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European IP Bulletin, Issue 5, October -
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Many businesses familiar with the European patent system will be aware of the expense (relative to the USA and Japan) of obtaining patent protection in a number of European countries. Many will also be familiar with the fragmented nature of a “European Patent”, which in reality consists of a basket of national patents each of which must be enforced separately in the European states which have been designated by the patentee for protection.
Following the success and popularity amongst businesses of the Community Trade Mark, it was announced earlier this year that a new, unitary patent, legally valid throughout the whole of the European Union, is to be created, known as the Community Patent. After the European Union has expanded (to include a number of the former Eastern bloc countries, such as Poland) in May 2004, and the Community Patent has come into being, businesses will be able to obtain a patent which can be enforced on a pan-European basis in 25 countries.
The cost of obtaining a Community Patent is likely to be approximately €25,000. Although the cost will still be higher than in the USA and Japan, the Community Patent will offer potentially significant costs savings for those businesses interested in seeking pan-European patent protection under the umbrella of the Community Patent.
Businesses are expected to be able to apply for a Community Patent within five years. The European Patent Office in Munich will administer the grant procedure. It is well known that the cost of filing translations can significantly add to the expense of obtaining European patent protection. An application for a Community Patent must be prosecuted in one of the three official languages of the European Patent Office: English, German or French. At the time of grant, the applicant will have to file translations of the patent claims into the other two official languages. After a Community Patent has been granted, the patentee will have to file translations of the claims into all of the official languages of the European Union. This is likely to be a significant cost burden, although the European Commission is analysing whether savings in the process can be made, to keep the cost of a Community Patent competitive.
When it comes to enforcing rights under the Community Patent, this will be done through a new Community Patent Court, which is to be set up by 2010. This Court will have exclusive jurisdiction in claims for infringement of Community Patents. It will be able to award pan-European injunctions and to award damages. The Community Patent Court will consist of three judges, all of whom will have experience of patent law. The Court will also have technical experts, to assist the judges.
Detractors of the Community Patent have said that businesses may not necessarily want to stake all on one unitary right since if the validity of a Community Patent is successfully challenged in infringement proceedings patent protection throughout the whole of Europe will be lost. However, the system as presently operated by the European Patent Office will continue to be available if a patentee prefers instead to designate individual European Member States for protection. It will also continue to be possible to file national patent applications in individual countries on a country by country basis. Businesses will be able to select the type of patent protection which is most suited to their needs and to their budgets.
In the 1970s, the European Patent Convention established a new system of patent law and a new patent granting authority for all Contracting States, the European Patent Office. The European Patent Office was to be responsible for the granting of patents under the new system of law set out in the Convention. A European patent granted by the EPO would take effect as a collection of national patents and be subject to the same conditions in national courts as national patents granted by the Contracting States.
In accordance with the EPC, the Contracting States were to harmonise their national laws as to patentability so that as far as possible the national courts of each State would approach the issue of validity of patents in the same was as the EPO. In order to assimilate the national patent law in the UK to the system of law of the EPC, the UK Patents Act 1977 included many changes in the law of patents. Similar steps were taken in all the other Contracting States and presently it can be said that the substantive law of patents is for the most part harmonised across Europe.
This is not to say that the current EPC system is perfect. Apart from decisions by the EPO on oppositions filed within 9 months after grant of a European patent, the EPO has no further role in examining issues of infringement and validity. There is no central court of appeal on issues of validity and no central court of appeal on issues of infringement. Instead, subject to the EPC, patent disputes (including those concerning European Patents) are referred to national courts. The result of this is that there is room for slightly differing interpretations of the validity of patents to be found across Europe. Indeed the current situation is that although the substantive law as laid down in the EPC might be harmonised, it has received differing interpretations by the different national courts of the Contracting States.
Despite acknowledging that there may be different standards of interpretation of patentability across Europe, it cannot be said that in practice the UK courts have taken a unique approach to validity. The UK courts need not pay any heed at all to the EPO as a non-judicial authority. Nonetheless in the first English case (Wyeth and Schering) to address the patentability of second medical use claims the court specifically recognised that it was necessary to have regard to the decisions of the EPO, particularly the decisions of the Enlarged Board, in order to achieve conformity.
John Wyeth and Brothers Ltd's Application and Schering AG's Application (1985) RPC 545 was decided in the aftermath of the landmark European EISAI case in 1985 (EPO Decision G 5/83, EISAI/Second Medical Indication OJEPO 1985, 64). Historically in Europe, patents for methods of treatment had been regarded as not being capable of industrial application and consequently not patentable. Only the first inventor of a new product suitable for use in medical treatment was entitled to a claim to the product. Difficulties had arisen where the product and the use of the product for medical use was known, and the invention resided in the discovery of a novel second medical use. The EPO tackled this problem in EISAI. The Enlarged Board of Appeal of the EPO held that, whilst a claim to the method of use could not be permitted, a claim for the use of a product for the manufacture of a medicament for a specified new and inventive medical use (the Swiss-type claim) could be permitted on the basis that the novelty of the claim resided in the new therapeutic use and not the method of manufacture. This decision became the authority for the second medical use claims granted by the EPO. Although the English judges voiced a preference for excluding such claims in Wyeth and Schering's Application they followed the EPO decision and held that the novelty of a use claim directed to a second, or subsequent, therapeutic use was possible under the corresponding provisions of the 1977 Act.
It can thus be seen that to this point the interpretation of patentability standards by the English courts accorded with that of the EPO. Second medical use claims could be obtained. A divergence occurs however with the later decision of Bristol-Myers Squibb Company v Baker Norton Pharmaceuticals Inc and Napro Biotherapeutics Inc ((2000) EWCA Civ 169) which was followed by Teva Pharmaceutical Industries Ltd v Merck and Others ((2003) EWHC 5). In Bristol-Myers Squibb v Baker Norton the English court qualified the patentability of patents claiming second medical uses in the situations of patents claiming dosage regimes. Opting for a similar approach to the Dutch Court of Appeal in Bristol-Myers Squibb v Yew Tree Pharmaceuticals [Netherlands] (2000) ENPR 26, and distinguishing EISAI, Aldous J held that a claim must be for an application of a substance for a different therapeutic purpose and not for a mere discovery about an old use. Where the medicaments and their therapeutic purpose were known and the only novel feature related to the way that such a medicament was used it was not be sufficient for a valid second medical use claim. The more recent case of Teva v Merck adopted the same position. Again the claim related to a new use for an old compound. The courts maintained their position that claims to new dosage regimes are seen as claims to methods of treatment and therefore unpatentable.
Though this is a relatively minor qualification of the law as provided by the EPO, for pharmaceutical companies that rely on patents claiming dosage regimes it is a large barrier. A claim for a dosing regime may well be granted by the EPO but will be found to be invalid in the UK courts. Unfortunate for the pharmaceutical industry as this situation may be, it can only be remedied by a decision of the English higher courts. The reluctance of Jacob J in Teva to follow Bristol-Myers Squibb v Baker Norton might be interpreted as a change in direction by the courts. However, until this problem next arises before the Court, the UK line remains that patents claiming dosage regimens where the dosage regimen is the only novel feature will not be patentable as second use medical claims.
This varied approach to second medical use claims also can be seen to occur across the other European jurisdictions. For example, the EPO decision in EISAI has been followed in Sweden (Hydropyridine [Sweden] (1988) 19 IIC 815) and Germany (Hydropyridine [Germany] OJEPO 1984, 26) , however, as seen above, in the Netherlands the Dutch Court of Appeal has held that such a claim in a Dutch national patent does not meet the requirements of patentability. Meanwhile the EPO continues to grant patents adopting a very wide view of patentability. More recently claims have been allowed when the sole point of novelty was the mode of drug administration (EPO Decision T 51/93, unreported) and also where novelty resided only in the frequency of drug administration (EPO Decision T 570/92, unreported).
Excluding the importance of the matter for pharmaceutical companies, in the grand scheme of the harmonisation of European Patent law this is a relatively minor point. It must be remembered that the European patent system as it now stands, unlike other Patent systems, did not come into existence in order to fill a patent law vacuum nor did it replace any existing patent laws thus the level of harmonisation is commendable considering the number of Contracting States each with their own patent system and especially in the absence of a Community patent court.
The continuing advance towards harmonisation most notably in the plans to establish a Community patent court could provide a more favourable position in relation to dosing regimens in the future. In its ultimate aim to create a Community patent system for the EC, the Community Patent Convention has as the key feature a patents court and judicial system for Europe. The jurisdictional system will be based on a unitary system for the community patent, the aim being to secure uniformity of jurisprudence. Litigation of a community patent shall at first instance be before a judicial panel. This judicial panel, called the Community Patent Court (CPC), shall be attached to the Court of First Instance (CFI) of the European Union. Its seat shall be at the CFI. An appeal against a decision of the CPC may be brought at the CFI. The CPC is to have exclusive jurisdiction, inter alia relating to invalidity, infringement proceedings, declaration of non-infringement, and counter claims for invalidity. The system will operate similarly to the ECJ and the national courts will be bound by the decisions of the European patent court. It is hoped that this will definitively ensure harmonisation of patent law in Europe with one European standard for patent validity being applicable in all Contracting States.
Although the general view is that the Community patent Court would improve the Community Patent system it is difficult to foresee the consequences. The creation of the Community Patent Court undoubtedly has the potential to harmonise patent harmonisation across Europe and ensure legal certainty. Further, as a European institution one might expect the EPO jurisprudence to be favoured.. However, the plans for the CPC are still very much in their infancy and until it is established it would be almost impossible to predict which direction will be taken on the matter of the patentability of dosing regimens.
The Office for Harmonisation in the Internal Market (Community Trade Marks and Designs Registry) (OHIM) has published, on its website , details of how to file for design protection electronically. The website gives full instructions on what can be supplied electronically, the advantages to electronic filing, and links to the form that can be completed and filed with the design in electronic format.
The electronic filing circumvents the need to use email to supply OHIM with the design. The system allows for all the details of filing being included, with the design itself attached electronically and details of additional relevant designs, such as those from which priority is being claimed can also be attached. The requirements for obtaining a filing date as set out in Article 1 of The Community Designs implementing Regulation (EC)6/2002 will include the electronic signature of the applicant.
OHIM identifies the ability to obtain real-time confirmation of receipt of the application and the resulting online verification of an error free communication as the key benefits of the new system. The applicant will have the certainty of knowing what has been delivered to OHIM and when. To those familiar with the filing of applications by fax, this system is to be welcomed, as the use of faxes can result in delays due to blocked or slow fax machines or the part receipt of forms, and human error, such as mis‑dialling.
The introduction of electronic filing raises the question of whether in the future communications with OHIM can all be conducted online. This would lower costs for applicants. Clearly if the system of electronic filing is successful then further integration of technology can be expected. A broad range of designs can benefit from protection by the Community design. This system should also be welcomed by the owners of two-dimensional device trade marks as these can be easily scanned in and attached, broadening the market entry protection from an early stage of test marketing.
A Russian studio, Soyuzmultfilm, has applied to the Moscow Arbitration Court to obtain a ruling annulling the sale of 1,200 classic Soviet-era cartoons to a US film company.
In 1992, a Californian-based company called Films by Jove purchased the international rights to 1,200 classic Soviet-era animated motion pictures from the state-run studio Soyuzmultfilm. Films by Jove paid $500,000 for the rights to the cartoons for a 30-year period and also agreed to give Soyuzmultfilm 39.5 percent of future profits.
Films by Jove invested $3 million restoring the films which were often “scratched, bleached, ripped down the middle and held together with Scotch tape” and through a digital process re‑dubbed the cartoons, commissioning stars such as Sarah Jessica Parker, Charlton Heston and Julio Iglesias to do voice-overs.
“When the cartoons became popular around the world, the Russian Government realised how much they were worth” said Mrs Borsten, the director of Films by Jove, “the government set out to get them back with no compensation for the time and money spent on restoration”.
The Russian studio’s director, Ernst Rakhimov, said the animations that were produced by the studio between 1936 and 1992 belong to Russia’s national heritage. He said that the Soyuzmultfilm studio of 1992, which was reconstituted in 1999, was not the legal owner of the rights to the studio’s productions and had no right to sell them. He added that the old Soyuzmultfilm “simply had the use of the buildings and studio facilities”, and that the new company was the legal owner of the rights to the films.
For four years the catalogue of Soviet cartoons has been at the centre of a legal battle which shows few signs of ending. In August 2001, the US Federal Court found that Films by Jove had legally purchased rights from the entity authorised to grant the lease. Four months later, the Russian High Court decided in favour of Soyuzmultfilm. In April 2003, the Federal Court the upheld its original decision, but Soyuzmultfilm which had initially agreed to abide by the US judge’s decision brought the case back to the Moscow Court of Arbitration.
Film by Jove’s bill for the restoration of the cartoons and its legal fees now runs to $4 million. “We would all be in profit by now if we had not been sandbagged by legal fees” said Mrs Borsten.
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