India: Do we need Patent Term Extension and Non-Patent Exclusivities for Pharmaceuticals?

India, though in a phase of rapid economic development, still has the bane of poverty. In this country, around 22% of the population is Below the Poverty Line [1], and hence most of the nation’s policies are oriented towards the poor. India’s IP Policy is no different, as the IP legislature in India is mostly oriented towards giving the general public an easy and inexpensive access to medicines. Indian IP policy drafters have used every flexibility in the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS), to which India is a signatory, for this purpose.

The curious case of drug development

The process of development of the drugs to treat the diseases and ailments is pretty much painstaking. A drug regulatory authority, (e.g. The US Food and Drug Administration-US FDA; Central Drugs Standard Control Organization-CDSCO in India) monitors and governs the testing of the New Chemical Entities (NCEs) through pre-clinical and clinical trials to prove their safety and efficacy to treat an ailment. Several NCEs fail at some or the other stage, rendering all the money and efforts in vain. The amount of money invested in each NCE is of the order of billions of dollars. [2] The time period it takes for the development of the NCEs as approved ‘Drugs’ typically ranges from 10-15 years [2]. The chances of a candidate making it through this whole of the process, to the desk of the pharmacy, are merely 2% [2]. So, in this precarious situation, the 20 years of patent protection granted to the drug products is not sufficient to recover the huge investment made in the R&D of the product. So, the pharma companies usually demand the extension of the protection of their monopoly over the drug product. This Patent Term Extension (PTE) is granted by the Patent Office of the region or country.

Now, these clinical trials generate data regarding the therapeutic activity and safety of the drug. So, if a generic player wants to launch the same drug, it will need this data to prove that its generic version of the drug is ‘equivalent’ to the innovator’s product. Since the innovator companies invest huge amounts of time, money and efforts into generating this data, they demand exclusivity of this data. This Clinical Trial Data Exclusivity is under the discretion of the drug regulatory authority and regardless of the existence of a valid patent on the subject matter. If granted, it gives an additional layer of protection to the innovator drug product.

In the following paragraphs, we will discuss the Patent Term Extension and Clinical Trial Data Exclusivity provisions present in the US and European, legislature, in comparison with the Indian scenario. Several other countries also provide these provisions, but we will limit our discussion to these three jurisdictions.

 

Patent Term Extension

In the US, according to the Drug Price Competition and Patent Term Restoration Act, or the Hatch-Waxman Act, 1984 [3], the patent term can be extended up to 5 years, however, the total patent term (including extension) should not be more than 14 years after the date of approval of the product by FDA. This period may be extended by a period of another six months of Pediatric Exclusivity.

The European Patent Office similarly provides an extension of protection in this regards, by giving the Supplementary Protection Certificate (SPC). [4] The SPC allows extending the Patent term by 5 years. however, the total patent term (including extension) should not be more than 15 years after the date of approval of the product by the European Medicines Agency. Additional 6 months’ protection is given to medicinal preparation to treat children (Pediatric Formulations). This extension is not applicable to orphan drugs [11]

Non-Patent Exclusivities:

The US FDA grants different types of Non-Patent Exclusivities [5] [6]

  1. 5 years for a New Chemical Exclusivity (NCE) for the Active Ingredient approved for the first time
  2. 180 days exclusivity for the generic player who first files and maintain an ANDA (Abbreviated New Drug Application) with Paragraph IV certification, which requires the applicant to prove either that he will not be infringing the innovator’s patent or that the innovator’s patent is invalid/not enforceable.
  • 3 years of New Clinical Study Exclusivity for submission of “reports of new clinical investigations (other than bioavailability studies) essential to the approval of the application [or the supplemental application] and conducted or sponsored by the applicant”. For example, in case of preparation of a drug previously approved, which differs in the route of administration, drug delivery system, dosing regimen, modification of the drug such as salt or ester, which won’t affect the pharmacological actions of the drug. The exclusivity period would start from the date of NDA approval of the same drug. This is for the Active Ingredient has been approved before in another application.
  1. 5 additional years in case of antibiotics that treat some serious condition, for products that have obtained Qualified Infectious Disease Products (QIDP) designation under the Generating Antibiotics Incentives Now (GAIN) Act.
  2. 7 years for an orphan drug, i.e. the drug for the treatment of the rare diseases
  3. 6 months of Pediatric Exclusivity which gets added to the existing Patents and exclusivities.

The table below summarizes these exclusivities in relation to whether innovator and/or generic players can avail them.

Table 1. Scheme of Exclusivities granted by the US FDA

Sr. No. Description  NDA Applicant  ANDA Applicants
1 New Chemical Entity (NCE) 5 years NA
2 New Clinical Investigation (NCI) (Same drug, different route of administration or another form of the same drug, e.g. salt form) 3 years NA
3 First Abbreviated New Drug Application, under Para (IV), with applicant successfully proving the innovators patent invalid, or not infringing, or in case the infringement suit is not filed within 45 days of application NA 6 months
4 Antibiotics with Qualified Infectious Disease Product (QIDP) designation to treat serious conditions 5 additional years NA
5 Drugs to treat rare disease (Orphan Drugs) 7 years NA
6 Pediatric preparation 6 additional months NA

The European Medicines Agency, after 2005,started the 8+2(+1) formula which dictates that the innovator will be getting 8 years’ data exclusivity, and 2 years of market protection, during which no generic can be placed on the market, and an additional 1 year exclusivity for the new indication which shows significant clinical benefit (same as NCI in the US). Prior to this rule, there was a distinction for nationalized procedure and centralized procedure. The following table indicates the exclusivity period based on the application date and type.

Date of submission of application For Centralized Procedure For Nationalized Procedure
Before

20.11.2005 (CP)

30.10.2005 (NP)

10 years’ data exclusivity 6a or 10b years’ data exclusivity
After

20.11.2005 (CP)

30.10.2005 (NP)

8 years data exclusivity

+2 years market protection

(+1 year market protection for the new indication showing significant clinical benefit)

a – Austria, Denmark, Finland, Ireland, Portugal, Spain, Greece, Poland, Czech Republic, Hungary, Lithuania, Latvia, Sweden, Slovakia, Malta, Estonia, Cyprus, Bulgaria, Romania, Norway, Iceland, and Liechtenstein. (‘6-year countries’)

b – Belgium, Germany, France, Italy, Netherlands, Sweden, United Kingdom, Luxembourg. (’10 year countries’)

In addition to this, the orphan drugs get 2 more years of exclusivity. [7], [11]

India

India has not, as of yet, implemented such provisions, because-

  1. Granting of the PTE and Non-Patent Exclusivities would require the establishment of the Patent Linkage system in effect, which is not there at present, and India is not planning to do it in the near future, because India has not, as of yet, entered into any trade agreement which requires such provisions.
  2. The TRIPS agreement also does not require members to grant such benefits to the innovators, this means that India is in no obligations to grant PTE and Non-Patent Exclusivities. [8] Whatever pressure is there on Indian policymakers to implement such benefits, are there due to the Trade Agreements like the Trans-Pacific Partnership (TPP), Regional Comprehensive Economic Partnership (RCEP). These agreements constitute to a new regime called as TRIPS Plus, which is lobbied by the big pharma companies of the developed countries. Currently, India is not signatory to any of such agreements.
  3. If at all these provisions are implemented, they would severely delay the entry of generic versions of the drugs into the market. India, being a developing country, simply cannot afford granting PTE and DE to every request, at the expense of access to the poor.
  4. On the same lines, the Indian Pharma sector is largely thriving on the generic players, so the industry is hardly affected by the absence of provisions for PTE and DE.

These provisions have long been sought by the Big Pharma lobby of the developed nations, by criticizing India’s ‘weak’ IP policies. Companies like Bayer, Novartis have tried to tweak with the legislature for the same purpose. [9] Several generic pharma companies and access-to-medicines activists like Médecins Sans Frontières (Doctors without Borders) have constantly warned India about the effects of such provisions, saying that India will no longer remain the ‘Pharmacy of the world’. [10]

Implementing these would be advantageous only to the innovator companies, and millions will be stripped off their right to live a healthy life. This is being sugarcoated to say that these provisions will boost the trade and innovation in India. On the other hand, if these provisions are not introduced, India will be under constant pressure to do so at the earliest, but it won’t kill anyone. Now it is up to the policy makers whom they are going to put first.

About the Author: Mr. Swapnil Chandwade intern at Khurana and Khurana, Advocates and IP Attorneys. In case of any queries, feel free to reach on swapnil@khuranaandkhurana.com.

References:

  1. http://data.worldbank.org/country/india
  2. http://www.nature.com/nrd/journal/v9/n3/full/nrd3078.html
  3. http://www.fda.gov/newsevents/testimony/ucm115033.htm
  4. http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31992R1768
  5. http://www.fda.gov/downloads/drugs/developmentapprovalprocess/smallbusinessassistance/ucm447307.pdf
  6. http://www.orangebookblog.com/files/nonpatent_exclusivity.pdf
  7. http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2013/05/WC500143122.pdf
  8. https://indiankanoon.org/doc/1123372/
  9. https://iiprd.wordpress.com/2010/05/17/bayer-vs-cipla/
  10. http://www.thehindu.com/sci-tech/health/If-India-signs-RCEP-it-will-not-be-the-pharmacy-of-the-world-MSF/article14422200.ece
  11. Chakrabarti, G., 2014. Need of data exclusivity: Impact on access to medicine. Journal of Intellectual Property Rights, 19(5), pp.325-336.

First Symposium of IIPRD in 2017

After successfully conducting several symposiums in 2016, IIPRD is coming up with one-day seminar on software and electronics patent portfolio with focus on preliminary preparation, prosecution, and litigation in India and US.  While the programme is being organized in Pune on February 23, the one in Bengaluru will be hosted February 24.

The seminar is being arranged by IIPRD along with Khurana and Khurana, Advocates and IP Attorneys and Sughrue Mion.

With speakers like Chid Iyer-partner of International Law Firm of Sughrue Mion, Anubhav Kapoor-Tata Technologies’ General Counsel and Company Secretary, Vinod Khurana-Senior Partner at IIPRD and Khurana & Khurana, IP Attorneys, Irfan Modi-Senior IP Law Attorney at IBM India, Subhadip Sarkar- Senior Director and manages Intellectual Property at Cognizant Technology Solutions, Mr. R. Lakshminarayanan- Head of Intellectual Property Rights (IPR) Management in Samsung R&D India, Mr. Ajay Panwar- having 11 years of experience in the field of IP with domain expertise in software and electronics, Tarun Khurana- having over 14 years of experience in a broad range of IP subject matters, and Co-Founding Partner and Patent Attorney of Khurana & Khurana, Abhishek Pandurangi- partner at Khurana & Khurana, having over a stretch of 7 years as an IP practitioner, entrepreneur, legal expert and a trainer, one cannot afford to miss same. This event turns out to be great opportunity for IP Groups, R&D experts, In-House IP/Legal Counsels, Patent Agents & Attorneys in the field of Practice, Patent Litigators, and Professionals in Legal Domain related to Software,Information Technology, Instrumentation, Electronics, Electrical, Embedded, Mobile Technology, IoT, and Telecom Domains.

Fee per delegate is INR 5,000 for Indians and is INR 10,000 for foreign applicants.

For more details about profiles of partners, programme outline, speakers, why and how to apply, please see http://www.iiprd.com/iiprd-symposium-23rd-february-2017-24th-february-2017/.

Analysis of the rejection of Lumacaftor (Polymorph) patent application in India

We have been receiving requests from our Pharma clients/readers of the blog for the analysis of the decision/ facts that led to rejection of Lumacaftor (Polymorph) patent application in India since last year.

Here is our take:

Details of the Patent Application and important dates:

Patent application number in India 2056/KOLNP/2010
Title of the invention SOLID FORMS OF 3-(6-(1-(2,2-DIFLUOROBENZO[D][1,3] DIOXOL-5-YL) CYCLOPROPANECARBOXAMIDO)-3-METHYLPYRIDIN-2-YL) BENZOIC ACID
Applicant VERTEX PHARMACEUTICALS INCORPORATED
International application number/ International filing date PCT/US2008/08545/

 

04/12/2008

Priority Application Number/ Priority date US61/012,162

 

07/12/2007

National phase Filing date 04/12/2008
Publication date 03/09/2010
Request for examination date 25/11/2010
Pre-Grant Opposition under section 25 (1) 19/02/2011
First examination report Date 20/08/2014
Date of communication of outstanding objections 01/03/2016
Date of hearing after failure to put the application in condition of allowance 18/03/2016
Date of decision of rejection 31/03/2016

Application Area:

Lumacaftor is given with another active ingredient Ivacaftor in the treatment of cystic fibrosis which is caused by F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) protein.

Facts of the case:

First Examination Report (FER) was issued on 20/08/2014 which not only objected claims based on the prior arts cited in International Preliminary Report on Patentability (IPRP) corresponding to PCT application but also used section 3 (d), 3 (i), 3 (n) of the Patents Act, 1970, and procedural grounds for objection.

As the FER was issued on 20/08/2014 (before 16/05/2016), period of twelve months was allowed to put the application in condition of allowance. Controller found the application not to be in condition of allowance even after 12 months and communicated the objections on 01/03/2016. Finally, hearing was held on 18/03/2016.

As reported in the decision of controller dated 31/03/2016, “There were nine (09) objections mentioned in the hearing letter including major technical objections on the grounds of novelty, inventive step and non-patentability of the claimed subject matter u/s 3(d) of the ‘Act’.”

Section 3 (d) has been reproduced below for the reference:

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;

Analysis of the rejection decision:

Dr. I. S. Bhattacharya, attorney of the applicant, who attended the hearing, relied on the technical data filed as affidavit along with reply statement in respect of pre-grant opposition already filed under section 25(1) for the instant application to argue that form 1 of Lumacaftor ought to be considered be Novel and Inventive. She asserted that better pharmacokinetic properties / superior bioavailability of the formulation of claimed polymorphic Form I compared to the hydrochloride salt of the compound were enough to win the Patent.

Controller in response declined to accept the arguments on the ground ‘Anything beyond the disclosure of complete specification is not acceptable’ as the technical data was not part of the complete specification yet. The technical details were also rebuffed on the ground that different pharmacokinetic properties / superior bioavailability results were natural results of comparison of Form I (free solid) with hydrochloride salt of the same compound. He further opined that better bioavailability does not necessarily lead to better efficacy.

Based on these grounds, controller went on to reject the Patent Application under section 15.

Controller also took into consideration the pre-grant opposition that had also been filed under section 25(1) by Indian Pharmaceuticals Alliance, Mumbai for the instant application. Controller did not conduct a separate hearing under section 25 (1) as the grounds and prior arts were incorporated in the hearing letter and were heard on 18/03/2016. Controller accepted the petition under section 25 (1) while refusing the grant of the patent application no. 2056/KOLNP/2010.

Reference:

http://ipindiaservices.gov.in/decision/2056-KOLNP-2010-16971/2056-KOLNP-2010.pdf

A Primer to Patent Application Drafting with special emphasis on standard practise(s) before the Indian Patent Office

An enforceable Patent being the key to effective Commercialization/Out-Licensing of any technology needs to be drafted well. No matter how good a technology is, if the description of the technical subject matter of a Patent is not enabling or fails to disclose all necessary embodiments, and in case the claims are narrowly drafted and do not gain support from the specification, the worth of the technology is insignificant.

Patent application (whether provisional or complete specification), being a complex techno-legal document and difficult to prepare, mostly requires inventors to seek professional assistance from a patent practitioner. Nevertheless, many inventors facing the economic crunch decide to proceed on their own. This is a perfectly fine choice, but it needs to be done with eyes wide open. It also requires the do-it-yourself inventor to become as knowledgeable and familiar with the process of describing an invention and drafting a patent application as possible before he/she decides to embark on the path of preparing his/her own patent application. Patent claims, particularly, are enormously difficult to draft due to the peculiar format/rules prescribed by the Patent Offices of different jurisdictions. The claim set section defines the boundaries (i.e., scope) of patent protection afforded under the patent. The claim set must particularly point out and distinctly claim the subject matter which the inventor regards as his/her invention. There is much to be learned with respect to drafting claims, which is why inventors are at a substantial disadvantage if they are to represent themselves. However, avoiding pitfalls, an inventor can still strive to conclude a complete and descriptive patent application successfully. Further, as a do-it-yourself inventor develops his style of patent drafting, it is useful for him/her to occasionally look back to the rules of practice to ensure that they are still being followed.

Considering this need of several inventors, this document (http://www.khuranaandkhurana.com/wp-content/uploads/2017/01/ANATOMY-OF-PATENT-SPECIFICATION.pdf) is prepared, which may serve the purpose of a primer delineating some standard practices which can be followed to pen down the invention in the best possible manner. The information provided as part of the document explains and elaborates on the following important elements/parts/aspects of the patent application to be filed before the Indian Patent Office:

1) Title of Invention
2) Field of Invention
3) State of the art in the field (Background & Prior Art)
4) Object of invention
5) Brief description of drawings
6) Preamble to description
7) Detailed description of Invention
8) Sequence Listing (if any)
9) Claims; and
10) Abstract

The Mickey Mouse Debate

Mickey Mouse has always been synonymous with Disney, and has served as their ultimate mascot.Disney Corporation has always been protective of its creations and has ensured that their copyrights and their beloved mascot, Mickey Mouse, never fall into the public domain.  Every time the first Mickey Mouse copyright is set to expire, Disney springs into action to extend the copyright term.

The debate of copyright term duration is a long standing one. Initially, US copyright law provided for a copyright term which lasted for a period of fourteen years from the date of publication. This term could be renewed for an additional fourteen years if the author was still alive at the expiry of the first term. In 1831, the Copyright Act was amended and the term was extended from fourteen years to 28 years, which could be renewed for an additional 14 years.

In 1976 the copyright act went through major changes when the first Mickey Mouse copyright was set to expire. The amendment extended the term of copyright for works copyrighted before 1978 to life of the author plus fifty years after the author’s demise and 75 years for works of Corporate.

With only 5 years left on Mickey Mouse’s copyright term in 1998, Congress again changed the duration with the Copyright Term Extension Act, 1998 (CTEA) providing retroactive extension of the copyright term.It extended the term of protection to life of the author plus 70 years, and for works of corporate authorship to 120 years after creation or 95 years after publication, whichever endpoint is earlier. According to the Act works made in 1923 or afterward will not enter the public domain till 2019 or afterward, depending on the date of production. Disney’s Mickey Mouse is set to expire on 2023 and the debate on extension is set to begin again.

The Debate

So why is there so much debate about how long creative work can be protected by copyright? Copyright provides duality of purpose which is fundamentally at odds with each other. One purpose of copyright is to educate the public culturally by disseminating cultural knowledge. The other purpose is to foster creativity by allowing authors to reap benefits from works for a limited period thus encouraging them to create more works. It is in this battle that the debate for duration of copyright finds place.

The longest debate on duration of term with respect to copyright laws is in the US. Both proponents and opponents of extension have put put forth several arguments in favour of their stand, and this debate is set to resume soon, with the effect of the CTEA expiring at the end of 2018 and the first Mickey Mouse copyright entering the public domain in 2023.

Proponents of extension have maintained that the purpose of copyright is to promote creativity and art by allowing monopoly to the creators, thus giving them an incentive to create more. According to them, by giving exclusive rights to the creator for a limited time, both the author and the public benefit. The purpose of granting exclusive rights to authors isn’t so that they recoup their initial investment, but to let them earn substantial amounts so that they can create more works. In order to achieve this, copyright term must be for a considerable period.

Proponents of extension also argue that if works fall into the public domain they will go unused. If owners know that a particular copyright is going to lapse into the public domain, they would be unwilling to utilize it further, or create derivative works, and the public could lose out.

Another argument put forth by proponents of extension is that due to increase in life expectancy and longevity of business, copyright term must also be extended.Also, with better technology, the lifespan of a created work has become virtually infinite. This means that works can be exploited longer. Therefore, proponents of extension argue that unless copyright term is extended it to match the longevity of owners, and the longevity of the work itself, it no longer becomes an incentive for authors to create more work.

Copyright is as an extension of the creator’s persona. If it gets distorted or tarnished due to lack of protection, creators are discouraged from creating more works, potentially damaging their reputation. This also means that creators will be unwilling to disseminate quality copies of work if they are soon to fall in the public domain and risk being tarnished. This would mean that the public would lose out on culturally rich works.

Opponents of extension argue that authors have always known that their works would fall into the public domain, but this has never deterred them from creating new works. Further, extension of copyright stifles creativity as another person cannot build upon the works of the owner if it has not entered the public domain. Getting permission and licenses deters new creators from building on already existing works. This means the public would miss out on better works.

Opponents also argue that the increase in life expectancy argument is invalid as copyrights are protected for the lifetime of the author. Hence, if the life expectancy has increased it means that the copyright term will automatically increase as well.

When it comes to business entities owning copyrights, longevity of the creator is irrelevant. The opponents of extension have argued that copyrights are borrowed rights from the sovereign. Copyright is not an inherent, but a statutory, right given by the sovereign. However, irrespective of copyright being a statutory right, it needs to foster creativity. When business concerns know that copyright term is limited to a shorter duration, they are discouraged from investing further or creating derivative works. For example, when concerns like Disney know that their copyright over Mickey Mouse is set to expire soon, they would stop creating further derivative works, such as theme parks, products, animated works etc,.

In 2003, a study proved that the last two major copyright changes before CTEA, the Copyright Act of 1976 and the 1988 Berne Convention, had significant effects on copyright registrations.Yet another study, conducted in 2006, proved that countries that extended the terms of copyright from the author’s life plus fifty years to the author’s life plus seventy years anytime between 1991 and 2002, saw a significant increase in movie production.This clearly shows that copyright extension is in the best interest of creativity.

The Indian Scenario

The media and entertainment industry in India is still in its nascent stage. Copyright protection under the Indian Copyright Act is for a period of 60 years from death of the author. In 2008 Yash Raj and FICCI approached the HRD Ministry to extend the copyright term to 95 years like in the CTEA.The ministry welcomed film producers’ recommendations in extension of copyright term for the Copyright Amendment Act, 2010. While Parliament may not have agreed to extending the term of a copyright to 95 years like in the US, they did amend the law dealing with copyright term of films. The amendment has allowed joint authorship of the producer and the principal director for a film. Thanks to the amendment, a principal director will have a copyright protected for 70 years, as opposed to the producer who has only 60 years. This has effectively increased the term of protection for movies from 60 years to 70 years. The momentum for increasing copyright term is just starting and India will soon get to see similar debates as faced by CTEA in the US.

About the Author : Nadine Kolliyil, an intern at Khurana & Khurana, Advocates and IP Attorneys looks into the debate surrounding copyright extension in the US, and Bollywood’s attempt to extend copyright term.

References:

Merk’s patent valid but Teva’s Nasonex generic non-infringing

In Merck Sharp & Dohme Corp.  (hereinafter referred to be as “Merck”) v. Teva Pharms. United States, Inc. (hereinafter referred to be as “Teva”) decided on November 16, 2016, Teva’s application of Abbreviated New Drug Application (hereinafter referred to as “ANDA”) no. 205149 had triggered Merck to file infringement suit against Teva in respect of US patent number 6127353 (hereinafter referred to be as “353” patent) which is currently listed against NDA number of New Drug Application (hereinafter referred to as “NDA”) number 020762. The‘353 patent is set out to expire in April 03, 2018 with Pediatric Exclusivity. NDA 020762 was approved for ‘NASONEX’ having MOMETASONE FUROATE (hereinafter referred to as “MMF”) as active ingredient in the dosage form EQ 0.05MG BASE/SPRAY. Merck further stated in its complaint that Teva’s ANDA application contained certification (PARA IV) that US patent no. 6127353 is invalid and unenforceable and will not be infringed by Teva producing its generic, the complaint also stated that Teva refused to allow Merck access to its ANDA application or samples.

Anhydrous Mometasone Furoate (“MFA”) was earlier patented by Merck in the early 1980s. MFA and MFM are the polymorphs. On July 3, 2014, plaintiff i.e. Merck brought this action alleging infringement. Merck filed an amended complaint on August 17, 2015, which Teva answered on August 31, 2015. Independent claims 1 and 6 and dependent claims 9-12 of the ‘353 patent titled ‘Mometasone furoate monohydrate, process for making same and pharmaceutical compositions’ were asserted by Merck.

Independent claim 1 and claim 6 have been reproduced below for the reference:

Claim 1:

9.alpha.,21-dichloro-16α-methyl-1,4-pregnadiene-11β,17α-diol-3,20-dione-17-(2′-furoate) monohydrate.

Claim 6:

A pharmaceutical composition comprising mometasone furoate monohydrate in a carrier consisting essentially of water.

Teva’s ANDA contains MFA as the active ingredient and has shelf life of 2 years. Merck did not allege the inclusion of MFM in the pre-formulation active ingredient of Teva’s formulation.

Teva had challenged the ‘353 patent on the grounds of double patenting with U.S. Patent 6,180,781 (hereinafter referred to be as ‘781’) and lack of subject matter description. Court rejected both the arguments and found the Patent to be valid. To ascertain whether Teva’s ANDA product contains any MFM during shelf life, Teva presented six different batches of its product to Merck. Merck’s expert, Dr. Victor Young (“Dr. Young”), testified in favor of Merck by placing a high premium on his ability to visually distinguish between MFM and MFA using a microscope. Teva’s expert, Dr. Leonard Chyall (Dr. Chyall), however, contended that protocol required visual observation to be paired with a more accurate method of measurement. Court observed that “Dr. Chyall has offered up a reasonable criticism of such findings. At bar, Dr. Chyall’s testimony is more credible and consistent”. Finally the court ordered in favor of Merck for the issues of validity but declared Teva’s product to be non-infringing the ‘353 patent. In the form 10K submitted with Securities and Exchange Commission on February 26, 2016, Merck apprehended decline the sale of Nasonex after the entry of generics. Here is their take ‘For example, a court has ruled that a proposed generic form of Nasonex does not infringe the Company’s U.S. patent for Nasonex. If the generic form of Nasonex receives marketing approval in the United States, the Company will experience a loss of Nasonex sales.’

About the Author :  Ms. Rashmi, intern at Khurana and Khurana, Advocates and IP Attorneys. For any queries, please write to swapnil@khuranaandkhurana.com.

Simplified account of Design Registration in India

This article is intended with covering the basic FAQs about Design registration in India. For the sake of better focusing, format of questions and answers has been adopted.

Industrial Designs are protected by different laws in different countries, i.e. some countries choose to go for Patent Registration and some go for specialized systems. Unlike USA which has chosen to protect the designs through Patents, India has chosen a sui generis system. In India, Design registration is covered under The Designs Act, 2000.

In India, functionality is protected under Patents and not Industrial Designs which are meant to protect external ornamental or aesthetic appearance such as patterns, colour, lines, shape or surface of the article.

  1. What is Design under the Design Act, 2000?

Section 2 (d) deals with this.

Design means only the features of shape, configuration, pattern or ornament or composition of lines or colour or combination thereof applied to any article whether two dimensional or three dimensional or in both forms, by any industrial process or means, whether manual, mechanical or chemical, separate or combined, which in the finished article appeal to and are judged solely by the eye, but does not include any mode or principle or construction or anything which is in substance a mere mechanical device, and does not include any trade mark, as define in clause (v) of sub-section of Section 2 of the Trade and Merchandise Marks Act, 1958, property mark or artistic works as defined under Section 2(c) of the Copyright Act, 1957.

  1. What is Article under Design Act, 2000?

Section 2 (a) deals with this.

Article means any article of manufacture and any substance, artificial, or partly artificial and partly natural and includes any part of an article capable of being made and sold separately”

  1. What are the benefits of Design Registration?

Registered Proprietor has the exclusive right to apply a registered design to the article in the class in which Design is registered. Rights obtained by Design Registration can be licensed and/or assigned. In case of infringement, damages can be claimed by the registered Proprietor.

  1. Who may apply for Design Registration?

Any person claiming to be the proprietor of any new or original design may apply for registration. A proprietor may be from India or from a Convention Country.

A proprietor may be:

  1. an author of design,
  2. a person who has acquired the design,
  3. a person for whom the design has been developed by the author, or
  4. a person on whom the design has devolved.

The application for registration of design can be filed by the applicant himself or through a professional person (i.e. patent agent, legal practitioner). However, for the applicants not residing in India, address of an agent residing in India can be used as address for service.

  1. Where to apply for Design Registration?

Applications can be filed in either the Design Office in Kolkata or the branch offices of the Patent office in Delhi, Mumbai or Chennai. For e-filing, FAQs available at https://ipindiaonline.gov.in/eDesign1/faqs/index.html can be referred.

  1. Is it necessary to have prototype article before applying for Design Registration?

No, it’s not mandatory to have prototype. However, Design must be capable of being applied to article by an Industrial Process.

  1. What is the correct time to apply for Design Registration?

Application for Design Registration must be filed before making the design available to the Public as not novel Design cannot be given registration. It is also to be noted that Design Registration is granted to whoever files the application first.

 

  1. What are the types of Applications?
  2. Ordinary application: An ordinary application does not claim priority.
  3. Reciprocity application: In case priority of foreign application is to be claimed, it has to be done within six months of filing foreign application. Such applications being filed in India are termed as reciprocal applications. This period of six months is not extendable.
  4. What is considered to be Date of Registration in Designs?

In case of ordinary applications, the date of making the application for registration is the date of registration of the Design.

In case of reciprocal applications, the date of filing the application in the convention country is the date of registration of the Design.

  1. Is there any period of pre-grant opposition for Design registration in India?

No

  1. What is time allowed for putting application in condition of grant?

In a Substantive examination, objections may be raised based on whether criteria of something being called as design as set out by definition is met or not, is Design new/original or not, is Design prejudicial to public order or morality, and is Design prejudicial to the security of India. The period allowed for removal of objections can not exceed six months from the date of filing of the application. However,   said   period   of   six   months   can   be extended  for  a  further  period  not  exceeding  three months  provided  a  request  in  Form-18  is  filed  before the expiry of initial six months. On consideration  of  response  of  the  applicant, if  the Controller  is of  opinion  that  the requirements  of Act and Rules have   not   been   met, the   fact is communicated to the applicant clearly mentioning that the application is liable to be refused for reasons to be detailed and fixing a date for hearing. If the applicant fails to appear for the hearing without any request for adjournment, the application is refused. If written submissions are filed, while the opportunity to  be  heard  is  not  availed  by  the  applicant,  no  further opportunity  to be  heard is  provided  and  the matter   is   decided   based on   the  written submissions. If the applicant complies with all the requirements laid down  under  the  Act  and  Rules,  communicated  in  the form  of  statement  of  objections,  the  application  shall be registered forthwith.

  1. How to know whether any registration already exists?

Two different forms have to be used in two different situations.

When the registration number is known:

Request can be made by any person in form 6 along with the fees and mentioning registration number of the design for which information is required.

When the registration number is not known:

Request can be made by any person in form 7 along with information in his possession. Based on such information, controller causes search to be made in class indicated therein as much as possible. Where Form 7 is accompanied by a representation or specimen of the design, such representation or specimen is to be furnished in duplicate.

  1. What are the criteria for Design Registration?

A design should:

Be new or original registration

Not been disclosed to the public anywhere by publication in tangible from or by use or in any other way prior to the filling date, or where applicable, the priority date of the application for registration.

Be significantly distinguishable from known designs or combination of known designs.

Not comprise or contain scandalous or obscene matter.

Not be a mere mechanical contrivance.

Be applied to an article and should appeal to the eye.

Not be contrary to public order or morality.

Not be prejudicial to the security of India

  1. What is the term of Protection if Design is registered?

The copyright in a registered design may be extended by a period of five years, from the  expiration  of original period of ten years. An  application  for  extension  of  copyright  shall  be filed before  the  expiry  of  the  original  period  of  ten years. A registration of design ceases to be effective on non-payment of extension fee. However, lapsed designs may be restored provided application for restoration in Form-4 with prescribed fees is filed within one year from the date of lapse stating the ground for such non-payment of extension fee with sufficient reasons. If the application for restoration is allowed the proprietor is required to pay the prescribed extension fee and requisite additional fee and finally the lapsed registration is restored.

  1. Is it possible to renew the term of the Design Registration?

No, there is no provision for renewing the term of the Design registration once a period of 15 years is over.

  1. Is Cancellation of registered Design Possible?

The registration of a design may be cancelled at any time after the registration of design.

Petition for cancellation has to be made in form 8

Following grounds can be used for the same:

    That the design has been previously registered in India or

    That it has been published in India or elsewhere prior to date of registration or

    The design is not new or original or

    Design is not registrable or

    It is not a design under Clause (d) of Section 2.

  1. Can the Refusal of Design Registration be appealed?

Yes, the jurisdiction lies with High Court.

  1. Are the abandoned applications published? Can same applicant apply for registration of same Design again?

Abandoned applications are not published by the Design Office. Another application can be made for the same design if Applicant has himself not made the Design available to the public.

  1. What are the remedies available in case of piracy of Registered Design?

In case of piracy of registered Design, a suit for injunction and/or recovery of damages may be instituted against the accused in any court not below the court of District Judge.

Section 22 of the Design Act 2000 provides the legal proceedings to be followed in case of Piracy of Registered Design.

One of the below remedies can be sought against the accused:

  • Paying to the registered proprietor of the design a sum not exceeding twenty-five thousand rupees recoverable as a contract debt provided that the total sum recoverable  in  respect  of  any one design shall not exceed fifty thousand rupees; and
  • Recovery of damages for any such contravention, and an injunction against the repetition thereof, to pay such damages as may be awarded and to be restrained by injunction accordingly

References:

http://www.ipindia.nic.in/faq-designs.htm

http://www.ipindia.nic.in/writereaddata/images/pdf/ten-steps-to-design-application.pdf

http://www.ipindia.nic.in/writereaddata/Portal/IPOGuidelinesManuals/1_30_1_manual-designs-practice-and-procedure.pdf

Simplified account of Copyright Registration in India

This article is intended with covering the basic FAQs about Copyright registration in India. For the sake of better focusing, format of questions and answers has been adopted.

  1. What is Copyright?

Copyright is a right given by the law to creators of literary, dramatic, musical and artistic works and producers of cinematograph films and sound recordings. It is important to note that Copyright does not protect the ideas but protects the expression of the ideas.

  1. What kind of works can be protected by Copyright?

The Copyright Act, 1957 protects original literary, dramatic, musical and artistic works and cinematograph films and sound recordings from unauthorized uses.

  1. What kind of works cannot be protected by Copyright?

Ideas, procedures, methods of operation or mathematical concepts as such, titles, or names, short word combinations, slogans, short phrases, methods, plots or factual information are not protected by Copyright.

  1. Who can file for Copyright registration?

Any individual who is an author or rights owner or assignee or legal heir can file application for copyright of a work.

  1. Where can applications for Copyright be filed?

Applications can be filed both online and through Physical mode. Physical applications have to be directed to:

Copyright Division.

Department Of Industrial Policy & Promotion,

Ministry of Commerce and Industry;

G-30 Super Market August Kranti Bhawan

Bhikaji Kama Palace

New Delhi- 110066

For e-filing, instructions available at http://copyright.gov.in/UserRegistration/frmLoginPage.aspx may be referred.

  1. Can both the unpublished and published works be protected by Copyright?

Yes

  1. Is quality of work important for Copyright registration?

It is the originality of the work that is mandatory for the registration and not the quality of the work.

  1. What is the procedure for Copyright Registration in India?

After application has been filed and diary number has been allocated, applicant has to wait for a mandatory period of 30 days to check if any objection is filed in the Copyright office against applicant’s claim that particular work is created by him. If such objection is filed it may take another one month time to decide as to whether the work could be registered by the Registrar of Copyrights after giving an opportunity of hearing the matter from both the parties. If no objection is filed then application goes for scrutiny from the examiners. If any discrepancy is found the applicant is given 30 days time to remove the same. Therefore, it may take 2 to 3 months time for registration of any work in the normal course.

copyright_blog

Source: http://copyright.gov.in/ 

  1. What kind works of website can be protected through Copyright?

A web-site contains several works such as literary works, artistic works (photographs etc.), sound recordings, video clips, cinematograph films and broadcastings and computer software too. Separate applications have to be filed for registration of all these works.

  1. Whether computer Software or Computer Programme can be registered?

Yes. Computer Software or programme can be registered as a ‘literary work’. As per Section 2 (o) of the Copyright Act, 1957 “literary work” includes computer programmes, tables and compilations, including computer databases. ‘Source Code’ has also to be supplied along with the application for registration of copyright for software products.

  1. What kinds of right are granted to Copyright owner?

Copyright owner has two types of rights related to his work:

Economic Rights: Economic rights include for example right of reproduction, right of performance, right of broadcasting and right of communication which are derived from right of performance, rights of translation and adaptation.

Moral Rights: These are the rights that allow owner to maintain his image. These rights allow author to claim authorship of the work and to restrain or claim damages in respect of any distortion, mutilation, modification or other act in relation to the said work which is done even after the expiration of the term of copyright if such distortion, mutilation, modification or other act would be prejudicial to his honour or reputation. It’s important to note that moral rights remain with original creator even after whole or in part assignment of the work.

  1. What is the term of Protection granted by Copyright?

Term of the protection depends on the type of work. Generally, it’s until the expiration of the 50th year after the author’s death. In case of anonymous work, it’s until 50th year after the work has been lawfully made available to the public. In case of pseudonymous work, it’s until 50th year after the work has been lawfully made available to the public, but if author leaves no doubt about the identity or reveals the identity of his or her work, the general rule applies. In case of Audiovisual (cinematographic) works, it’s 50 years after the making available of the work to the public (“release”) or if such event did not take place, then from the creation of the work. In case of applied art and photographic works, it’s 25 years from the creation of the work.

  1. Is India member of the international treaties related to Copyright?

Except, WIPO Copyright Treaty (WCT) and the WIPO Performances and Phonograms Treaty (WPPT), India is a member of most of the important international conventions governing the area of copyright law, including the Berne Convention of 1886, the Universal Copyright Convention of 1951, the Rome Convention of 1961 and the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS).

  1. Which sections of the Act define what is and what is not infringement of Copyright?

Section 51 of the Act deals with the provisions related to infringement of the Copyright. Section 52 of the Act provides a detailed list of acts that do not constitute infringement. Owner of the copyright can seek criminal and civil remedies against accused infringer.

Reference:

copyright.gov.in/frmfaq.aspx

Simplified account of Trademark Registration in India

We had written an article giving a simplified account of Patenting procedures in India to enable readers who are new to the Patents. Similar attempt is being made here to provide answers to the Trademark FAQs so as to enable readers who are new to the Trademark.

  1. What is trademark? What is mark? What are some examples?

Answer: Trademark can be defined  as “trade mark” means a mark capable of being represented graphically and which is capable of distinguishing the goods or services of one person from those of others and may include shape of goods, their packaging and combination of colours;..”.

“Mark” includes a device, brand, heading, label, ticket, name, signature, word, letter, numeral, shape of goods, packaging or combination of colours or any combination thereof.

Below are some examples of trademarks:

  1. Word: IBM, Google
  2. Fanciful designation: Kodak
  3. Names: Disney
  4. Slogan: Hum hain na! (ICICI bank limited)
  5. Device: pepsi_2007
  6. Number: the 4711 cologne

7.Picture:   lacoste-logo-880x660 Lacoste logo

Registering your trademark helps you secure exclusivity over your mark, helps you get geographical coverage throughout country/region of registration, gives you a complete defence that you are not infringing rights of other person, helps you create brand value.

  1. What does trademark-logo1 and  registeredtm-svg  signify, when can we use them?

Answer:  trademark-logo1 is used to indicate that the trademark is unregistered but this mark is used for promote goods. trademark-logo1 can be used even for trademarks for which registration is not applied to claim use over it.

 registeredtm-svg is used to represent a registered trademark/ service mark that provides the applicant complete ownership and legal rights over the trademark/ service mark.

  1. Who can apply for trademark? Where should trademark application be filed?

Answer:  An application can be made for registration of trademark actually used or proposed to be used by any person claiming to be proprietor of the trademark. In India, for facilitation of the registration of the trademarks, Trademark registry operates from five locations i.e. Delhi, Mumbai, Ahmadabad, Kolkata, and Chennai.  In case of Indian applicants, jurisdiction is decided based on the principal place of business of applicant and in case of foreign applicants, jurisdiction is based on where applicant’s agent or attorney is situated.

More info about jurisdiction and locations of Trademark registry can be obtained from by visiting http://ipindia.nic.in/tmr_new/location_jurisdiction.htm .

For e-filing, manual available at https://ipindiaonline.gov.in/trademarkefiling/UsefullDownloads/User_Manual_etrademarkfiling.pdf may be referred.

  1. What are the general stages of trademark registration?

trademark-flowchart

  1. An optional initial trademark search (identical search or similarity search) may be conducted on the government
  2. Once there is a go ahead for trademark filing, an application for Trademark will be made through relevant forms provided by the trademark office/ Registrar of
  3. In the next step, the trademark office will issue an examination report and formality check report to communicate objections or to request clarifications with the There is no need to file request for examination i.e. examination of trademark is automatic. In this examination report, mark is examined basically on three grounds i.e. distinctiveness, descriptiveness and similarity to the prior marks. To qualify for registration, mark should be distinctive, non-descriptive, and there should not be any similar prior marks.
  4. A reply has to be made to the trademark office in lieu of the reports that may be accepted or may be followed by a The applicant or agent if appointed is required to respond to the examiner’s objection(s) within a period of one month from the date of receipt of Examination Report. Failure to respond to examination report within this specified period can lead to abandonment of application.
  5. If the trademark office is satisfied that the trademark request complies with all the necessary provisions under the act, the mark is advertised before
  6. Once the mark is advertised in trademark journal, it is open for a period of 4 months for third parties to
  7. If no opposition is received during the specified period, the Trademark is deemed to be
  8. Once registered, there is no post-grant opposition.

 

  1. Is the registration of trademark compulsory?

Answer: No. Registration of a trademark is not compulsory. However, the registration is the prima facie evidence of the proprietorship of the trademark under registration. However,  it is to be noted that no suit can be instituted for infringement of unregistered trademarks. For unregistered marks, action can be brought against any person for passing off goods or services as the goods of another person or as services provided by another person. The latter is said to be common law right.

  1. Can a registered trademark be amended at later date?

Answer: Yes, the filed mark is allowed to be amended as per the provision of Section 22 of the Trademarks Act, which allows the amendment of the mark provided it does not amount to a substantial change in the character of the mark as such. It is practice of the Registrar of Trade Marks that if the mark applied as a label mark, any superficial or insignificant character or feature of the said mark, is allowed to be amended, if a request filed in the prescribed format along with 16 copies of the amended label mark.

  1. What is collective Trademark?

The collective mark is owned by an association of persons not being a partnership. It belongs to a group and its use therefore is reserved for members of the group. The primary function of a collective mark is to indicate a trade connection with the association or organization who is the proprietor of the mark. Section 63 of Trademarks Act, 1999 and Rule 128 of the Trademarks Rules, 2002 deal with this.

  1. What is Certification mark?

The purpose of a certification trade mark is to show that the goods or services in respect of which the mark is used have been certified by some competent person in respect of certain characteristics such as Origin, mode of manufacture, quality etc. Section 74 of Trademarks Act, 1999 and Rule 135 of the Trademarks Rules, 2002 deal with this.

  1. What are the modes of filing trademark internationally? Can a foreign applicant claim the priority based on earlier application?

Answer: International registration of trademark is facilitated through Madrid Protocol which allows trademark application in one country/region to take priority from trademark application filed in other country/region. This priority has to be claimed within six months. India is member of the Madrid Protocol with effect from July 08, 2013.

  1. Once registered for what period of time, a trademark is effective? Can a trademark registration be renewed?

Answer: The registration of a trademark is valid for a period of 10 years. It can be renewed every 10 years, perpetually. In India, renewal request is to be filed in form TM-12 within six months before the expiry of the last registration of trademark. If renewal fee is not paid till the expiration of last registration, surcharge has to be paid along with prescribed fee accompanied to form TM-10. If renewal fee along with surcharge is not paid till the expiry of six months after expiration of last registration, trademark is liable to be removed. Once removed, restoration of trademark can be requested in form TM-13 along with prescribed fees and applicable renewal fees. TM-13 can be filed from six months of expiration of last registration till the expiry of 1 year from the expiration of last registration.

  1. Is the trade mark liable for removal on the ground of non-use?

Answer: Yes, a registered trademark can be removed on the basis of non use. Except as excused in clause 3 of section 47 of trademarks act, 1999, a trade mark may be removed on the ground of non-use if:

  1. that the trade mark was registered without any bona fide intention and was not used till a date three months before the date of the application for removal; or
  2. trademark was not used for a continuous period of five year from the date of registration of trademark and application was made after three months from the expiry of five years.

  1. Is the sound or smell registrable as trademark? How are these marks specified?

Answer: Yes, sounds or smells are registrable as a mark. However, they should be capable of being reproduced graphically and should be distinctive. Sound can be represented as musical notations along with the sound recording Smell can be represented as chemical formula along with the sample.

  1. Is a three-dimensional mark registrable?

      Answer: Yes, a three-dimensional mark is registrable.

  1. What is classification of goods adopted in India?

Answer: International Classification of goods and services (Nice Classification) is adopted in India.

  1. What are the grounds for refusal of registration of trademark?

Answer:  Section 9 of the trade marks act, 1999 provides absolute grounds and section 11 provides relative grounds for refusal of registration of India. Trademark laws mandates trademark to be distinctive and non-descriptive in order to get registered. Rationale behind this provision is that non-distinctive or descriptive marks can’t be granted monopoly being generic to the trade and are open for public use without any exclusive rights over the same. Some of the examples of non-distinctive or descriptive marks are give below:

  1. Dalal street for financial services
  2. Best restaurant for food services
  3. Strong furniture for furniture
  4. High tech for technology related goods/services

  1. Can a registered user restrain third party from using identical or similar mark if third party is continuous and prior user of the mark?

Answer: A registered user can’t restrain third party from using identical or similar mark if third party has been continuously using the mark in relation to the same goods or services for which mark of registered user is registered provided third party has been using the mark from a date prior to date of use of registered mark or date of registration, whichever is earlier.

 

  1. Before applying for registration, where can search be done to check if identical or similar marks already exist?

Answer:  In case you wish to carry out your own search (identical as well as similarity), following are the recommended steps for the same:

At the first step, you may check your mark’s availability on a free government portal using the following steps:

  1. Go to the government search portal : https://ipindiaonline.gov.in/tmrpublicsearch/frmmain.aspx
  2. Select the relevant class of search from a list of 45 different business classes listed here: http://ipindiaonline.gov.in/tmrpublicsearch/classfication_goods_service.htm

For  Wordmark:

  1. Search using the “Contain” in the drop-down instead of “Start With” to have a broader
  2. Please note that Trademark Registry will also object if the name is similar Thus, for better results, search similar sounding words as well. Example: A keyword like Kryzal can have following terms that are similar sounding: Crizal, Cryzal, Creezal, Crisal, Crysal, Creesal, Krizal, Kreezal, Krisal, Kreesal, Krysal.
  3. Also note that the website often encounters downtime error, and sometimes shows “no record found” while that is And thus a minimum of 2 time confirmation is recommended if such a scenario occurs.
  4. Please note that the normal update in the portal is done on an average period of one Thus recent filings will not reflect in the search.
  5. If you find any result similar to your mark and the same/ similar class or same similar business description, the name is recommended to be changed to avoid any objection/opposition during the trademark registration

For Logo:

  1. For a logo, Vienna code classification search is to be carried The relevant Vienna code class can be searched on this interface: http://www.wipo.int/classifications/nivilo/vienna/index.htm#  by clicking on the search button (top left) and then enter the keyword (top right), followed by browse through the category to identify relevant Vienna Classification.
  2. Once the relevant Vienna code is found out, please enter the same in the Search interface using dropdown to select Search Type as “Vienna Code” instead of “Wordmark”
  3. Enter the Relevant Vienna Code in the following format: 1.1.1 will become 010101 while 1.2.12 will become 010212.
  4. Enter the relevant class and Relevancy criteria will be similar to the wordmark

Foreign Filing Permission: Indian Patent System Perspective

Different countries having regard to National Security Considerations and with the intent of having a check on the defence and atomic energy related inventions, have different restrictions in place. While some countries make it mandatory to file Patent Applications in their country before applying in any other country, some countries require only prior permission before applying in other countries.  Here is the link for a quick overview of the requirements of different countries.

While filing Patent application outside India for the invention conceived by Indian resident, it is not compulsory to first file Patent Application in India. However, it’s important to note that if Patent Application is not to be first filed in India, written permission is to be sought in form 25 from the Indian Patent Office. It’s also important that mandate of seeking permission for foreign filing remains there even after filing Indian application for six weeks.

Attention of the readers is also sought to the language of the governing section (reproduced below) of the Patent Act, 1970 which uses the word ‘resident’ and not the citizen. Therefore if the invention has been conceived by citizen/national of any country while he was residing in India, section 39 has to be complied with before applying for foreign Patent Applications.

Official fee for form 25 is as follows:

Natural person(s) and/ or Startup:

E-filing- 1600

Physical filing: 1750

Small entity, alone or with natural person(s) and/ or Startup:

E-filing- 4000

Physical filing: 4400

Others, alone or with natural person(s) and/ or Startup and/ or small entity                        

E-filing- 8000

Physical filing: 8800

 

Regarding timeline, Indian Patent Office has to dispose of such request within 21 days of receipt of such request. However, this timeline changes for the inventions related to defence or atomic energy, where the period of twenty-one days starts from the date of receipt of consent from the Central Government.

Related sections and rules have been reproduced below. Sections dealing punishments in case of failure to comply with relevant sections have also been reproduced.

Section 39. Residents not to apply for patents outside India without prior permission.—
(1) No person resident in India shall, except under the authority of a written permit sought in the manner prescribed and granted by or on behalf of the Controller, make or cause to be made any application outside India for the grant of a patent for an invention unless— (a) an application for a patent for the same invention has been made in India, not less than six weeks before the application outside India; and (b) either no direction has been given under sub-section (1) of section 35 in relation to the application in India, or all such directions have been revoked.

(2) The Controller shall dispose of every such application within such period as may be prescribed: Provided that if the invention is relevant for defence purpose or atomic energy, the Controller shall not grant permit without the prior consent of the Central Government.

(3) This section shall not apply in relation to an invention for which an application for protection has first been filed in a country outside India by a person resident outside India.

Rule 71: Permission for making patent application outside India under section 39.—

(1) The request for permission for making patent application outside India shall be made in Form 25.

(2) The Controller shall dispose of the request made under sub-rule (1) within a period of twenty-one days from the date of filing of such request:
Provided that in case of inventions relating to defence or atomic energy, the period of twenty-one days shall be counted from the date of receipt of consent from the Central Government.

Below given sections deals with the penalties for not complying with section 39:

Section 40:

Liability for contravention of section 35 or section 39.—Without prejudice to the provisions contained in Chapter XX, if in respect of an application for a patent any person contravenes any direction as to secrecy given by the Controller under section 35 or makes or causes to be made an application for grant of a patent outside India in contravention of section 39 the application for patent under this Act shall be deemed to have been abandoned and the patent granted, if any, shall be liable to be revoked under section 64.

Section 118: Contravention of secrecy provisions relating to certain inventions.—If any person fails to comply with any direction given under section 35 or makes or causes to be made an application for the grant of a patent in contravention of section 39 he shall be punishable with imprisonment for a’ term which may extend to two years, or with fine, or with both.