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European IP Bulletin, Issue 13, June - Patents
Patents
The European Patent Office (EPO) reported on 18 May 2004 that following a public hearing, the opposition division at the EPO had decided to revoke European patent EP 699 754, known as the “Myriad/Breast Cancer”. The patent had been granted to the US company Myriad Genetics Inc., The University of Utah Research Foundation, and the United States of America in January 2001, and related to a “method for diagnosing a predisposition for breast and ovarian cancer in a human subject” on grounds that it did not meet the requirements of the European Patent Convention (“EPC”).
Oppositions to the patent were filed with the EPO in October 2001 by a number of parties including French research organisation Institut Curie, the Assistance publique – Hôpitaux de Paris, the Institut Gustave Roussy, the Belgian Society for Human Genetics and the Associazone Angela Serra per la Ricerca sul Cancro. They had been contesting the monopoly imposed by the excessively wide-ranging claims of the patent since the patent was granted in 2001.
The main arguments of the opponents to the patent was that the invention was not novel under the provisions of the European patent law and that it could jeopardise the development of research and the identification of new tests and diagnostic methods in breast cancer research. After rejecting the claims made by Myriad Genetics, the Opposition Division of the EPO found that the grounds for opposition prejudiced the maintenance of the patent and revoked the patent on the grounds of lack of inventiveness under Article 56 EPC which provides that patents should not be granted if, having regard to the state of the art, they are obvious to the person skilled in the art.
The ruling of the Opposition Division will be published within the next two to six months. Myriad Genetics will then have two months to challenge the ruling in front of the EPO’s technical board of appeal. Whereas the Opposition Division is composed of three patent examiners and a legal expert, the Technical Board of Appeal should consist of three technically qualified members and two legally qualified members.
The ruling is a victory for scientists who oppose the patenting of human genes. According to the Curie Institut, it will pave the way for further research growth and development of new tests for diagnosing predispositions for breast and ovarian cancer.
On 19 May 2004, the European Commission published a press release IP/04/659 welcoming the Council of Ministers agreement of a "common position" on the proposed Directive on computer-implemented inventions (including but not limited to software patents).
Computer related inventions are essential tools for businesses and the backbone of practically every industry. The question of intellectual property protection for computer-implemented inventions is therefore of significant importance to the general and hi-tech business community as well as to the competitiveness of Europe as a territory.
The term "computer-implemented invention" (which is not used by computer professionals) was introduced by the European Patent Office in May 2000 in appendix 6 of the trilateral conference. The term as defined in the EPO's Trilateral Appendix 6 and in the Directive refers to any invention the performance of which involves the use of a computer, having a feature(s) which are realised by means of a computer program(s). This definition is broad and consequently the directive has implications outside the computer industry. For example, it will cover software applications in consumer electronics, telecoms, broadcasting, domestic appliances, transport, medical devices, drug design, biochips and bioinformatics, to name a few.
Article 52 (2)(c) of the European Patent Convention excludes "computer programs as such" from patentable subject matter. The exclusion only affects computer programs in their abstract form and the EPO has in practice granted many patents on software and computer implemented inventions (since the EPC came into force in 1978, more than 30,000 software-related patents have been granted), by narrowly interpreting this exclusion.
The Directive was intended to harmonise the way in which national patent laws deal with the patentability of computer-implemented inventions, but ill-informed critics argued the draft wording was vague enough to legitimise wider software patents, which would lead to patent wars dominated by large corporations.
The new draft of the software patents directive dismisses many controversial changes made by the European Parliament in its first reading. The result is a reasonable text not far from what has been recent European practice.
The European Commission welcomed Council agreement on the Directive on patentability of computer-related inventions. However, there remain some differences in principle between the parties involved, in particular the Council and European Parliament. These differences mainly relate to exceptions from patentability for computer-implemented inventions. The Parliament which has been influenced by minority lobby groups wanted wide exclusions covering the use of patented technology for interoperability and data handling. Whereas the Commission and Council believed that adequate provisions were included and that anything more went beyond what was required to set the right balance between rewarding inventors for their efforts and allowing competitors to build on these inventions.
The Directive will now be sent back to the European Parliament for another vote there in the autumn. If the Parliament still disagrees with the new draft of the Directive, it has to have a majority of all Ministers of the European Parliament to pass its amendments.
On 19 May 2004, Laddie J delivered his judgment in the case of Celltech R & D Ltd. V Medimmune Inc. [2004] EWHC 1124 (Pat) .
In this case, the claimant Celltech claimed royalties from Medimmune under a patent licence under which Medimmune was obliged to pay royalties on products made or sold which, but for the licence, would infringe a valid claim of the licensed patents. The patent licence related to the creation of a set of “rules” of general application for guiding a choice of amino acid sequences. These sequences are used for making hybrid antibodies which have good antigen binding properties without inducing the human body to reject antibodies produced by mice.
The defendant’s product, instead of using a donor residue (mice amino acid) at H23 as mentioned in the patent specification and claim, used a residue found in human a antibody. The issue under contention was whether Medimmune’s selling and manufacturing of an antibody preparation for treatment of respiratory illness in babies and young children infringed Celltech’s patent and therefore made Medimmune liable to pay royalties. This issue, as per the terms of licence agreement, had to be decided by English Courts applying German Patent Law.
After reviewing the expert evidence, the Court identified the following principles of German patent law from the decision of the German Supreme Court “Budnesgerichtshof” in the Formstein case:
- It is for the Court to construe the patent and to decide the issue of infringement, viewing the patent through the eyes of a notional skilled, but uninventive addressee.
- The first step in determining an infringement is to construe the “semantic” meaning of the claims taking into account that figures, dimensions and numerical items are able to delimit the scope of protection. If the defendant’s product or process falls within those limits, there is infringement.
- Otherwise, the next step is
to determine how far away from the semantic meaning, if at all, the scope
of protection extends. For this purpose, a
three-stage test adopted by the German Supreme Court in Custodial II (which is similar to, but not identical to Improver questions) is
applicable. This is:
- Does the offending device or process work in the same way as, and by equivalent means to, the patent? And, if so;
- Would it be obvious to the notional addressee that the variant is equivalent? And, if so;
- Would the person skilled in the art consider the different embodiment with its modified means as being the specific equivalent solution, keeping in mind the semantic content of the technical teaching protected in the patent claim?
- German patent law does not allow the patentee to correct mistakes made by him, if he has imposed a clear limit on his monopoly, even though such limitation is recognised as being unnecessary or based on mistaken science by the notional addressee.
Thus, under German law, a device that would work in the same way and by equivalent means is not an infringement if the notional addressee concludes from the teaching in the patent that the patentee intended to exclude variants in general or in particular. Holding the third limb of the test to be determinative in the present case, the Court found the defendant’s product a variant outside the scope of protection of the patent. In particular the defendant’s residue is from a human antibody, unlike the mouse amino acid specified in the patent claim.
Last December, in BL Macchine Automatiche v Windmoeller und Hoelscherthe, the Italian Supreme Court ruled against the use of the “Italian Torpedo” technique in cases of patent infringement. The decision of the Court was made public last month.
The “Italian Torpedo” was a defensive technique that used one of the basic principles of jurisdiction in European civil cases litigation. Article 21 of the Brussels Convention establishes that, when two or more parties are involved in procedures related to the same action in courts of more than one state, the later case shall stay until the first court has expressed its findings.
Italian patent litigation cases can take up to seven years. For this reason companies looking to tie up pan-European litigation could file a suit in Italy for a negative declaratory judgment as a defensive strategy for patent infringement. Once a court accepted the petition, any potential case in another European country would be delayed until the Italian decision was given. This system made some companies unwilling to send a warning letter for patent infringement, for fear of triggering a “Torpedo”. Some multinational companies even excluded Italy in their European patent applications or withheld their product from the Italian market.
In the BL Macchine case, the Italian Supreme Court reversed the Italian court’s traditional acceptance of the “Torpedo” technique. The Supreme Court held that because the plaintiff is trying to show non-infringement there is, by definition, a denial that any tort has actually been committed. As a result, the procedure cannot be used to prevent an action for tort in another jurisdiction.
This decision should encourage entry into the Italian market and improve the enforceability of patents in other EU countries.
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