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EDITORIAL
In addition to the August edition of the patent newsletter we have published a supplement which details D Young & Co's expertise in opposition and appeal proceedings before the European Patent Office, particularly focussed on the chemical, pharmaceutical and life sciences areas of technology.
Aylsa Williams, August 2009.
OPPOSITION TO THE GRANT OF EUROPEAN PATENTS IN CHEMISTRY, PHARMACEUTICALS AND THE LIFE SCIENCES
The European Patent Convention (EPC) provides an opposition procedure which allows for the validity of granted European patents to be challenged centrally. For businesses concerned about third party patent rights, the procedure offers a cost effective tool for contesting problematic patents. However, an opposition must be filed at the European Patent Office (EPO) within nine months of the grant of the patent in question and therefore it is important that businesses keep an eye on the patenting activities of at least their main competitors. It is becoming even more important that the correct representation is selected for defending or pursuing oppositions. At D Young & Co we are well placed to provide you with that representation.
The European Patent Convention (EPC) provides an opposition procedure which allows for the validity of granted European patents to be challenged.
The centralised procedure allows for a single challenge to be made that is effective in all the countries covered by the granted European patent.1 Outside of this opposition procedure, the validity of a European patent may only be challenged on a country-by-country basis, usually by filing revocation actions in each of the countries covered by the patent.
If successful, the opposition will lead to the revocation or amendment of the European patent. Current statistics indicate that about one third of oppositions result in total revocation of the patent, about one third result in amendment of the patent and about one third are unsuccessful, i.e. the patent is maintained as granted.
The filing of an opposition can also be used as part of a strategy for seeking an alternative resolution to a patent dispute, such as a licensing agreement. However, it should be noted that the EPO may continue with an opposition even if the opponent withdraws; although without an active opponent the outcome may be very different.
An opposition must be filed at the EPO within nine months of the grant of the European patent. Therefore it is important that businesses maintain a regular watch on patenting activities of their major competitors and that problematic third party patents are addressed promptly. A European patent may only be opposed on three grounds:
The identity of an opponent need not be revealed to the EPO or the patent proprietor. Although not a legal requirement, opponents and patent proprietors are usually represented by European patent attorneys during opposition proceedings.
The opposition must set out the basic case against the patent and provide references to any prior art or other evidence relied on. Although further relevant information which comes to light during the opposition procedure is often admitted into the proceedings, there is no right to have further facts and evidence considered and such information may be ignored, particularly if it is filed very late. Hence, it is important to set out the reasons why the patent should be revoked or amended in as much detail as possible at the outset and that any further relevant information is notified to the EPO and the other parties promptly. This is especially the case where experimental data has been generated, as the other parties should be given sufficient time to verify such information and consult with an expert if necessary.
Following receipt of an opposition (or in some cases a number of oppositions) the patent proprietor is given an opportunity to provide counter-arguments and/or amendments in response to the objections. It is possible for there to be one or two additional rounds of correspondence between the parties during this phase of the opposition.
Although the EPO opposition procedure is primarily a written procedure, it is usual for the opposition to culminate in an oral hearing where all parties are invited to present their case before the Opposition Division. The Opposition Division is a panel of three EPO examiners and the hearings take place in Munich (Germany) or the Hague (the Netherlands).
The receipt of an invitation to attend an oral hearing is a key milestone in any opposition. The invitation includes a brief outline of the case, the initial opinion of the Opposition Division on the merits of the objections raised and a final date for further written submissions. Thus, this invitation gives the parties an opportunity to submit further arguments which focus on the areas still in dispute.
The oral hearing itself is akin to a mini-court hearing, but in some respects is less formal. Typically, the hearing will be held in the language of the patent and simultaneous translation is available to any party requesting it. The purpose of the hearing is to give each party the opportunity to present their case on the objections raised and to counter the arguments presented by the other parties. In principle, the case presented at the hearing should be based on the facts and evidence submitted during the written proceedings; however, parties frequently attempt to present new arguments and evidence at this stage. Also, at the hearing, the patent proprietor will usually be given an opportunity to file further amendments to the patent to overcome successful objections. Consequently, despite there being rules designed to prevent this, it is not unusual for the opponent(s) and patent proprietor alike to be presented with new information which needs to be addressed on the day. Hence, in selecting representation for an opposition case, it is important to choose an attorney experienced at both written and oral advocacy before the EPO.
At the end of the hearing, the Opposition Division will usually announce its decision as to whether the patent is maintained (in unamended or amended form) or revoked. The reasons for the decision are communicated to the parties in writing at a later date and this written decision initiates the opportunity for filing an appeal.
The appeal procedure is really a de novo hearing of the case before one of the EPO’s Technical Boards of Appeal. The Appeal Board will usually consist of three members (although more members may sit for important cases) at least one of whom will be legally qualified. The Appeal Board members are not EPO examiners, but are more akin to judges found in national courts.
In some respects, the appeal procedure is similar to that before the Opposition Division. However, the overall procedure is generally much more formal. In particular, the rules for filing further facts and evidence and the time in which submissions must be made are much more tightly controlled. In addition, typically, the level of advocacy skills before the Appeal Board has to be much higher. The written phase of the appeal proceedings will again normally culminate in an oral hearing which is similar to that before the Opposition Division, but more formal. Again, at the end of the oral hearing the Appeal Board will usually announce their decision. The decision can be maintenance of the patent as granted, maintenance of the patent in amended form, or revocation. In some instances, the decision may be remittal back to the Opposition Division to consider the case further. In rare situations, the decision may be remittal of one or more questions to the Enlarged Board of Appeal (the EPO’s Supreme Court). Referrals to the Enlarged Board of Appeal occur where a point of fundamental law has arisen or if different Appeal Boards have come to contradictory conclusions on the same or similar facts. The reasons for the Appeal Board’s decision are provided in writing at a later date. Normally no further appeal is possible. However, it is now possible to have a referral to the Enlarged Board if – for example - either party believes that there has been fundamental defect in the procedure or there has been a criminal act.
Typically it takes 2 to 4 years from filing an opposition to the handing down of the decision by the Opposition Division and another 2 to 4 years for the appeal to be heard. However, in certain circumstances, e.g. if an infringement action is pending before a national court, opposition and appeal proceedings may be accelerated. Although the proceedings are lengthy, the cost of dealing with a potentially relevant European patent centrally, at the EPO, compared to commencing national revocation actions is usually favourable for an Opponent. For the patent proprietor, the risk of losing the patent centrally further emphasises the critical decision of having the correct representation, which may not necessarily be the attorney who prosecuted the application to grant.
Footnotes:
As of 1 July 2009, a European patent may designate up to 36 separate countries.
ABOUT US
D Young & Co is one of the premier firms of patent attorneys in Europe with a thriving chemical and life sciences practice. D Young & Co is recommended by the Legal 500 as a top tier UK patent practice.
D Young & Co is the UK recipient of the 2009 Managing Intellectual Property (MIP) award for patent prosecution services. In making the award, MIP particularly noted our achievements in the field of EPO oppositions, especially in the chemical and life sciences area.
Two members of the D Young & Co Chemistry and Life Sciences Group, Charles Harding and Neil Nachshen, feature as leading UK patent attorneys in the 2009 ‘MIP Expert Guide to the Leading Patent Law Practitioners’.
OPPOSITIONS: CHEMISTRY AND LIFE SCIENCES GROUP
D Young & Co’s Chemistry and Life Sciences Group are experienced advocates before the EPO Opposition Divisions and Boards of Appeal. We regularly practice across the whole spectrum of the chemical and life sciences area both for established clients and on an ad hoc basis for new/returning clients who entrust us with matters of particular importance to them. We have particular expertise and a good success rate in both defending commercially important patents and clearing the way of third party patents so our clients can continue their commercial activities without fear of infringement. As representatives of both patent proprietors and opponents we are particularly active in the areas of:
BIOTECHNOLOGY (e.g. antibody technology, stem cell technology, biopharmaceuticals, plant biotechnology, gene sequences and protein and enzyme technologies);
PHARMACEUTICAL AND VETERINARY PRODUCTS (e.g. formulation technology, organic chemistry, medical sciences and protein chemistry);
FOOD SCIENCE (e.g. enzymology, microbiology, including probiotics and starter culture technology, emulsifier technology, stabilisation technology and texturiser technology); and
POLYMERS AND PETROCHEMICALS (e.g. fuels and lubricants).
D Young & Co attorneys are especially adept at handling cases at the sharp end of European patent practice. In receiving the MIP award, we were recognised for our representation of Plant Bioscience Limited, in defending their patent, EP1069819B, in opposition proceedings. This case has now been referred to the Enlarged Board of Appeal, and is one of only four opposition cases currently before the Enlarged Board of Appeal.
D Young & Co attorneys are experienced in representing clients in opposition proceedings involving multiple opponents. Such oppositions require particular strategies to keep the case focused on the key issues and to deal with the number of opponents with potentially competing agendas. In this regard, the 2009 MIP award particularly noted D Young & Co’s representation in opposition proceedings involving Merck’s osteoporosis drug Fosamax® (alendronate); the oppositions against Merck’s European patents (EP0998292B and EP1175904B) involved up to seventeen separate parties.
In cases such as Fosamax®, we often work closely with lawyers from across Europe and from other jurisdictions, especially the US, in co-ordinating our handling of EPO opposition matters with national litigation in other countries.
We are certainly no strangers to high value oppositions, particularly in the area of pharmaceuticals. In the last year, in addition to Fosamax®, we have successfully represented our clients in opposition/appeal proceedings in relation to some of the world’s leading pharmaceutical products such as Nexium® (esomeprazole), Aprovel® (irbesartan) and Celebrex® (celecoxib) to name but a few.
D Young & Co attorneys also have expertise in the area of veterinary medicine and regularly represent world-leading animal health company Merial in opposition and appeal proceedings at the EPO. In 2007, we successfully represented Merial in appeal proceedings resulting in the revocation of Virbac’s second medical use patent relating to the treatment of A. perfoliata infection in horses (EP0717993B). In addition, we successfully co-ordinated pan-European litigation for Merial in relation to the combination product “Eqvalan Duo” (worming paste for horses), culminating in the revocation of Virbac’s Supplementary Protection Certificate in multiple territories.
Although much of our work is for blue chip clients, we also work closely with a large number of smaller clients, such as SMEs. As patent attorneys for both large and small clients, we are integrally involved in protecting and defending their intellectual property. By way of example, we are currently defending a portfolio of patents relating to medical applications of xenon gas. The portfolio was built upon applications drafted and prosecuted by us and in-licensed by our client.
As experienced practitioners in more contentious matters our services extend to assisting clients in identifying and challenging third party patents that may hinder their commercial activities. Thus, D Young & Co attorneys are adept at due diligence, preparing freedom to use opinions and identifying problematic patents so that these patents can, if necessary, be opposed in time. Recently, in representing two separate biopharmaceutical companies, we were successful in having the EPO revoke patents directed to the human oestrogen receptor ERbeta (T0762/07) and a patent directed to Aurora kinase, a protein target for cancer chemotherapy (EP0868519B), thereby removing potential obstacles to our clients’ drug development programs.
At D Young & Co, our attorneys provide opposition and related services to a variety of clients from start-ups and academic institutions to blue chip companies and global organizations. Thus, whether your opposition (as patentee or opponent) is part of a multi-party or multi-jurisdictional dispute which may require the services of several experienced attorneys, or whether you need an attorney with knowledge of a particular technology, as a large and modern practice we are able to tailor our services to your suit your needs.
FURTHER ADVOCACY EXPERIENCE BEFORE THE EPO
Like many European patent attorneys, in obtaining patent protection for our clients, we regularly participate in written and oral proceedings before the EPO Examining Divisions. Additionally, our expertise in advocacy before the EPO has led our clients to entrust us with other important issues that arise less frequently.
We are currently representing Merial in their fight to select the language of proceedings before the EPO. This matter, previously before one of the EPO’s Legal Boards of Appeal, has now been transferred to the Enlarged Board of Appeal for consideration of a fundamental point of law (G4/08). Thus, D Young & Co attorneys are involved in two out of the five cases currently pending before the Enlarged Board of Appeal (G2/07 and G4/08).
Similarly, D Young & Co attorneys were selected to represent a client in a case before the EPO’s Disciplinary Board of Appeal. This case was an appeal from the EPO’s Examination Secretariat refusing to allow a candidate to sit the examinations necessary to qualify as a European patent attorney. D Young & Co attorneys were integral in reversing this decision for their client (D34/07).
SELECTED PROFILES: CHEMISTRY AND LIFE SCIENCES GROUP
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CHARLES HARDING Charles has had over 15 years advocacy experience before the EPO Opposition Divisions and the EPO Appeal Boards. This has been gained whilst he has been at D Young & Co and, before, when he was an in-house European Patent Attorney at Rohm and Haas. At Rohm and Haas, he was responsible for matters outside of the Americas concerning the patent portfolio of the polymer division, which entailed defending and pursuing numerous Oppositions - both at the EPO and elsewhere (e.g. Australia). Charles’ current extensive portfolio of EPO Oppositions and EPO Appeals touches on various technologies - such as molecular biology, immunology, biotechnology, virology, veterinary science, food science, protein chemistry, chemistry, pharmacology, pharmaceuticals and devices. A large number of his Oppositions and Appeals are multi-party cases. He has been involved in a number of important EPO Appeal cases in the life sciences field – such as Technical Board of Appeal cases T0411/02 and T0062/04. In his involvement in the latter case, he also took an active role in the co-ordination of pan-European litigation, resulting in revocation of at least a UK patent. Recently, he argued a case before the EPO Appeal Boards that related to Alzheimer’s disease, resulting in a successful conclusion for our client (Technical Board of Appeal case T1483/07). He also has experience in handling EPO Appeals in other fields (e.g. Technical Board of Appeal Case T0823/03). He is currently handling EPO Enlarged Board of Appeal case G 4/08. G 4/08, which evolved from Legal Board of Appeal case J 8/07, concerns a fundamental procedural point of law regarding the language of the proceedings for a European patent application on entry into the EP regional phase from a PCT patent application. |
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CATHERINE MALLALIEU Catherine has extensive experience of successfully defending and opposing patents specifically in the area of greener standards within the chemical industry. Such cases are often multiparty proceedings. She also has a successful record of working in areas such as natural products, plant protection and gene therapy, with growing companies, both defending patents and opposing competitor’s cases. Through her work on genomics and vaccine cases, Catherine has shown great expertise in presenting the right mix of data to make successful submissions at all levels of the EPO. Catherine and her team edit the Opposition chapter in the Chartered Institute of Patent Attorneys’ European Patent Handbook. |
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NEIL NACHSHEN Neil has extensive experience of contentious issues such as EPO opposition practice and UK High Court litigation, especially in the pharmaceutical sector. He has successfully represented clients in numerous opposition proceedings over the last 10 years and advised clients in relation to a number of UK litigation actions. He recently represented Teva Pharmaceuticals in their successful opposition to Merck’s Fosamax® (alendronate) patents (EP0998292B (Technical Board of Appeal case T1388/04) and EP1175904B) and has been involved in co-ordinating Teva’s on-going Fosamax® litigation across Europe for several years. This year Neil has represented his clients in successfully revoking Roche’s European patent to the use of Kytril® (granisetron) (T1409/06) and Sepracor’s European patent relating to the use of Triludan® (fexofenadine). Previous successes at the Board of Appeal have included patents relating to formulation of metformin (T0951/05) and uses of ribavirin/interferon-alpha (T0531/04). Many of Neil’s oppositions are multi-party proceedings due to the commercial value of the patents involved. Neil has a Patent Litigator’s Certificate which allows him to conduct patent litigation at the UK High Court. |
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DAVID ALCOCK David is regularly involved in multiple opponent oppositions/appeals. His experience in many overseas jurisdictions, in particular the US, enables David to reflect during written and oral arguments the considerations of those territories and also to co-ordinate worldwide attack/defence. This year, in the food science area after successful revocation of a patent in a six opponent opposition, David is working with co-opponents to revoke a remaining Swedish national patent. |
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AYLSA WILLIAMS Aylsa is currently representing Plant BioScience Limited before the Enlarged Board of Appeal (G2/07). Due to the commercial relevance of much of her work, Aylsa works closely with lawyers from other jurisdictions, especially the US and Australia to co-ordinate the handling of EPO matters with national litigation in other jurisdictions. Aylsa also has experience in entitlement disputes, as well as arbitration in European jurisdictions. |
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KIRK GALLAGHER In addition to his professional qualifications as a European and Chartered (UK) Patent Attorney, Kirk has a Master’s degree in Intellectual Property Litigation which involved a substantial amount of advocacy training. Prior to joining D Young & Co., Kirk worked as an in-house attorney with GlaxoSmithKline and has also spent time working in the United States on secondment with a New York based Law firm. |
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JO BRADLEY Jo Bradley has had over fourteen years of experience of oil industry clients including previous in-house experience with BP. Jo currently advises The Lubrizol Corporation on opposition matters relating to fuels and lubricants. This is a contentious area with several key companies keen to maintain a competitive edge. As a result, Jo frequently represents The Lubrizol Corporation at oral proceedings before the Opposition Division and the Board of Appeal. Jo is also active in opposition work in the fields of polymers and pharmaceuticals. |
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The content of this newsletter is for information only and does not constitute legal advice. For advice in relation to any specific situation, please contact your usual D Young & Co advisor.
Copyright 2008 D Young & Co. All rights reserved. D Young & Co and the D Young & Co logo are registered service marks of D Young & Co.
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Aylsa Williams, Partner |
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Neil Nachshen, Partner |
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Kirk Gallagher, Partner |