Patentability of Genes, Gene Sequencing & DNA based Primers

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

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

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

Important Case Study

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

Facts of the case:

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

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

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

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

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

Country- Wise comparison of various Biotechnology Inventions

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


Indian Patent Scenario

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

Gene Isolation

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

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


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

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

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

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

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

Few Examples

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

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

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

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



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


Specific Issues with Biotechnology and Gene Patents

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

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

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

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

Interpretation of Section 31 of Indian Patents Act, 1970

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

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

Questions which need to be addressed are:

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

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

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

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

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

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

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

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

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

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

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

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


IIPRD, this year, with the support from Khurana & Khurana, Advocates and IP Attorneys (K&K), and Sughrue Mion PLLC, has launched a one of its kinds competition in India on Patent Drafting called as “National Patent Drafting Competition” or NPDC to promote development of Patent Drafting as a Skill Set and encourage more and more technical people to take up Patent Drafting as a Professional Competency, along with identifying and encouraging Top Patent Drafters in Country.

The competition took place from 01st September 2015 to 20th September 2015 wherein IIPRD disclosed three invention disclosures in technical domains of (i) Chemistry/Pharmaceutical/Biotechnology, (ii) Mechanical Engineering and (iii) Electronics/Software Engineering on its website for the above mentioned time period. We had kept First and Second Prizes in each technical domain with the First Prize amounting to INR 1,00,000/- and the Second Prize amounting INR 50,000/-.

We got tremendous response from the participants all across India. The participants were spread across all sectors including law firms, patent searching firms, companies, institutes, independent professionals, among others. We received 81 patent specifications in Pharma/Chemistry/Biotech domain, 47 patent specifications in Mechanical domain, and 33 patent specifications in Electronics/Software domain.

The evaluation was done collectively by representatives from each International Law Firm and Khurana & Khurana, IP Attorneys, coordinated by IIPRD. Broadly, the marking criteria were based on a combination of numerous factors such as flow of the specification, scope covered through embodiments, claim drafting strategy, and accurary of technical coverage. For example, for Chemistry/Pharma invention disclosure, the following marking criteria was set up:

  1. Detailed Description of Uses/ Methods of uses
  2. Coverage of Salts, isomers, compositions, dosage etc.
  3. Background: Description of Prior Art and description of the need of the art
  4. Claims and Claim Strategy
  5. Coverage and Detailed Description of Markush Structure
  6. Definitions of all terms and variables
  7. Detailed Description of Synthetic Processes
  8. Detailed Description of the Examples section– Chemistry and Biology
  9. Overall Quality of the Descriptive Language
  10. Parts of the specification, Format, Title, Abstract

After following a rigorous evaluation process in each category, we identified the following  winners of the First and Second Prizes:


All the winners were intimated individually on their email IDs along with public announcement of the winners list on our website on 25th September, 2015. We once again congratulate big time to all the winners!

We look forward to announce NPDC 2016 next year!!

The Curtain Raiser Formal Guidelines for Examination clarifying Patent Examination Position on Computer Related Inventions in India

The much debated and iterated ‘Guidelines for Examination of Computer Related Inventions’ formally released by the Office of Controller of Patents finally dawns the light upon the much elusive position on Software and Business Method Patents in India. The Indian Software Patent ecosystem for years has been echoing various voices behind the curtains – from the extremities of ‘Software is not patentable in India‘ to techno-legal jargons such as ‘software claims can be patented by restricting with embedded systems’ and ‘if there is a technical effect, software is patentable‘ – all of which silently represent the good, bad and ugly albeit perceptively true picture. It is plausible that the latest Guidelines represent an honest and progressive effort of the Indian patent office to remove these curtains and attempt to elaborately lay down, impressively with examples, the true nature of how the patent office and examiners plan to examine computer related invention, more so for hardcore software and business methods.

Coming straight to the meat of the guidelines: for the first time it is loud and vocal in an official document that ‘Software’ and ‘Business Methods’ – with provisos ofcourse – are indeed patentable in India.

In so far as Software claims are concerned, the guidelines expressly referencing the legislative intent, aim to shrink the doubt on the expression ‘computer program per se‘ by stipulating guidelines allowing computer programs’ patentability in various sections:

Page 12:

“Therefore, if a computer programme is not claimed by “in itself” rather, it has been claimed in such manner so as to establish industrial applicability of the invention and fulfills all other criterion of patentability, the patent should not be denied.”

Page 13:

“a novel computer programme with a known hardware which goes beyond the normal interaction with such hardware and affects a change in the functionality and/or performance of the existing hardware”

Page 13:

“A computer program, when running on or loaded into a computer, going beyond the “normal” physical interactions between the software and the hardware on which it is run, and is capable of bringing further technical effect may not be considered as exclusion under these provisions”

Whereas, when it comes to Business Methods, the age old trick of tying them down to something tangible appears to have been endorsed:


The claims drafted not directly as “business methods” but apparently with some unspecified means are held un-patentable. However, if the claimed subject matter specifies an apparatus and/or a technical process for carrying out the invention even partly, the claims shall be examined as a whole

Plausibly, the guidelines have attempted to illustrate specific criteria and examples to unfold the grey pixels of software and business method inventions into expressly compared black and white of the patentable vs non patentable.

The caveat though lies in some conflicting illustrations and some generic/broad misplaced guidelines:

Example 8.4 of Page 16 does not appear to be resonating with stipulations of patentable vs non-patentable examples. The example is as follows:

A computer-implemented method comprising: identifying one or more person names in a set of one or more documents, with each identified person name more likely to refer to a single person in a profession than other person names in the document: identifying descriptive language from one or more documents, based on the identified names; and identifying within one or more documents other person names that refer to persons in the profession, based on one or more portions of the identified descriptive language.         

Further, the exclusion of claims directed at ‘Computer Program Product’ is not deriving its basis from the legislation which limits the exclusion to ‘computer program per se’. That said, foreign precedence including the European Patent Office asserts the patentability of Computer Program Products, having matched the other criteria, as specified in the Guidelines for Examination – Part G – Chapter II – 3.6 (link) which reads as:

the computer program itself as well as the physical media carrying the program (see T 424/03), i.e. computer program product claims, such as “data carrier”, “storage medium”, “computer readable medium” or “signal”.

To add to the above, a ghastly stipulation lies in the following example which would not be excluded under Section 3(k):

Method of encoding/ decoding, method of encrypting/ decrypting, method of simulation though employing a mathematical formula.

It is apprehended that something went amiss with that statement, as the literal and plain interpretation suggests that if one devises a new method merely to encrypt data and decrypt it (a new cryptogram for example), that ought to constitute a patentable subject matter if construed novel and inventive by a mathematician, a person skilled in that art – which practically wouldn’t be the case when the examiner draws out such a patent application for assertive review.

In summary, while the Formal Guidelines add an appreciable leaf to the patents office’s chapter of reforms and promoting transparency, it does leave a few stones unturned in being able to absolutely do so, and the part at the end of the introduction section 1.5 spelling out, ‘The guidelines are subject to revision from time to time based on interpretations by Courts of law, statutory amendments and valuable inputs from the stakeholders‘ must be held on to.

The complete ‘Guidelines for Examination of Computer Related Inventions (CRIs)’ can be accessed here while the official order for its release can be accessed here

About the Author: Abhishek Pandurangi, Partner at Khurana & Khurana, Advocates and IP Attorneys and can be reached at:

“Well, You have not made out prima facie case for Compulsory License”: Notifies Rajiv Agarwal, Controller General of Patents, Designs and Trademarks, to Lee Pharma!

In a major update for the patent circle (and of course Pharma industry), reportedly, Lee Pharma, a Hyderabad based Indian pharma company, which had filed a Compulsory Licensing (CL) Application on June 29, 2015 in India, against one of the patented drug Saxagliptin of AstraZeneca (used for treating Diabetes Mellitus), has failed to make out prima facie case for the same.  Cognizance of the same has already been taken by Economic times and SpicyIP.  This is the second blog written on the CL filed by Lee Pharma by IIPRD, earlier blog which discusses patent details, grounds of application can be accessed directly by clicking here.

This development has to be recognised as a major one because application by Lee Pharma is the third instance of applying for Compulsory Licensing in India and of earlier two, one was accepted and other was rejected. Of course, this development is also important when Pharma and Patent world wants to see how India is responding to US pressure on amending the patent laws.

It is noteworthy that Controller has not refused CL application for Lee Pharma, rather he has only notified Lee Pharma that it has not made out the prima facie case for the order under section 84. Controller was required to do so by Rule 97 (1). Further according to the rule 97 (1), Lee pharma has one month from the date of notification to request for the hearing, if it wants to proceed with the application and if request for hearing is not made, controller shall refuse the application. According to Rule 97 (2), if request for hearing is made within 1 month from the relevant notification, the Controller shall, after giving the applicant an opportunity of being heard, determine whether the application may be proceeded with or whether it shall be refused.

Though, Economic times claims to have seen the copy of notification given to Lee Pharma by the controller, and also claims that controller has found Lee Pharma’s proposed selling price several times the import cost and only marginally below that of AstraZeneca and controller has also stated that manufacture in India is not a necessary precondition to establish working in India according to the relevant section. It is expected that Lee Pharma will likely exercise the provision for hearing available to it.

So here we are, all eyes on you now, Lee Pharma, the clock is already ticking.

Once the final decision regarding CL application is issued and made public, we will be back here for detailed discussion on the same, as this is something we just can’t afford to miss, right?

About the Author: Swapnil Patil, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: comes the ‘Trade Marks Agent Exam’

Yes, you all read it right. Long waiting has come to an ending. Here is the link for the notification dated August 20th, which was published at the Indian Patent Office (IPO).

Long (in fact too long) wait for the Trade Mark Agent Exam since 2010 (when it was held last) has come to an end with the announcement for the Trade Mark Agent Exam-2015 from the IPO. The notification gives details regarding who can apply, how to apply, form to be used for applying purpose, and nature of exam. Last date for applying is September 07th, 2015. List of eligible candidates and dates for the written examination and Interview will be posted on official website of the IPO i.e. on or before September 11th, 2015. For any further clarification regarding this reader can call on 022-24132735/24132393 or send email at of the IPO.

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

Denial of Injunction on the grounds of Acquiescence and Delay by Plaintiffs: SRF Foundation v. Ram Education Society

Devina Choubal, an intern at Khurana & Khurana looks into grounds of denial of injunction by analyzing the recent case of SRF Foundation v. Ram Education Society.


‘SRF Foundation’ plaintiff no.1 is a registered non-profit society engaged in several social and community work including running schools such as “The Shri Ram School”. The name/mark “Shri Ram” is used by the Plaintiff No.1 since 1988 having a good reputation. While plaintiffs No.2 is engaged in setting up schools in India and abroad. With this goodwill, the plaintiffs fulfilled its objective to meet the shortage of good schools by entering into an agreement with “Educomp Infrastructure and School Management” to set up five schools under the name of “The “Shriram Millennium School”. “Ram Education Society” defendant opened “Shri Ram Global Pre School” next to the plaintiff no. 1’s school in Gurgaon. The plaintiffs filed for the registration of trademark, thereafter subsequently withdrawn and the defendant instead registered their mark. The plaintiffs being the real brother of the defendant’s trustee wrote emails to his brother to alert the defendant of the reputation and goodwill of the name/mark and to stop using it. However, the defendant continued to use the name/mark “Shri Ram. The plaintiffs advertised stating that the name/mark of the school does not belong to them. Thereupon, the defendant’s lawyer sent a legal notice to the plaintiffs to withdraw the advertisement and to render public apology. The plaintiffs filed a suit for permanent injunction, passing off and account of profits in the Delhi High Court and also filed an application seeking interim injunction. The Hon’ble High Court passed an order with respect to interim injunction which is discussed in detail as below. The complete order can be accessed here


  • It was contended by the plaintiffs that the inherent right to use the name “Shri Ram” rests with each member of the Shri Ram family but such a right is subject to restricting oneself to its domain of business and not encroaching upon others rights. They have no objection if the said mark is used by the defendant in other activities or services but not this activity, as they have being using the name/ mark “Shri Ram” for almost 25 years, the reason being they have goodwill in these services, leading to monopoly over the name/mark. Though the plaintiff and the defendant belong to the same family, still the use by the defendant hampers the plaintiff’s reputation. Because of passing off the services of the plaintiffs by the defendant, the public are confused about which school belongs to whom. Thus, there is no bonafide use of the name/mark. The use of “Shri Ram” in the name/ mark causes confusion and is deceptively similar.
  • The plaintiffs further contented that there is a prior use of the name/mark by them, as the name/mark has been used by them extensively for many years before the defendant.


  • There exist parallel rights to use the name/ mark, thus, the defendant is protected under the legacy of the Late Shri Ram Family. The defendant and the plaintiff share a common family name. Therefore, there cannot be a claim of any proprietary right or monopoly by the plaintiffs. The defendant’s schools are “Shri Ram Global School”, “Shri Ram Centennial School”, “Shri Ram Global Pre School” which is distinctive from Plaintiffs, which are “The Shri Ram School” and “Shri Ram Millennium School” in terms of different suffix and logos. Therefore there is a bonafide use of the mark by the defendant and the plaintiffs cannot have monopoly rights over the mark “Shri Ram”. Also it was further contended by the defendant that the name/mark is not deceptively similar or confusing as it can be distinguished because of different logos & suffix, as stated above. It was further submitted that the email dated 28th September, 2011 stated that there is no objection/ admission on the part of the plaintiffs to running of the schools by the defendant. The said email is as follows: – “I want to mention that if you ever wanted to divest or reduce your shareholding, you would then be reduced to minority shareholding in your company. You must remember that the ‘Shri Ram’ brand might then go to wrong outsiders. One would have no control over how they would use this brand.”
  • The defendant did not deny the prior use by the plaintiffs but they rather denied an exclusive proprietorship, being aware about the plaintiffs having established the schools before them. However, the defendant represented by Mr. Anand, after becoming aware of the fact that the name/mark existed before the use by the plaintiffs as the Shri Ram School in Mawana, UP established by the family’s relatives, they argued on the contention of no prior use by the plaintiffs.



The elements of passing off:-

In order to succeed in an action of passing off, 4 main requirements have to be satisfied by a party who intends to seek the relief of injunction.

  • Prior use;
  • Party who is claiming right must be the proprietor of the mark;
  • Confusion & deception;
  • Delay, if any.

In respect of the first and the second requirement the defendant already approved of the prior use by the plaintiffs though denying the exclusive right over the mark/name. The Hon’ble Judge was brought to notice by the defendant about no such written document existing which tells that the plaintiffs have an exclusive right. However, the plaintiffs have a reputation and no other family member though involved in contribution to education have acquired such goodwill, for the simple fact that the operation of Mawana School started by the Shri Ram family relatives prior to the use by the plaintiffs is limited to the place as pointed out by the plaintiffs and thus considered by the Hon’ble Court.

While in respect of third requirement, it was held that the defendant adopted the trademark even though the plaintiffs has been using it since 23 years, thus, creating confusion by starting school with the name/mark “ Shri Ram” in the same vicinity as that of the plaintiffs. Therefore, the name/ surname being distinctive is protected as per law.

The delay of about 3 years in approaching the court was because the plaintiffs though being aware about the use of “Shri Ram” by the defendant, they did not take any action against them. Thus, there was a delay for a considerable amount of time leading to the applicability of principle of acquiescence. The reason given by the plaintiffs was of proximity of relation between the founding members of the plaintiff and defendant because they are real brothers and the plaintiffs tried to warn and end the matter amicably.

The similarity of marks:-

The Judge observed that the parties have Shri Ram in common and the same was an essential part of their services. It was held in Himalaya Drug Company v/s M/s SBL Ltd. that the essential features of the mark if they are same then the logos are deceptively similar. The mark “Shri Ram” is also used by the defendant like the plaintiffs. Therefore it is deceptively similar.

The admission by the plaintiffs:-

It was further held that the admission made by the plaintiffs cannot operate as an estoppel against the person making it.  As held in Gulabchand vs. Bhaiyalal, AIR 1929 Nag 343. There cannot be an estoppel against the law or statutory provisions. When one is concerned with the statutory right or constitutional guarantee, there cannot be any estoppel against the same.

Bonafide Use:-

It was observed that the “bonafide use” as per the Section 35 of the Trademark Act, 1999 is not to be considered in the present case because the defendant’s school is started in the vicinity of the plaintiffs and they issued licenses and appointed franchises despite warnings from the plaintiffs.


The Hon’ble Court hel that the defendant to display the disclaimer while continuing the functioning of the schools within 6 months about no connection with the plaintiff’s school. The reason being, the interim injunction of the use of the name/mark would cause hardship to the students and the parents who have already paid fees and taken admission in the defendant’s school. The defendant would be entitled to give bonafide description in the nature that the school is run by Vivan Bharat Ram under the legacy of his grandfather Shri Ram for future schools.

OMG! Over 2.26 lakh patent applications pending with Patent offices in India for approval…Why? Shortage of professionals says Commerce and Industry Minister!

In worrying statistics, Commerce and Industry Minister Nirmala Sitharaman, as reported in a news article dated 31st July 2015, informed parliament in a written reply to the Lok Sabha that as many as 2, 26, 339 patent applications are pending for approval with various Patent offices in India due to shortage of professionals. She also said that pending requests of examinations which are awaiting disposal at different stages of processing in patent offices is used to measure the pendency of application. Therefore numbers of pending patent applications must be much higher than the reported figures.

Based on statistics provided, Delhi patent office tops the list with 83,291 pending requests of examinations. Mumbai patent office is having the least number of pending cases at 28,100. Chennai and Kolkata patent offices are the second and third with 74,390 and 40,558 pending cases for disposal.

A look at Dynamic utility to view ‘Month of Request for Examination for which FER is being issued, (can be accessed at reveals following statistics:

For the Electrical/Electronics group, Delhi patent office is issuing the FERs for July 2009, while other three patent offices are issuing FERs for the year 2010 with Mumbai patent office being ahead of others issuing FERs for October 2010. For the Biotechnology group, Chennai patent office, which is issuing the FERs for February 2012, is ahead of the pack with Kolkata patent office lying at the bottom of the table issuing FERs for March 2010. For the  Chemistry group, Mumbai patent office is ahead of others by issuing FERs for June 2012 with Chennai patent office at the bottom by issuing FERs for  October 2010. For the Mechanical, Kolkata patent office is  issuing FERs for February 2009 and is the only patent office issuing FERs for the year 2009 and Delhi patent office is ahead of the rest with issuing FERs for December 2011.

While explaining the efforts taken by the government to clear the pendency, Nirmala Sitharaman said that government has approved additional 252 posts of examiners and 76 posts of controllers. This will increase total sanctioned strength of examiners and controllers to 589 and 170 respectively. She further informed of steps taken by the government by sanctioning 263 posts of contract examiners of patents as a short-time measure.

For those who are looking for an opportunity to work with Indian Patent Office as an examiner, applications can be filed online, starting date was July 25th, 2015 and last date of application is August 24th, 2015. Further details regarding advertisement and instructions for filing online application can be obtained at

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

Revocation of Valganciclovir patent by Controller of Patents, Chennai

Recently in a matter remanded from IPAB to Controller of Patents, Chennai, a decision of revoking Roche’s patent IN207232 for Valganciclovir was delivered after hearing both the parties. The subject patent was granted on January, 2009 followed which post grant oppositions were separately filed by CIPLA, Matrix, Ranbaxy and Bakul Pharma along with two NGOs Delhi Network of Positive People and lndian Network for People living with HIV/AIDS & The Tamil Nadu Networking People with HIV/AIDS (hereinafter INP+ and TNNP+), wherein INP+ and TNNP+ were allowed by the Apex court to raise all contentions in the form of an intervention cum affidavit before the Assistant Controller and the parties agreed to be heard along with CIPLA, Matrix, Ranbaxy and Bakul Pharma. In the opposition proceedings, the patent was revoked limiting it to single process claim by the Controller of Patents on 30.04.2010 and being aggrieved by this decision, Roche filed an appeal at IPAB challenging the decision. IPAB on 30.01.2014 set aside the Patent Controller’s decision to revoke the patent on technical grounds and remanded it to the Controller for re-consideration.

Issues before the controller:

  • Determining whether the expert evidence was prior art publication or disclosure

Answering the issue, controller observes that the expert evidence is not a prior art document to be relied upon for deciding a case, but it may be considered for understanding the prior art documents, if the evidence covers such prior art documents. The opinion of the expert evidence, if it is based on further laboratory or animal study of a given subject matter, it cannot be considered for concluding such invention because it is later acquired knowledge, but it can be used for understanding the present invention. Therefore, expert evidences cannot be considered as prior publications/disclosures, but it can be taken as opinion on the prior arts.

  • Deciding upon the obviousness of the present invention

The next issue which the controller addressed was whether the present invention was obvious with respect to prior art references. The controller observes that the present invention is obvious against two prior arts US 4957924 and EP 0375329A2.

Claim 1 of the present invention recites,

  1. The compound 2-{2-amino-1, 6-dihydro-6-oxo-purin-9-yl} methoxy-3-hydroxy-1-propanyl-L-valinate or a pharmaceutically acceptable salt thereof, in the form of its (R) or (S)- diastereomers, on in the form of mixtures of the two diastereomers.

Regarding this , the controller states that the monovaline ester of ganciclovir is disclosed in the form of Markush formula in EP ‘329, which covers both monovaline and di-valine ester of ganciclovir where support for the both mono and di-valine ester of gancicloviris is provided in the specification. Thus the disclosure of EP ‘329 is clear and unmistakable direction to the mono valine ester of ganciclovir. Hence, a skilled person working in the synthetic chemistry field can easily arrive at the present invention without further experimentation. Therefore mono valine ester of present invention is anticipated by EP’329. Controller further emphasizes that claim 1 of EP ‘329 clearly and unambiguously discloses as at least one of the substituents is valine residue which indicate the presence of mono valine ester. Therefore, EP’329 undoubtedly disclosed mono valine ester of ganciclovir.

With respect to process claim, controller observes that the synthetic method for preparing mono valine ester of ganciclovir as claimed in independent claim 12 of present invention may not be explicitly disclosed in EP ‘329, but said method is just a general method for coupling acid group in the amino acid with hydroxyl group, which can be adopted for any type of alcohols. Therefore, using EP’329, a person working in the synthetic chemistry can easily prepare ester of ganciclovir with lysine without undue burden.

Further the controller observes that the object of the present invention is to provide a prodrug of ganciclovir with improved oral bioavailability. Controller notes that the solution for poor absorption in the gastrointestinal tract for acyclovir is disclosed in US ‘924 patent. Therefore a person skilled in the art can perceive to prepare mono valine ester of ganciclovir from the teachings of both EP’329 and US’924 references. Thus all the claims including process claim are obvious to a skilled person in the art.

  • Deciding upon the efficacy of substance under the subject patent under section 3 (d)

Deciding upon the efficacy of substance under the subject patent, the Controller observes that the new form L-monovaline ester of ganciclovir molecule has shown improvement in oral bioavailability than bis-valine ester of ganciclovir and ganciclovir, whereas there is no support in the specification pertaining to efficacy. Controller observes that the ester modification of the present invention was made to protect the substance from destruction in the gastrointestinal tract and make the molecule more bioavailable. Thus the controller has ruled that while bioavailability is one of the factors affecting efficacy, it cannot be directly equated to efficacy. Citing Hon’ble Supreme Court of India’s decision on Novartis case, the Controller rules that: “lmprovement in bioavailability of the new form cannot be considered directly related to efficacy. Even any unforeseen property observed in new form, unless such property directly relate to efficacy, it will be considered as inherent property of such substance. Since there is no direct relation shown for the improved bioavailability of new form of ganciclovir in the description with regard to significant difference in the efficacy, and therefore such a new form shall be considered as a same substance. Thus new form of the present case Monovaline ester of ganciclovir is considered as a same substance i.e. ganciclovir because,the difference in enhanced efficacy is not shown in the complete specification.” According to the controller, since there is no direct relation shown for the improved bioavailability of new form of ganciclovir in the description with regard to significant difference in the efficacy, therefore such a new form shall be considered as a same substance. Further regarding process used for preparing present invention, the controller held that the process used to prepare new form is a conventional process as it is already known process as disclosed in EP ‘329. Thus, the Controller rules that the present patent was a ‘mere use of a known process’ which was not patentable under S. 3(d), Patents Act.

  • Locus standi of the two NGOs as “person interested” under section 2(1)(t)

Deciding the locus standi of the two NGOs, as person interested under section 2 (1)(t) of patent act, Controller notes that NGOs would fall under the ambit of persons interested as the criteria of locus standi in post grant opposition is to be viewed in broader perspective to grant quality patent. According to the Controller, the two NGOs are the end users or directly affecting parties, if the patent is granted. Thus it is held by the controller that viewing in to the broader prospective, the two NGOs falls under the purview of under section 2 (1)(t) of the patent act and hence the parties have locus standi to oppose the patent.

Thus hearing all the parties and considering all facts and relevant arguments, the Controller revoked the patent granted for the drug Valganciclovir under section 25(4) of Indian Patent act.

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

Three Days International Symposium on Strategies for Managing Pharmaceutical, Biotechnology and Chemical Patent Portfolios (United States, European and Chinese Scenario)

We are happy to inform you all that IIPRD and Khurana & Khurana, in association with Sughrue Mion, PLLC, USA, TEE & HOWE IPATTORNEYS, CHINA and MAIWALD, GERMANY are holding an International Patent Symposium covering all major and relevant Pharmaceutical, Biotechnology and Chemical Patent Portfolios in the month of October, 2015 in India. The Three-Days International Symposium would be covering Strategies for Managing Pharma, Biotech & Chemical Patent Portfolios in US, EP & China and is being held from 5’th to 7’th October 2015, at Hotel Hyatt, Vastrapur, Ahmedabad and 7’th to 9’th October 2015, at Hotel Hilton (Andheri East), Mumbai.


About the Speakers: The speakers are a unique gathering of Patent Attorneys, Legal Counsels, who have extensive years of experience in their professional fields. These Speakers will put across to the delegates a real insight of Patent Laws & Practices, and Commercial perspectives as prevalent and practiced in Europe, United States, and India.

The speakers include:

  • Mr. Chid Iyer, Partner at Sughrue Mion PLLC, USA
  • Mr. Michael R. Dzwonczyk, Partner at Sughrue Mion PLLC, USA
  • Ms. Aiyda Ghahramani, Associate at Sughrue Mion PLLC, USA
  • Mr. Shackelford, Associate at Sughrue Mion PLLC, USA
  • Ms. Azy S. Kokabi, Associate at Sughrue Mion PLLC, USA
  • Dr. Toby Mak, Partner at TEE & HOWE IPATTORNEYS, CHINA
  • Ms. Yeping DING, Partner at TEE & HOWE IPATTORNEYS, CHINA
  • Dr. Alexander Wittkopp, Managing Partner at Maiwald Patentanwalts GmbH
  • Mr. Vinod Khurana, Senior Partner at Khurana and Khurana, Advocates & IP Attorneys

Please see the complete details including Program Schedule, Topics, Speakers Profiles etc. in a brochure available over here.

If you wish to attend the symposium, please send your nominations to


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