Category Archives: Indian Patents Act

Office Memorandum From Ministry Of Environment, Forest And Climate Change: A Much Needed Respite For The Bioscience Researchers And Companies

Biological diversity and ecosystem have always been global concerns, due to which various countries including India signed and ratified Convention on Biological Diversity (CBD). In order to meet the obligation under the said convention and furthermore to conserve the biological diversity as well as to provide mechanism for its sustainable use and equitable sharing of benefits arising out of the use of biological resources and knowledge, the Government of India introduced The Biological Diversity Act, 2002. The Act focuses on conservation of biodiversity, sustainable use of bio-resource and access and benefit sharing from the utilization of biological resources through a body called National Biodiversity Authority (NBA).

The Act regulates access to biological resources in diverse scenarios through its various provisions. Utilization of Indian biological resource or associated knowledge not only for commercial utilization but even for research, bio-utilization or bio-survey by non-resident Indians, foreigners, foreign companies, or Indian corporate with non-Indian participation is barred without prior approval of the NBA as per Section 3 of the Act. Even licensing of any research relating to biological resource from India to a foreigner, foreign companies, Indian corporate with non-Indian participation, or non-resident Indians can only be done after taking prior approval from the NBA under provision of Section 4 of the Act. Considering a wide scope of Intellectual Property, possibly with the intent of curbing bio piracy though this channel the Act under Section 6 also mandates a prior approval of National Biodiversity Authority for making an Application for IPR involving research on biological resource from India. Such approvals impose benefit sharing fee or royalty or both or impose conditions including the sharing of financial benefits arising out of the commercial utilization of such rights.

Awareness of such a statute however, is unfortunately not prevalent among much large section of public, which makes it one of the major factors of non-compliance of provisions mandated by this statute even if they are desirous of complying with the same. The Central Government has issued a notification on September 10, 2018, under section 48 of the Biological Diversity Act, 2002 to provide an opportunity to all such entities which required prior approval in past as per Sections 3, 4 and 6 of the Act and regulate these provisions in a manner that enhances implementation of the Act. This directive is not only in line with the objectives of the Act but enhances proper implementation of the Act, being one of the few targets the Government of India has set to achieve by 2020, (read here).

NOTICE F. N. C.- 12025/8/15-CS-III dated 10th September’ 2018

The Central government has taken note of all the provisions of the Act and by exercising powers under section 48 of the Act, has issued Office Memorandum (OM) directing the National Biodiversity Authority to hear all such cases where prior approval of NBA was required (including the cases which needs prior approval of NBA in IPR related applications such as Patent registration application based on research based biological resource of India but the person/entity has not obtained such approval.

It is required that the authority should hear such cases on the merits and take decision within a period of 100 days from the date of issuance of this Office Memorandum (OM). The NBA can pass appropriate orders in furtherance of the powers available to it under section 18 of the act for facilitating and enhancing implementation of the act in public interest toward meeting the objectives of the act such as conservation of biological diversity, sustainable use of its components and fair and equitable sharing of the benefits arising from use of biological resource. Also, the NBA is required to abide by the principles of natural justice and various judgments of Hon’ble courts while implementing the directions.

As per the OM, the National Biodiversity Authority shall also look into the judgment as well as intent and reasoning behind such ruling pronounced by various Honorable Courts in order to decide such case in an unambiguous and clear manner.

In one incident, The Ministry had issued a notification in respect of prior environmental clearance under the Environment Protection Act, 1986 wherein six months period was provided to apply for environmental clearance for projects on which the project proponent has started work on site, expanded the production beyond the limit of environmental clearance. The High court of Madras had vacated the stay on the notification in the matter of Puducherry Environment Protection Association v. Union of India saying that the protection of environment and prevention of environmental pollution and degradation are non-negotiable. One time relaxation is not impermissible in cases where projects are in compliance or can be made to comply with the pollution norms.

Similarly, with respect to requirement of prior forest clearance from Central government, the Hon’ble Supreme court in SC Monitoring Committee v. Massoorie Dehradun Development Authority held that it is required to forward the case to the central government for seeking ex-post facto approval. With respect to situations where fait accompli situation arose, SC in T.N Godavarman Thirumulpad v. Union of India did not interfere with the decision of MoEF granting site clearance. The court held that since fait accompli situation arose, there was no option but to recommend the case for grant of permission for the use of forest land for mining lease, conveyor belt system and associated activities. The Bombay HC in Vijay Krishna kumbhar v. The State of Maharashtra held that in situation where fait accompli arose, there is no alternative except to follow the action which has become fait accompli and take further actions in accordance with the government’s directions.

IP AND BIODIVERSITY

It is very clear from the above that the objective of the statute majorly is to provide equitable sharing of benefits arising out of the use of biological resources and knowledge and Section 6 of Biological Diversity Act mandates a prior approval from NBA before making an application for any intellectual property right in or outside India, for any invention based on any research or information on biological resources obtained from India. It is pertinent to mention that the aforesaid provision provides some relaxation to IPR application:

  • Provided that if a person applies for a patent, permission of the National Biodiversity Authority may be obtained after the acceptance of the patent but before the sealing of the patent by the patent authority concernedand

  • Provided further that the National Biodiversity Authority shall dispose of the application for permission made to it within a period of ninety days from the date of receipt thereof.

The statute also provides for penalty against any violation of this particular provision, which leads to imprisonment which may extend to 5 years, or fine up to Rs.10 lakhs (approx. USD 15500) or damages with fine.

Such Authority (National Biodiversity Authority) is a Statutory body that performs facilitative, regulatory and advisory function for Government of India on issue of Conservation, sustainable use of biological resource and fair equitable sharing of benefits of use and is established to ensure that the essential provision of the statutes are being implemented.

The Biological Diversity Act, 2002 mentions that permission from NBA is to be obtained before the sealing of the patent. Thus, it is observed that there was no conformity to the timelines in grant of permission from NBA for patent applications which are based on research or information on a biological resource obtained from India. However, despite of a statutory time limit of ninety days being provided to the NBA for grant of such permission to patent applicants, NBA takes many years in issuance of such permission, which directly and adversely affects the patent right of the applicant. Such delay in permission means that in case an applicant complies with all the requirements for the grant of the patent, the patent shall be pending until the permission from NBA is granted.

Moreover, very few stakeholders are aware of this provision and therefore fail to comply with this provision. On account of this, the Central Government issued the OM dated 10.09.2018. This notification would not only help in spreading awareness among people about such compliances but will also be able to help expedite the whole procedure of grant of approval by providing a specific time line of 100 days. This, notification also regularizes the procedure of the approval by NBA providing much respite to those persons/entities for obtaining the requisite approval without facing the harsh penal action for unintentional failure to comply the Act merely because of not being fully aware of the provisions of the Act.

The question pertains to what has to be done by the Patent examiner in cases where patent application in relation to biological resource has been made, before the issuance of such notification?

According to the provisions of Patent Rules, 2015, the Controller may pass an appropriate order in case where the applicant has not submitted necessary permission from the competent authority within the period as prescribed under Rule 24B and 24C in order to receive grant under section 21 of Patent Act.  

Rules 24B and 24C of the Patents Rules, 2003 mention that the time for putting an application in order for grant under Section 21 shall be four months from the date on which the first statement of examination is issued to the applicant to comply with the requirement extendable for a further period of 2 months. Thus, in case, NBA is unable to provide with such permission, by the time as prescribed under Rules 24B and 24C, the Controller has discretion to issue the “appropriate orders”.

Since, the two statutes i.e. Patent Act, 1970 and The Biodiversity Act, 2002 are directed towards different subject matter, thus, they are independent of each other and neither is bound to follow directions of each other.

The Notification issued by the Central Government providing for a specific timeline of 100 days for approval of any application regarding IPR shall be towards harmonizing the two procedures prescribed by the two statutes expediting grant of patent as well as implementation of the Biological Diversity Act.

The OM issued by the Ministry of Environment, Forest and Climate change thus is a huge and a productive taken up by the Government, which will also lead to an expedited grant of patent as an allied benefit.

Author: Ms. Mita Sheikh, Principal Associate and Ms. Pratistha Sinha, Trademark Associate at Khurana & Khurana,  Advocates and IP Attorneys. In case of any queries please contact/write back to us at mita@iiprd.com.

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Emerging Trends in IP

Intellectual Property has seen numerous modifications. Different Intellectual Properties have come about to exist, which some would say is the impact of IP Maximalism and some would regard them as a matter of necessity of changing times, which reminds me of Victor Hugo, he spoke in a speech and I quote, “no power on earth can stop an idea whose time has come.” This is very well the era IP evolution. Where software is expressly ousted from patent protection, CRIs come to their rescue. New types of intellectual property rights are on the rise, for example, Data Exclusivity, Orphan Drug Exclusivity, Standard Essential Patents etc. India lags behind in several of these emerging trends, partly because of the lack of legislature in several issues and partly because of its mixed priorities. Legal framework needs to substantiate these issues more coherently, while maintaining India’s pro public-benefit approach towards IP.

Invention in softwares

While identifying what kind of protection is to be granted to an IP, one needs to identify on what is the “intellectual” in that property, is it an invention or a literary work?Software i.e. computer programme has found its mode of protection in the Indian Copyright Act, 1957. S2(ffc) defines computer programme as “a set of instructions expressed in words, codes, schemes or in any other form, including a machine readable medium, capable of causing a computer to perform a particular task or achieve a particular result”. These are as such included in “literary work” defined in S.2 (o) of the Act, “literary work includes computer programmes, tables, and compilations including computer literary databases.”

On the other hand, the Indian Patents Act, 1970 expressly excludes computer programmes from the ambit of patentable subject- matter, visavis including it in Section 3 what are not inventions, S. 3 (k) a mathematical or business method or a computer programs  per se or algorithms; and S.3 (m) a mere scheme or rule or method of performing mental act or method of playing game; expressly excludes computer programs from patentable subject matter.[1]

However, the Patent Office prescribes guidelines to outline various regulations and explanations regarding patentability of computer related inventions (CRIs), last updated on 30 June, 2017.[2]

The legislative intent to attach the suffix per se to computer programme is evident by the following view expressed by Joint Parliamentary Committee while introducing Patents (Amendment) Act, 2002:

“In the new proposed clause (k) the words “per se” have been inserted. This change has been proposed because sometimes the computer programme may include certain other things, ancillary thereto or development thereon. The intention here in not to reject them for grant of patent if they are inventions. However, the computer programmes as such are not intended to be granted patent. This amendment has been proposed to clarify the purpose”.[3]

Example:

1. In re Accenture Global Service GMBH Vs. The Assistant Controller Of Patents & Designs[4], relates to Indian patent application number 1398/DELNP/2003, which is now a granted patent as patent number 256171, whose present legal status at the patent office database is, “Enforce with Due date of next renewal as 21/02/2017”. This patent application was initially refused for patent registration by patent office under the provisions of Section 3(k) of the Indian patents act.

However, the patent applicant appealed before the IPAB and as per the Controller’s decision, it was held that the instant invention as claimed is not software per se but, a system is claimed which is having the improvement in web services and software. Accordingly, it was held that the invention since not falling in the category of section 3(k), viz software per se, corresponding objection was waived and the patent was granted.

2. Nissan Motor filed a series of patent applications in 2017 with respect to the computer softwares inter alia a travel control device and method for vehicle[5] comprising: a target acquisition means for acquiring target information which includes the location of an avoidance target that exists near a vehicle, a vehicle information acquisition function for acquiring information which includes the location of a vehicle, and drive assist device[6] which is a driving assistance device for assisting driving when a host vehicle is changing lanes wherein the device is provided with; a position measurement means for measuring the position of the host vehicle; a detection means provided to the host vehicle the detection means detecting the conditions around the host vehicle; a database for recording map information.

The aforementioned claims of Nissan Motor are claims concerning Computer Related Inventions (CRIs) which mean to perform the function as mentioned above and hence are termed as means + functions defined in the Guidelines for Examination of Computer Related Inventions.[7]

In light of the guidelines published by the Indian patent office for examination of software patents / computer related inventions (CRIs), software patents can be applied in India by way of combination of hardware and software features, which are novel, inventive and possess industrial applications. It may be categorized as Hardware based inventions: apparatus/ system/ device, Method/process based, Computer program product/ computer readable medium. Unless the software is a computer program per se, it may be granted a patent in India, and hence Nissan stands a fair chance to be granted the aforementioned patents. However, in the case of any conflict between The Indian patents Act and the said Guidelines, the Act is to prevail and for such instances, it is essential to have rules with the effect of laws incorporating CRIs in patentable subject matter.

On the same lines European Patent Convention expressly excludes computer programs, per se, from the purview of patentable subject matter.

Whereas in USA, there is no specific exclusion of software or business methods from patentable subject matter.  The law states that the subject matter, to be patentable, must be a useful process, machine, manufacture or composition of matter. According to the US Supreme Court, the Congress intended the statutory patentable subject matter to include “anything under the sun made by man,” but the laws of nature, natural phenomena and abstract ideas are three specific areas which are not patentable.[8]

Emerging new IPs

SEPs and FRAND Licensing

A patent that protects technology essential to a standard is called a standard-essential patent.[9] A standard is a document that sets out requirements for a specific item, material, component, system or service, or describes in detail a particular method or procedure.[10] For example, a modern laptop computer implements around 251 interoperability standards.[11]

The concept of SEPs evolved in India when Ericson in 2011 objected to the importation of handsets by Kingtech Electronics (India), claiming that the handsets infringed several of their SEPs in AMR Codec (Adaptive Multi-Rate) technology. The Indian Patents Act, 1970 does not contain any special provision for SEPs. Although, the same have been recognized by the jurisprudence, SEP is defined as …for a technology that forms a part of a standard, the patent is regarded as an essential patent for such standard.An essential patent can be said to be a patent that corresponds to an industry standard. The same standard is mutually agreed by various service providers, equipment manufacturers etc to be mandatorily implemented for a particular technology (such standards are recognized and implemented by the concerned government authority as well). It is meant to ensure that complete compatibility is achieved. It is impossible to claim compatibility with a technology (as defined by the concerned standards) without actually infringing the specific patent (and hence the requirement to obtain a license).[12]

 Following cases in India,

  1. Ericsson and Micromax case,
  2. Ericsson and Intex case
  3. Ericsson and Best It World (India)
  4. Ericsson and Xiaomi Technology
  5. Ericsson and Lava International Private Limited
  6. Telefonaktiebolaget lm Ericsson (publ) v.Competition Commission of India and another,

have established clearly that the necessary steps to be taken by any company/ legal entity, intending to incorporate any technology in its product that is standardized by any SSO (Standard Setting Organisation). It has to,

1.Incorporate the patent which is essential to obtain that standard.

2. To enable themselves of the use of aforesaid patent, without infringing it, they require obtaining a license from the holder of the aforesaid patent.
However, such a situation can have an obvious monopolistic outcome in the hands of the patent holder, and to curb such a situation before-hand, the patent holder has its commitments as a member of the SSOs, these commitments are known as FRAND commitments. Whereas the question remains as to what are the clear boundaries of fair, reasonable and non-discriminatory license terms, is to be determined by the consensus reached by the parties, and if the parties are unable to reach such consensus, they may appoint a mediator for the purpose, and yet if the party seeking the license considers the license terms to be abusive of the dominant powers of the patentee, the CCI holds proper jurisdiction to inquire and investigate into the same.

Data Exclusivity

Data Exclusivity is a TRIPs Plus element that is much debated in India. It arises from the interpretation of the Article 39 of the TRIPs agreement, “Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use [13]wherein the big Pharmaceuticals and countries like USA interpret, “protection against unfair commercial use” to obviously mean, “protection of clinical data required to be submitted to a regulatory agency to prove safety and efficacy of a new drug, and prevention of generic drug manufacturers from relying on this data in their own applications.” USTR (United States Trade Representative) has been negotiating bilateral agreements enforcing the said interpretation of TRIPs, which is beyond the actual agreement and is thus referred to as a TRIPs Plus clause, with India. The Drugs and Cosmetics Act, 1940 provides for data exclusivity for a “new drug” under section122E for a total period of 4 years from the date of approval. There were considerations in November, 2016 that this period of four years to be increased to ten years.[14] Such exclusivity is itself a protection and does not depend upon the validity of the patent associated to the same drug, so even if the patent associated to the drug stands invalidated, the exclusivity stands unaffected and the drug remains out of the reach of the generic producers. There is no evidence that the four years of protection, already provided, was insufficient, and neither is there any protocol necessitating India to increase the said period. Such provision would delay market access of drugs at reasonable prices to the common people. Although, USA itself provides for 7 years of data exclusivity but the economic and developmental status of India, would suffer with such an amendment to the section.

Orphan Drug Exclusivity

An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition. India currently has no regulations for orphan drug manufacturing or selling. Treating rare or orphan diseases is important to India but very costly, which increases the patient burden. In India, 72,611,605 people are suffering from rare diseases, and 6,000–8,000 rare diseases can be found, including LeishmaniasisNorrie disease,ArthrogryposisCystic FibrosisWilson Disease, etc., many of which still do not have any cure and are mostly genetic in nature.[15]

Many countries have different definitions and regulations of orphan drugs,

USA under its The Orphan Drugs Act (ODA) is a federal law concerning rare diseases that affect fewer than 200,000 people or are of low prevalence, oraffects more than 200,000 in the United States and for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will recovered from sales in the United States of such drug. Determinations under the preceding sentence with respect to any drug shall be made on the basis of the facts and circumstances as of the date the request for designation of the drug under this subsection is made.[16]

According to the Orphan Drug Regulation in Europe, an orphan disease is a disease or disorder that affects fewer than 5 in 10,000 citizens.[17]

In Australia, RareDiseases are defined as a condition, syndrome or disorder that affects 1 in 10,000 people or less (The Australian Therapeutic Goods Authority).[18]

The lack of regulation in India increases the burden on the patients but also negatively impacts the economic success of India’s pharmaceutical industry. Orphan drugs may help pharmaceutical companies reduce the impact of revenue loss by patent expiration of blockbuster drugs. Although there may still be challenges ahead for the industry, orphan drugs seem to offer the key to recovery and stability within the market. Governments of various countries have proactively implemented special incentives for the manufacturers of orphan drugs. For example, regulations include accelerated marketing procedures, marketing exclusivity, tax credit grants for research, reconsideration of applications for orphan designation, and technical assistance for elaboration of the application file.

Intellectual Property Rights came into existence with the primary objective of promoting the progress of science. Patents are the rights that grant exclusivity to the patent holders, where they can exclude others from exploiting their invention which they have spent their R&D upon. This creates a monopoly in the hand of the right holder; this monopoly was intended to serve as an incentive for creation.
What we can observe with the emerging trend of IP is that the protection is shifting its focus from promoting innovation in every field to reserving exclusivity. Pharmaceuticals have been trying to evergreen their patents on blockbuster drugs by merely changing the form of the drug, which when restricted by the Indian Courts by the mandate of S.3(d) of the Indian Patents Act, the validity of which section was found to be challenged in the Supreme Court. The Supreme Court held the section to be constitutionally valid, thereby striking down Bayer’s contentions[19], leading to many disappointed Pharmaceutical Companies. Data exclusivity is yet another tool aiming at the same monopolistic outcome, protecting the clinical data of any “new drug” for an absurd period of time. A “new drug” is not defined as a patented drug but simply a drug which has not been used in the country to any significant extent under the Drugs and the Cosmetics Act[20].

In re Ericsson v. CCI, it was alleged that Ericsson had added a covenant subjecting all disputes relating to matters under their FRAND license to the jurisdiction of Swedish Courts, thereby causing unnecessary costs for Indian mobile phone companies.[21] There are no specific guidelines as to what is fair, reasonable and non- discriminatory, due to which big fishes in the market construe the terms in their own brackets of convenience. Considering the economic condition of the Indian market, such licensing terms can lead to winding up of small and medium enterprises which is to be further evaluated by the Competition Commission of India.

This prevailing trend is untimely exclusivity masked in the disguise of evolution. However, exclusivity is an innate part of evolution, provided, used in the solution of overlooked issues such as orphan care drugs. Exclusivity is indeed very appealing for pharmaceutical companies to invest their R&D in the production of orphan drugs. It curbs their fear of negative commerce which appears to be an obvious result of producing any product with low commercial demand. With regulations such as a fixed exclusivity period over their drug and royalty standards, a profit margin can be achieved in addition to the recovery of production costs in the aforesaid duration.The shifting trend towards exclusivity can positively shape the Indian IP regime, if given the right direction.

About the Author: Namisha Jain, ILS law college, Intern  at Khurana and Khurana Advocates and IP Attorneys and can be reached at info@khuranaandkhurana.com

[1]  Indian Patents Act, 1970

[2] www.ipindia.nic.in/writeraddata/Portal/Images/pdf/Revised_Guidelines_

for_Examination_of_Computer-related_Inventions_CRI.pdf

[3] Report of the Joint Committee presented to the Rajya Sabha on 19th December, 2001 and laid on the table of Lok Sabha on 19th December 2001.

[4]  http://www.ipabindia.in/Pdfs/Order-283-2012-OA-22-2009-PT-DEL%20(Final).pdf

[5] Application No. 201747007327 A; www.Ipindia.nic.in/writeaddata/Portal/IPOJournal/1_471_1/Part-2.pdf

[6]  Application No. 201747015385;www. Ipindia.nic.in/writeaddata/Portal/IPOJournal/1_471_1/Part-2.pdf

[7] http://www.ipindia.nic.in/writeraddata/Portal/Images/pdf/Revised_Guidelines_for

_Examination_of_Computer-related_Inventions_CRI.pdf

[8] Bilski v. Kappos

[9]  http://ec.europa.eu/competition/publications/cpb/2014/008_en.pdf

[10]  http://www.cencenelec.eu/standards/DefEN/Pages/default.aspx

[11]  http://www.standardslaw.org/How_Many_Standards.pdf

[12]  In re Telefonaktiebolaget lm Ericsson (publ) v. Intex Technologies (India) Limited I.A. No. 6735/2014 in CS(OS) No.1045/ 2014

[13]  https://www.wto.org/english/docs_e/legal_e/27-trips.pdf

[14] https://www.ip-watch.org/2016/11/06/indian-generic-pharma-warns-government-caving-us-pressure-data-exclusivity/

[15] Adapted from the Rare Diseases List provided by the Foundation for Research on Rare Diseases and Disorders (accessed May 7, 2015)

 [16] https://www.fda.gov/forindustry/developingproductsforrarediseasesconditions

/howtoapplyfororphanproductdesignation/ucm364750.htm

[17] http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2000:018:0001:0005:en:PDF

[18] http://www.rarediseasedayaustralia.com.au/what-is-a-rare-disease/

[19]  Novartis AG v. Union of India CIVIL APPEAL Nos. 2706-2716 OF 2013 (ARISING OUT OF SLP(C) Nos. 20539-20549 OF 2009)

[20] Rule 122E of the Drugs and Cosmetics Act, 1945- Directorate General of Health Services. The Drugs and Cosmetics Act and Rules. D&C Rule’s 1945- 122E:2005. Delhi: D&C; 2005. p. 134.

[21]  Ericsson v. CCI W.P.(C) 464/2014 & CM Nos.911/2014 & 915/2014

Power to review decisions or setting aside orders of the Controller [Indian Patents Act, 1970 Section 77 (f), (g)]

The Indian Patents Act, 1970, Section 77 gives the Controller of Patents the powers of a Civil Court to deal with a suit under the Code of Civil Procedure, 1908 for matters stated in Section 77 (1) Clause f and g of the Indian Patents Act, 1970 which reads as follows –

“Section 77.  Controller to have certain powers of a civil court –

(1) Subject to any rules made in this behalf, the Controller in any proceedings before him under this Act shall have the powers of a civil court while trying a suit under the Code of Civil Procedure, 1908 (5 of 1908), in respect of the following matters, namely: —

(f) reviewing his own decision on application made within the prescribed time and in the prescribed manner;

(g) setting aside an order passed ex- parte on application made within the prescribed time and in the prescribed manner;”

 

The Clause (f) of sub-section (1) of Section 77 of the Indian Patents Act, 1970 says that an applicant can make an application under Form 24 of Patent  Rules, 2003 to the Controller of Patents to review the decision of the Controller within one month from the date of communication of such decision to the applicant or within such further period not exceeding one month thereafter as the controller may on request made in Form 4 allow and shall be accompanied by a statement setting forth the grounds on which the review is sought. Where the decision in question concerns any other person in addition to the applicant, the Controller shall immediately transmit a copy of each of the application and the statement to the other person concerned as specified in Rule 130 (1).

The Clause (g) of Sub-Section (1) of Section 77 of the Indian Patents Act, 1970 says that an applicant can make an application in Form 24 of the Patents Rules, 2003 to the Controller of Patents for setting aside an order passed by the controller ex-parte. Such application shall be made according to Rule 130 (2) within one month from the date of communication of the order of the controller to the applicant or within such further period not extending one month as the controller may on a request made in Form 4 of the Patent Rules, 2003 for the extension of time allow and shall be accompanied by a statement setting forth the grounds on which the application is based. If the order of the Controller concerns to any other person in addition to the applicant, the Controller shall, immediately transmit a copy each of the application and the statement to the other person concerned.

These provisions can be explained with the help of some recent case studies. In a recent dispute between Abbott Biotechnology and Glenmark Pharmaceuticals. The Patent office set aside its former order by powers advanced to the controller of patents under Section 77(f) of the Indian Patent Act, 1970, granting patent to Abbott Biotechnology ltd. on rheumatoid arthritis (called as HUMIRA) drug in respect of the pre-grant application filed by Glenmark Pharmaceuticals under section 25(1) which reads as

“any person or any third party or Government may challenge the application of grant of patent and inform to the controller of Patents for opposition, in writing against the grant of a patent after the application for a patent has been published but before the grant of a patent”

and rule 55 of the Indian Patents Act, 1970. This decision came after the patent office was asked by the Delhi High Court in an appeal by Glenmark which alleged that on 4th September 2008 Glenmark’s pre-grant opposition was not considered by the controller while granting the patent as given under section 25(1) of the patents act and Abbott was granted the patent for Humira drug on June 8, 2009. The then controller treated the patent held by Abbott as cancelled immediately through a letter on October 30, 2009. Abbott approached the Delhi High Court against the Controllers order. The Delhi High Court stood still on the controller’s order of cancellation of the Patent held by Abbott.

On 9th September 2010, the Delhi High Court ordered that the pre-grant opposition of Glenmark to be considered as review application on decision of the controller under section 77(f) of the Indian Patents Act, 1970 and set aside their previous order of the cancellation of the Patent.

The Senior Joint Controller of Patents and Designs, K S Kardam, following the Delhi High Court’s order, observed, “…. I firmly conclude that the impugned invention as disclosed in the specification and claimed in the claims is obvious to person skilled in the art and hence lacking in inventive step. I am also of the opinion that the description of the impugned invention is also insufficient and ambiguous as described in the specification.”

“In view of the above circumstances and considering the order of the Honorable High Court of Delhi dated September 9, 2010, I hereby set aside the order of grant of patent dated June 8, 2009 in respect of patent application number No. 526/DELNP/2005 under section 77 of the Patents Act, 1970 and consequently the serial number of the patent No 234555 is hereby treated as void,” added the order dated December 31, 2014.

About the Author: Aditya Sehgal, Symbiosis Law School Intern at Khurana and Khurana Advocates and IP Attorneys and can be reached at intern@khuranaandkhurana.com