Tag:  “EPO”  | (13) posts

Almost a year ago I wrote on the Awapatent IP Blog about the efforts of the EPO and USPTO to harmonize their patent classification systems to form the Cooperative Patent Classification (in short CPC). The work is progressing, and it has now become time for an update.

The CPC is now taking shape, and it has become possible for users to familiarize themselves with the new classification scheme as the results this far have been made available by the EPO and the USPTO in what they have named a “CPC launch package”. The launch package includes the complete CPC scheme, the presently finalised CPC definitions and an ECLA-to-CPC-to-IPC concordance table. The launch package is available here.

The EPO and the USPTO explain that the CPC scheme for classifying patent documents according to the technological field of the invention is based on the latest version of the International Patent Classification (IPC) system. The CPC scheme will have sections A through H similar to the IPC as well as an additional brand new section Y including new technological developments and cross-sectional technologies.

There will be CPC definitions available for every CPC subclass and each definition will contain a description of the technical subject-matter covered in the subclass. The CPC definitions will be continuously maintained. Also, a CPC-to-IPC concordance table has been published to help users find the relevant part of the IPC on which the CPC is based.

The CPC is scheduled to be launched on 1 January 2013, and the Awapatent IP Blog will continue to monitor the development with interest to keep our readers updated.

Troels Peter Rørdam, European Patent Attorney & Certified Danish Patent Agent

I have previously written about the PPH MOTTAINAI agreement, which aims at easing the requirements for requesting patent examinations. The latest news is that the EPO (European Patent Office) entered the PPH MOTTAINAI agreement at the beginning of the year (29 January) and thus the PPH MOTTAINAI agreement has now been signed by a total of nine countries.

With the PPH MOTTAINAI program, two previously strict requirements have been removed: Firstly, the original priority application, from which a patent family stems, may now originate from any country. Secondly, within one patent family, it is now possible to use a decision to grant originating from any of the participating offices to request prosecution under the PPH at any other of the participating offices, provided a mutual PPH-agreement actually exists and remaining requirements are met.

The Intellectual Property Office of the Philippines entering the PPH-network
Furthermore, a number of new PPH agreements with the JPO as one participant have been launched, namely with the Intellectual Property Offices of Taiwan, Portugal and the Philippines; the latter two relating both to the use of national and PCT work products for requesting accelerated prosecution under the PPH.

With these agreements, the PPH-system can be said to have reached a small landmark, as the Intellectual Property Office of the Philippines is the 25^th office to join the PPH-system.

Read more about the Patent Prosecution Highway.

Troels Peter Rørdam, European Patent Attorney

Last week, the European Patent Office released two new decisions by the Enlarged Board of Appeal on petitions for review, R 2/11 and R 10/11. Both the underlying petitions were based on what the petitioners regarded as fundamental procedural defects before respective Boards of Appeal 3.2.04 and 3.2.03.

Both cases are appeals from opposition proceedings. In R 10/11, the Board had refused to discuss late-filed requests for claim amendments. In R 2/11, an Opponent had been allowed to make an oral presentation of the technical background. The Proprietor was taken by surprise by the Opponent’s presentation; he had not prepared his counterarguments, he could hear at least one half-truth in the presentation – and to his great horror, the presentation had a very convincing effect on the Board!                          

However, the Enlarged Board did not go into the details of neither case, but noted only that neither of the petitioners had raised an objection in respect of the procedural defect in due time. Indeed, as provided by Rule 106 EPC, the Enlarged Board shall not deal with a purported procedural defect unless the Board of Appeal has been made aware of it during the appeal proceedings.

Looking at the decisions on petitions handed down by the Enlarged Board in 2010 and 2011, we see that a breach of Rule 106 EPC was a sufficient ground for rejection in 7 out of 34 non-withdrawn petitions (R 3/11, R 7/11, R 17/10, R 1/10, R 6/10, R 7/10, R 9/09). In other words, appeal proceedings are no place for silent suffering; if you are unhappy with the way the proceedings are conducted, you should voice your concern and make sure it gets written down in the minutes.

Anders Hansson, European Patent Attorney

The Court of Justice of the EU (CJEU) has recently issued a decision clarifying the situation on patentability, in Europe, of inventions relating to human embryonic stem cells. In the decision it is declared that the concept of a “human embryo”, the exploitation of which is excluded from patentability according to the EU Biotechnology Directive 98/44/EC, should be understood in a wide sense. This implies that patents relating to human embryonic stem cells will likely be more difficult to obtain, or at least enforce, also in more embryonic stem cell friendly states of the EU.

The case (C-34/10) pertains to a method and cells invented and patented by Oliver Brüstle, Professor of Reconstructive Neurobiology at the University of Bonn. Professor Brüstle invented a method for converting human embryonic stem cells into neural precursor cells, which can be used for the treatment of a range of neurological disorders, such as Parkinson’s disease. The embryonic stem cells used in the method of Professor Brüstle were cells isolated at the blastocyst stage. Thus, they were pluripotent but not totipotent, i.e. they had the ability to develop into all cell types of a human, but were not able to develop into a human being since they could not form extra-embryonic tissue, such as the placenta.

The patent was opposed by Greenpeace in Germany, and the case was subsequently referred by the German Federal Court to the CJEU. In its decision, the CJEU provides an interpretation of Article 6 of the European Biotechnology Directive (98/44/EC), which states that inventions related to ”use of human embryos for industrial and commercial purposes” shall be considered unpatentable.

Three main points are made:

1. The term “human embryo” should be understood in a broad sense.
According to the Court, the purpose of Article 6 of the European Biotechnology Directive was to ensure exclusion from patentability where respect for human dignity could be affected. Thus, any cell or organism that is capable of commencing the process of developing into a human being must be considered a “human embryo” within the context of the Directive.

The Court explicitly mentions that a fertilised ovum, a non-fertilised ovum into which the cell nucleus from a mature human cell has been transplanted and a non-fertilised human ovum whose division is stimulated by parthenogenesis all must be considered “human embryos”.

Regarding the pluripotent cells of Professor Brüstle’s invention, the Court notably held that it is for the referring court to decide whether a stem cell obtained from a blastocyst is capable of commencing the process of developing into a human being and therefore would fall within the definition of a “human embryo”. It is thus left to the national courts to decide on the patentability of blastocyst-derived, pluripotent stem cells, as long as the capability of the cells to develop into a human being is considered. The evaluation of patentability should also be made “in light of scientific development” and may therefore vary over time. This might have the rather interesting effect that the more technology in this field progresses, the less of the same technology constitutes patentable subject-matter.

2. The use of human embryos in scientific research is excluded from patentability.
The Court states that the use of human embryos for purposes of scientific research cannot in this context be distinguished from industrial and commercial use. Consequently, the Court concludes that scientific research entailing the use of human embryos cannot access the protection of patent law.

3. Inventions that require the destruction of human embryos are excluded from patentability.
In the case of Professor Brüstle, the patent specification does not mention the use or destruction of human embryos or blastocysts to obtain pluripotent stem cells. The Court, however, holds that an invention is excluded from patentability where its implementation requires either destruction or prior use of human embryos, even if the patent application does not explicitly refer to this use. Also, the Court states that the fact that destruction may occur at a stage long before the implementation of the invention, e.g. as is the case with embryonic stem cell lines, is irrelevant.

In conclusion, the CJEU interprets the term “human embryo” broadly, such that all cells that are capable of developing into a human being are excluded from patentability. Whether pluripotent human stem cells fall within this definition or not is left for the national courts to decide and may vary from case to case. In addition, only embryonic stem cells that are obtainable by methods that do not involve use or destruction of human embryos can be patentable. As is pointed out in the decision, inventions that are for therapeutic or diagnostic purposes which are applied to the embryo and are useful to it remain patentable.

Although the decision is not binding on the European Patent Office (EPO), it is binding on the EU member states, and will consequently most likely be followed by the EPO examiners in the grant procedure of European patent applications. Of note, the Enlarged Board of Appeal of the EPO has also, in decision G 2/06, reached the same conclusions as above with regard to points 2 and 3.

 So what are the implications of this decision? On the one hand it might be sound that the economic incentives for developing therapies involving the destruction of embryos are reduced, and that the funding of such research will be more dependent on sources under public control. On the other hand, such research, which has the potential to be of immense benefit for patients with various serious diseases, might be more efficient when carried out with private funding. How this decision will affect the development of therapeutic methods based on embryonic stem cells thus remains to be seen.

Maria Malmqvist, Associate, Awapatent

The EPO starts cooperation with Google to provide machine translation of patents

On 24 March, the EPO and Google signed an agreement to collaborate on machine translation of patents. Using Google Translate technology, the EPO will offer translations into 28 European languages, and into Chinese, Japanese, Korean and Russian. In order to be able to adapt the machine translation to the specific language used in patents, Google will get access to the accumulated mass of translated patents that is available at the EPO. At first, machine translations between the three official languages of the EPO, English, French and German, will be available. Later, the other languages will be added.

There have been prophecies that machine translations will break down all language barriers. In patent databases, machine translations into English of at least the abstracts of the patent applications are often available, but the quality of these translations is questionable. Trying to sort out the interesting documents using badly translated abstracts is tedious at best, and sometimes errors in the translations even make it impossible to recognize documents that are really important. With a basic knowledge of the original language of the abstract, the researcher may spot some of the errors and still find the relevant documents, but if the original language is completely foreign, the researcher is lost. Anyone who has tried the experiment of translating back and forth between a few languages using machine translation knows that the original meaning is quickly distorted, making the translation process an advanced version of the children’s whispering game.

The ambitions of the EPO and Google in their quest to provide machine translations are commendable. There is most definitely a need for quick access also to patent documents in languages other than English, or whatever the language skills of the person searching the patent literature. Actually translating, manually, all patents of the world from other languages into English would of course be a help, but it would not be feasible. Then, think of translating between all the official languages of the EU, not to mention Chinese, Japanese, Korean and Russian, and the task becomes insurmountable. Therefore, machine translation is necessary. If training of the Google Translate tool on patent texts improves the quality of the machine translations and reduces the risk of completely misleading machine translations, this will be a valuable service to anyone searching the patent literature. However, once an interesting document has been found and a more complete understanding of it is sought, manual translation will most likely still be necessary. The day is not yet here, if ever it will come, when real, live, human translators will be redundant as a profession. And then, interpreting the scope of protection of the patent is a whole other story.

Nina Milanov, European Patent Attorney and Partner

A brighter future for the EU patent

11 EU member states have decided to move towards an EU patent under an enhanced cooperation aiming to reduce costs of patenting in the EU.

Progress towards implementation of the long desired EU patent has until now been hindered by disagreements between the EU member states regarding translation requirements. However, at a meeting at the Council of the European Union on 10th December it was decided by a group of member states to ask the Commission to present a formal proposal for initiating a so-called “enhanced cooperation” to move ahead on the creation of an unified EU patent system. An enhanced cooperation is a last resort option when at least nine member states agree to proceed to reach a goal for which unanimity cannot be reached by all member states. At the meeting the sufficient number of states, i.e. Denmark, Germany, Estonia, France, Lithuania, Luxembourg, the Netherlands, Slovenia, Finland, Sweden and the UK, thus authorised the Commission to submit the legislative proposal, which will be submitted on 14th December.

It is expected that the EU patent emerging from the enhanced cooperation will significantly reduce costs for translations by letting the European Patent Office prosecute the application in English, German or French with no further immediate translations required. The states supporting the enhanced cooperation are all parties to the London Agreement and thus already have reduced translation requirements compared to other member states/EPC-countries. However, the EU patent system may allow a further reduction of the translation costs by no longer requiring a translation of the patent claims, and moreover it may also provide a simplified procedure for validation of the patent once granted. Additional expectations from the EU patent system are that machine translations of published patent applications will be made available on demand, online and free of charge.

When the enhanced cooperation is implemented it will be open to other member states wishing to join in.

Keep track of the progress of the EU patent system on the websites of the Council: http://www.consilium.europa.eu/app/newsroom/PressHome.aspx?id=221&lang=EN and the Commision: http://ec.europa.eu/news/index_en.htm

Anders Heebøll-Nielsen, European Patent Attorney, Awapatent

An ongoing lawsuit in the US has attracted a lot of attention worldwide. The American Civil Liberties Union has, together with other parties, sued the US Patent and Trademark Office, Myriad Genetics and others. On Monday 29 March 2010, a judge in a federal District Court in New York ruled that the “Myriad patents” in the USA are invalid, and that patents on isolated genes are not lawful. The verdict is likely to be appealed to the Court of Appeals for the Federal Circuit.

The controversy centers on patents on breast cancer genes BRCA1 and BRCA2. In 2009, when a decision was reached about the BRCA1 patents in Europe, Niklas Mattsson had the following to say about the European situation. The article has been previously published in Swedish in the magazines Pharma Industry and Onkologi i Sverige.

Patents on genes, especially human genes, have been a focus of fierce debate over the past ten years or so. The debate has been profoundly influenced by the controversy surrounding the “Myriad patents”, a number of patents covering the BRCA1 and BRCA2 genes, and the use of the genes in the diagnosis of cancer. The patents were initially held by Myriad Genetics Inc and a number of research institutes and US government agencies. Through two decisions in November 2008 the European Patent Office (EPO) decided the proper scope of the patents for the BRCA1 gene in Europe. See also our previous blog post.

Different views on gene patents
According to established jurisprudence in Europe, patents on isolated genes and their use are permissible, as long as the general requirements on novelty and inventive step are fulfilled. Detractors of the patenting of gene inventions often refer to the Myriad case, claiming that it illustrates the undesirable consequences of the current situation. These detractors argue that the system should be changed so that gene inventions can no longer be patented, or at least so that the possibilities are strictly limited. Proponents, on the other hand, have argued that the current patent system works well. According to the proponents, the problems arising in the Myriad controversy have more to do with business ethics and licensing policies than with a perceived but non-existent problem in the patent system.

Myriad and the BRCA patents
Myriad was established in 1991 as a spin-off from the University of Utah. The founder, Mark Skolnick, was a researcher at the university, and member of an international consortium that sought to find genetic links to breast cancer. Through extensive research, scientists from Myriad, the University of Utah and other institutions succeeded in identifying and sequencing the two genes BRCA1 (in 1994) and BRCA2 (in 1995). In addition, they identified links between certain mutations in the genes and an increased risk of breast and ovarian cancer.

Based on this genetic information, Myriad was able to develop diagnostic tests and start commercializing them. Naturally, the company had an interest in protecting its investment with the aid of patents.

Consequently, Myriad and its partners filed a number of patent applications in the USA, following these up with applications in other countries. In Europe, they made use of the EPC, filing the applications with the EPO. The scope of protection in the patent applications was directed to the genes as such, as well as the use of different gene variants to determine the risk of breast and ovarian cancer. In 2001 after what, in the circumstances, may be regarded as a more or less normal prosecution time, the EPO granted the patents with some amendments.

Broad BRCA1 patents granted in Europe
Through three different BRCA1 patents, Myriad was awarded exclusive rights to the isolated BRCA1 gene (European patent, EP, 705 902 B1), to use of the gene in cancer diagnosis in general (EP 699 754 B1), and to some 30 different mutations in the gene that are associated with an increased risk of cancer (EP 705 903 B1). Regarding BRCA2, there is one patent (EP 785 216 B1) covering detection of one specific BRCA2 mutation in a particular population, and a pending application (EP 1 260 520 A1). The present article is concerned only with the BRCA1 patents.

Having obtained these patents, Myriad contacted healthcare providers throughout Europe and offered licenses for the patents. Many people felt, however, that the prices that Myriad asked for using the technology were excessive: fees of up to 3,000 USD per sample were reported. Also, the licensing terms did not allow licensees to perform tests themselves, but mandated sending samples to Myriad for analysis. Myriad, on the other hand, has pointed out that its analysis is very accurate, and that the company provides a level of confidence that cannot be equaled in a general hospital or clinical laboratory that does not specialize in the analysis.

 In addition to the controversies surrounding Myriad’s demands, some commentators held that the situation illustrated a more general problem; namely, the negative consequences of granting this type of patent in the first place. Interestingly, very few other gene patents have attracted the same amount of attention, despite the fact that thousands of such patents have been granted in Europe, both before and after Myriad’s patent applications (see for example Caulfield et al, Nature Biotechnology 24(9):1091-1094 (2006)).

Opposition against the patents
Embodied in the EPC is a possibility to question the decision of the EPO to grant a patent through the filing of a notice of opposition within nine months from grant. The opposition is examined in a form similar to a lawsuit, and the EPO determines whether the patent owner or the opponent is right. The possible outcomes are that the patent is revoked in its entirety, limited in some way, or upheld in unchanged form.

In the light of the conflicts surrounding Myriad’s licensing policy and the general debate on gene patents, it is hardly surprising that the EPO received an uncommonly large number of oppositions against the BRCA1 patents granted in 2001. Also unusual was the fact that most of the opponents were not direct competitors of the patent owner, but organizations and institutes that were eager to question the existing system.

Oppositions were filed by, among others, Greenpeace, the Minister for Public Health in the Netherlands, and the Social Democratic party in Switzerland. Oppositions were also filed by the French research institutes (including Institut Curie) that had once been involved in the breast cancer consortium together with Skolnick and the University of Utah.

 
EPO decisions limit the patents
The opposition procedure concerning the first patent – that covering the BRCA1 gene as such – was concluded in 2007, following an appeal procedure (Board of Appeal decision T1213/05). After the dust had settled, it became clear that Myriad had lost patent protection for the gene as such in Europe. It is important to note, however, that the outcome was not the result of a decision that genes cannot be patented, but a consequence of Myriad’s failure to satisfy the traditional criteria for obtaining a patent. The patent applications originally filed described a DNA sequence that contained errors. After the filing of these applications, the correct DNA sequence was published before Myriad had filed a patent application disclosing this sequence. Thus, the correct DNA sequence was already known before a patent application containing this sequence was filed: it was, therefore, not novel. No novelty, no patent.

The final decision with regard to the oppositions against the two other patents on BRCA1-related inventions was reached in November 2008, also after appeals against the first instance decisions (Board of Appeal decisions T80/05 and T666/05). The written decisions were issued by the EPO on 7 March 2009. From the file histories it is clear that the broad protection sought by Myriad from the outset – and initially granted by the EPO to some extent – has been severely limited. What remains is patent coverage of one single specific cancer mutation, and of the detection of frame shift mutations in the gene.

The decisions state the exact reasons why the patent claims had to be limited, and in these two cases, too, this is due to failures to meet the “classic” existing rules, rather than any sign of a change in jurisprudence concerning gene inventions in general.

 It remains to be seen what future commercial effect these patents will have on the testing of BRCA1-related cancer risk. Whoever supplies tests for BRCA1 mutations for the purpose of diagnosis should study the patents as now finally decided, to ensure that there is freedom to operate.

A working system of checks and balances
The general debate on the patent system and gene inventions continues in Europe, despite the fact that the Myriad case is, to all intents and purposes, closed. At present, there is a discussion concerning whether the best way forward would be to introduce a limitation of the scope of protection, such that a patent owner should not be able to block all uses of a gene, even though it had never before been identified and isolated, but only obtain an exclusive right to the actual use described in the patent application. Some European countries have introduced such legislation, but it is too early to tell what the consequences will be.

To summarize, the European chapter in the Myriad Genetics patent saga is practically concluded. Despite widespread concern that European patent offices are over-generous in granting patents on gene inventions, it appears that the existing system and the conventional patentability criteria – including the possibility of opposition – have worked well in this case. The application of the criteria during EPO’s processing of the applications led to limitations on the patent protection that Myriad applied for, and what is left could be said to correspond to a reasonable compensation for the contribution to the art that Myriad and their collaborators provided.

 Niklas Mattsson, European Patent Attorney, Awapatent

The language of proceedings used before the EPO can never be changed – this includes the language used before the international receiving office if that language is English, French or German

The Enlarged Board of Appeal of the European Patent Office (EPO) has for the second time this week issued a decision. This latest decision, G 4/08 of 16 February 2010, relates to the language of proceedings, and it clarifies that it is never possible to change the language of the proceedings. According to Article 14(3) of the European Patent Convention, the official language of the EPO in which the European patent application is filed or into which it is translated shall be used as the language of the proceedings in all proceedings before the EPO, unless the Implementing Regulations provide otherwise. The three official languages of the EPO are English, French and German.

The European patent application in question, EP 02759818.4, relates to a vaccine against the Nile Fever virus. It is the European regional phase application of an International application, which was filed and published in French. When the regional stage before the EPO was entered in November 2003 it was requested that the language of the proceedings should be English, and an English translation of the application was filed at the same time. If the EPO would not allow the language to be English, an appealable decision on this was also requested. The applicant further made two auxiliary requests in case the EPO would not allow the change of language. Thus they requested that if English was not allowed as language of the proceedings, the EPO should use English in all written proceedings and decisions, and finally, if this was not allowed, the prosecution of the application should proceed in French. In December 2006, the EPO issued a decision to reject the request for a change of the language and also the first auxiliary request. This decision was appealed by the applicant, and after oral proceedings held in April 2008, the following three questions were referred to the Enlarged Board of Appeal in December 2008:

Question 1
If an international patent application has been filed and published under the Patent Cooperation Treaty (PCT) in an official language of the European Patent Office (EPO), can the applicant, on entry into the regional phase before the EPO, file a translation of the application into one of the other EPO official languages with the effect that the language of this translation must then be considered as language of the proceedings to be used in all proceedings before the EPO?

Question 2
If the answer to that question is no, can EPO departments use, in written proceedings on a European patent application (or an international application in the regional phase), an EPO official language other than the language of proceedings used for the application?

Question 3
If the answer to question 2 is yes, what are the criteria to be applied in determining the official language to be used? In particular, must EPO departments accede to such a request from a party or parties?

In its decision the Enlarged Board of Appeal explains that the EPC (neither in the form of the current EPC, EPC 2000 or the earlier EPC 1973) does not allow replacement of a euro-PCT application published in an official language with a translation into another official language. Thus the response to Question 1 is that when an international patent application has been filed and published under PCT in an official language of the EPO, it is not possible, on entry into the European regional phase, to file a translation of the application into one of the two other languages with the effect that the language of this translation is considered as language of the proceedings to be used in all proceedings before the EPO. In this context the Enlarged Board of Appeal refers both to Article 14(3) EPC, discussed above, and to Article 158 EPC 1973 corresponding essentially to parts of Article 153 of the current EPC, respectively. The Enlarged Board of Appeal in particular refers to Article 158(2) EPC 1973. The same Article is not explicitly found in the current EPC, however, it has become part of Article 153(4). The latter in combination with Rule 159(1)a) specify that a translation of an international application shall be supplied upon entry into the European phase if the Euro-PCT application is published in another language than English, French or German, and that this translation shall be published. Article 153(3) further specifies that the international publication of a Euro-PCT application in an official language of the EPO shall take the place of the publication of the European patent application. The term Euro-PCT is explained in Article 153(2) as an international application for which the EPO is a designated or elected office, and it is further stated that if an international date of filing has been accorded, it shall be equivalent to a regular European application. They further conclude that there is no conflict between these regulations and the regulations of the PCT.

The Enlarged Board of Appeals goes on to clarify that the only applicable law to Question 2 is the current EPC, and that it does not allow the EPO departments to use, in written proceedings on a European patent application or an international application in the regional phase, an EPO official language other than the language of proceedings used for the application in accordance with Article 14(3). The decision is thus stricter than similar decisions issued prior to EPC2000, including J 18/90.

Since the response to Question 2 thus is no, the Enlarged Board of Appeal does not respond to Question 3.

The complete text of the decision can be here. It is only available in French – the language of proceedings.

Maria Stenbäck, European Patent Attorney

EPO is seeking to limit the submission of divisional applications, which would be a severe blow to small, newly started technical companies in particular. Although a stop was put to their latest proposal by the Committee on Patent Law, it is highly likely that despite this setback we will see a modified version put before the Administrative Council meeting in March.

EPO’s proposal
EPO has proposed limiting the option of submitting divisional applications to a period of 24 months following either a first order from the Examining Division or a first notification that the parent application lacks unity of invention. The proposal represents a significant limitation of the possibilities allowed to applicants under current rules, which enable divisional applications to be submitted for as long as the basic application remains valid.

The proposal is intended in part to limited alleged misuse of the submission of divisional applications. Based on the figures presented by EPO, it is estimated that alleged misuse occurs in fewer than one in a thousand applications.

However, the proposal is very far-reaching. If it is passed, it will no longer be possible to submit a divisional application in connection with oral proceedings. At present, this method can sometimes be the only way to ensure that an applicant has the possibility to obtain protection for patentable material contained in the submitted application. In cases where the patent application is rejected during the course of the proceedings, under current rules the applicant has the option of pursuing other lines of retreat through divisional applications, but under the proposed change in the rules divisional applications must be submitted at an early stage.

Small players hit hardest
EPO’s line will particularly hit small, newly started technical companies, which often lack both the economic resources and a precise knowledge of the position of the technology. At the same time, the innovation which forms the basis of such a newly started company often includes a number of inventions for which the company may be totally dependent on being granted strong protection.

Given that a company may often lack the resources to submit a large number of patent applications during the start-up phase, it has to rely on one or two broader-based applications. But due to a lack of the resources needed to fully protect the position of the technology beyond the basic idea behind the invention, as formulated in the applicant’s principal requirements, it often becomes necessary to utilise the option of divisional applications.

As the application is scrutinised, any changes to a principal requirement are defended in a rejoinder. Under EPO’s proposal, where the rejoinder does not have the desired effect, the time limit for submitting divisional applications would meantime have expired. Consequently the applicant must, at the time of submitting the rejoinder, already submit divisional applications for the set of inventions that can be identified by the applicant, in the event that an umbrella claim contained in the basic application is not approved. Given the fact that this entails a significant increase in procedural costs for a regular applicant, for a start-up company this option becomes prohibitively expensive. The proposal is therefore hostile to start-up companies of the type which EU common market policy otherwise claims to support.

The industry’s position
Against this background, Swedish and European industry together with representative associations are strongly opposed to EPO’s proposal, and a majority of the national delegates who spoke at the CPL meeting were also responsive to the concerns of the industry and the representative associations’ misgivings. The original proposal failed to muster support, subsequent to which a revised proposal was put forward whereby the option of submitting a divisional application would have to be justified and receive the approval of the Examining Division. This proposal also failed to gain sufficient support.

I would like to see a limitation introduced which would simply establish an exception in the case of divisional applications whose submission constitutes clear misuse of the regulatory system. The issue is whether EPO continues to pursue its hard line against divisional applications and whether this will gain resonance at the Administrative Council meeting in March.

Nils Ekström, European Patent Attorney

During the last decade, the debate in Europe regarding the patentability of human gene inventions has been heavily influenced by “the Myriad case”, concerning patent applications by Myriad Genetics Inc (and others) that relate to the breast cancer susceptibility genes BRCA1 and BRCA2.

Through two decisions spaced less than a week apart, the European Patent Office has now finally settled the outcome of two European patent cases dealing with the BRCA1 gene.

On 13 November, an EPO Technical Board of Appeal decided T 666/05, concerning European patent EP 705 903, maintaining it in amended form. According to the EPO press release, the final scope of the claims is somewhat broader than what had previously been allowed by the first instance (Opposition Division), and relates to specific cancer mutations in the BRCA1 gene. The written decision in this case will not be available for some time, but we expect to have access to the granted claims as well as the minutes from the oral hearing within the coming weeks.

On 19 November, the same Board of Appeal decided T 80/05, concerning European patent EP 699 754. This patent had been completely revoked by the Opposition Division, but was re-instated by the Board of Appeal with amended claims that cover the detection of frameshift mutations in the BRCA1 gene. Again, the written decision will not be available for some time, but we will be able to comment in more detail shortly, once the minutes and claims are made public.

Opponents against granting patents on gene inventions have pointed to the Myriad case as illustrating the undesirable consequences of the existing European system, in which patents on genes are possible. Others have maintained that the patent system is working well, and that any problems arising from the Myriad case have more to do with unsound and aggressive licensing policies.

Whatever your standpoint on the issue of gene patents, it remains a fact that, among the thousands of patents on human and animal genes, the Myriad patents have attracted by far the most attention. For an interesting review of media and policy reactions to the Myriad case, see Caulfield et al, Nature Biotechnology 24(9):1091-1094 (2006).

Niklas Mattsson, European Patent Attorney