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

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:

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:

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 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:

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


  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


* 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


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:

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.


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

The Coarse Course of the Trademark Agent Examination and the Viva Voce marks

A long wait of 5 years finally dawns upon the announcement of the Indian trade marks agent exam 2015 reigniting ageing dreams of aspirants. Notwithstanding the sigh of relief the announcement brought with itself, the onset of the trademark agent 2015 procedure and preparations however are not left untouched by certain rhetorics and concerns.

To un-curtain this position on concerns, attention is sought towards the Rule 154 of Trademark Rules, titled ‘Procedure on application and qualifying requirements’ specifying:

The qualifying marks for the written examination and for interview shall be forty percent and sixty percent respectively and a candidate shall be declared to have passed the examination only if he obtained an aggregate of fifty percent of the total marks.

A prima facie reckoning of impropriety grips one, to see that no heed was paid to quite the parallel Patent Agent examination matter, where the Honorable High Court of Delhi in Ms. Anvita Singh vs Union of India, pertinantly and specifically negated the rule requiring even as much as 50% minimum marks attributed to VIva Voce.

To provide a brief background to the case, Ms. Anvita while managing to get 61 and 72 marks in paper I and II respectively at patent agent exam, 2011, was failed by IPO as she could manage only 40 marks in the ever so subjective viva voce. She subsequently challenged the rule requiring a minimum of 50% in the viva voce, which ultimately led to striking down the requirement of minimum 50% marks in viva and implementation of Patent (Amendment) Rules, 2012. Patent (Amendment) Rules, 2012 thereafter not only reduced the weightage of total marks to 50 marks from 100 marks, but removed the requirement of minimum marks at viva completely as was followed in the Patent agent exam 2013. Plausible arguments asserting minimum 50% for viva voce is too high a prescription and gives unquestionable arbitrary power to the interview board to downslide a candidate even regardless of written examination viva voce making it discriminatory, arbitrary and violative of Articles 14, 16 and 19(1) (g) of the Constitution were submitted and accepted by the court with the background that in most developed countries, no viva voce forms a part of the evaluation process of Patent Agents Registration. The Delhi High Court acceded to Anvita Singh’s contentions.

This decision was later even referred and upheld in the Renu Rampal vs Union of India case decided on May 29, 2012.

Furthermore, not only do the concerns stand on the substantive terms as opined above, it gets supplemented by an observation of a curious mind on the calculations and calibrations of the Viva Voce Minimum Marks requirement.

According to the recent notification by IPO announcing the trade marks agent exam-2015, which has made clear that written examination and interview shall be for 90 and 10 marks respectively, with total of 100 marks.  This means one has to get minimum 36 marks in written examinations and 6 marks in viva and 50 in aggregate. So the mathematical connotation here betraying the letter of law is  this: when one can get maximum 10 marks in viva, and the aggregate has to be 50, then the minimum marks required in the written examination cannot be lesser that 40 which turns out to be 44.44% and not 40% as the rules require it to be.

One sullenly wonders that while these concerns glare back, the path to address them might mean another long stretched road of a PIL, one which will likely just elongate the time to crystallize the dreams of aspirants, most of which just resumed flight after 5 long years of wait.

From our side, we extend to all the aspirants the best of our wishes, and may this Trademark Agent Examination be a stepping stone to a more robust, thriving and positive IP ecosystem in India !

About the Author: Abhishek Pandurang, Partner at law firm Khurana & Khurana, Advocates and IP Attorneys and Swapnil Patil, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: and

The Game of Fame and Name

One of the famous quotes of Shakespeare is ‘what’s in a name’. As well acclaimed and with due respect to his views  “a rose would smell like a rose even if it were called by another name” has lost its relevance in present day scenario. These days in the highly competitive environment and globalisation most of the world renowned celebrities are running behind name and  fame and want to  secure their reputation, which keeps on being bigger with every passing moment. So, there is a new buzz among celebrities to secure their reputation from unauthorised exploitation by registering their name as a “Trademark”.

The Trade Mark Act, 1999, prohibits the use of personal names under section 14 where an application for the registration of trademark is likely to be rejected if it suggests  connection with a living person ,or person whose  death took place within 20 years prior to date of application. Certain names like Sri Sai Baba, Lord Buddha, Sri Ramakrishna, the Sikh gurus cannot be registered under section 16(1) of 1940, 23(1) of Trade & Merchandise Act 1958 &159(2) of the Trade Mark  Act, 1999.

Individuals may apply for the protection of their name and “likeness” among many other things with the Indian Trademarks Registry in order to obtain statutory protection against misuse. This is of strategic importance for celebrities who intend to use their image and “likeness” to identify and endorse their own or an authorized line of merchandise and prevent any inappropriate usage of their celebrity drawing powers.

The trend of celebrities in India seeking protecting under the trademark law has seen a phenomenal  increase and they seem to be taking a cue from celebrities across the globe. Some of the famous international celebrities mentioned below have already either filed or got the trademarks registered with the relevant Trademark Registry:

Victoria and David Beckham

Soccer star David Beckham and his wife Victoria have led the way in exploiting their names, after registering them, as well as Beckham Brand Limited. David and Victoria Beckham’s value soared to more than £190 million after they successfully trademarked their names, using them to sell everything from underwear to perfume. The couple has been rumoured to make £100,000 everyday, courtesy their names.

Shahrukh Khan

First Bollywood star who come into lime light for filing Trademark in non other than “Badshah” of Indian Film Industry ‘Shahrukh Khan’. Shahrukh Khan filed Trademark with  his signature mark  ‘SRK’ in almost all classes to secure his Brand name and as on date, holds twelve registration in his name.

Shahrukh Khan also known as ‘SRK’ has Brand Value not less than ‘million and millions’ and it is a very smart step from “King Khan” to secure his name. ‘SRK’ will indeed have a right to sue those who are in fact infringing his Intellectual Property rights or passing off any goods or services using his brand value/name and that could well include the local hair-dresser or a shop selling garments.

Akshay Kumar Bhatia

After back to back “Khiladi” venture, Akshay Kumar Bhatia claims that ‘Khiladi’ is a brand with which he is being associated with since 1992.With a view to strengthen the association with the title, and gain the statutory edge, the actor has filed an application for registration of trade mark  ‘Khiladi’ in his name with the TM registry under many Trademark Classifications.

Sachin Ramesh Tendulkar

God of Cricket, Legend, Father of Cricket and many more names are actually some of the titles  to describe this man. This God of Indian cricket has made India Feel so Proud across the world. The Cricketer has his initials ‘SRT’ trade marked. The great cricketer has big brand value worldwide, TM ‘SRT’ is smartest step by the cricketer to secure his reputation which he has earned after a lot of hard work and dedication. No one without his permission can use title Sachin Ramesh Tendulkar ‘SRT’, in fact the film maker, who had used the cricketer’s reference in his film ‘Ferrari Ki Sawaari’, had to seek the cricketer’s permission before using his name.

Amitabh Bachan TM his baritone voice

Can some one Trademark his/her voice? Yes, according. to the definition of Trademark in Trademark Act “trade mark” means a mark capable of being represented graphically and which is capable of distinguishing the goods and services of one person from those of others.

Angry Young man who is famous for his dialogue delivery and specially for his ‘Voice’ filed an ‘Sound Mark’ which is not so known in India. Many companies advertise their products using his voice without any authorization or notification to him. A Gutkha company used his voice for advertisement after which Amitabh Bachan had to give clarification that he had not done such an advertisement. The step of seeking protection of his voice under sound mark is a good measure towards protection of his reputation and brand.

There are still many in line and waiting to get their fame.

Its all about Game of Name………..

Source: Google

About the Author: Paras Khurana, Trademark Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at:

Research Exemption in Indian Patent Law

The research or experimental use exemption permits researchers and product manufacturers to make certain use of a patented invention. The general idea behind this exemption is that it sets boundaries to patent holder rights such that the patent holder cannot prevent third parties from undertaking certain activities with respect to the patented invention. In pharmaceutical context, the experimental use exemption is referred to as “Bolar exemption”. The Bolar exemption provides an exception from patent infringement to the generic manufacturers from using patented drugs for research and development, for the sole purpose of submission of information for regulatory approvals of generic versions of patented products before the concerned patents expire.

            Section 107A of the Indian Patent Act, 1970 is generally referred to as India’s “Bolar exemption”. In the competitive generic market of India, it is important to balance the individual interest i.e. patentee’s rights and societal interest i.e. need for better and cheaper access of products to the society.

Section 107A of the Indian Patent Act, 1970 recites:

107A. Certain acts not to be considered as infringement – For the purposes of this Act,—

(a) any act of making, constructing, [using, selling or importing] a patented invention solely for uses reasonably related to the development and submission of information required under any law for the time being in force, in India, or in a country other than India, that regulates the manufacture, construction, [use, sale or import] of any product;

(b) importation of patented products by any person from a person who is duly authorized under the law to produce and sell or distribute the product,

shall not be considered as an infringement of patent rights.”

Delhi High Court Interprets Scope of Section 107A of the Indian Patent Act:

            On November 2014, in Bayer Corporation Vs. Natco Pharma Limited, the High Court of Delhi examined the scope of India’s Bolar exemption. Specifically, the issue to be decided in this case was whether the exportation of an active pharmaceutical ingredient (API) constituted a defense to infringement under Section 107A of the Patents Act.

            Petitioner (Bayer Corporation) was granted a patent (IN215758) for a pharmaceutical product titled “Nexavar” (compound being Sorafenib Tosylate) which is used for the treatment of patients with advanced stages of kidney and liver cancer. Natco (respondent no. 5) applied for and was granted a “compulsory license” to manufacture pharmaceutical products which were covered under the Bayer’s patent on the ground that reasonable requirement of the public with respect to the aforesaid product was not met and it was not made available at reasonable and affordable price. Specifically, the “compulsory license” was “solely for the purpose of making, using, offering for sale and selling the drug covered by the patent for the purpose of treating HCC and RCC in humans within the territory of India”. Subsequently, Natco started manufacturing the product under the brand name ‘Sorafenat’ but was not permitted to export the same.

            Bayer allegedly received information that Natco was exporting the API, Sorafenib Tosylate outside India in violation of the terms of the compulsory license. Consequently, Bayer filed a writ petition with the Court requesting that the product covered under the compulsory license be confiscated and any consignment for export be seized. On March 26, 2014, the Court passed an interim order directing Natco to ensure that no consignment containing Sorafenib Tosylate covered by the compulsory license was exported.

            In the mean time, an application was filed by Natco before the court inter alia praying for permission to export 1 kg of Sorafenib Tosylate (API) to a Chinese pharmaceutical company for the purpose of conducting development/clinical studies and trials. Natco produced a certificate from the Chinese company stating that the company required 1 kg of Sorafenib for the purpose of “formulation R&D purpose and the same was not intended for any commercial purpose”.

            Natco argued that the 1 kg of Sorafenib was required for conducting regulatory studies in China and despite the compulsory license, export of the API was exempt by virtue of Section 107A of the Patents Act, 1970. Bayer argued that the regulatory approvals in China were being sought by the Chinese Pharma company and not by Natco, and hence Section 107A would not apply. Bayer further argued that exportation of Sorafenib was not permitted by the terms of the compulsory license and would not fall within the scope of Section 107A. Bayer stressed that the use of Sorafenib by a third party for development purposes did not entitle Natco to infringe Bayer’s patent. Additionally, Bayer argued that because Natco was not conducting any development studies, exportation of Sorafenib to China could not be construed to be solely for uses related to the development and submission of information required by any regulatory authority. Finally, Bayer noted that Section 107A did not permit export of Bayer’s product because the word “export” was missing from the section 107A.

            After a review of the facts, the Court accepted that the product Natco sought to export was not for commercial purposes since the amount was only sufficient to make 1000 to 2000 tablets (which was approximately the single trial batch size required by the Chinese Regulatory Authorities). Thus, according to the Court, the only question that had to be addressed was whether Section 107A covered export of a patented product for use by an overseas importer to conduct studies and generate data for the purpose of seeking regulatory approval in that country.

            Bayer relied heavily on the history of Bolar exemption in US (which allows sale only in the United States) and the Polish decision ‘Polpharma’ to contend that the applicability of Section 107A of the Act must be restricted to only self-use.

            The Court rejecting the reliance placed by Bayer on ‘Polpharma’, held that a sale which is related to submission of information as required by any law in India or outside India would be permissible by virtue of Section 107A. The Court further stated that the exclusion to a patentee’s right as provided under Section 107A is wider than the exceptions provided by the laws of the U.S.

Specifically, the Court stated:

“India is one of the largest producers of generic versions of drugs around the world. Given the economic realities of our country, providing cheaper medicines is a necessity. The parliament in its wisdom has, thus couched the exclusion to a patent, as provided under Section 107A, in wide terms. The sweep of the plain language of Section 107A, thus, cannot be restricted in the manner as canvassed on behalf of Bayer.

…Plainly, Section 107A of the Act takes within its fold any sale of a patented invention which is required for development and submission of information under any law in a country other than India that regulates the manufacture or sale of any product. Indisputably, under the Chinese Law, submission of studies and data related to bio-equivalence and bio-availability of API in a generic version, is required as discussed earlier and the sale of 1 kg. of Sorafenib to Chinese company can be reasonably stated to be related to the studies that are required to be conducted by Chinese company for obtained the regulatory approvals.

…[t]he language of Section 107A of the Act is determinative of the question whether export as sought for by Natco is permissible within the exemption of Section 107A of the Act. The use of the expression ‘reasonably related to’ as used in Section 107A of the Act would plainly mean a reasonably nexus. Thus, the only question that needs to be answered is whether there is any reasonable nexus between the sale of Sorafenib by Natco to Chinese company and submission of information under the law in force in China. In my view, the answer to this question is clearly in the affirmative.

…It is also important to note that the language of Section 107A of the Act is materially different from the law as applicable in U.S. Whilst, the US Law restricts the safe harbour to a sale within United States and solely for purposes related to information under a Federal Law, Section 107A of the Act is circumscribed by no such conditions. Thus, a sale even outside India would fall within the sweep of Section 107A, provided it is reasonably related to development and submission of information as required under a law in force in India or outside India.”

            The Court also rejected Bayer’s arguments that the language of Section 107A excluded “exports” because this term was not specifically recited. However, the Court stated:

“I am not inclined to accept this contention for the reason that the expression ‘selling’ is wide enough to even include cross border sales (i.e. exports). If the Parliament intended to restrict the exception to only sales within India, the same would have been expressly stated as was done by the US Congress under 35 US Code 271(e)(1).”

            The court stated that the sweep of the plain language of Section 107A, thus, cannot be restricted in the manner as canvassed on behalf of Bayer. Eventually, the court allowed the application filed by Natco on the ground that the sale of 1 kg of Sorafenib Tosylate to the Chinese pharmaceutical company, in China could be reasonably stated to be related to the studies that are required to be conducted for obtaining the regulatory approvals. The Delhi High Court interpreted Section 107A expansively to conclude that Section 107A is applicable when a party exports a patented product to a third party outside India as long as the purpose of export is the facilitation of research.

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

Patentability of Genes, Gene Sequencing & DNA based Primers

Patents have been granted in various biotechnology fields such as genetically engineered plants, human genetic sequencing, recombinant DNA molecule, diagnostic kits, stem cells, isolated nucleic acid encoding a gene and DNA related inventions such as preparing vectors, primers etc, but it was not the same before genetically engineered microorganism was granted a patent first.

The patenting of genes and/ or DNA sequences has always been popular in the US, European Union (EU) and Japan. However, patenting of DNA sequences/ genes per se was not allowed in India until January 2005, but processes involving recombinant DNA technology to produce proteins involving a gene or DNA sequence was a patentable subject matter. Following the third amendment of the TRIPS agreement, product patents for DNA, RNA or genetic inventions are also included as a patentable subject matter.

This blog would be addressing patentability aspects of DNA based primers, Genes and Gene Sequencing and comparison of granted patents of same patent family in three main jurisdictions i.e. USA, Europe and India.

Important Case Study

2013 was a major year for biotechnology (biotech) companies regarding patentable subject matter as United States Supreme Court, Ass’n for Molecular Pathology v. Myriad Genetics, Inc. decided deoxyribonucleic acid (DNA) was not a patentable subject matter.

Facts of the case:

Myriad, is the assignee of US5753441 which covered specific mutations of the BRCA1 gene, US5747282 talked about method of diagnosis, US5837492 covered BRCA2 gene and not only sequence of the gene but also use of it for diagnosis, risk prediction, screening/ therapy and US5709999 covered the gene itself, protein and possible diagnostic kits.

Myriad alleged patent infringement against Ambry for many claims. Six claims were at issue in the appeal, and requesting a preliminary injunction against Ambry. Four of six claims on appeal were directed to DNA primers, which are “short, synthetic, single-stranded DNA molecules that bind specifically to intended target nucleotide sequences” (primer claims). Further, remaining two claims were method claims reciting comparisons of the wild-type BRCA sequences with the patient’s BRCA sequences.

  1. S. Court of Appeals for the Federal Circuit invalidated a number of Myriad’s composition or method claims and matter claims as directed to patent-ineligible subject matter under 35 U.S.C. § 101gene. The Federal Circuit found that composition claims covering DNA primers that bind to specific nucleotide sequences were directed to naturally occurring products of nature.  It was also found out found that the method claims covering comparison of wild-type DNA sequences to patients’ DNA sequences were directed to the abstract idea of comparing DNA sequences and lacked any inventive concept.

Further, with respect to the DNA primer claims, Myriad argued on appeal that synthetic DNA primers are not naturally occurring because single-stranded DNA cannot be found in the human body.  Moreover, Myriad argued that DNA primers have a fundamentally different function than when they are part of the DNA strand.  Relying on the Supreme Court’s Myriad decision, the Federal Circuit rejected Myriad’s arguments and concluded that the fact that primers are synthetic and it makes no difference since synthetic primers “are structurally identical to the naturally occurring compositions” and function just like naturally occurring DNA by binding to complementary nucleotide sequences and separating DNA “from its surrounding genetic material is not an act of invention.”

While many have hailed this decision as a victory for public health and individual rights, others feel this decision effectively sounded the death knell for patents on genetic based testing and diagnostics.

Country- Wise comparison of various Biotechnology Inventions

International Survey of the Patentability of Genes, Proteins and Other Genetic Materials (SOURCE: BricWall)


Indian Patent Scenario

Considering all the amendments to the concerned/relevant sections of the Indian patent act, below is discussed the latest scenario regarding Gene Isolation and Diagnostic Methods in India.

Gene Isolation

In sub-section 3(c), “the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature ” is not an invention. Thus, merely isolated naturally occurring genes are considered a discovery and not an invention and are therefore deemed to be not patentable as per sub-section 3(c). Gene isolation is required to be patentable. Genes as they are found in situ are not patentable. For instance, a patent can be granted for the isolated DNA sequence corresponding to the coding region of a human gene only if the sequence is new and was isolated by a method that would be considered non-obvious by a skilled person, and if it presents unexpected, surprising properties. For this reason then, the sequence function must be disclosed in the patent application and filed to meet the industrial applicability requirements.

The Indian Patent Office’s Manual of Patent Practice and Procedure (March 22th 2011) states, under the guidelines for the unity of invention, states that independent claims of different categories may relate to a single inventive concept in case of In case of a genetically modified Gene Sequence/ Amino Acid Sequence claims may be directed to a Gene sequence / Amino Acid sequence, a method of expressing the sequence, an antibody against that protein / sequence, a kit containing such antibody / sequence.


Claim: Bacillus sp. IN123 comprising rDNA (ribosomal DNA) sequence represented as SEQ ID NO: 1 (deposition No. XXXXXX).

Analysis: The subject-matter of claim falls within the scope of Section 3 (c) of the Act, as it attempts to claim an isolated Bacillus sp. IN123 (i.e. a living substance) occurring in nature (i.e. from soil as disclosed in the specification). Thus, what is claimed in the claim is treated as a discovery of a living thing occurring in nature and hence, not patentable.

In sub-section 3(i), only those methods purposely designed to free any concerned subject from an existing disease, or designed to increase its economic value or, better, the product thereof, are patentable

Further, it explains that in vivo diagnostic methods practiced on human/animal body cannot be patentable but if diagnosis is performed in vitro i.e. on tissue or fluids that have been removed from body are entitled to be patentable in light of inventive measures. Hence, diagnostic methods employing DNA primers or probes or the like that are different from naturally occurring genes/DNA sequences that exhibits modified functions  would be considered as patentable inventions.

Further, in sub-section 3(j), anything relating to a human body or its parts, including a cell, and any process employing any living part or cell is not patentable. Indian examiners believe that life forms, even if they are genetically modified, are not inventions and thus do not meet the criteria of patentability.

Few Examples

  1. If the claimed invention relates to a polynucleotide/polypeptide having mutation(s) in a known sequence of polynucleotide/polypeptide, which does not result in an unexpected property whatsoever, then the claimed subject-matter lacks inventive step.

Claim: A recombinant DNA sequence of SEQ ID NO: X encoding human interferon α2 polypeptide. Prior art discloses a nucleic acid sequence of SEQ ID NO: X1 encoding human interferon α1 polypeptide.

Analysis: The claimed human interferon α2 is close structurally to the prior art’s human interferon α1. However, the alleged invention can be held non-obvious, because of the certainty that the claimed human interferon is 30 times more potent in its antiviral activity than its analogue (prior art). 

  1. Comparison of Granted Patent (same family) claims “AKT-3 nucleic acids, polypeptides, and uses thereof” in Three Jurisdictions i.e. Europe, USA, India in order to understand the differences in the framing of claims in the respective jurisdictions.



Indian (IN226034) patent first claim seem moderately wider, and includes a substantially similar sequence and also other variants of a sequence are claimed. Further there are several different nucleotide sequences that can code for more than amino acid and does not specifically pin down the actual sequences encoding the protein. Whereas US6881555 first claim is only for the specified sequence as mentioned in the ID as opposed to covering a wide range of nucleic acids as seen in European (EP1144600) and Indian (IN226034) patent where the protein sequence is used to define the nucleic acid sequence.


Specific Issues with Biotechnology and Gene Patents

Patenting of genes and DNA (deoxyribonucleic acid) sequences has been at the centre of a disagreement for many years now. On one side are the exponents of gene patents, composed of pharmaceutical, biotech and agricultural bio industries, who argue that genes must be patentable to give firms the confidence to invest money and time required in the development of gene-based drugs or genetically modified crops.

More of global cooperation is required in the Biotechnology field since unlike other industries which can deliver competitive advantages through cheaper or rapid manufacturing, biotechnology companies gain monetary benefits by virtue of IP protections for their inventions. The current system of legal uncertainty, legal uncertainty, un-even patent enforcement about the patentability of DNA sequences could add to the decline in level of innovations.

Whereas on the other hand, critics of gene patents maintain that genes are not new discoveries at all, and by allowing them to be patented, control is placed in the hands of a few forestall research and restricting access to new treatments for the poor.

About the Author: Sugandhika Mehta, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at:

Interpretation of Section 31 of Indian Patents Act, 1970

While the focus of the article is specifically on the interpretation of section 31, mentioning other relevant sections of the act and trying to understand the purpose of section 31 will help us interpret the section 31 correctly. Chapter VI of Indian Patents Act, 1970 titled ‘Anticipation’ sets out the circumstances that are not anticipation. Section 34 of the act titled ‘No anticipation if circumstances are only as described in sections 29, 30, 31 and 32’ makes it clear that if circumstances are different from that described in sections 29, 30, 31 and 32, then they would cause anticipation. Section 13 titled ‘Search for anticipation by previous publication and by prior claim’ deals with circumstances which can be considered anticipatory, to which circumstances as described in section 31 form exception. In order to interpret ‘application for the patent’ in section 31, consideration of the section 7 and 138 is important. It is also necessary to interpret section 31 in light of relevant case studies.

Because the questions which need to answer for correct interpretation of section 31 are many, it will be important that we address them one by one.

Questions which need to be addressed are:

  1. What is the intent behind section 31?
  2. Regarding interpretation of the terms ‘learned society’ and ‘transaction’ in section 31:
    1. What is the scope of the terms ‘learned society’ and ‘transaction’ in section 31?
    2. Is the similar provision available under the patent laws of other countries?
    3. Are these terms defined under the laws of India or other countries?
    4. What do relevant case studies point out?
    5. If any enabling disclosure is made available to the non-members of a ‘learned society’ either free or on payment of fees, will it constitute anticipation?
    6. Is publication of the transaction of learned society on internet anticipatory?
  3. Does ‘application for the patent’ also include conventional application and international applications?
  1. What is the intent behind section 31?

As the section starts with ‘An invention claimed in a complete specification shall not be deemed to have been anticipated by reason only of’, the section has been written in negative language. Section 31 is one of the sections included in the chapter VI, which sets out the circumstances which are exceptions to the circumstances considered as anticipatory under section 13.  Section 34 of the act titled ‘No anticipation if circumstances are only as described in sections 29, 30, 31 and 32’ makes it clear that if circumstances are different from that described in sections 29, 30, 31 and 32, then they would cause anticipation. For interpretation of this section, it should be kept in mind that any broad (unreasonably) interpretation will broaden the scope of exceptions the anticipation, and on the other hand we opt for restrictive interpretation then it should at least serve the purpose of the section. Had the section 13 begun with ‘Notwithstanding anything’, we would have interpreted the section 13 independent of section 31 and had the section 13 begun with ‘Subject to anything’, we would have allotted key player’s roles to section 31. Because of absence of this, interpretation is not straightforward.

  1. Regarding interpretation of the terms ‘learned society’ and ‘transaction’ in section 31:
  1. What is the scope of the terms ‘learned society’ and ‘transaction’ in section 31?
  2. Is the similar provision available under the patent laws of other countries?
  3. Are these terms defined under the laws of India or other countries?
  4. What do relevant case studies point out?
  5. If any enabling disclosure is made available to the non-members of a ‘learned society’ either free or on payment of fees, will it constitute anticipation?
  6. Is publication of the transaction of learned society on internet anticipatory?

For the sake of convenience and better understanding all questions from a to e regarding interpretation of the terms ‘learned society’ and ‘transaction’ in section 31 are answered together.

It is pertinent to note that patent acts of India, and UK are silent on the definitions of ‘learned society’ and ‘transaction’. Even no decision by court in India has interpreted these terms. The reason for not defining these terms seems to be the requirement to define threshold for ‘learned’. Australia, New Zealand, Singapore and Israel also have similar provision in patent laws which exempt the publication in transactions of the society from being considered for the purposes of novelty and obviousness. In Ethyl Corporation’s Patent (1963 RPC155) and Ralph M. Parsons Application (1978 FSR 226), UK courts have interpreted these terms in restrictive manner. Ralph M. Parsons Application suggests that a “learned society” is any non-commercial body of persons seeking to promote and organise the development of specific subjects by the provision of a forum for the exchange and discussion of ideas and the dissemination of information, usually through the publication of its proceedings.

As we move ahead to understand the effect of the word ‘transaction’ on the scope of section 31, we have to appreciate that mere presence of the word ‘transaction’ reduces the scope of the exceptions provided by section 31 to the anticipation. Further we need to note that language of the section is ‘published with his consent in the transactions of such a society’ not ‘published with his consent of the transactions of such a society’. It suggests that any interaction of the ‘learned society’ that has qualified to be described as ‘publication in the transactions of society’ will fall within the scope of section 31 and will not constitute the anticipation.

A question which might sound interesting to many, of course it interests me, if any enabling disclosure is made available to the non-members of a ‘learned society’ either free or on payment of fees, will it constitute anticipation or not. Answer of this question to me is ‘yes’ and reason is, the moment the enabling disclosure is made available to the non-member, it is no longer ‘publication in the transactions of society’. This is also consistent with the interpretation adopted by the UK court in Ethyl Corporation’s Patent and Ralph M. Parsons Application. In Ethyl Corporation’s Patent court held that transaction meant ‘published record of the proceedings of the learned society’. In Ralph M. Parsons Application, the reporters present at the meeting of the learned society where inventor read paper, got the copy of the paper and published the subject matter. The argument of the inventor that the subject matter was published in effect reporting the proceedings of that learned society was rejected and circulation of the paper and publication were held to be anticipatory. Judgment also sets out that “An essential prerequisite of a publication, if it is to be regarded as “transactions” is that it should be published under the auspices of and finally be the responsibility of the Association—the learned society—whose organ of publication it is.”

Another interesting question yet to be considered by courts is whether publication of the transaction of learned society on internet anticipatory or not. Applying the logic of subject matter being extended to non-members of the learned society, this appears to be anticipatory.

Finally to conclude, any interaction of the learned society for benefit of the non-members of the society will be termed by as anticipatory publication. The purpose of the subsection 31 (d) is to provide opportunity to the inventors to disseminate the knowledge to the members of the society and it should not be interpreted to mean that one can publish research paper from the date of which patent application is to be made not later than twelve months. It is recommended that one should file patent application and then publish research paper.

  1. Does ‘application for the patent’ also include conventional application and international applications?

While the UK courts interpreted corresponding sections in the act to exclude the conventional and PCT applications, laws relating to PCT applications in India need to be interpreted considering section 7 and 38 which clearly set out that ‘Every international application under the Patent Cooperation Treaty for a patent, as may be filed designating India shall be deemed to be an application under this Act, if a corresponding application has also been filed before the Controller in India.’ For the clarity on whether base applications of convention application filed in India are to be covered under the scope of section 31 or not, no explicit provision has been given.

About the Author: Swapnil Patil, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at:


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