Monthly Archives: November 2015

Delhi High Court Upholds Roche’s Patent Claims on Lung Cancer Drug (Tarceva) against Cipla

A division bench of Delhi High Court on 27th Nov 2015 held that the Indian drug manufacturer Cipla infringed Swiss pharmaceutical company Roche’s patent on Erlotinib hydrochloride, marketed under the name of “Tarceva”.

Roche was granted a patent in India on Erlotinib hydrochloride (Tarceva) in 2007. Roche sued Cipla for patent infringement in January 2008 soon after Cipla announced its intent to launch a generic version of Erlotinib (i.e. Erlocip) at Rs.1,600 per tablet, compared to Roche’s selling price of Rs.4,800 per tablet.

The verdict came on the pleas of Cipla and Roche, both of which had challenged the single judge’s order of September 7, 2012. The single judge in his order had held that Cipla was not infringing Roche’s patent and refused to grant any injunction against Cipla, and it allowed the Indian drug firm to continue selling its generic product, Erlocip. The judge had also refused to revoke the patent of the Swiss company as sought by Cipla.

A division bench of justices Pradeep Nandrajog and Justice Mukta Gupta held that the single judge “erroneously compared the products of Roche and Cipla when he ought to have mapped the claims of the suit patent against Cipla’s product”.

Cipla in its plea had urged that while the patent sought to be enforced was for polymorphs A+B of Erlotinib hydrochloride, the product under manufacture by both Roche and Cipla was polymorph B, which ought to be assumed to be in the public domain and, hence, the Indian company’s activities were non-infringing in nature.

Roche in its plea had contended that the basic patent was not confined to any polymorphic form of Erlotinib hydrochloride and, hence, as long as the compound was present in Cipla’s product Erlocip, it infringes the patent.

The division bench in its decision held that:

“This (the patent claim) is a sufficiently broad claim that is clearly not limited to any polymorphic version of erlotinib hydrochloride, but to erlotinib hydrochloride itself,”. “This compound may exist in several polymorphic forms, but any and all such forms will be subsumed within this patent. Therefore as Cipla’s Erlocip is admittedly one particular polymorphic form of the Erlotinib Hydrochloride compound (Polymorph B), it will clearly infringe IN’774 patent.”

The court, however, refused to issue any injunction against Cipla restraining it from manufacturing the medicine, after observing that the life of the patent granted to Roche was ending in March 2016. However, the Court has directed Cipla to render accounts to Roche and make payment for the patent infringement.

“…keeping in view the fact that the life of the patent in favour of Roche in India would expire in March, 2016 we do not grant the injunction as prayed for by Roche against Cipla (because as noted above there was no interim injunction in favour of Roche and due to said reason Cipla continued to manufacture and sell Erlocip),” held court.

Also, the division bench in its 106-page judgment said that as Cipla “could not establish prima facie that the suit patent was obvious”, its plea for invalidating Roche’s patent on the ground of ‘obviousness’, “fails”. In addition, Cipla had demanded Roche’s patent be revoked under Section 3(d) of the Indian Patent Act that essentially bars incremental innovations unless significant efficacy is proven.

Bringing clarity to Section 3(d), the judges wrote: “We understand Section 3(d) as a positive provision that in fact recognizes incremental innovation while cautioning that the incremental steps may sometimes be so little that the resultant product is no different from the original. The inherent assumption in this is that infringement of the resultant product would therefore be an infringement of the original i.e. the known substance and by no stretch of imagination can Section 3(d) be interpret as constituting a defence to infringement.”

Roche welcomed the decision of the Court which upheld the patent covering Erlotinib hydrochloride (Tarceva) and found Cipla to have infringed it.

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

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Establishment of Commercial Courts Division at Delhi High Court

Pursuant to the Promulgation of the Commercial Courts, Commercial Division and Commercial Appellate Division of High Courts Ordinance, 2015 the Hon’ble the Chief Justice vide orders dated 15.11.2015 has declared the constitution of Commercial Division at Delhi High Court with Six Benches, consisting of a Single Judge each, under Section 4(1) of The Commercial Courts, Commercial Division and Commercial Appellate Division of High Courts Ordinance, 2015, with effect from 16.11.2015.

Hon’ble the Chief Justice vide orders dated 17.11.2015 has further declared constitution of Commercial Appellate Division with four Division Benches at Delhi High Court under Section 5(1) of The Commercial Courts, Commercial Division and Commercial Appellate Division of High Courts Ordinance, 2015 with effect from 17.11.2015 and has further ordered that the four Division Benches in the Commercial Appellate Division shall be DB- 1, DB-2, DB-3 and DB-4.

The detailed orders to see the judges who have been nominated to be judges of the Commercial Courts and Commercial Appellate Division can be accessed here.

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

VPATAPP – An Android Based Free Mobile App

We at IIPRD are glad to associate with a team of IP Enthusiasts who have developed an android-based mobile application called “VPATAPP”, and are happy to give a brief introduction of the same to our readers. This is first of its kind of offering on android play store and is available free of cost.

About the app:

VPATAPP is a simple tool which acts as a repository for the patent data across the globe. The app exclusively deals with the patent related resources across the globe and does not cover other forms of IPR. This tiny app is meant for patent professionals across the industries and academia. This app currently has seven different features:

  1. Patent Blogs: The app provides links to various IP blogs across the globe.
  2. Weblinks for Worldwide full time LLM/Masters/ Graduate courses in IP from USA, Europe, India, Singapore, Australia, Korea, Israel and South Africa.
  3. Various journals in the area of Intellectual Property Law especially patents;
  4. Weekly or monthly official gazettes or registers published by different patent offices across the world; Currently 54 countries/regions are covered under this tab.
  5. Patent classification systems;
  6. Patent search websites available from patent offices across the world; Currently 62 countries/regions are covered under this tab.
  7. Updated full text patent acts of different countries as published by the patent offices or WIPO; Currently 55 countries/regions are covered under this tab.

Please See: https://play.google.com/store/apps/details?id=org.gunadhya.vpatapp

About the team of app developers:

A team of four IPR enthusiasts created the app. The team is led by Mr. Vijay kumar Shivpuje, whose profile can be accessed here: https://in.linkedin.com/pub/vijaykumar-shivpuje/14/50a/75a.

The second version of the app is under development and would be with added features and would be available in the month of December 2015.

The comments, feedback and reviews about the app are welcome to vijayksl123@gmail.com or can be sent directly to +91 9768665354.

Commercial Courts, Commercial Division and Commercial Appellate Division of High Courts Ordinance Promulgated in India

The President of India on October 23, 2015 promulgated the Commercial Courts, Commercial Division and Commercial Appellate Division of High Courts Ordinance, 2015, No. 8 of 2015. The ordinance aimed towards constitution of Adjudication Authority for speedy disposal of commercial dispute of specified value and matters connected thereto.

Highlights of the Ordinance are as follows:

Commercial Dispute:

Ordinance provides definition of Commercial dispute to include disputes relating to transactions between merchants, bankers, financiers, traders, Intellectual Property Disputes, Contractual disputes related to the commerce, licensing and distribution agreements, partnership agreements, technology development agreement inter alia.

Valuation of Dispute:

Ordinance provides that all matters relating to commercial disputes involving an amount of Rs One Crore or more to be dealt with by commercial divisions in High Courts and Commercial Courts.

Commercial Courts:

Ordinance provides State governments to set up commercial courts, equivalent to district courts, after consulting with their respective high courts. However, a commercial court will not be set up in an area where the high court exercises ordinary original civil jurisdiction.

Commercial Divisions in High Courts:

Ordinance provides Commercial divisions to be set up in those High Courts which exercise ordinary original civil jurisdiction, that is, the High Courts of Delhi, Bombay, Calcutta, Madras and Himachal Pradesh.

Commercial Appellate Divisions:

Ordinance provides Commercial appellate divisions to be set up in all High Courts to hear appeals against:

  • orders of commercial divisions of high courts,
  • orders of commercial courts, and
  • appeals arising from arbitration matters that are filed before the high courts.

Right to Appeal:

Section 13 of the Ordinance provides for Appeal from order of Commercial Court or Commercial Division of High court to Commercial appellate division of that High Court to be filed within 60 days from the date of judgment or order.

Transfer of Pending Suits:

Section 15 of the Ordinance provides for transfer of all suits and application relating to the commercial dispute of specified value pending in High Court or Civil Court in any district to the Commercial Division. However any matter wherein the final judgment has been reserved by the Court prior to the constitution of the Commercial Division or Commercial Court shall not be subject of transfer.

Conclusively, the Ordinance aims towards faster disposal of the Commercial disputes in India and in pursuance to that provide for certain strict timeline for the disposal of the suit. Ordinance provides timeline of less than two years for the procedure to resolve the commercial dispute excluding the time for pleadings, arguments and disposal of the Ordinance further made certain important amendments to Civil Procedure Code in order to meet the aim of speedy disposal of the commercial dispute.

The Ordinance is a very positive move towards the commercial growth of the country which shall definitely change the face of Indian Legal System by rendering speedy disposal of the commercial disputes which shall ultimately help to reduce the high Pendency of the litigation matters in India.

The Commercial Courts, Commercial Division and Commercial Appellate Division of High Courts Ordinance, 2015, No. 8 of 2015 can be accessed here.

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

A Simplified Account of Patenting Procedure in India

Well, this is something for which we have been getting queries on regular basis from individual inventors, universities and companies in India as well as outside India. This article comprehensively addresses all the procedural issues which normally applicant faces while patenting invention in India. Though this article focuses on the procedural aspects, it is always a good idea to start a discussion with basics. Patents are territorial rights which mean to secure invention in India, one has to get it patented in India. No regional patent applies to India. It is to be noted that patent does not confer on the patentee positive rights rather it confers on the patentee negative right i.e. right to exclude other from doing certain acts (see section 48 of The Patents act, 1970 (hereinafter referred to as ‘act’)).

We will address all the procedural aspects in Question and Answer format.

  1. Who may apply for patent?

True and first inventor, his assignee or legal representative of either of them after their death (According to section 6 of act)

  1. Where to apply?

Kolkata (Head Office), Mumbai, Delhi or Chennai depending on the jurisdiction of which applicant resides, has domicile or place of business in India (first applicant in case of joint applicants) or  the place where invention originated or patent attorney’s office is situated (in case of foreign applications). When applicant does not have a place of business or domicile in India, address for service in India needs to be submitted.

  1. Types of application:
  1. Provisional application: This is to be filed when inventor is not ready with the complete details of the invention but wants to secure the priority date. Claims may be filed with (though we at Khurana & Khurana do not recommend it) provisional application.
  2. Complete specification: It has to be filed within 12 months from the date of filing of provisional specification, failing of which will cause application to be abandoned.  It may be filed directly (without filing provisional specification) when the applicant is ready with the complete details of the invention. Every convention application, application filed under Patent Cooperation Treaty, divisional application has to be filed with complete specification. According to section 135 of the act, for same or substantially same application (s) for patent filed in convention countries, application for patent may be filed in India by the same person who has filed application in convention country or his legal representative or his assignee, which is known as convention application within 12 months from the date of priority of the application filed in convention country. National phase application under Patent Cooperation Treaty may be filed designating India within 31 months of the date of priority. This period of 31 months and period of 48 months within which request for examination has to be filed are non-extendable. As one application for patent can only be filed for a single invention or a group of closely related invention, if claims of the complete specification relate to more than one invention, applicant if he so desires or with a remedy the objection raised by the controller, may file a further application known as divisional application at any time before the grant of the patent. For filing complete specification, applicant needs to submit form 1 (application for grant of patent), 2 (provisional/complete specification), 3 (statement and undertaking u/s 8), form 5 (declaration of inventorship), form 26 (form of authorization of patent agent), and form 28 (to be submitted by small entity) along with other documents. Form 9 needs to be filed if early publication is desired. Form 18 needs to be filed for examination or express request for examination. These forms need to be filed either with the application or within prescribed time period.
  1. What is patent of addition?

It is the application made by the applicant or patentee of the main invention for any improvement in or modification of the invention disclosed in the complete specification therefor.  Reader is further advised to click here for an interesting and knowledgeable article on patent of addition.

  1. Is there any period during which pre-grant can be filed for sure?

Pre-grant opposition can be filed any time after the publication of the application till the grant of the patent. According to rule 55 (2003 rules), no patent shall be granted before the expiry of a period of 6 months from the date of publication so during this period pre-grant opposition can be filed for sure.

  1. Who may file request for examination and what is time allowed for putting application in condition of grant?

It may be filed by the applicant or any other interested person but examination report is sent to the applicant only. In case request for examination was made by the any other interested person then intimation of examination is sent to such other interested person. The time for putting an application in order for grant is twelve months from the date on which first examination report is issued to the applicant.

  1. Is it possible to file pre-grant opposition even though there is no request for examination filed?

Yes, it is possible to file representation for pre-grant opposition even though no request for examination has been filed. However, the representation will be considered only when a request for examination is received within the prescribed period. As representation for pre-grant will be considered only when a request for examination is received within the prescribed period, one can choose to file request for examination as ‘any other interested person’ so that one does not need to wait till applicant files request for examination. This will help to expedite the process and decide the fate of patent application.

  1. What is the relevant date from the infringement perspective?

Though suit for infringement can only be instituted after the grant of patent, patentee shall have privileges as if it is patent was granted on the date of publication of application.

  1. We have summarized below important timelines and also compared and contrasted different procedures involved in the patenting in India.procedure_patenting

A graphical representation of the procedure of patenting in India

Notes:

  1. In case, secrecy directions have been given in respect of any application, then application shall be published after the expiry of 18 months or the expiry of such directions, whichever is later.
  2. If request for examination is not made within applicable time limit, then application is treated as withdrawn by the applicant.
  3. In case, secrecy directions have been given in respect of any application, then request for examination has to be made within 48 months from the date of priority or date of filing of the application, or 6 months from the date of revocation of the secrecy direction, whichever is later.
  4. In case of divisional application, request for examination has to be filed within 48 months from date of filing or priority of first mentioned application, or within 6 months from date of filing of further application, whichever expires later.

Table 1: Comparison of procedures for publication and Examination of patent application

procedure_publication_examination

* Request is compulsory for early publication and needs to be made in form 9.

**The patent office does not commence the processing of an application filed corresponding to international application designating India before the expiry of 31 months from the date of priority, unless express request is made in form 18.

Table 2: Comparison of procedures for Pre-Grant and Post-Grant opposition to patent application

procedure_pre_grant_post_grant

While filing for pre-grant opposition has no charges, post grant opposition can be done only on charges.

  1. Payment of annuity:

No annuity/maintenance/renewal fees needs to be paid for first 2 years out of 20 years of term of patent. According to section 53 (2) of the act, renewal fees needs to be paid in order to keep patent in force at the expiration of 2 years or subsequent years from the date of patent which shall be renewal fees for the third year or subsequent year. It means that maintenance fees needs to be paid in nth year in respect of nth plus 1 year. According to section 142 (4) of the act, where a principal patent is granted later than 2 years from the date of the filing of the application, the fees which have become due in the meantime may be paid within a term of three months from the date of the recording of the patent in the register or within the extended period not later than nine months from the date of recording. Renewal fees due in respect of 2 or more years may be paid in advance. Extension of period to pay fees up to 6 months can be sought in form 4. This period of six months is not extendable.

  1. Costs involved in the patenting in India:

They can be divided into statutory fees and attorney fees.

Statutory fees:

Statutory fees as revised by the patent (amendment) rules 2014can be accessed here. For physical filing, 10% additional fees have to be paid more than e-filing. In other than natural person(s) category, fees for small entity fees are half to those entities which are not small entities.

Attorney fees:

These charges vary from attorney to attorney and task to be done. Attorneys also vary charge depending on whether client is Indian or foreign. For Indian client, generally charges by attorneys for preparing patent application are INR 20 to 50 K,  for patent searches are INR 15-20 K, for responding to examination reports are INR 15-20 K,  for filing pre-grant opposition are INR 25-30 K.

For foreign client, generally charges by attorneys for preparing patent application are US$ 450-500, for filing reply to objection raised by patent office are US$ 600-800, for attending hearing and replying to hearing notice are US$ 600-800, for drafting and filing opposition are US$ 600-800.  It is to be noted that quoted charges are just for general idea and actual charges may vary. Khurana and Khurana also helps clients with other patent related tasks than those mentioned above for quoting charges. Quoted tasks and charges are just exemplary. To know the charges of our firm, please contact us at the contact details given at our site.

Khurana and Khurana has on board patent agents who are experienced, are qualified to practice before patent office and are well versed with all the procedures of patenting. Khurana and Khurana would be obliged to help you with any patenting issues.

It is to be noted that patent (amendment) rules 2015 are not taken into consideration as said rules are still into draft stage.

About the Author: Swapnil Patil, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: swapnil@khuranaandkhurana.com.

Draft Patents (Amendment) Rules 2015

Indian Patent Office (IPO) has recently published Draft Patents (Amendment) Rules 2015 and has invited comments (objections or suggestions) from public within 30 days from the publication of the notification (26th October 2015). The proposed draft can be accessed here.

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The major change suggested (proposed) under the draft Rules are as follows:

In addition to above rules, there are some proposed amendments in Form 1, 2, 3, 4, 13 and Form 27.

Further 3 new forms have been proposed namely:

  • Form 18A: Request for expedited examination of application for patent;
  • Form 29: Request for withdrawl of request for examination and request for withdrawl of application of patent;

Form 30: To be used when no other form is prescribed.

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