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Wednesday, April 10, 2013


On April 8, 2013, India has become signatory to Madrid Protocol for International Registration of Marks at the World Intellectual Property Organisation. Currently there are 88 other member countries to Madrid System (Madrid Protocol and Madrid Agreement) for the international registration of trademarks. The system is administered by the International Bureau of the World Intellectual Property Organization (WIPO), which maintains the International Register of marks. The system will come into force in India in 3 months i.e. July 8, 2013.

Advantages of Madrid system is that it allows filing a single application, in one language to be filed with the trademark office of the home country to obtain protection in several countries. It guarantees on the period within which potential grounds of refusal to protect a mark can be raised by the offices of the designated countries. It allows a single request to record changes (transfers, changes of name or address, etc.) which may affect the registration as a whole or in part. A single request for renewal can be made.

Prerequisites for filing an International Application:
  • Existence of a registered or pending mark for same goods and service with “Office of origin” from where international application is to be filed.
  • Applicant must be person who has a real and effective industrial or commercial establishment or a domicile in, or who is a national of, one of the countries party to the Protocol.
  • Basic fee of 653 Swiss francs for black and white mark or 903 Swiss francs where the mark is in color
  • Name of the Countries where protection is sought must be listed in the international application. Additional countries can be designated at any time, provided they are party to the Protocol at the time of the designation. Such subsequent designations are useful where new countries accede to the Protocol or simply where the holder’s interest in a country develops after the international registration has been made.
  • Either a standard designation fee of 73 Swiss francs or an individual designation fee whose amount is fixed by the country concerned (but may not be higher than the amount that would be payable for registering the mark directly with the office of the country concerned, for example in respect of India the amount fixed by Trademark Registry cannot exceed INR 3500) for each designated country;

The Office of origin may charge a handling fee for forwarding the international application to the International Bureau. The fees are to be paid direct to the International Bureau although, in some cases, the Office of origin may collect and forward them.

A supplementary fee of 73 Swiss francs is payable for each class of goods and services beyond the third class.  This supplementary fee is payable only if there are one or more countries designated with standard designation fee. Accordingly if all the countries designated are ones in respect of which an individual designation fee is payable, no such supplementary fee is payable.
An international application can be filed in any one or more language amongst English, French or Spanish as the Office of origin may restrict.

It is also possible to claim priority in an International Application from a first national or regional application, by filing the International Application within six months of the filing of that first application.

The Office of origin then forwards the international application to the International Bureau of WIPO. The office of origin has to supply the International Application to WIPO with all essential details within 2 months of filing. The Office of Origin has to certify that the mark in the international application is the same as in the basic application or registration, that the applicant is the same person as the owner of the basic application or registration and that the goods and services listed in the international application are covered by those listed in the basic application or registration. The International registration bears the date on which the international application was filed with the Office of origin.

The International Bureau checks that all the filing requirements are met and that the goods and services are correctly classified. If so, the mark is recorded in the International Register. The International Bureau then notifies the international registration to the Offices of the designated countries. The International Bureau does not examine whether the mark as such qualifies for protection, or whether an identical or similar mark has already been registered; that is to be examined by the respective Offices of the designated countries.

From the date of the international registration, the protection of the mark in each of the designated countries is the same as if the mark had been the subject of an application filed direct with the Office of that country. If no refusal is notified within the prescribed time limit, the protection of the mark in each designated country is the same as if the mark had been registered by the Office of that country. The Office of a designated country has the right to refuse protection of a mark in the territory of that country. Refusal may be made on any of the grounds on which an application for registration filed direct with that Office might be refused. Refusal is notified to the International Bureau and recorded in the International Register.

Normally, any refusal must be issued within 12 months from the date on which the Office concerned was notified of such designation. By making a declaration, a country may extend this time to 18 months. Similarly, by making a declaration, a refusal based on opposition may be issued after expiry of 18 months period, but in that case the country must notify the International Bureau about possibility of such opposition within 18 months. It allows holder of an international registration to know whether his mark has been accepted for protection in each of the designated countries, or whether protection has been refused in one country or whether there is still a possibility of refusal on the basis of an opposition in a particular country.

The holder has the same right to contest the refusal with the Office that issued it as if the mark had been deposited direct with that Office. It is advisable to hire services of Local Attorneys within such jurisdiction to attend to the objections/ refusal, who may guide the holder as to local provisions and practices to counter such objections/ refusals. If the refusal relates to only few of the goods and services listed in the international registration, and the refusal is not contested and/or contest is not successful, the mark stands protected for the remaining goods or services, without any action being needed on the part of the holder. In India typically objections in relation to one class is not only based on identical-ness or similarity of goods or services, but mainly because of existence of another identical or deceptively similar mark in same class, there objection has to construed as objection to such entire class.   

The international registration shall be dependent on the application or registration with the Office of origin (the “basic application” or “basic registration”) for the first five years. After the end of the five-year period, the international registration becomes independent of the basic application or basic registration. It is the period within which the basic application is subject to “central attack”. If, during the first five years following the date of the international registration, the basic application is refused or withdrawn, or the basic registration is canceled, the international registration must also be canceled. This is also the case if the basic registration is refused after the end of this five-year period as a result of an action begun within that period. If the refusal or withdrawal of the basic application or cancellation of the basic registration is for only some of the goods or services, the cancellation of the international registration will likewise be partial and limited to those goods or services.

Duration of an international registration is ten years from date of filing or priority. It is further renewable for periods of ten years each, on payment of requisite fees to the International Bureau.

Sunday, April 7, 2013

Novartis Patent for Beta Crystalline form of Imatinib Mesylate rejected by Supreme Court of India

Supreme Court of India while hearing the Appeal ( as a matter of exception this appeal was admitted and heard, though all appeal against Order of IPAB are to be heard by High Court first) preferred by Novartis AG against the order of Intellectual Property Appellate Tribunal (IPAB) rejected the product Patent rights for Beta Crystalline form of Imatinib Mesylate for failing in both test of invention (under Section 2(1)(j) & 2(1)(ja) as well as patentablity (under Section 3(d)). The Court consequently allowed the counter-appeal filed by two of the respondents i.e. Natco Pharma Ltd. and Cancer Patients Aid Association.

There is no separate finding on the counter-appeals preferred by Natco Pharma Ltd. and Cancer Patients Aid Association therefore it can be assumed that Novartis AG still retains the process Patent rights for manufacturing Beta Crystalline form of Imatinib Mesylate. 

It would be essential to go into the brief history of the Patent Application filed by Novartis AG for Beta Crystalline form of Imatinib Mesylate and its prosecution in India: 

1.         On July 17, 1998 Novartis AG filed Patent Application in India i.e 1602/MAS/1998, claiming priority from Swiss Patent Application dated July 18, 1997 for invention titled "Crystal modification of N- phenyl-2-pyrimidineamine derivative, process for its manufacturer and its use. The said Patent Application was opposed by way of Pre-Grant Opposition under Section 25(1) of Indian Patents Act by Cancer Patients Aid Association, Natco Pharma Ltd., Cipla Ltd, Ranbaxy Laboratories Ltd., Hetero Drugs Ltd. 
2.         Vide order dated January 25, 2006 the Assistant Controller of Patents rejected the Patent Application for following grounds
(i) Anticipated by Zimmermann Patent  (US Patent no. 5, 521,184, continuation in part of US Patent Application serial no. 08/042,232 dated September 9, 1993) and article published on May 1996 in “Nature Medicine” and Patent extension certificate issued by USPTO that mentions Imatinib Mesylate (Gleevac) as product. Also on the satisfactory proved by Natco pharma that salt normally exists in beta crystalline form which is most thermodynamically stable product.
(ii) Obvious for reasons of prior publication as mentioned above
(iii) Non Patentable under of Section 3(d) of Indian Patents Act, claims new form of a known substance without any significant improvement of efficacy.
(iv) Claiming wrong priority as Switzerland was not a conventional country on date of making of application
3.         Novartis AG filed Writ petitions against the said order of Assistant Controller of Patents in Chennai High Court as at that time the IPAB was not established, vide order dated February 23, 2007 the High Court converted said writ petitions to appeal.
4.         Simultaneously Novartis AG itself and through its POA holder in India filed two writ petitions challenging the provision of Section 3 (d) of the Indian Patent Act, as being unconstitutional and against the TRIPS obligation of India
5.         During pendency of writ petitions on April 3, 2007 the Govt. of India brought provisions as to appeal to IPAB with effect from April 2, 2007 and consequently the 5 appeals were transferred by High Court to IPAB vide order dated  April 4, 2007.
6.         The Technical member (Patents) to the IPAB previously hold post of the Controller General of Patents, therefore Novartis AG filed Petitions for ceasing the Technical member (Patents) from hearing the appeals. By Order dated July 20, 2007 the petitions were dismissed relying on doctrine of necessity.
7.         Novartis AG challenged the order by a writ petition before the Chennai High Court and the High Court directed IPAB to constitute a special bench of Chairman, Vice Chairman to hear the appeals and for seeking assistance of Scientific advisers, if they found fit. 
8.         Natco Pharma filed a SLP before Supreme Court against said order for appointment of new Technical Member to hear instant appeals because of involvement of high technology in the matter as well as for statutory requirement of presence of technical member in the Board having special qualification. Supreme Court vide order dated 1, 2008 directed reconstitution of IPAB including Dr. P.C. Chakraborti, Assistant Controller as Technical Member and to hear appeals on daily basis from November 3, 2008.
9.         IPAB vide Judgment dated June 26, 2009 allowed only the process claims for manufacture of Beta crystalline form. 
10.       Against the impugned judgment by IPAB, Novartis AG approached the Supreme Court directly and after hearing all the parties, a very detailed, well-reasoned order was passed by Supreme Court of India on April 1, 2013.

While adjudicating on the issue Supreme Court considered interplay between qualifying criteria of invention and criteria of patentability of an invention. It had to consider if the product qualifies as “invention” within the meaning of clauses (j) and (ja) of section 2(1), can its patentability still be questioned and denied on the ground that section 3(d).

Few historic date concerning the development of product Imatinib, Imatinib Myselate and Beta crystalline form of Imatinib Myselate are as follows:

April 28, 1994                        Application for derivatives of N-Phenyl-2 pyrimidine-amine including Imatinib filed before USPTO by Jurg Zimmermann

January 1, 1995                     On March 26, 1999 Parliament passed the Patents (Amendment) Act 1999 (Act No. 17 of 1999) which amended the provisions of the Patents Act 1970 retrospectively, with effect from January 1, 1995, the date when the TRIPS Agreement came into force. By the Amendment Act of 1999, section 5 of the Parent Act was amended to provide for making “a claim for patent of an invention for a substance itself intended for use or capable of being used, as medicine or drug. The Amendment Act further incorporated in the Parent Act, Chapter IVA, which contained provisions for grant of exclusive marketing rights in respect of pharmaceutical substances for which a claim for patent was made under section 5 of the Act. The Amendment Act of 1999 thus complied with Article 70(8) and (9) of the TRIPS Agreement.

January 1996                         Cancer Research published an article under the title “Inhibition of the Abl Protein-Tyrosine Kinase in Vitro and in Vivo by a 2- Phenylaminopyrimidine Derivative” authored by several people, including Jurg Zimmermann. There was detailed discussion about the antitumoral properties of Imatinib and its methanesulfonate salt, i.e., Imatinib Mesylate.

May 28, 1996                         Patent granted by USPTO (5, 521, 184) referred herein after as Zimmerman Patent

July 18, 1997                          Application filed in Switzerland by Novartis AG, for grant of Imatinib Mesylate Patent to Beta Crystalline Form

April 9, 1998                          Novartis AG filed for Investigational New Drug Application (IND #55,666) for Gleevac before Food and Drug Administration (FDA) USA

July 17, 1998                          Application filed in India by Novartis AG, for grant of Imatinib Mesylate Patent to Beta Crystalline Form (1602/MAS/1998) claiming priority from Swiss Patent Application

November 30, 1998              Switzerland notified as convention country

January 18, 2000                   Novartis AG made application for Patent for Beta Crystalline Form of Imatinib Mesylate in USA

February 27, 2001                 Novartis AG filed for Original New Drug Application (NDA #21-335) for Imatinib Mesylate before Food and Drug Administration (FDA) USA. It declared that active ingredient of the drug is Imatinib Mesylate. The drug substance, active ingredient, drug product (composition/ formulation) and method of use were declared to be covered by US Patent no. 5, 521, 184. It was declared that said patent covers composition, formulation and/or method of use of Imatinib Mesylate.

May 10, 2001                         FDA approval granted to drug “Gleevac (Imatinib Mesyalte) 50 mg and 100mg capsules.

July 3, 2001                            Patent Term extension application made for US Patent no. 5, 521, 184 and term extended to further 586 days from original expiry date of May 28, 2013

March 27, 2002                      Novartis AG, made application for grant of Exclusive Marketing Rights (EMR) to Indian Patent Office

November 10, 2003              EMR granted to Novartis AG, by Indian Patent office

November 23, 2003              US Appellate Court reversed rejection of Beta Crystalline Form of Imatinib Mesylate by the USPTO
January 1, 2005                     Provisions related to Product Patent introduced w.e.f. January 1, 2005 in India
May 17, 2005                         Patent for Beta Crystalline Form of Imatinib Mesylate Granted in USA
January 25, 2006                    The Assistant Controller of Patents rejected the Patent Application for Beta Crystalline Form (1602/MAS/1998) of Novartis filed in India on basis of pre Grant oppositions
February 23, 2007                  Writ Petitions filed against the Assistant Controller’s order converted into Appeals
April 3, 2007                          Govt. of India brought provisions as to appeal to IPAB with effect from April 2, 2007

April 4, 2007                          Appeals of Novartis AG were transferred by High Court to IPAB.

June 26, 2009                         IPAB allowed only the process claims for manufacture of Beta crystalline form and rejected the product and use claims for beta crystalline form

April 1, 2013                          Supreme Court rejected the appeal of Novartis AG against the judgment of the IPAB

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