Newsletter No. 3 May Table of contents EDITORIAL. Events. ABG s News and activities. Subscription

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1 Page 1 Table of contents Editorial Annual renewal fees under Spanish Patent Law and remedies for nonpayment Court decision opens a new route to revive Spanish patents when applicant fails to timely request the establishment of the search report Gardasil/Silgard and Cervarix Supplementary Protection Certificates in Spain Interpretation of product-by-process claims in the U.S. Collaboration between main patent offices for accelerating patent prosecution: the IP5-PPH pilot programme Utility models in Europe: amendment of the Spanish utility model Possibility of partial reimbursement of the appeal fee by early withdrawal of the appeal Events ABG s News and activities Subscription To subscribe to the newsletter please send an to newsletter@abgpatentes.com Enric Carbonell Editor European Patent Attorney EDITORIAL In the national section of this issue we address two important prosecution-related topics, namely the existing options to revive Spanish patents becoming abandoned either as a consequence of non-payment of renewal fees or for failing to request the compulsory prior art search in due time. In a separate article we also look into the interesting situation concerning Supplementary Protection Certificates for Human Papiloma virus vaccines in Spain following an important decision from the European Court of Justice. On a more international level, we report on recent changes on the way US courts interpret product-by-process claims and we provide an overview of the IP5 patent prosecution highway. At a European level, we provide a brief overview on utility models as available under different jurisdictions across the old continent and we include a short article on the possibility of obtaining a reimbursement of the appeal fee at the EPO. Finally, in the section devoted to ABG news we briefly report on the seminar held last May 29 on occasion of our firm s 10th anniversary and on the prizes and recognitions received in the last six months. Happy reading!

2 Page 2 Available remedies for non-payment of annual renewal fees have suffered important changes in November 2013 Paula Carrero Patent Adviser ANNUAL RENEWAL FEES UNDER SPANISH PATENT LAW AND REMEDIES FOR NON-PAYMENT Annual renewal fees for national Spanish patents and utility models filed either at the Spanish Patent and Trademark Office 1 (SPTMO) or as international applications designating Spain are paid only upon and after grant. Payment upon grant has to be made within three months after publication of the mention of the grant in the Official Bulletin of Industrial Property 2 and the payment is due for the annuities corresponding to the third and any subsequent life year of the patent which have expired at the time of grant. Therefore, various renewal fees may need to be paid at the time of grant. In contrast with this, in the case of European patents validated in Spain, the first payment of a renewal fee must be made only in relation to the first renewal fee that falls due after the publication of the mention of the grant of the European patent in the European Patent Bulletin. This first annual renewal fee for European patents validated in Spain may be validly paid during the time period starting three months before the due date and finishing one month after said due date. The due date is the last day of the month on which the anniversary of the date of filing falls. Subsequent annual renewal fees both for European patents validated in Spain and for national Spanish patents (either filed at the SPTMO or as a PCT application) may also be validly paid during the time period starting three months before the due date and finishing one month after said due date. The due date is the last day of the month on which the anniversary of the date of filing falls. If the renewal fee is not paid within the above period, it may still be paid within the three following months, i.e. 1+3 months from the due date, with a surcharge of 25%, and if the renewal fee is still not paid within this time frame, it may further be paid within the three following months, i.e. 1+6 months from the due date, with a surcharge of 50% of the corresponding fee (Art. 161 SPL and Art. 77 SRD 2245/1986) 3. It is worthwhile mentioning that the requirements for paying annual fees in Spain are incorrectly summarized in the National Phase Chapter of the PCT applicant s Guide concerning Spain (ES). Furthermore, after the expiry of the period to validly pay the renewal fee with a surcharge and up to the due date of the renewal fee for the following year, the payment can still be regularized by paying the equivalent of the 20 th renewal fee in the case of patents and the equivalent of the 10 th renewal fee in the case of 3 SPL: Spanish Patent Law 11/1986; SRD: Royal Decree. 1 Spanish Patent and Trademark Office (Oficina Española de Patentes y Marcas, OEPM) 2 Known in Spanish as Boletín Oficial de la Propiedad Industrial (BOPI)

3 Page 3 utility models (Art. 77 SRD 2245/1986 and 245/2010). According to Art. 116 (1)(c) and (3) SPL, if the renewal fee is still not paid within the one-year period from the due date, the patent is considered to have expired at the beginning of the year for which the annuity has not been paid. However, remedies still exist to restore the proprietor s rights. Remedies for non-payment Reinstatement (Art. 117 LP 11/1986) Reinstatement can only be used when the expiration of a patent or utility model is due to the non-payment of an annual fee. The process begins with the submission of a request for reinstatement justifying that the failure to pay was due to force majeure, e.g. a natural disaster, war, civil disorder, etc. The request must be submitted within six months of the publication of the mention of the patent (or utility model) expiry date in the Official Bulletin of Industrial Property. According to a recent internal consultation to the SPTMO, the petition for reinstatement should be accompanied on the one hand by the payment of the unpaid annuity along with a 50% surcharge, and by the payment of the reinstatement fee on the other hand. Re-establishment of rights (Art. 25 and additional provision number 7 STL 4 17/2001 and Arts. 47 and 48 RD. 687/2002) The practical calculation of the period for requesting re-establishment of rights has varied after entry into force of the Patent Law Treaty (PLT) in Spain and has since become a confusing task. According to Art. 6(1) of the SPTMO instruction dated 15 October 2013 regarding the implementation of the PLT, the request for reestablishment of rights shall be filed within two months of the removal of the cause of noncompliance with the officially stipulated period to pay the annuity in question, provided that the period to request the re-establishment of rights does not exceed twelve months counted from the end of the period stated in Art. 77 SRD 2245/1986. As explained above, Article 77 establishes a period of up to twelve months from the date on which a particular annuity is due to pay said annuity. It would thus appear that there is a period of twenty four months for requesting a re-establishment of rights. However, according to communication 3410X1 from the SPTMO dated November 2013, the request for re-establishment of rights shall be filed within two months of the removal of the cause of non-compliance with the designated period, but within 12 months from the end of the six-month grace period stipulated in Art. 5bis (1) of the Paris Convention which reads (1) A period of grace of not less than six months shall be 4 STL: Spanish Trademark Law 17/2001 of 7 December 2001, in force as from 31 July 2002

4 Page 4 allowed for the payment of the fees prescribed for the maintenance of industrial property rights, subject, if the domestic legislation so provides, to the payment of a surcharge. Considering that the six-month grace period under the SPL is counted from the end of the period to validly pay without surcharge, the period for requesting re-establishment of rights would be (=19) months from the due date. After consulting this matter with the SPTMO, we have been informed that the current understanding at the SPTMO is that the period which applies is indeed the nineteen-month period. It should in any case be noted that up to the entry into force of the PLT in Spain on 6 November 2013, the period for requesting reestablishment of rights under SPTMO regulations was two months from the date of removal of the cause of non-compliance, but under no circumstance could said period exceed one year counted from the end of the stipulated period to pay without surcharge, which in practice meant 1+12 (=13) months from the due date. There has not been a transitional provision related to this change, however after consulting the matter with the SPTMO, it appears that the nineteen-month period to request the reestablishment of rights applicable since entry into force of the PLT in Spain may be retroactively applied to any case. Thus, from , it is possible to request a reestablishment of rights after non-payment of an annuity even if the thirteen-month term according to practice prior to had already expired on Example: Date of filing (of a national Spanish application): Date of grant: (payment of the 3 rd and 4 th annual fees are due) Due date for the payment of the 5 th annual fee: Start of the period to pay the 5 th annual fee without surcharge: End of the period to pay the 5 th annual fee without surcharge: End of the period to pay the 5 th annual fee with 25% surcharge: End of the period to pay the 5 th annual fee with 50% surcharge: End of the period to pay the 5 th annual fee with the 20 th annual fee and due date to pay the 6 th annual fee: End of the period to request re-establishment of rights (pre-plt): Entry into force of the PLT: End of the period to request re-establishment of rights (post-plt):

5 A court decision allows requesting establishment of the search report up to the day on which the withdrawal of the patent application is published in the Official Bulletin If the fee is not paid, or the request for reestablishment of rights is not accepted, the patent is considered to have expired on , thus ceasing to have any legal effect from Formal requirements The requirements to have a request for reestablishment of rights admitted are the following: The payment of the renewal fee must be fulfilled when the re-establishment of rights is requested. The request for re-establishment of rights must be filed in writing, in Spanish, and on paper or on line. The request must state the grounds on which the non-compliance with the designated time-limit is based despite all due care 5 having been taken to comply with said timelimit, and the request must be accompanied by a declaration or any other evidence in support of the statement. Payment of the fee for the re-establishment of rights. If the Office refuses the re-establishment of rights, an administrative appeal may be lodged within one month after the publication of the 5 The SPTMO interprets the legal concept of due care under the light of Article 1104 of the Spanish Civil Code and taking into account the decisions of the Board of Appeals of the European Patent Office. Page 5 mention of refusal in the Official Bulletin of Industrial Property. The use of form 3410x is recommended when requesting either a re-establishment of rights or a reinstatement. Near future The last draft of the new Spanish law does no longer include the figure of reinstatement and only foresees the re-establishment of rights. According to this draft, the period to request reestablishment of rights will be two months from the date of removal of the cause of noncompliance, however said period will under no circumstance exceed twelve months from the end of the six-month grace period to pay the annuity with the 50% surcharge, in accordance with the above mentioned (=19) month-period. Furthermore, the possibility to regularize the nonpaid fee by payment of the 20th renewal fee in the case of patents and of the 10th renewal fee in the case of utility models will be also eliminated. Laura Durán Patent Adviser COURT DECISION OPENS A NEW ROUTE TO REVIVE SPANISH PATENTS WHEN APPLICANT FAILS TO TIMELY REQUEST THE ESTABLISHMENT OF THE SEARCH REPORT Patent prosecution procedures are subject to time limits and failure to comply with them may result

6 Page 6 in loss of rights. Current Spanish Patent Law 11/1986 (hereinafter SPL ) provides two mechanisms to address the legal effects of failure to meet certain time limits. These two mechanisms are reinstatement of rights and reestablishment of rights. Reinstatement of rights is regulated by Art. 117 SPL and it can only be made use of when a patent application has been refused due to non-payment of annual fees. On the other hand, reestablishment of rights, regulated by Art. 25 of Spanish Trademarks Law 17/2001, allows resetting a patent application to the moment before the expiry of a time limit provided that all due care can be convincingly shown and only when the period is not expressly excluded by the Law. An important example of one of said expressly excluded periods is that for requesting the establishment of the Search Report or IET ( Informe del Estado de la Técnica ) as it is known in Spain. According to Art SPL, applicant may request the IET within fifteen months from the filing date of the patent application or from the priority date (if priority has been claimed). However, if said time limit has expired by the time applicant receives the notification pursuant to Art SPL from the Spanish Patent and Trademark Office (SPTO) informing of the need to request the IET, applicant may still request the IET within one month from the date of said notification, as established in Art SPL. If applicant does not meet these time limits, the application shall be deemed to be withdrawn (Art SPL). Neither reinstatement of rights nor re-establishment of rights can be applied to correct the failure to meet said time limit. In addition, the Law does not seem to provide any other legal route to prevent the refusal of a patent application in cases in which the time limit for requesting the IET has been missed. However, a recent decision from the Spanish Supreme Court (STSJ MAD 1247/2014) has opened a new possibility to revive patent applications refused due to failure to request the IET. In particular, the decision relates to a patent application filed before the SPTO by applicant on 7 December Applicant failed to request the IET within any of the time limits provided by Art. 33 SPL and thus, the SPTO deemed the application to be withdrawn according to Art SPL. However, applicant performed the omitted act on the date (18 of April of 2011) on which the withdrawal of the patent application was published in the Official Industrial Property Gazette (BOPI). In an appeal, applicant alleged that Art of Law 30/1992 of the Legal Regime of Public Administrations and the Common Administrative Procedure provided a valid remedy applicable to patent applications deemed to be withdrawn on the basis of Art.33.3 SPL. The above mentioned Art states: Those parties not complying with the provisions of the preceding

7 The marketing authorization of a multivalent vaccine that contains a combination of two or more antigens has been successfully employed to obtain an SPC independently for each of the antigens in said combination paragraphs 1, may have their rights to the corresponding act declared ceased; however, parties shall be excused and compliance with the corresponding act shall have a legal effect if said compliance occurs prior to or within the day of the notification of the resolution of loss of rights It should be noted that according to the 12 th Additional Provision of the Spanish Trademarks Law, Industrial Property procedures shall be governed by the specific regulations in the field, such as the Spanish Patent Law or the Spanish Trademark Law, and secondarily also by the above mentioned Law 30/1992. On this basis the Supreme Court ratified that since the request for the IET was made on the day on which the withdrawal of the patent application was officially published (18 of April of 2011), as had been claimed by the appellant, Art.76.3 could be applied since there is no provision in the Law to the contrary. Accordingly, the Supreme Court decided that the patent application was to be considered as pending and that the SPTO was to continue prosecution and to perform the IET for said patent application. 1 Art. 76.1: The procedural steps that must be completed by interested parties must be undertaken within ten days of the notification of the corresponding act, except when a different period is provided in the corresponding rule. Art. 76.2: Whenever it appears that any of the acts performed by the interested parties do not meet the necessary requirements, the Administration shall inform the party, granting ten days to complete the act. Page 7 The importance of this decision is that it opens up the door to a new mechanism to prevent the refusal of patent applications for failure to meet a time limit, including those time limits for which reinstatement of rights and re-establishment of rights is not available. Vicente González Partner European Patent Attorney GARDASIL/SILGARD AND CERVARIX SUPPLEMENTARY PROTECTION CERTIFICATES IN SPAIN Application in Spain of decision C-630/10 (University of Queensland and CSL Ltd v Comptroller General of Patents, Designs and Trade Marks) from the Court of Justice of the European Union (CJEU) on Supplementary Protection Certificates (SPCs) for multivalent vaccines Summary The marketing authorization of a drug (e.g., a multivalent vaccine) that contains a combination of active ingredients (e.g., two or more antigens) can be employed to obtain an SPC independently for each of the active ingredients (antigens) in that combination. Different basic patents in force protecting a same medicinal product may be designated for the purpose of the procedure for the grant of an SPC

8 Page 8 for that medicinal product but only one SPC may be granted for each basic patent with respect to said medicinal product. Facts 1. The drugs (medicinal products) GARDASIL (also marketed under the name SILGARD ) [Human Papillomavirus (Types 6, 11, 16, and 18) Vaccine, Recombinant] is a multivalent vaccine containing L1-only virus-like particles (VLPs) for all four clinically important Human Papillomavirus (HPV) serogroups (6, 11, 16 and 18). CERVARIX [Human Papillomavirus (Types 16 and 18) Vaccine, Recombinant] is a multivalent vaccine containing L1-only VLPs for the two cancer-causing HPV serotypes only (16 and 18). These products are medicinal products for the prevention of cervical cancer. 2. The SPC applications in Spain, the products in the sense of Art. 1(b) Regulation No. 1768/92 and the relevant patents A number of applications for SPCs, in the name of different applicants, were filed at the Spanish Patent and Trademark Office (SPTO) in February, March and December 2007, February 2008 and July 2011, for the VLPs contained in the multivalent vaccines GARDASIL /SILGARD and CERVARIX. Out of said SPC applications, some were for independent particles contained in GARDASIL /SILGARD, some were for independent particles contained in CERVARIX and others were for the combination of the particles contained in either drug (vaccine). The SPC applications, the products in the sense of Art. 1(b) of the SPC Regulation No. 1768/92 (SPCR), the basic patents and the applicants/owners of the SPC applications are summarized below: SPC C Product [Art. 1(b) SPC Regulation No. 1768/92] Gardasil/HPV vaccine (6, 11, 16 and 18) Basic patent EP B1 Applicant/ Owner Medimmune, Inc. C Gardasil/HPV6 VLP EP B1 CSL Ltd & UQ C Gardasil/HPV11 VLP EP B1 CSL Ltd & UQ C Gardasil/HPV16 VLP EP B1 CSL Ltd & UQ C Gardasil/HPV16 VLP EP B1 Gov. USA C Gardasil/HPV18 VLP EP B1 CSL Ltd & UQ C Gardasil/HPV6 VLP EP B1 MSD C Cervarix/HPV16 and 18 VLP EP B1 LUCh C Cervarix/HPV16 VLP EP B1 LUCh C Cervarix/HPV16 VLP EP B1 GU C (1) Cervarix/HPV16 VLP EP B1 GU C (2) Cervarix/HPV18 VLP EP B1 GU C Gardasil/HPV16 VLP EP B1 GU C (2) Gardasil/HPV11 VLP EP B1 GU C (2) Gardasil/HPV6 VLP EP B1 GU C C Gardasil/HPV6, 11, 16 and 18 VLP Cervarix/HPV16 and 18 VLP EP B1 EP B1 GU GSKB C Cervarix/HPV16 VLP EP B1 CSL Ltd & UQ C Cervarix/HPV18 VLP EP B1 CSL Ltd & UQ C Cervarix/HPV16 VLP EP B1 Gov. USA C Gardasil/HPV18 VLP EP B1 UR

9 Page 9 (1) Lapsed by waive (2) Withdrawn UQ: University of Queensland Gov. USA: The Government of the USA, represented by the Secretary, Department Health and Human Services MSD: Merck Sharp & Dohme Corp. LUCh: Loyola University of Chicago GU: Georgetown University GSKB: GlaxoSmithKline Biologicals, S.A. UR: University of Rochester 3. Comments The above table shows that: 1. SPCs for independent active ingredients contained in multivalent vaccines, wherein said active ingredient is specified in the wording of the claims of the basic patent relied on, and where the multivalent vaccine for which the marketing authorization is submitted in support of the SPC application contains not only the active ingredient but also other active ingredients, have been obtained. Indeed, as can be established from the above table: 1.1 The marketing authorization of the multivalent vaccine GARDASIL /SILGARD has been used to obtain an SPC independently for each of the active ingredients in said multivalent vaccine [C , C , C , C , C , C , C and C ]; and 1.2 The marketing authorization of the multivalent vaccine CERVARIX has been used to obtain an SPC independently for each of the active ingredients in said multivalent vaccine [C , C , C , C and C ]. 2. Different basic patents in force protecting a same active ingredient have been designated for the purpose of the procedure for the grant of an SPC for that active ingredient but only one SPC has been granted for each basic patent with regard to said active ingredient. Indeed, as can be established from the above table: 2.1 HPV6 VLP C based on EP B1 and GARDASIL /SILGARD C based on EP B1 and GARDASIL /SILGARD C based on EP B1 and GARDASIL /SILGARD [withdrawn] 2.2 HPV11 VLP C based on EP B1 and GARDASIL /SILGARD C based on EP B1 and GARDASIL /SILGARD [withdrawn] 2.3 HPV16 VLP C based on EP B1 and GARDASIL /SILGARD C based on EP B1 and GARDASIL /SILGARD C based on EP B1 and CERVARIX C based on EP B1 and CERVARIX C based on EP B1 and CERVARIX [lapsed by waive] C based on EP B1 and GARDASIL /SILGARD

10 Page 10 C based on EP B1 and CERVARIX C based on EP B1 and CERVARIX 2.4 HPV18 VLP C based on EP B1 and GARDASIL /SILGARD C based on EP B1 and CERVARIX [withdrawn] C based on EP B1 and CERVARIX C based on EP B1 and GARDASIL /SILGARD Marta Rodríguez. Patent Adviser European Patent Attorney INTERPRETATION OF PRODUCT-BY-PROCESS CLAIMS IN THE U.S. A product-by-process claim is a product claim where the product is defined by its process of manufacture. This claim format is most frequently used for chemical and biological technology, where it can sometimes be difficult or impossible to define a product solely in terms of its structure or composition. Indeed, in some cases the precise structure or composition may not be completely known at the time the patent is drafted. Examples of this type of claim include Product X obtained by process Y, Product X obtainable by process Y, Product X produced by process Y. In this way, if an inventor discovers a new and When determining patentability the USPTO considers a product-by-process claim as directed to the product per se independent of the process limitations recited in the claim. In contrast, the process steps of a product-byprocess claim serve as limitations in determining infringement unobvious product the structure of which is not fully known or is too complex, he is allowed to describe the product by reference to the process from which it is made. In line with the above, product-by-process claims are typically considered to extend protection beyond that conferred by process claims alone. However, the interpretation of product-by-process claims during examination and enforcement varies between jurisdictions. Patentability Product-by-process claims were originally permitted in the U.S. only when the product could not be described in any other manner. However, the USPTO now allows product-by-process claims even when the product can be sufficiently described in structural terms. During examination for patentability in the U.S., product-by-process claims are treated as directed to the product per se not limited to the manipulations of the recited steps, only to the structure implied by the steps. Therefore, a product-by-process claim would not be patentable if the prior art discloses a product with the same characteristics as the claimed one, even if it was prepared by a different process. Manual of Patent Examining Procedure states (MPEP 2113 (quoting In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985))):

11 Page 11 [E]ve n though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In summary, in a product-by-process claim the product itself must be novel and unobvious over the prior art. The fact that the process is patentable does not make the product claimed under the product-by-process format patentable. Infringement With regard to the interpretation of the scope of a product-by-process claim for assessing infringement, during much of the 90s and until 2009 a marked inconsistency in Federal Circuit jurisprudence cast doubt over said task. In 1991, one Federal Circuit panel held that process limitations in product-by-process claims were not to be considered for infringement (Scripps Clinic & Research Foundation v. Genentech, Inc., 927 F.2d 1565, 1583 (Fed. Cir. 1991): the correct reading of product-by-process claims is that they are not limited to product prepared by the process set forth in the claims ). A year later, a different Federal Circuit panel held that productby-process claims only covered products that are produced by the process steps recited in the claims (Atlantic Thermoplastics v. Faytex Corporation, 970 F.2d 834, 846 (Fed. Cir. 1992): process terms in product-by-process claims serve as limitations in determining infringement ). In 2009, this inconsistent case law was resolved. In Abbot Labs v. Sandoz, 566 F3d 1282 (Fed. Cir. 2009), the Federal Circuit decided en banc that process steps in a product-by-process claim serve as limitations in determining infringement, upholding the decision in Atlantic Thermoplastics. In other words, a product-by-process claim is not infringed by products obtained by processes different from the one claimed. The Court explained that if an inventor invents a product whose structure is either not fully known or too complex to analyze [...] this court clarifies that the inventor is absolutely free to use process steps to define this product. The patent will issue subject to the ordinary requirements of patentability. The inventor will not be denied protection. Because the inventor chose to claim the product in terms of its process, however, that definition also governs the enforcement of the bounds of the patent right. and concluded that it is both unnecessary and logically unsound to create a rule that the process limitations of a product-by-process claim should not be enforced in some exceptional instance when the structure of the claimed product is unknown and the product can be defined only by reference to a process by which it can be made. Such a rule

12 Page 12 would expand the protection of the patent beyond the subject matter that the inventor has "particularly point[ed] out and distinctly claim[ed]" as his invention. As a consequence, a product-by-process claim will be only infringed if the potentially-infringing product is obtained by the same process defined in the claim. Conclusions Product-by-process claims are construed differently for validity and for infringement in the U.S. When determining patentability the USPTO considers a product-by-process claim as directed to the product per se independent of the process limitations recited in the claim. In contrast, the process steps of a product-by-process claim serve as limitations in determining infringement. Consequently, product-by-process claims are disadvantageous compared to conventional product claims in the U.S. In order to obtain a patent which includes a product-by-process claim, the applicant has to demonstrate patentability of the product irrespective of the process by which it is made, whereas the claim will only be infringed if the accused product is produced by the process to which the claim refers. Patent applicants must therefore carefully consider the value of product-by-process claims in the U.S. and limit their use to only those instances where the product can only be defined in terms of the process by which it is made. The IP5-PPH program launched in January 2014 allows the use of both PCT and national work products to accelerate the examination of patent applications in the countries which are part of said program María Corral Patent Adviser COLLABORATION BETWEEN MAIN PATENT OFFICES FOR ACCELERATING PATENT PROSECUTION: THE IP5-PPH PILOT PROGRAMME Patent offices from different countries have been cooperating over the last years in order to fasttrack patent prosecution by sharing information between them. This cooperation has been established under a framework of different agreements named Patent Prosecution Highway (PPH) programmes. Through these agreements, two or more patent offices pledge to share information about the examination of patent applications, so that an office can take advantage of the work of another office, avoiding duplication of efforts and saving time and costs for both the office and the applicant. In the last years a myriad of PPH programmes have been signed by different patent offices throughout the world. In an attempt to simplify their collaboration schemes, the main five main patent offices in the world (IP5 offices), namely the European Patent Office (EPO), the United States Patent and Trademark Office (USPTO), the Japan Patent Office (JPO), the State Intellectual Property Office of the People s Republic of China (SIPO) and the Korean Intellectual Property Office

13 Page 13 (KIPO), which handle over 90 per cent of the patent workload in the world 1, have launched a PPH pilot programme, the so-called IP5-PPH, effective from 6 January 2014 until 5 January Through the IP5-PPH a number of bilateral agreements have been replaced by a single multilateral agreement that establishes a single set of requirements for a patent application to benefit from this programme before any of the IP5 offices. IP5-PPH enables an applicant whose claims have been found patentable/allowable by one of the IP5 offices (the Office of Earlier Examination or OEE) to benefit from an accelerated examination of a corresponding application filed with another IP5 office (the Office of Later Examination or OLE). The accelerated examination under IP5-PPH can be based on a work product that has determined one or more claims to be patentable/allowable. This work product may be one of: (a) the latest product issued during international prosecution of a PCT application, which may be either a Written Opinion (WO) or an International Preliminary Examination Report (IPER) established by one of the IP5 Offices as Search Authority (ISA) or International Preliminary Examining Authority 1 ion/chapter3.pdf (IPEA) respectively, or (b) the national work product established during the processing of a national application or a PCT application that has entered the national phase before one of the IP5 Offices. Requirements for requesting participation in the IP5-PPH pilot programme Common requirements established by the IP5 offices are the following. (1) The application for which participation in the IP5-PPH programme is being requested must share the same earliest date (priority or filing date) with the corresponding application filed with the OEE, whether this corresponding application is: - a corresponding national or regional application, or - a corresponding PCT application for which one of the IP5 offices has been the ISA and/or the IPEA. (2) The OEE must have found at least one claim in the corresponding application to be patentable/allowable. The IP5 offices have specified different cases in which a claim is considered patentable/allowable. EPO - The claim has been regarded as novel, inventive and industrially applicable by the ISA/IPEA.

14 Page 14 - When the OEE was the JPO: the claim has been clearly identified as patentable/allowable in the latest office action. - When the OEE was the SIPO: the claim has been explicitly identified to be patentable/allowable in the latest office action. Otherwise, the applicant must file an explanation that no rejection has been issued regarding that claim. USPTO - A claim regarded as novel, inventive and industrially applicable by the ISA or IPEA is considered as patentable/allowable. JPO - The claim has been regarded as novel, inventive and industrially applicable by the ISA/IPEA. In case any observation is described in Box VIII of WO-ISA, WO-IPEA or IPER, the applicant must identify the allowable claims and explain whether amendments are submitted to correct said observation. - When the OEE was the EPO: (a) A communication regarding the intention to grant a European patent was issued on the claim. (b) A positive opinion regarding the claim has been issued in the European Search Report. (a) The claim is indicated to be allowed in a Notice of Allowance, Non-Final Rejection or Final Rejection. (b) The claim is objected in a Non-Final Rejection or Final Rejection for being dependent on a rejected claim, but it has been indicated that the claim would be patentable/allowable if re-written as indicated by the examiner. - When the OEE was the SIPO: the claim has been explicitly identified to be patentable/allowable in the latest office action. Otherwise, the applicant must file an explanation that no rejection has been issued regarding that claim. - When the OEE was the KIPO: the claim has been identified to be patentable/allowable in the Notice of Submission of Opinion or Notice of Final Rejection. SIPO - The claim has been regarded as novel, inventive and industrially applicable by the ISA/IPEA. In case any observation is described in Box VIII of WO-ISA, WO-IPEA or IPER, the application will not be eligible for participating in the IP5-PPH program. - When the OEE was the EPO: (a) A communication regarding the intention to grant a European patent was issued on - When the OEE was the USPTO:

15 Page 15 the claim. (b) A communication from the examining division was issued explicitly indicating the claim being patentable/allowable. Otherwise, an explanation that no rejection has been made regarding that claim must be filed. - When the OEE was the USPTO: (a) The claim is indicated to be allowed in a Notice of Allowance, Non-Final Rejection or Final Rejection. (b) The claim is objected in a Non-Final Rejection or Final Rejection for being dependent on a rejected claim, but it has been indicated that the claim would be patentable/allowable if re-written as indicated by the examiner. - When the OEE was the JPO: the claim has been clearly identified as patentable/allowable in the latest office action. - When the OEE was the KIPO: the claim has been indicated to be patentable in the latest office action. Otherwise, an explanation that no rejection has been issued by the KIPO regarding that claim must be filed. KIPO - The claim has been regarded as novel, inventive and industrially applicable by the ISA/IPEA. In case any observation is described in Box VIII or WO-ISA, WO-IPEA or IPER, the applicant must explain why the claim is not subjected to the observation. - When the OEE was the EPO, USPTO, JPO or SIPO: the claim was explicitly identified as patentable/allowable in the latest office action. Otherwise, an explanation that no rejection has been made regarding that claim must be filed. (3) All claims in the application for which participation in the IP5-PPH programme is requested must sufficiently correspond to the claims that were found to be patentable/allowable by the OEE. Claims are considered to sufficiently correspond if: - the claims have the same or similar scope, or - the claims in the application for which participation in the IP5-PPH programme is requested have a narrower scope than the claims in the corresponding application. When considering sufficient correspondence between claims, differences due to formal requirements are not taken into consideration, as long as the scope of the claims is similar. Claims with different categories are not considered to sufficiently correspond. Additionally to those mentioned above, the following requirements are established by the different IP5 offices regarding the application

16 Page 16 for which participation in the IP5-PPH programme is being requested: EPO, USPTO, JPO and SIPO require that substantive examination has not begun. However, it should be noted that the KIPO establishes that the request may be filed even if the examination has already begun. The JPO and KIPO require that a request for substantive examination has been filed at the time of or prior to the request for participating in the IP5-PPH programme. The SIPO requires that the application: (a) has entered substantive examination, (b) has been published and (c) is an electronic patent application. Documents required for participating in the IP5- PPH pilot programme (1) Request for participating in the IP5-PPH. (2) Declaration of claim correspondence indicating how all the claims in the application for which participation in the PPH programme is requested correspond with the claims that were found to be patentable/allowable by the OEE. (3) Copies and translations of: - all the Office Actions corresponding to the patent application containing the patentable/allowable claims that are the basis for the PPH request, or - the latest work product in the international phase of a PCT application. The EPO requires translations into one of the three EPO official languages, the USPTO requires translations into English and the JPO, SIPO and KIPO require translations either into English or into Japanese, Chinese and Korean respectively. (4) Copies of all non-patent documents cited in the Office Actions or PCT work products of the OEE. The USPTO also requires copies of all cited patent documents other than US patent and US patent application publications. In addition to the above documents, the EPO, JPO, SIPO and KIPO also require the following: (5) A copy of the claims that were found to be patentable/allowable by the OEE and a translation thereof, if applicable. Documents under items (3) and (5) do not need to be submitted if they have already been filed prior to requesting participation in the IP5-PPH, or if they are available through the respective Dossier Access System (DAS) or Patentscope. Procedure for accelerated examination under IP5-PPH pilot programme If the OLE considers that the request for participation in the IP5-PPH programme meets all necessary requirements, the request is granted

17 New legislation on utility models to be passed in Spain will require absolute novelty and will widen the technical area of inventions protectable as utility models to encompass the field of chemistry. and the application is processed in an accelerated manner. As a side note, when the OLE is the EPO, said accelerated processing is equivalent to the processing applied under the PACE programme. If the request does not meet all the requirements, the applicant will be given one opportunity to correct any formal deficiency identified. Juan Arias Partner European Patent Attorney UTILITY MODELS IN EUROPE: AMENDMENT OF THE SPANISH UTILITY MODEL A utility model is an exclusive right granted in some countries for the protection of inventions. Similar to patents, utility models allow the right holder to prevent others from commercially using the protected invention, without his authorization, for a limited period of time. In its basic definition, which may vary from country to country, a utility model is similar to a patent although there are a few important differences between the two types of rights: The requirements for acquiring a utility model Page 17 are in some countries less stringent than for patents. While the requirement of "novelty" is always to be met, that of "inventive step" may be lower or even absent. The term of protection for utility models is shorter than for patents (usually between 6 and 10 years). In most countries patent offices do not perform substantive examination prior to registration. Therefore the registration process is often significantly simpler and faster, taking, on average, six months. Utility models are much cheaper to obtain and to maintain. In some countries, utility model protection can only be obtained for certain fields of technology and only for products but not for processes. Due to the abandonment of the European Commission's utility model directive proposal in 2000, utility models in Europe have finally not been unified through a Community utility model; moreover, the requirements to be met by national utility models have not been harmonized throughout Europe. Thus, requirements to obtain a utility model differ from one country to another; even the names are different: for instance, Utility Certificate in France or Short Term Patent in Ireland. Furthermore, many European countries such as the United Kingdom, The Netherlands, Belgium, Luxembourg, Switzerland, Sweden and Norway do not even have such IP right.

18 Page 18 Nevertheless, in spite of this lack of harmonization, utility models in Europe present certain similarities like, for instance, absence of substantive examination, simple and fast registration process (around six months) and a shorter term of protection (6 to 10 years) than a patent. In spite of these simpler requirements when compared to patents, utility models confer nearly the same rights than patents. A further common characteristic of utility models in Europe is their suitability for fast injunctions, i.e., an infringement lawsuit can be launched six months after the filing of the utility model. Two main requirements of utility models that vary from country to country are the level of inventive step and the technical areas of inventions which are protectable as utility models. The first requirement is very relevant when taking into account that utility models are granted in the absence of substantive examination. Thus, in those countries where the level of inventive step is lower than the level of said requirement for patents, it is usually quite difficult to achieve the nullity of the utility model once it has been granted, particularly when the prior art relevant to the evaluation of novelty consists only of disclosures in the country were the utility model is filed. This is the case in Spain where utility models are at present only available for mechanical or tridimensional inventions. It has been argued that this conjunction of legal requirements (limited prior art and lower inventive step) create an unfair situation for third parties. In the light of these requirements the following classification by countries has been established. - Finland, Italy, Spain and Portugal Lower level of inventive step requirement, but limited to mechanic or tridimensional inventions. - Denmark, Greece and Ireland Lower level of inventive step requirement, with no restriction regarding the technical area. - Austria, France and Germany Same level of inventive step requirement and hardly any restriction regarding the technical area. It should be highlighted that both in Austria and in Germany, contrary to the original intention of the legislator, case law has evolved to apply a similar standard of inventive step for utility models and patents. This raising of the bar is supplemented in the German system by the possibility of filing a cancelation action (Löschungsantrag) before the German Patent Office during the life of the utility model. Spain is now, as informed in the previous edition of this Newsletter, in the process of amending the Patent Act. Actually, one of the most controversial issues is the modification of both grant process and patentability requirements for utility models.

19 The modification of Rule 103 of the EPC introduces the possibility of obtaining a 50% refund of the appeal fee even after filing the statement of grounds provided the appeal is withdrawn within certain time limits. Last draft of the proposal of amendment of the Patent Act, which was made public on the 6 th of May 2014, widens the te chnical area of inventions protectable through utility models to chemistry (theoretically excluding pharmaceutical inventions), maintains a pre-grant opposition and, finally, substitutes relative novelty (only disclosures in Spain) by absolute novelty (disclosures anywhere in the world), whereas the lower level of inventive step for utility models with respect to patents is maintained. As a result, if this proposal is, as expected, not substantially amended, unfortunately Spain may end up granting exclusive rights for inventions, not only in the mechanic field but also in the chemistry area, which do not fulfill the standard requirement of inventive step. This may potentially create an unfair situation for third parties, since dubious exclusive rights could be granted which, besides, will be difficult to revoke. Consequently, unless the law suffers further amendments, it seems advisable that players in the chemical industry rethink their IP strategy in Spain by seriously considering the possibility of filing utility models, which will be easy to obtain and difficult to revoke, additionally (avoiding double protection) or alternatively to patent applications. Page 19 Agustín Alconada Partner European Patent Attorney POSSIBILITY OF PARTIAL REIMBURSEMENT OF THE APPEAL FEE BY EARLY WITHDRAWAL OF THE APPEAL In proceedings before the European Patent Office, any party affected by an adverse decision by the Examining Division, the Opposition Division or the Legal Division can challenge the decision by filing an appeal. This allows the revision of the adverse decision by the Boards of Appeal, an independent body within the European Patent Office. The filing of an appeal requires the payment of a fee (1860 EUR as of April 2014), which is payable within two months of the date of notification of the adverse decision. The Appeal must also contain a statement of grounds of appeal, which has to be filed within 4 months of the date of notification of the decision. Until recently, the appeal fee would be reimbursed in full only if the appeal was withdrawn before the filing of the statements of grounds or when the Board of Appeal considered that a substantial procedural violation had taken place in the proceedings before the first instance. As of 1 April 2014, a modification of R. 103 has entered into force. This modification introduces the possibility of obtaining a 50% refund of the appeal fee even after the filing of the statement of grounds provided that the appeal is withdrawn within the following time limits:

20 Page 20 ABG Patentes, S.L. again in the top tier of the Managing Intellectual Property World Patent Survey - if a date for oral proceedings has been set, at least four weeks before that date; - if no date for oral proceedings has been set, and the Board of Appeal has issued a communication inviting the appellant to file observations, before expiry of the period set by the Board for filing observations; - in all other cases, before the decision is issued. Amended R. 103 creates a financial incentive for withdrawing pending appeals in cases for which the parties have lost interest and thus, will most likely result in a substantial reduction in the number of pending appeals. The EPO has recently approved a modest increase in the appeal fee which is also likely to lead to a reduction in the number of appeals being filed. In view of these recent changes, it is expected that the length of time needed by the Boards of Appeal for reaching a decision for those cases for which the parties have a real interest will decrease. New Rule 103 entered into force on 1 April 2014 and applies both to appeals pending on that date and to appeals filed after that date. ABG S NEWS AND ACTIVITIES ABG Patentes, S.L. again in the top tier of the Managing Intellectual Property World Patent Survey again ranked ABG in the top tier for Spanish Patent Prosecution. It is ABG s sixth appearance in Tier 1 since its foundation in 2003, clearly reflecting ABG s standing in the market over the years. Notably, ABG was named Spanish Patent Prosecution Firm of the Year in 2011, 2012 and 2013 by the same publication. Moreover, on 10 February 2014 Managing IP published the names of the nominees for the Global Awards 2014, which recognize firms that have had a particularly good year in 2013, and ABG is proud to be included in this list. View all rankings online at ABG Patentes at the XXIX Conference on Industrial and Intellectual Property hosted by the Spanish Group of AIPPI (International Association for the Protection of Intellectual Property) On 14 February 2014, Juan Arias, (European Patent Attorney and Spanish Patent & Trademark Agent), participated in the panel discussion Towards a new Patent Law as part of the XXIX Conference on Industrial and Intellectual Property hosted by the Spanish Group of AIPPI, which was held in Barcelona on 13 and 14 February. Mr. Arias discussed topics relating to the recent Patent Law Reform, such as modifications on the ABG Patentes, S.L. is pleased to announce that the Managing IP World Patent Survey has once

21 Page 21 On 29 May 2014, ABG Patentes hosted their seminar entitled IP Perspectives patentability of medical uses, changes introduced in the grant procedure, substantial aspects of the Utility Model, revocation and limitation procedures, patents relevant to national defense, International Agreements implementation, agents and representatives, official fees and annuities, among others. Enric Carbonell, partner of ABG Patentes, is awarded the prestigious Client Choice Award International 2014 On 1 April 2014, Enric Carbonell, European Patent Attorney and partner of ABG Patentes, was awarded the Client Choice Award International 2014 by International Law Office (ILO). Enric is the exclusive winner of the award in the Intellectual Property Patents category for Spain. This year 450 individual winners across 73 jurisdictions were recognised. A complete list of winners is available at Enric Carbonell advises clients on IP matters in the chemical, pharmaceutical and biotech areas and his background as in-house counsel in industry and as a qualified attorney is most valued by clients. Enric is also frequently involved in key pharmaceutical patent litigation in Spain. ABG Patentes hosted the seminar IP Perspectives On 29 May 2014, ABG Patentes was proud to host their seminar entitled IP Perspectives, held at the Hotel Villa Magna in Madrid. This was the first seminar hosted by the firm, and it was unique in that it coincided with the celebration of the firm s 10 th Anniversary The seminar featured prominent speakers from diverse areas of IP profession, as well as representatives from various Patent Offices. The majority of the seminar touched on the latest IP developments in Europe and the United States, as well as the role and management of IP in the industry. Moreover, the programme included an interactive panel discussion on the Unitary Patent and the future of the Unified Patent Court. More than 80 representatives from various companies, national and foreign IP firms, law firms, the European Patent Office and the Spanish Patent and Trademark Office were in attendance.

22 Page 22 Overall, it was an excellent opportunity to share opinions and discuss pertinent topics. Due to the positive feedback we received, we plan to continue this initiative, and thus next year, ABG will organize the second edition of the IP Perspectives seminar to further discuss relevant IP topics.

23 ABG Patentes, S.L.: The firm ABG Patentes, S.L. (ABG) is one of the leading Spanish IP firms and provides highly-qualified advice on intellectual property in all its fields and aspects. ABG, founded in Madrid in 2003, now boasts more than sixty expert staff in all IP fields in its Madrid and Barcelona offices. ABG staff combine in-depth technical knowledge (over twenty ABG attorneys and advisers have advanced degrees covering a full range of technical disciplines, including chemistry, biotechnology and electronics and most of them hold PhDs and have industrial or academic work experience in Spain, other parts of Europe, and the United States) and legal expertise (including three former EPO examiners, twelve qualified European Patent Attorneys, seven Spanish Industrial Property Agents, four Attorneys-at-Law, and Community Trademark & Design Attorneys). This combination reinforces high quality service and dedication to the creation and enforcement of our clients IP rights. Our specialist practice groups serve clients in the fields of: Chemistry, Pharmaceutical and Chemical Engineering Biotechnology, Biology and Life sciences Electronics, Mechanics and Telecommunications.