The patent opposition process

Transcription

1 The patent opposition process Interested parties can use the two-stage opposition procedure to challenge a patent either pre or post-grant a broad window in which to take action By G Deepak Sriniwas and Rajeev Kumar, The grant of invalid patents is a serious evil insomuch as it tends to the restraint of trade and to the embarrassment of honest traders and inventors Fry Committee, 1901 When a right is granted to a party, checks should be in place in order to prevent the abuse of such a right. Under patent law, third parties can oppose the grant of a patent in order to contain abuse of a monopoly right. This is separate from and independent of the extensive examination conducted by the Patent Office which takes place before the opportunity to oppose the grant of a patent. Patent laws in different countries vary with respect to such checks during the grant procedure. For instance, in the United States and Australia, on the issuance of a patent a party can request re-examination on the grounds of patentability, in view of a relevant prior art citation that was not included or considered during the examination. In China, the pre-grant opposition mechanism was replaced with procedures for post-grant opposition or revocation by a 1992 amendment. UK law provides for representation on the grounds of patentability in the case of published pending applications, according to which any person may make observations in writing to the comptroller, stating the reasons for those observations. Recently, the World Intellectual Property Organisation has also provided an opportunity to submit third-party observations. All of these provisions constitute efforts to minimise the grant of bad patents. Indian patent law also provides for a series of checks and balances in this area. How the system works The 2005 amendment to the Patents Act 1970 brought about significant changes in the law. One of the primary changes was to introduce a two-stage opposition procedure. The Patents Act now provides for the Indian Patent Office to receive from interested parties representation by way of opposition in a pregrant opposition and a notice of opposition in a post-grant opposition. Section 25 of the act deals with these two forms of opposition. Section 25(1) of the act provides that the Patent Office may entertain a representation by way of opposition after the application has been published, but before the grant of the patent, thus making it a pre-grant opposition. On the other hand, Section 25(2) provides that a notice of opposition must be considered by the Patent Office within one year of the date of publication of the patent grant, and is thus referred to as a post-grant opposition. Who can oppose a patent application and a patent? The pre-grant representation can be filed by any party, but the post-grant opposition can be filed only by a person interested. This subtle yet important difference is clarified by Section 2(1)(t) of the act, which states that a person interested includes a person engaged in or promoting research in the same field as the invention. In Enercon (India) Limited v Aloys Wobben (ORA/6/2009/PT/CH; Order India: Managing the IP Lifecycle

2 With the introduction of digital documents at the Patent Office and the online availability of patent information, an upsurge in patent oppositions has been seen in the past few years 18/2013) the Intellectual Property Appellate Board (IPAB), which handles appeals against decisions of the controller, held that a person is an interested person if he or she establishes a real and genuine interest, together with a commercial interest, which may be prejudiced when such a patent is granted or maintained. This substantiated the Delhi High Court s 1983 ruling in Ajay Industrial Corporation v Shiro Kanao of Ibaraki City, which defined a person interested to be a person who has a direct, present and tangible commercial interest. Grounds for opposition The major grounds under which a pre or postgrant opposition can be filed are: wrongful obtaining of the invention; anticipation in view of prior publication in India or elsewhere; anticipation in view of prior claiming in India; anticipation in view of prior public knowledge or public use in India; obviousness or lack of inventive step in view of prior publication in India or elsewhere, or prior public use in India; not being an invention or not being patentable under the act; insufficiency and lack of clarity of description of the invention; failure to disclose information or provision of false information pertaining to related foreign filing patent application; failure to file a convention application within 12 months of filing the first application in a convention country; failure to disclose or wrongful mention of the source and geographical origin of the biological material used for the invention; and anticipation in view of traditional knowledge of a community (oral or otherwise) anywhere in the world. Procedure before controller of patents The representation for opposition must be filed before the controller of patents at the Patent Office in the jurisdiction where the application was filed (India has four patent offices: the head office in Kolkata and three branch offices in Delhi, Chennai and Mumbai). The representation must include: a statement of case; evidence, if any, in support of the representation; and a request for a hearing, if desired. The controller can consider the representation only after a request for examination for that patent application has been filed. The Indian patents regime provides that a request for examination can be filed, even by an interested person, if he or she can provide evidence of his or her interest. After considering the representation, the controller notifies the applicant with a copy of the representation. Usually, alongside such notification, the controller also issues an examination report, citing his or her observations based on the examination of the application for compliance with the act, and the patentability of the invention. 8 India: Managing the IP Lifecycle 2013

3 The applicant is required to respond to the notification with a statement and evidence (if any) in support of the application within three months of the date of the notice. Based on the statement and evidence, the controller then either refuses to grant the patent or asks the applicant to amend the specification. In the interests of natural justice, a hearing is offered to both parties (even if they have not sought one), and the controller then either rejects the representation and grants the patent (with or without amendments to the complete specification), or accepts the representation and refuses to grant the patent. A decision will be issued upon completion of these proceedings. A notice of opposition must be filed before the controller of patents in the jurisdiction where the patent was granted. On receiving a notice of opposition, the controller notifies the patentee and establishes an opposition board, which conducts the examination. The board comprises three members, one of whom is nominated as the chairman by the controller. The examiner who examined the original application is not eligible to be a member of the opposition board. The opponent is required to file a written statement of opposition alongside the notice of opposition. Such written statement sets out the nature of the opponent s interest, the facts of the case, the relief sought and any evidence. The patentee must file a response statement and evidence within two months of receipt of the opponent s statement and evidence. The opponent and the patentee must serve copies of the documents on each other directly. The opponent also has an opportunity to file responding evidence, dealing only with matters raised in the patentee s evidence, within one month of receipt of the patentee s response statement and evidence. Once the above submissions are complete, the opposition board examines the pleadings and submits a reasoned report, along with its recommendations on each ground of opposition contained in the notice of opposition. The opposition board is expected to do this within three months. On receiving such communication from the opposition board, the controller fixes a hearing and notifies the parties. Recently, in M/s Diamcad NV v Assistant Controller of Patents and Designs (OA/4/2009/PT/CH, Order 189/2012), the IPAB held that the recommendations of the opposition board must be made known to the patentee and the opponent before the date of the hearing, as well as to the controller. The parties must notify the controller of their desire to be heard. After hearing the parties and considering the recommendations of the board, the controller will rule on the opposition and notify the parties of its decision under a reasoned order. Regarding the reasoned order, in Sankalp Rehabilitation Trust v F Hoffmann-LA Roche AG (OA/8/2009/PT/ CH, Order 250/2012) the IPAB suggested that: The Controller and the Opposition Board must bear in mind that their orders and recommendations must have clarity. They need not be lengthy, but they must be selfcontained, speaking orders. However, the IPAB also clarified that the controller is not bound by the recommendations of the opposition board, and must decide the case independently. In oppositions, it is usual practice to submit expert evidence, and the parties appoint their own experts. In Fresenius Kabi Oncology Limited v Glaxo Group Limited (ORA/17/2012/ PT/KOL, Order 71/2013) the IPAB recognised the challenges faced by experts and opined that the expert must be agreed on by both parties. Considering the increase in the number of cases being contested, and the advanced areas of technology under consideration, the IPAB felt that in future, the need for court experts will arise more often and their expertise will enhance the quality of the orders issued. The IPAB also ruled that: When we appoint a neutral witness we would be giving the expert, the copies of the complete specifications, the prior arts and other evidence referred to by both sides. The pleadings will not be given. We would request the expert to examine the materials furnished and give his opinion on the novelty, obviousness, insufficiency as the case may be. The IPAB further clarified that: It is needless to say that this expert opinion will only assist us and will not bind us. A copy of this opinion will be given to both the parties. And while arguing the case, the counsel may make their submissions on this court witness evidence. This practice will go a long way towards avoiding the appointment of parrot experts by the opposing parties. India: Managing the IP Lifecycle

4 An appeal against the controller s decision issued in either type of opposition can be filed with the IPAB within three months of the controller s order. While no official fee is payable to file a pregrant representation, the same does not hold true for post-grant actions. The official fee for filing a notice of opposition is approximately $110, with an additional fee of around $110 to notify the controller of a desire to be heard. Recent trends With the introduction of digital documents at the Patent Office and the online availability of patent information, an upsurge in patent oppositions has been seen in the past few years. According to the Patent Office s annual reports, in only six post-grant oppositions were filed; this number rose to 29 post-grant opposition filings in Also, in only 0.91% of the applications published were opposed in pre-grant representations that is, only 294 of 32,213 published patent applications were challenged. Further, the Patent Office website reveals that since 2009, 161 decisions in pre-grant oppositions and 56 decisions in post-grant oppositions have been rendered. In addition, the majority of opposition cases relate to the pharmaceutical industry. potential. In addition, cases which are opposed and litigated in India have had a significant impact over the world. The much-discussed Novartis case, involving its application for Gleevec (Imatinib mesylate), was initially opposed by way of representation. Novartis took the case to court and in April 2013 the Supreme Court delivered its verdict, rejecting Novartis s patent application and providing guidance on the interpretation of Section 3(d) of the Patents Act. In addition to the opposition procedure, the Patents Act provides for a revocation procedure. The revocation procedure is available until the end of the patent term and the additional grounds (as compared to the opposition procedure) are made available. The revocation procedure can be commenced in front of the IPAB. Use of opposition system As the grounds in both types of opposition are identical, in effect this provides a broad window for opposition, starting from publication of the application and ending 12 months after publication of the grant. No statutory bar prevents the party which files a pre-grant representation from also filing a post-grant opposition on providing evidence of interest. Further, the law does not prevent a party from filing pre-grant and post-grant oppositions on the same grounds. The post-grant opposition may also provide an opportunity to consider additional grounds which were omitted while considering the pregrant representation. In view of the growing importance of the Indian market, particularly in the field of pharmaceuticals, and the increase in the number of filings, it is clear that the opposition system is not yet being utilised to its full 10 India: Managing the IP Lifecycle 2013

5 Contributing profiles 709/710 Tolstoy House, Tolstoy Marg New Delhi , India Tel Fax Web G Deepak Sriniwas Head of patents deepak@lexorbis.com Rajeev Kumar Head of patent prosecution rajeev@lexorbis.com G Deepak Sriniwas leads the patent prosecution group at Lex Orbis. His areas of practice include advising clients in the engineering and life sciences sectors. He holds a bachelor s in engineering (electronics and communications) and a master s in technology with energy management as a specialisation from the Indian Institute of Technology, Delhi. Mr Sriniwas is a registered Indian patent attorney and a registered Indian patent agent, and regularly represents clients in contentious matters at the Patent Office, including oppositions, revocations and challenges to Patent Office orders. Rajeev Kumar leads the patent prosecution group for science cases. Mr Kumar holds a master s in pharmacy from the prestigious Delhi Institute of Pharmaceutical Sciences and Research. With over eight years experience, Mr Kumar has acquired proficiency in patent prosecution across the board. He regularly advises national and international clients on filing and prosecution strategies in India. Mr Kumar also has experience in handling oppositions and writing legal opinions for invalidity India: Managing the IP Lifecycle