effects of parallel trade.
European Generic Medicine Association. A proposal to include a development and testing provision for generic medicines in national and EU laws. Brussels, EGA Position Paper, July 2000.
This paper proposes to the EU that national and EU laws be amended in line with the WTO Panel Decision (WT/DS114/R) of 17 March 2000. This Decision relates to the dispute between Canada and the EU on the issue of the development, testing and experimental work required for the registration of a generic drug before the expiration of patent protection. The WTO Panel held that testing, development and production of samples is compatible with TRIPS. This paper argues that incorporating this development and testing provision into national and EU laws would provide Europe with major economic benefits in the areas of investments, employment, balance of trade, public health and know-how, with no negative effect on patent holders.
European Generic Medicine Association. TRIPS Article 39.3 does not require data exclusivity provisions (a critical issue for access to medicines). Brussels, EGA Position Paper, July 2000.
This paper contends that the clause "protect such data against unfair commercial use" provided in Article 39.3 of the TRIPS Agreement is not the same as "data exclusivity" which is operated in the EU or USA. It emphasizes the difference between the "repression of unfair competition" and other forms of IPP. Furthermore, it maintains that the interpretation that Article 39.3 requires data exclusivity is beyond the agreed terms of the TRIPS Agreement. According to the author, Article 39.3 cannot be interpreted in a way to prevent a regulatory authority from using/relying on the data registered for a particular product in order to assess and register other "similar" products, as in the case of generic pharmaceuticals. The paper also includes the definition and examples of unfair competition as provided by WIPO, together with other supporting evidence.
Kucher E. Taking control of parallel trade in Europe. Scrip Magazine, February 1999, 14-16.
Parallel trade is not specific to the pharmaceutical industry and happens wherever there are price differentials. It increases the effectiveness of the market and usually benefits the customer. However, to reap these benefits, the markets must be free. In the pharmaceutical industry, markets are not free and different strategies are required to stem the rapid growth in parallel trade within the EU. According to the author, the outlook for parallel trade may seem bright in the short-term but too many factors speak against a prosperous future beyond that, the most crucial being pan-European pricing strategies.
Scherer FM, Weiburst S. Economic effects of strengthening pharmaceutical patent protection in Italy. International Review of Industrial Property and Copyright Law (IIC), 1995, 26(6): 1009-1024.
The Italian experience of introducing pharmaceutical patent protection is particularly interesting because it presages legal changes that are likely to happen in some developing countries in the WTO TRIPS era. This article investigates how Italian producers adapted to the intellectual property regime changes of 1978. In particular, it undertakes a detailed statistical analysis of changes in drug R&D expenditures and patenting. In addition, it supplements that with information on new drug product introductions, foreign direct investment by multinational enterprises and import-export balances.
Segura P. The peculiar patent and generic situation in Spain. Available from: URL: http://www.egagenerics.com
When Spain modified its law on generics, it introduced an unusual and controversial set of regulations. This article looks at these changes, and provides the industry point of view.
Senior I. Patents and parallel trade in prescription medicines within the EU. Patent World, October 1996, 26-32.
This article deals first with the issue of parallel trade in the EU: its link with price regulation, how parallel trade takes place, whether it results in a market correction or distortion, what are the main exporting and importing countries and those driving parallel trade. It then stresses the importance of the judgement at the European Court of Justice (ECJ), Merck & Co. v. Primecrown Ltd., and of Bayer's appeal against the Commission's decision regarding Adalat.
Watts J, Treacy P. Parallel imports: reaffirming euro-puritanism. Patent World, February 1997, 28-32.
The ECJ's judgement in Merck & Co. v. Primecrown Ltd. confirmed that patentees cannot exclude from patented territories goods which they or their licensees have sold in EU Member States where the goods have no patent protection. This article argues that patentees who do not obtain, and maintain, Europe-wide coverage for their entire patent portfolio are faced with a continued choice between selling Europe-wide at close to unpatented prices, and leaving unpatented territories unexploited.