Category Archives: IPAB Decisions

Appointment of Chairman of the Intellectual Property Appellate Board

IPAB is one of the most important IP tribunals in the country and was established by the Central Government by notifying in the Official Gazette on 15.07.2003. IPAB is an administrative body that has appellate jurisdiction over the decisions of the Controller of Patents, Registrar under the Trade Marks Act, 1999, and the Geographical Indications. However, IPAB has no statutory powers for trial infringement proceedings.

After the retirement of the Chairman of IPAB, K.N Basha on 13th May 2016, IPAB was run by only one member i.e. Mr.  Sanjeev Kumar Chaswal (Technical Member of Trade Mark) leaving behind other two posts vacant namely Vice-Chairman and Technical Member (Patents). This situation left IPAB almost non-functional for an year, leading to backlog of almost about 50,000 applications, due to which India was put under Priority watch list by US. Trade Representative.

As a result of which writ petitions were filed in Delhi as well as in Chennai, in order to fill up the vacant seats so as to make IPAB functional. This resulted in an expedited appointment of the Chairman, however, other positions are yet to be appointed. Therefore, through the Notice dated 1st January 2018 issued by IPAB (here) in accordance to the order dated 29.12.2017 of Ministry of Commerce and Industry (Department of Industrial Policy and Promotion), Shri Justice Manmohan Singh has been appointed as the Chairman of the said Board.

Justice Manmohan Singh is a well renowned persona in the field of IPR, who practiced the over 10 years and served as the Additional Judge of High Court of Delhi from 11th April, 2008- 21.09.2016.

As to who appointed the present Chairman and the constitutionality thereof are still contentious issues as the Madras High Court had upheld that the selection committee for appointing members of IPAB, shall have a predominant role of the Judiciary rather than of the Executive. Further, pointed that while appointing the ‘chairperson’, the recommendation of the Chief justice of India must be given ‘due consideration’. The concerned High Court,  elaborately explained and also struck down various parts of Section 85[1] of the Trade Mark Act, 1999 in order to upheld the ‘Doctrine of Separation of Power’[2], thereby making the IPAB, a constitutionally valid Judicial body.

However, it is alleged that this appointment has been made under Tribunal, Appellate and other Authorities (Qualifications, Experience and other conditions of Service of Members) Rules, 2017. The said Act provides for composition of the selection committee that consists of Chief Justice of India or his nominee, two secretaries to the Government of India and two experts nominated by the Central Government, leading to greater dominance of Executive rather than judiciary in the appointment procedure of the Chairperson. This blatantly violates the judgement of the Madras High Court as mentioned earlier.

Moreover, let’s wait whether the said appointment of Justice Manmohan Singh will be challenged on the ground of constitutionality or not, keeping in mind the rulings held by the Hon’ble High Court of Madras.

Author: Ms. Pratistha Sinha, Intern at Khurana and Khurana Advocates and IP Attorneys and can be reached at


[1] Qualifications for appointment as Chairman, Vice-Chairman, or other Members.

[2]Shamnad Basheer vs Union Of India on 10 March, 2015, W.P.No.1256 of 2011; The petition challenged the constitutional validity of the eligibility criteria, appointment of the members of IPAB


Interpretation of the Term “Aggrieved Person” Under Section 47 of Trade Mark Act, 1999

The Hon’ble High Court of Delhi in the case Adidas AG v Union of India and Anr vide W.P.(C) 3125/2013 set aside the impugned ex parte order by IPAB dated 28th December 2012 and remanded the matter to IPAB for fresh consideration.


In the instant case, Petitioner has trademark “RESPONSE” with respect to footwear and apparels has garnered worldwide goodwill and reputation. Petitioner’s trademark “RESPONSE” is registered in various countries including USA and Germany in 1993 and 1995 respectively.  It came to the Petitioner’s notice that the mark Response has been already registered by the Respondent. Thus the Petitioner filed application for rectification of the impugned mark by the Respondent on the ground that the mark had been registered “without any good cause or bonafide intention to use the mark” and thus is liable to be removed under section 47 of the Trade Marks Act, 1999. IPAB by order dated 28th December 2012 dismissed the application stating that the petitioners in this case have not satisfied as to how they are aggrieved person; and there is confusion or deception among the public. In these circumstances, IPAB did not think it fit to remove the trade mark from the register. Thus the application was therefore dismissed. Being aggrieved by the order, the Petitioners filed writ petition challenging the impugned order by IPAB.


It was argued by the Petitioner by virtue of number of registrations for the mark “RESPONSE” and the long and continuous use of the said mark by the petitioner in the course of its business, the mark “RESPONSE” has attained distinctiveness in relation to footwear and it has come to be associated solely with the petitioner and no one else.

It was further argued on behalf of the petitioner that respondent no.2 had never appeared before the IPAB and even in the present proceedings it has not filed any response. Moreover the respondent No.2 has not even renewed its mark since 2011.


The Hon’ble Court held that the expression “person aggrieved” is a term of wide amplitude and an applicant for registration whose trademark has been objected or refused by reason of prior registration by a third party of the same or similar or identical mark for the same goods or description of the goods or whose application for registration is opposed on the basis of prior registration of the same or similar mark by the registry is a person aggrieved. It was further observed that the finding of IPAB that even when the marks and goods are identical, there is no person aggrieved is contrary to law.

It was also found that though the IPAB has given a finding that there is no evidence of use of the mark “RESPONSE” by the petitioner, yet it has itself held that the use, if any, is post 2005. Consequently, this Court opined that the finding given by the IPAB is contrary to facts of the case. Moreover, the effect of the use post 2005 has not been analyzed. Accordingly, the impugned order dated 28th December, 2012 of the IPAB was set aside and the matter was remanded back to the IPAB for reconsidering the matter in accordance with the law. The matter was accordingly directed to be listed before IPAB for direction on 4th April, 2016.

About the Author: Mr. Abhijeet Deshmukh, Trade Mark Attorney, Khurana & Khurana, Advocates and IP Attorneys and can be reached at:

Plant Varieties and Farmers‟ Rights Act, 2001

Ministry of Agriculture & IPAB failure in invoking the transitional provision as provided under Section 59 of The Protection of Plant Varieties and Farmers Rights Act, 2001 for setting up a tribunal.


  1. The variety of crops both edible and for commercial purposes has grown as the size and need of the human population has grown. This has resulted in experimentation of plant varieties and a need was felt for protection of the plant varieties and the right of the farmers and plant breeders to encourage development of the new varieties of plants. This is essential for accelerated agricultural development. It is towards this objective that India ratified the agreement of Trade-Related Aspects of Intellectual Property Rights (TRIPS) in 1994 requiring it to make provisions for giving effect to various articles of the agreement relating to protection of plant varieties. The Protection of Plant Varieties and Farmers‟ Rights Act, 2001(„the Act‟) was thus born. The Act received the assent of the President of India on 30.10.2001 for the establishment of an effective system for protection of plant varieties, rights of farmers and plant breeders and to encourage the development of new plant varieties.
  1. But it was not till four years later on 11.11.2005 that some of the provisions i.e. Sections 2 to 13 and Sections 95 to 97 came into force. However, these Sections only dealt with the creation of the Authority and the Registry as also the power to make Regulations and Rules. Substantive provisions being Section 1 and Section 14 to Section 94 came into force on 19.10.2006. Thus, there was a hiatus period of five years between receiving the assent of the President and the provisions of the Act effectively coming into force.
  1. In exercise of the powers conferred by Section 96 of the Protection of Plant Varieties and Farmers Rights Act, 2001 (53 of 2001) read with Section 22 of the General Clauses Act, 1897 (10 of 1897), the Central Government made the rules and published in the Gazette of India vide GSR 738(E) on 12.09.2003 and subsequently amended the same from time to time.
  1. The Act provides for the establishment of an effective system for protection of plant varieties, the rights of farmers and plant breeders and to encourage the development of new varieties of plants. The Indian PPV & FR Act is unique in the world as it recognizes the Farmers Varieties and also protects their rights. The Act has considered it necessary to recognize and protect the rights of farmers in respect of their contribution made at any time in conserving, improving and making available plant genetic resources for the development of new plant varieties.
  1. Thus it becomes clear from The Protection of Plant Varieties and Farmers‟ Rights Act, 2001 and its objectives that the Act not only recognizes the Farmers Varieties but also seeks to protect their Rights and it is in this background that the statute was created and notified.


  1. Chapter VIII of the Act envisages setting up of an Appellate Tribunal. This chapter consists of Sections 54 to 59.
  1. It is pertinent to mention here that the legislature was aware of the difficulty and the time which is required for setting up any appellate authority. The legislature realizing the above fact and also keeping in mind the necessity to set up effective remedy measures incorporated Section 59 of the Act. It is pertinent to mention here that the Section 59 of the Act would become redundant if the same is not implemented. However despite the same, the Ministry of Agriculture and IPAB, has failed to act under the said Provision.
  1. Section 59 is a transitional provision requiring the Intellectual Property Appellate Board (IPAB‟) established under Section 83 of the Trade Marks Act, 1999 to exercise jurisdiction of the Tribunal till the Tribunal is established under Section 54 of the said Act but requiring a technical member to be appointed under the said Act who would be deemed to be a Technical Member for constituting a Bench under Section 84(2) for the purposes of this Act.
  1. But Despite the lapse of more than 9 years, there is no sight of this Tribunal being constituted or implementation of the transitional provision. This is in addition to the hiatus period of five years from bringing into force the provisions of the said Act.
  1. The Ministry of Agriculture has failed to implement the transitional provision of The Protection of Plant Varieties and Farmers‟ Rights Act, 2001 despite a specific direction being issued by the Hon’ble High of Delhi, vide order dated 22/03/2013 in Writ Petition No. 4527 of 2011 wherein Hon’ble Justice Sanjay Kishan Kual showed the concern of non implementation of the transitional provision over a passage of 6 and a half years. In the said case it was also occasioned that IPAB has given its consent for invoking the transitional provision under Section 59 of the said Act and the Chairman and Vice Chairman of the IPAB will act as judicial members along with the Technical Member to be appointed under the said Act for purposes of exercising the transitional power and authority conferred on the Appellate Tribunal under the said Act. But despite all these the Ministry of Agriculture and IPAB collectively had failed to implement the Transitional provision.
  1. Some of the important observation and direction issued by the Hon’ble High of Delhi, vide order dated 22/03/2013 in Writ Petition No. 4527 of 2011 by Hon’ble Justice Sanjay Kishan Kual is reproduced herein below.

The rules for such an appellate Tribunal were brought into force only on 21.09.2010. Since we found an unexplained inaction in implementing the mandate of the Parliament, we called upon the Union of India to file an affidavit setting out the steps taken for constitution of the Tribunal for the implementation of the transitional provision from 2001 till date and to produce the relevant records in respect thereof. An affidavit affirmed by the Assistant Commissioner (Seeds), Department of Agriculture and Cooperation, Ministry of Agriculture referred to only the aforesaid dates and the factum of the Ministry of Agriculture being the Nodal Ministry for Protection of Plant Varieties and Farmers Rights Authority. It appears that the first communication in this behalf was addressed only vide letter dated 02.07.2009 to the Department of Industrial Policy and Promotion requesting to take note of Section 59 of the said Act and intimate the modalities for operationalization of the transitional provision. A request was also made to the IPAB to suggest the procedure for appointment of the Technical Member. Almost four years hence there appears to be no development. Not only that, even now no date was specified before us as to when the transitional provision of Section 59 of the said Act would be given effect to. One of the reasons stated before us was that the IPAB was reluctant to take up the work especially on account of lack of infrastructure even for its existing work. We thus called upon the Secretary of the two concerned Ministries to discuss the matter and to file an affidavit before us setting out the details of what prevented them from bringing into force at least the transitional provision through properly constituted consisting of a technical member.

An affidavit was filed by the Assistant Commissioner (Seeds) affirmed on 21.02.2013 itself. It is stated that the Act deals with sensitive issues pertaining to farmers rights; determination of “extant varieties”, “farmers variety” and “varieties of common knowledge”. The criteria for registration of the plant/seed varieties requires a lengthy process that includes field testing of the plant/seeds varieties in different conditions and it is after completing this extensive process, that the government formulated the Protection of Plant Varieties and Farmers Rights (Criteria for Distinctiveness, Uniformity and Stability for Registration) Regulations, 2009, which were notified on 29.06.2009 and came into force with effect from 30.06.2009. The Ministry of Agriculture being the Nodal Ministry addressed a communication dated 02.07.2009 as referred to aforesaid for the transitional provision to be implemented and the Department of Industrial Policy and Promotion in turn is stated to have referred the matter to IPAB on 26.08.2009. It furnished its comments on 14.09.2009. The Department of Industrial Policy and Promotion vide a communication dated 15.10.2009 furnished the requisite information to the Ministry of Agriculture. The Plant Varieties Protection Appellate Tribunal (Applications and Appeals) Rules, 2010 are stated to have been notified on 21.09.2010. The Protection of Plant Varieties and Farmers Rights Rules (Recognition and Reward from the Gene Fund) Rules, 2012 were notified on 31.07.2012 while the Protection of Plant Varieties and Farmers Rights (Use of Denomination and Registered Variety) Rules, 2012 were notified on 17.12.2012.

The aspect of implementation of Section 59 of the said Act is stated to be receiving the attention of the concerned Ministry, but there is stated to be some circumspection of this being unchartered territory.

In view of our order dated 21.02.2013, the same officer has filed another affidavit affirmed on 28.02.2013 stating that the IPAB has given its consent for invoking the transitional provision under Section 59 of the said Act and the Chairman and Vice Chairman of the IPAB will act as judicial members along with the Technical Member to be appointed under the said Act for purposes of exercising the transitional power and authority conferred on the Appellate Tribunal under the said Act. Earnest efforts are stated to be made by the Ministry of Agriculture for appointment of the Technical Member. However, it appears that the same is also at the stage of approval of the Expenditure Finance Committee whereafter the Search-cum-Selection Committee would decide the modalities of recruitment of the Technical Member. The time schedule laid down is of one year apart from the time required for approval of the Appointments Committee of the cabinet for which no time limit can be assigned. Thus, we are talking about a period of more than a year, which is stated to be realistic. So much for the interest in protection of plant varieties and rights of farmers!

We need to only emphasize what we have observed in our order dated 21.02.2013. Prior to the introduction and passage of a Bill in the Parliament, a number of steps are taken and considerable ground work is required. This ground work envisages not only the legislative drafting but the legislative impact of the legislation. The legislative impact in turn includes the litigation which it will generate, provisions for appropriately strengthening the judiciary to face the increase in litigation, creation of infrastructure and where specialized tribunals are envisaged, taking steps towards establishment of the same. The assent of the President is the culmination of this process. The will of the Parliament as reflected in the enactment of the said Act, which received the assent of the President, remained unimplemented for five years when only the basic provisions were brought into force without really the substantive provisions, which in turn were brought into force after six and a half years. Was this time not sufficient to analyze all aspects? Since the disputes would have aspects of scientific knowledge, the Appellate Tribunal envisaged a Technical Member. Leave aside the constitution of the Tribunal, even the transitional provision has not been brought into force. The absence of any such specialized Tribunal implies that it is the regular courts, which are already short of adequate number of judges to handle matters apart from technical issues which may arise, that will have to examine the controversy. The result is that neither are these specialized tribunals being brought into force nor is the existing judicial system strengthened to take care of the extra workload, a painful aspect to note. We would end this chapter with a sanguine hope that at least the transition policy is implemented on an urgent basis!


  1. It is quite relevant that the Ministry has failed to implement such an important provision of the Act which is to provide a effective remedy, despite such an observation by the Hon’ble High Court. Today the only recourse available to a party in any dispute under the Act is to file Writ Petition before the Hon’ble High Court.

The question still remain the same is when the Ministry of Agriculture will act in implementing such an important provision of the Act, which was specifically inserted with a view of setting up transitional effective remedy till an effective Authority is set up under the Act. Will the Section 59 of the Act will be given its importance or will it be redundant.

About the Author: Mr. Amarjeet Kumar, Senior Associate (Litigation), Khurana & Khurana, Advocates and IP Attorneys and can be reached

Revocation of Valganciclovir patent by Controller of Patents, Chennai

Recently in a matter remanded from IPAB to Controller of Patents, Chennai, a decision of revoking Roche’s patent IN207232 for Valganciclovir was delivered after hearing both the parties. The subject patent was granted on January, 2009 followed which post grant oppositions were separately filed by CIPLA, Matrix, Ranbaxy and Bakul Pharma along with two NGOs Delhi Network of Positive People and lndian Network for People living with HIV/AIDS & The Tamil Nadu Networking People with HIV/AIDS (hereinafter INP+ and TNNP+), wherein INP+ and TNNP+ were allowed by the Apex court to raise all contentions in the form of an intervention cum affidavit before the Assistant Controller and the parties agreed to be heard along with CIPLA, Matrix, Ranbaxy and Bakul Pharma. In the opposition proceedings, the patent was revoked limiting it to single process claim by the Controller of Patents on 30.04.2010 and being aggrieved by this decision, Roche filed an appeal at IPAB challenging the decision. IPAB on 30.01.2014 set aside the Patent Controller’s decision to revoke the patent on technical grounds and remanded it to the Controller for re-consideration.

Issues before the controller:

  • Determining whether the expert evidence was prior art publication or disclosure

Answering the issue, controller observes that the expert evidence is not a prior art document to be relied upon for deciding a case, but it may be considered for understanding the prior art documents, if the evidence covers such prior art documents. The opinion of the expert evidence, if it is based on further laboratory or animal study of a given subject matter, it cannot be considered for concluding such invention because it is later acquired knowledge, but it can be used for understanding the present invention. Therefore, expert evidences cannot be considered as prior publications/disclosures, but it can be taken as opinion on the prior arts.

  • Deciding upon the obviousness of the present invention

The next issue which the controller addressed was whether the present invention was obvious with respect to prior art references. The controller observes that the present invention is obvious against two prior arts US 4957924 and EP 0375329A2.

Claim 1 of the present invention recites,

  1. The compound 2-{2-amino-1, 6-dihydro-6-oxo-purin-9-yl} methoxy-3-hydroxy-1-propanyl-L-valinate or a pharmaceutically acceptable salt thereof, in the form of its (R) or (S)- diastereomers, on in the form of mixtures of the two diastereomers.

Regarding this , the controller states that the monovaline ester of ganciclovir is disclosed in the form of Markush formula in EP ‘329, which covers both monovaline and di-valine ester of ganciclovir where support for the both mono and di-valine ester of gancicloviris is provided in the specification. Thus the disclosure of EP ‘329 is clear and unmistakable direction to the mono valine ester of ganciclovir. Hence, a skilled person working in the synthetic chemistry field can easily arrive at the present invention without further experimentation. Therefore mono valine ester of present invention is anticipated by EP’329. Controller further emphasizes that claim 1 of EP ‘329 clearly and unambiguously discloses as at least one of the substituents is valine residue which indicate the presence of mono valine ester. Therefore, EP’329 undoubtedly disclosed mono valine ester of ganciclovir.

With respect to process claim, controller observes that the synthetic method for preparing mono valine ester of ganciclovir as claimed in independent claim 12 of present invention may not be explicitly disclosed in EP ‘329, but said method is just a general method for coupling acid group in the amino acid with hydroxyl group, which can be adopted for any type of alcohols. Therefore, using EP’329, a person working in the synthetic chemistry can easily prepare ester of ganciclovir with lysine without undue burden.

Further the controller observes that the object of the present invention is to provide a prodrug of ganciclovir with improved oral bioavailability. Controller notes that the solution for poor absorption in the gastrointestinal tract for acyclovir is disclosed in US ‘924 patent. Therefore a person skilled in the art can perceive to prepare mono valine ester of ganciclovir from the teachings of both EP’329 and US’924 references. Thus all the claims including process claim are obvious to a skilled person in the art.

  • Deciding upon the efficacy of substance under the subject patent under section 3 (d)

Deciding upon the efficacy of substance under the subject patent, the Controller observes that the new form L-monovaline ester of ganciclovir molecule has shown improvement in oral bioavailability than bis-valine ester of ganciclovir and ganciclovir, whereas there is no support in the specification pertaining to efficacy. Controller observes that the ester modification of the present invention was made to protect the substance from destruction in the gastrointestinal tract and make the molecule more bioavailable. Thus the controller has ruled that while bioavailability is one of the factors affecting efficacy, it cannot be directly equated to efficacy. Citing Hon’ble Supreme Court of India’s decision on Novartis case, the Controller rules that: “lmprovement in bioavailability of the new form cannot be considered directly related to efficacy. Even any unforeseen property observed in new form, unless such property directly relate to efficacy, it will be considered as inherent property of such substance. Since there is no direct relation shown for the improved bioavailability of new form of ganciclovir in the description with regard to significant difference in the efficacy, and therefore such a new form shall be considered as a same substance. Thus new form of the present case Monovaline ester of ganciclovir is considered as a same substance i.e. ganciclovir because,the difference in enhanced efficacy is not shown in the complete specification.” According to the controller, since there is no direct relation shown for the improved bioavailability of new form of ganciclovir in the description with regard to significant difference in the efficacy, therefore such a new form shall be considered as a same substance. Further regarding process used for preparing present invention, the controller held that the process used to prepare new form is a conventional process as it is already known process as disclosed in EP ‘329. Thus, the Controller rules that the present patent was a ‘mere use of a known process’ which was not patentable under S. 3(d), Patents Act.

  • Locus standi of the two NGOs as “person interested” under section 2(1)(t)

Deciding the locus standi of the two NGOs, as person interested under section 2 (1)(t) of patent act, Controller notes that NGOs would fall under the ambit of persons interested as the criteria of locus standi in post grant opposition is to be viewed in broader perspective to grant quality patent. According to the Controller, the two NGOs are the end users or directly affecting parties, if the patent is granted. Thus it is held by the controller that viewing in to the broader prospective, the two NGOs falls under the purview of under section 2 (1)(t) of the patent act and hence the parties have locus standi to oppose the patent.

Thus hearing all the parties and considering all facts and relevant arguments, the Controller revoked the patent granted for the drug Valganciclovir under section 25(4) of Indian Patent act.

About the Author: Mr. Sitanshu Singh, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at:

CIPLA & BMS may settle patent dispute over Entecavir in India

US based pharma major Bristol-Myers Squibb (BMS) and Indian pharma company Cipla Ltd. are heading towards an amicable settlement on a long-stretched patent dispute concerning BMS’ hepatitis B drug Entecavir, a leading anti-viral drug for Hepatitis B patients that brings in more than a billion dollars each year globally for BMS.

Entecavir, being a pre-1995 molecule, was not patented in India as the Indian patent law did not provide patent protection for “products” till 1995. However, BMS filed a patent application for its once daily composition comprising Entecavir and got a patent in India for the same. The patent application (IN/PCT/2002/00891/MUM) was filed at Mumbai patent office by BMS in 2001 and it was granted (IN213457) in the year 2008.

Claim 1 of IN ‘457 read as:

  1. A pharmaceutical composition effective for once a day oral administration to treat Hepatitis B virus infection in a human adult patient comprising up to 1 % of entecavir, adhered to a carrier substrate of kind such as herein described, and pharmaceutically acceptable excipients such as herein described in an amount as herein described, wherein the said percentage is based on a total composition weight of 100 mg.

Claim 12 of IN ‘457 read as:

  1. A method of preparing a pharmaceutical composition of entecavir as claimed in claim 1 comprising (a) dissolving said entecavir and an adhesive substance in a solvent wherein said solvent is water or water having an acidic or basic pH, (b) spraying said solution obtained in step (a) onto a carrier substrate while said carrier substrate is in motion, (c) drying said coated carrier substrate from step (b) to remove said solvent, and (d) combining said dried coated carrier substrate from step (c) with other excepients as claimed herein above to form said pharmaceutical composition.

In 2010, Cipla, had filed a revocation application with the India’s Intellectual Property Appellate Board (IPAB) against BMS’ patent IN ‘457 covering a pharmaceutical composition comprising up to 1% of Entecavir effective for once a day oral administration to treat Hepatitis B virus infection in a human adult patient.

When the case came up before the IPAB, the counsel representing Bristol-Myers Squibb informed the patent tribunal that both the drug makers are in negotiations to settle the patent dispute. The IPAB bench comprising chairman justice KN Basha and DPS Parmar, technical member, patents, adjourned the matter since both the parties were exploring the possibilities of an amicable settlement.

BMS previously reached a settlement with Indian generic firm Natco Pharma concerning the drug. Natco and BMS had entered into a similar settlement over the Entecavir composition patent, after Natco had applied for revocation of the patent at the IPAB.

Generic drug producers such as Dr. Reddy’s and Cadila launched their generic versions of Entecavir (Baraclude) in India earlier in 2010 by designing around the once daily composition patent. Ranbaxy had also launched a generic product of the drug earlier in the Indian market.

US scenario of Entecavir: (Patent dispute between BMS & Teva)

Entecavir is protected by two patents in United States viz. US 5206244, product patent which covers the Entecavir molecule and US 6627224 which covers Entecavir compositions effective for once a day oral administration. Teva Pharmaceutical, an Isreal based generics major, challenged the Entecavir product patent in a US court and launched its generic version of Entecavir in US market. Teva successfully invalidated the Entecavir product patent based on obviousness ground and an appeal by BMS was denied by the US Court of Appeals for the Federal Circuit, in 2014.

About the Author: Antony David, Senior Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at:

Recent decision of IPAB in the case of E.I.DU Pont De Nemours & Company V. Galpha Laboratories and Ors

This article is relates to a recent judgment of Intellectual Property Appellate Board (hereinafter IPAB) dated 4th December 2014 in the case “E.I.DU Pont De Nemours & Company V. Galpha Laboratories and Ors.

Brief Facts:

On 11th March, 2009 the trademark registry refused the opposition of the E.I.DU Pont De Nemours & Company (appellant herein) and allowed the application of trademark “NOMEX” under application No.499603 in Class 5 of the Galpha Laboratories (respondent herein) under the provisions of the Trade and Merchandise Marks Act,1958. Thus being aggrieved by the rejection by Indian trademark registry, an appeal was filed by the DuPont to IPAB. The copy of the decision made by IPAB can be accessed here.


The appellant’s Company is a limited company incorporated under Company’s Act 1956 having registered office in Mumbai. The appellant has production facilities for DuPont Crop Protection Products, Dupont Liquid Packaging Systems. The appellant has claimed that they have spent huge amount of time, money and efforts in promotion of trademarks registered under various classes in world over including India. The appellant has further claimed that they are registered proprietor of many trademarks covering more than 50 countries. The appellant has obtained registration and is registered owner of trademark “NOMEX” in many countries including India. The appellant has further stated that all the above registrations of the trademark has been renewed from time to time and are valid and subsisting. The appellant stated that they have obtained trade mark NOMEX under class 22, 16, 17, 23 and 24.

The appellant came to know through an advertisement dated 16th April, 1999 that vide journal No.1197, the respondent had filed an application under the name “NOMEX” vide application No.499603 dated 19th October,1988 under the Trade and Merchandise Marks Act, 1958 in respect of pharmaceuticals, medical preparations and substances in Class 5 claiming user as proposed to be used. The appellant has filed a Notice for Opposition dated 13th of August,1999 vide Opposition No.BOM-54010 against the registration of the trademark “NOMEX” in class 5 under the provisions of Trade and Merchandise Marks Act of 1958.

Decision by Assistant Registrar:

After hearing the pleadings by both the parties, the Assistant Registrar has passed an order on 11th of March, 2009 rejecting the Opposition of the appellant on the below grounds.

(i) The Assistant Registrar accepted the contention of the respondent herein that they took search on the trademark registry for the trademark “NOMEX” in Class 5 and also made a market survey in the market for medicinal products and there was no conflicting trademark in Class 5.

(ii) The Assistant Registrar held that there is no similarity and identical with the mark that of the opponent as per section 11(A) revised under section 11(1) of the Act. Hence, there is no possibility of confusion and deception under section 11 (C) revised under section 11 (3) of the

Trademarks Act, 1999. The goods of the applicants are entirely different from the opponent. Further the Assistant Registrar rejected the contention of the opponent that they have not proved prior user period from 1984 to 1988 and used his discretionary power under section 18(4) of the Act by granting registration of the trademark “NOMEX” in class 5 to the respondent.

Thus being aggrieved by rejection, the applicant preferred an appeal in IPAB for challenging the rejection of said Trademark opposition.

 Arguments advanced by the Appellant:

It was argued by the appellant that the Assistant Registrar has failed to appreciate the appellant’s use of the trademark “NOMEX” in the international market since 1963 and in India since 1984. Further Trademark registry has failed to appreciate that the trademark adopted by the respondent is identical to the appellant, who is a prior adopter and user in India. It was further contended that the Assistant Registrar has erred in holding that usage of the mark by the respondent would not cause confusion and deception amongst the members of the public and trade as the respondent buyers are different from that of the appellant.

The appellant further claimed that “NOMEX” is a well-known trademark. The appellant also argued that the Assistant Registrar has failed to appreciate that the respondent has no use and is yet to use the mark and it is identical to the appellant trade mark. The Assistant Registrar has erred in holding the appellant has not proved prior user from 1984 to 1988.The Assistant Registrar erred by disallowing opposition of the appellant and further erroneously used his discretionary power under section 18(4) of the Act, which are contrary to principals of law. The Assistant Registrar has also erred in holding the respondent had taken proper steps, despite of no search report brought on record.

Arguments advanced by the Respondent:

The respondent contended that they had taken care and prior search in selection, adoption as there was no prior use of the trademark in the pharmaceutical industry. The respondent conceived and coined the trademark “NOMEX” for use in respect of medicinal and pharmaceutical preparations falling in Class 5. Further the respondent argued that the registration of application “NOMEX” in Class 5 will not cause prejudice to the appellant under section 9 of the Act as under section 8 to respondent trade mark is distinctive and capable of distinguishing from the goods of the appellant.

Decision of IPAB:

IPAB stated that while perusing the impugned decision of the Assistant Registrar of 11th , March, 2009, the Assistant Registrar has rendered a short cryptic order without assigning cogent reasons by simply quoting the provisions under the Trade and Merchandise Marks Act, 1958 revised under sections 11(1) and 11 (3) of the Trademark Act, 1999. The impugned order of the Assistant Registrar failed to disclose on what grounds or on what material record that he has allowed the registration to go ahead by rejecting the contentions of the appellant / opponent and further does not disclose any judicious reasoning, while exercising his discretionary power vested with him under section 18 of the Act for granting the registration to the respondent herein.

Further IPAB observed that the Assistant Registrar at one end admits in his order that the marks are similar and identical, without divulging sound reasoning as to how he had arrived into conclusion that the mark though identical and similar but still there is no confusion or deception. IPAB stated that the Registrar has failed to discuss the cogent reasons in accepting the application of the respondent allowing their trademark to be registered.

Thus in the light of averments, IPAB set aside the impugned order by trademark registry observing that the order was passed in gross violation of principal of natural justice and remanded the matter to the Assistant Registrar to consider the matter afresh by affording opportunity to both sides and pass orders on merits in accordance with law.

About the Author: Mr Sitanshu Singh, Patent Associate, Khurana & Khurana, Advocates and IP Attorneys and can be reached

M/s Aditi Manufacturing Company v/s Mr. Bharat Bhogilal Patel , Section(64) patent act, 1970

Takshasheel Bouddha, an intern at Khurana and Khurana Advocates and IP Attorneys, analyses the case, M/s Aditi Manufacturing Company v/s Mr. Bharat Bhogilal Patel &The Controllers of Patents & Designs. This judgment is with respect to Section 64 of Patent Act, 1970.


The dispute was regarding of two patents i.e. Patent No.189027 and Patent No. 188787 granted to and held by respondent which the petitioner wanted to be revoked. Initially the petition for revocation was filed in honorable High Court of Gujarat from where it was transferred to IPAB. M/SAditi Manufacturing Company was petitioner while Mr. Bharat Bhogilalwas the respondent and both the parties were engage in the same set of business.

Both thepatents owned by respondent were on the same subject matter relating to the laser technology. Patent No.189027 was granted for a process of manufacturing engraved design articles on metals or non-metals using Lasers and Patent No. 188787 was granted for an improved laser marking and engraving machine.

 Petitioner‘s Argument

The petitioner M/S Aditi Manufacturing Company claimed that inventions are related to laser technology and engraving machine is not novel and it was already in public domain. The inventions also lack inventive step as per the requirement of Section 2(j)(a). A lot of prior arts were present disclosing identical product and process and therefore requirement of sections 3(k), 3(f) and 10(4) of ‘The Patent Act, 1970 were not met.

The revocation in both cases was sought on the ground that the invention has been used from 1996 by one Sarju Laser Marking Private Limited and sold in the market even before the date of patent.

The specification was notably alike to US Patent No. ‘789 dated 26/03/1985 for “Reliable low cost light weight CS pumped Nd:Yag laser with option at Q-switching”. The claims were analogous to US Patent No. 4467172 and Japanese Patent No. 141679.

The petitioner also relied on the publication by Excel Control Laser Inc. in 1992 which described both the machine and process

The counsel for the applicant argued that the word “improved” in the patent claimed is vagueand is not clear. It is ambiguous in nature and therefore more clarity should be there.

The petitioner further argued that it is just a collection of known integers.

They further contended that patent has been obtained by suppression of information and there is no inventive step.

The petitioner counsel relied on the proposition of law laid down regarding revocation in  Air Master Equipments India (P) Ltd. v/s. Mr. Ramesh Nana Mahtre;M/s Bishwanath Prasad RadheyShyamv/sM/s Hindustan Metal Industriesand Monosanto Company v/s CoromandalIndag Product (P) Ltd.

 Expert Witnesses:

IPAB relied upon the expert opinion of Dr. D.D. Bhawalkar who had obtained the degree of PhD in ‘Laser technology’ from the University of Southampton, U.K. He had an opinion that there is nothing new described in the patents. He has written to M/s Legasis Partners that the laser marker is identical to US Patent No. 178. He has also stated that Galvos is in the market for a long time.

IPAB also consider the opinion of Mr. Utpal Nandi, another expert and a qualified Engineer from the Raja Ramanna Center for Advanced Technology for about 30 years. In his opinion, the patentee has not disclosed the appropriate facts related to prior art in Patent Office. Furthermore laser marker which was developed from components available in the market in 1995 at the Raja Ramanna Center. In his view there is no novelty or innovativeness in the said invention and if the patentee claims that the machine is improved one, he should show where the improvement lies.

 Respondent’s Arguments

The patentee rebutted relating to the cause of action. He also vehemently opposed the presence of technology in public domain. He merely denied all the prior inventions stating that all are different from his invention and are not known components.He further argued that if laser beam is not focused properly, the object cannot be marked and that is the most important and basic step of their basic process that is patented.  They also contended that they are unaware of Excel Control Laser publication.

According to the respondent, the applicants being non-technical did not understand the technical aspect of the invention and further that it is not a combination of known-integers or rearrangements.

Decision of IPAB:

Objections raised by the applicant were sustained by IPAB and the patents were revoked on the grounds that the invention was already known and there is neither any novelty nor any inventive step.

Relief for Pfizer as IPAB stays Revocation on Drug Tolterodine

In a positive development for US drug giant Pfizer, the country’s Intellectual Property Appellate Board (IPAB) has issued an interim stay on an order stated by the Indian Patent Office removing a patent of Pfizer, for its extended release drug Tolterodine (Detrol), which is used for treating old age patients who suffer from frequent urination. On the post-grant opposition by Indian pharmaceutical company Daiichi Sankyo owned Ranbaxy Laboratories, the Assistant Controller of Patents and Designs had revoked the patent in November 2013 under section 25(2)b, 25(2)c, 25(2) and 25(2)e of the Patent Act, and subsequently removed it from the registry in December last year.


The turf war between the two multinationals started when the Chennai Patent Office revoked Pfizer’s claims on a formulation of its best-selling drug Tolterodine(Detrol).The patent on the drug was challenged by Ranbaxy Laboratories. In India, Pfizer has two patents on Tolterodine (Detrol), the first patent IN211539 was filed in August 1999, and the second (IN229260) three months later in November which cover its extended release capsule formulation. It is believed that the invention claimed in the revoked patent (IN 229260 ) was found to be “prior claimed” by another patent of Pfizer (IN 211539 ) on the same drug under Section 25(2)(c) of prior claiming. A comparison of claims of the two patents is given below. picture3The invention claimed in the revoked patent was also found to be obvious, and not involving any technical advancement compared to existing knowledge under Section 25(2)(e) of obvious over prior art. Ranbaxy relied on three prior documents i.e.; US 4800084, WO 98/03067 AND WO 96/12477. US 4800084 discloses the use of seal coat between the core and the drug layer in a multilayer medicated formulation whereas, WO 98/03067 discloses a method of use of Tolterodine in urinary voiding disorder in which various possible formulations of Tolterodine including the controlled release formulation are disclosed, but does not discuss any formulation in detail.WO96/12477 discloses a controlled release oral delivery system for oxybutynin, comprising a bead system of core and coatings. Oxybutin is a tertiary amine antiuscarinic used to treat urinary incontinence. The controller said that the “person skilled in the art would have been motivated to prepare controlled release bead for tolterodine with the teachings of preceding prior art together with common general knowledge in the art at that time of filing the application without undue experimentation”. Further, the study carried out by the patentee on ‘effect of sealcoat thickenss’ does not possess any inventive merit. The Controller further held that it is common general knowledge in the art when thickness of layer increases, release rate of the drug or permeability of water decreases. Workable range of sealcoat layer neither suggested nor described in the complete specification. Therefore, present patent do not involve any technical advancement as compare to the existing knowledge. However, the opposition board sided with the patentee and opined that inventive skill is involved in selecting quantity of the drug, core medium and compatible polymers for coating to arrive at a controlled release formulation as claimed in the instant patent IN 229260. The Assistant Controller revoked the said patent (IN 229260) of Tolterodine (Detrol) stating its obviousness and that it was prior claimed by another patent (IN211539) of Pfizer.

Further Developments:

Aggrieved by the developments, Pfizer moved to IPAB, requested for stay on the controller of patent’s order. However, when the matter came up at IPAB in March 2014, Ranbaxy’s counsel submitted that they have not been given enough time by Pfizer to prepare the counter against the appeal and the matter be adjourned, which was refuted by the latter. Considering the petition, IPAB Chairman held: “The balance of convenience is very much favourable to Pfizer and accordingly we are granting an interim stay on the assistant controller’s impugned order of November 27, 2013, which revoked the patent of Pfizer.” The order was on a miscellaneous petition of Pfizer for an interim stay. The IPAB bench also observed that Ranbaxy is open to file a counter-affidavit, seeking redressal of grievances under the applicable laws. Further in March 2014, the counsel for Pfizer, PS Raman, submitted that the controller of patents had removed the patent from the register on December 15, 2013, hardly a month after pronouncement of the revocation order on November 27, 2013. He pointed out this was done even before the limitation period for referring an appeal had expired. According to him, Pfizer had time till February 28, 2014, to appeal against the impugned order. While Pfizer informed the Board that it has served the notice to Ranbaxy on the hearing of the miscellaneous petition through courier-post on March 13, 2014, the latter in a letter dated March 21, 2014, stated that they have received the notice from the registry only on March 19, and sought a relief of adjournment. IPAB held that Ranbaxy having received the notice from the petitioner as early as March 13, 2014, had enough time to appear and argue the matter of stay petition. Hence there should not be any justification for seeking further time.


Since 1991, Pfizer has been using the subject patent at the international level and filed for Indian patent in 2001, and also seen that Pfizer did succeed in pre-grant opposition. In my opinion, this revocation decision has only reduced the Tolterodine patent term by three months ( IN 229260 expires on November 2019) since the other patent IN211539 is still valid till August 2019, but since both patents covering Tolterodine claim the same invention and one of the patents is revoked as being obvious over prior art, the second patent is now susceptible to revocation under same grounds of obviousness and lack of inventive step and hence will be an inspiration for other competitors as well to attack the first patent.

About the Author: Sugandhika Mehta, Patent Intern at Khurana and Khurana and can be reached at:

Clarification on Small Entity Status of Patent Applicants in India

I really wonder if the Indian Patent Act was already less troublesome that we needed a new set of rules, substantially increased fees, and more importantly introduction of the Small Entity Status of Applicants, which creates even more confusion on retrospectively payable fees, implications of change in status during prosecution, timeline for submission of Form 28, qualification for foreign applicants, among many other allied issues, which would now need clarity and potentially cause issues wherein there is deficiency of fees. Really hoping that this does not become a reason for abandonment of the patents applications, especially when even the provision of deposit account (Rule 7(5)), although mentioned in the Patent Act, is still not in practice.

Barely 2-3 days had passed by after our sending an update on the new rules and introduction of small entity status that we started receiving queries from across law firms, corporate houses with clarifications on small entity status for foreign entities. This led to this piece to help clarify certain doubts that have been asked for and we hope there is a FAQ released by the Patent Office soon to clarify and bring on record certain obvious questions arising out this amendment.

To go back one step, as a background, Rule 2(fa) of the Amended rules contains the definition of small entity. An entity will be a small entity if one of the two conditions is met:

(i)   the enterprise is engaged in the manufacture or production of goods, and has investments in plant and machinery that do not exceed ten crore rupees (approx. US$1,611,085),

(ii)  the enterprise is engaged in providing or rendering services, and has investments in equipment that do not exceed five crore rupees (approx. US$807,495)

The above amount limits are based on clause (a) and (b) of sub-section (1) of section 7 of the Micro, Small and Medium Enterprises Development Act, 2006 (27 of 2006), which can be accessed here.

  1. A new Form 28 has been introduced which needs to be filed by a small entity applicant. For Indian entities, Form 28 must be accompanied with the proof of registration under The Micro, Small and Medium Enterprises Development Act, 2006 (27 of 2006), whereas, for Foreign entities, Form 28 must be accompanied by any other document as proof. Such ‘any other document’ can be, for example, executed copy of Balance Sheet/P&L, Declaration by a Govt. Entity of Respective country, among other applicable documents)
  2. In case an application processed by a small entity is fully/partly transferred to a, say a large entity, the difference in the scale of fee(s) between the fee(s) charged from a small entity and the fee(s) chargeable from the large entity in the same matter, would be paid by the new applicant along with the request for transfer. Therefore, in case the Applicant transforms from a small entity to a large entity while filing the request for examination, as it presently appears, the increased fee would need to paid retrospectively, i.e., the difference in fee as would have been taken place at the time of filing of the Application, would also need to be paid.
  3. It would therefore be safer for companies to be aware of their current entity status at all times, as any change in the status, would lead to a change in the applicable fee, and as per the point 4 of the public notice dated 28’th Feb 2014 having Ref. No. CG/F/Public Notice/2014/307, it has been clarified that it shall be the sole responsibility of the Applicant(s) to select the correct category of the Applicant and file all supporting documents in respect thereof while filing an application or other documents, failure of which may attract provisions of section 142(3) of the Indian Patents Act.
  4. In case any Applicant believes that it is a small entity right now, they should, as soon as possible, file the executed Form 28 along with the MSME registration certificate in order to be eligible to pay the small entity fees. Even a provisional MSME registration certificate should ideally serve as an acceptable evidence, but the same may be at the discretion of the Examiner/Controller.
  5. Also, as the present online filing system does allow filing an application as a Small entity with no compulsion on the uploading of the Form 28, any such uploading of an application without an executed Form 28 may attract provisions under Section 142(3) of the Indian Patents Act,which may severely impact the patent rights during national phase filings, and therefore in case Form 28/Evidence thereof is not available, its much safer to file the Application as a normal (that is large) entity and then submit the Form 28 along with the evidence at a later date to gain benefits for subsequent activities.
  6. In case of joint applicants, as is usually the case, the highest fee category of the applicant among the joint applicants will be taken into consideration for the purposes of fee calculation.
  7. Incorrect claiming of Small entity status, or non-declaration of conversion from small-entity to large-entity, may also become a ground of revocation of patent by a third party trying to invalidation the patent in context, and therefore a careful note is to be made and stringent compliance of the amount limits should be done in case small-entity status is being claimed.

Roche sues Biocon and Mylan over biosimilar version of Herceptin in India

Trastuzumab/Herceptin has been amidst several controversaries off lately and this time it is regarding a biosimilar which has jointly been manufactured by Biocon and Mylan.


Roche’s breast cancer drug Herceptin sold under the brand names HERCEPTIN, HERCLONTM and BICELTIS is a biological drug used primarily for the treatment for human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer on a worldwide basis and enjoys a global reputation.

Since its the most prevalent cancer among Indian women,  with approximately 150,000 new patients getting diagnosed every year in India, the originator drug costing around US$3,000–US$4,500 (INR 1.64–2.45 lakh) for a month’s treatment, making it unaffordable to many of Indian citizens leading to lack of affordable treatment options for HER2+ patients which also lead to a campaign in March 2013 to urge the Govt to take appropriate measures to ensure affordability of Herceptin.

However after several months of deliberation and debates, the Department of Industrial Policy and Promotion (DIPP) refused a plea for compulsory licensing for Trastuzumab.

Also, last year in a very surprising development Roche decided not to pursue Herceptin patents in India.

Keeping in mind all these factors, the approval by the Drugs Controller General of India (DCGI)  and launch of Biocon’s CANMAb December last year the world’s first biosimiliar versions of Roche’s blockbuster cancer drug ‘Herceptin’ , is highly likely to be an alternative affordable option, being marketed at about 25% discount to the current list price of the reference product in India.

But inspite of all the pricing advantage, ex parte proceedings by Roche at the Delhi High Court last week has led to an injunction stopping two pharmaceutical companies i.e.; Biocon’s Canmab and its partner Mylan’s Hertraz from being launching, introducing, selling, marketing and/or distributing  its branded drug Herceptin on the grounds of not being able to satisfy the requirements for a biosimilar drug in accordance with the guidelines. Also, the other issue raised was that of passing off; where Roche contended that the defendants were seeking to pass off their products as being equivalent in quality and class to Herceptin by referring to their products as “biosimilar version of Trastuzumab/Herceptin.

Requirements for Biosimilars in accordance with guidelines

“Biosimilars” are biological products that are similar to the innovator biopharmaceutical product.

In view of the structural and manufacturing complexities involved in the production of the biopharmaceuticals, a biosimilar product can only be similar to the innovator biopharmaceutical product; it cannot be a generic equivalent of the innovator biopharmaceutical product.

Also, with the development and growth of the market for biosimilars in India and the international standards for approval of such products, the Guidelines on Similar Biologics were issued in 2012 which lay down specific standard for development and evaluation of similar biosimilar biologics.

After the issuance of the Guidelines on Similar Biologics, all the applications for manufacturing and marketing authorization of similar biologics in India are required to be evaluated on the basis of the standards set forth on it ie;

the demonstration of similarity depends upon detailed and comprehensive product characterization, preclinical and clinical studies carried out in comparison with a reference biologic.

However, Roche claims that DCGI has approved Biocon’s “protocol and design study for testing” related to the proposed drug even before its own regulatory guidelines were firmed up and there is no public record available, in the clinical trial registry India (CTRI) or elsewhere to show that these firms actually conducted phase-I or phase-II clinical trials for the drug.

Also, Roche has casted doubts in its submission saying the Indian drug regulator’s approval for biosimilars couldn’t have come about in ‘such a short period’ when its ‘prescribed procedure’ in the guideline is so long.

The Swiss company argues that there is no public record available, in the clinical trial registry India (CTRI) or elsewhere to show that these firms actually conducted phase-I or phase-II clinical trials for the drug.

In my opinion no matter whether it’s a biosimiliar of Herceptin or not, clinical trials should be rigorously practised according to the new guidelines issued by the Indian Govt.

With respect to the human safety, there is a very big question which highlights the negligence of the drug controller who gave an approval to Biocon and its partner Mylan without the necessary clinical trials being conducted.

About the Author: Sugandhika Mehta, Patent Intern at Khurana and Khurana and can be reached at: