Are there any unique requirements for India patents?
Kanchan Vadehra: The first and most obvious unique feature of the Indian patent system is the non-uniformity of practices of the four jurisdictions of the patent office - Delhi, Mumbai, Kolkata and Chennai. Two major areas evidencing divergence in practice are patentability of inventions related to electronics, telecommunications and computer related inventions, and permissible amendments in specifications and claims.
On the side of formal requirements, the decision of IPAB in NTT DOCOMO made it mandatory to submit some sort of proof of right to make and prosecute the application worldwide or at least in India, be it a Form 1 executed by the inventors or an assignment document or any other document transferring rights from inventor to applicant.
Another requirement which is likely to be news in coming months is the requirement under Section 146(2) of the Patents Act as read with Rule 131 of the Patent Rules, 2003 which requires every patentee and every licensee to furnish statements in Form 27 as to the extent to which the patented invention has been worked on a commercial scale in India. Patent working norms are particularly important during compulsory licensing cases to help establish whether the patentee has fulfilled the reasonable requirements of the public by selling the patented product at an affordable price. If a patentee fails to comply with the requirement, there is a penalty of up to INR 1,000,000 ($15,500), per Section 122.
However, I do not remember any precedent regarding the imposition of a fine by the Indian Patent Office for failure to file the statement of working or filing of incomplete information in Form 27. Here, I would like to highlight the public interest litigation has been filed in the High Court of Delhi Shamnad Basheer v Union of India asking the court to direct the government to fully enforce patent working norms and take action against errant patentees.
The disclosure requirements under Section 8 in view of decisions of courts and IPAB has placed a huge burden on applicants in terms of time, effort and money in collecting and filing information/documents in Indian Patent Offices for related foreign applications.
There are also some requirements at the patent office, despite clear statutory provisions to the contrary, that continue to trouble applicants. One such requirement is payment of extra fees for pages of sequence listing in the inventions relating to biotechnology, even though Rule 9 of the Indian Patents Rules, 2006 clearly states that if the patent discloses a sequence listing of nucleotides or amino acids, the same shall be filed in computer readable text format along with the application, and no print form of the sequence listing of the nucleotides or amino acid sequences is required.
Another area which lacks clarity is the requirement to file documentary proof to claim the benefit of “small entity” status under the Patents Act. There is ambiguity as to what kind of documents can be filed by a foreign entity in this regard. I believe any official document such as registration with any official body and tax returns which could establish the investment in plant and machinery or equipment less than the limit prescribed can be filed with the Patent Office. I would caution foreign applicants that the evidentiary proof must satisfy the criteria of small entity as prescribed by the Patents Act.
Apart from these, there is uniqueness in terms of permissible amendments in specification and claims for a convention application in comparison to the national phase of a PCT application. There is some relaxation for convention applications which seems to be lacking for national phase applications under the PCT route. For the national phase application, the title, description, drawings, abstract and claims as filed with the international application under the PCT shall be taken as the complete specification. A formal request may be filed for amendment in the specification and claims, along with the fee after national phase entry. However, an amendment in claims which do not fall wholly within the scope of the PCT claims may not be allowed. Also, the scope of the amended claims cannot be beyond the scope of the original claims, even if there is support in the original specification. Therefore, if amendment in specification including claims is desired for national phase applications, it is prudent to amend the specification before national phase entry of application in India.
For convention applications, the Patents Act provides more latitude for amendments. Thus, amendments to a Paris Convention application can be made at the time of the filing of the application in India even to the extent that the scope of the claims can be widened if the amended claims are based on the matter disclosed in the priority application.
It is to be noted here that even though India is a signatory to the PCT, several categories of claims are not patentable. In particular, claims directed to a new use of a known substance or a new form of a known substance without evidence of increase in efficacy, claims directed to method of treatment or method of diagnosis, and claims relating to computer programmes are not allowed. Therefore, if an applicant files a PCT application containing claims directed to such non-patentable subject matter and does not amend the application in the international phase, the applicant is thus compelled to enter India with claims as filed with WIPO. This results in the applicant paying huge official fees for claims which are never going to be allowed by the Indian patent office.
What are the newest developments regarding patentable subject matter?
Sharad Vadehra: One development which is likely to have a bearing on the patentability of inventions related to computer programmes, mathematical methods or business methods is Ericsson v Intex Technologies, which was decided by the High Court of Delhi this March. Here, the Court made the observation that “thus, it… appears to me prima facie that any invention which has a technical contribution or has a technical effect and is not merely a computer program per se… is patentable”. In this case the Court while making the above observation on Section 3(k) appears to have followed EPO jurisprudence.
Although the precedential value of this observation is debatable, this statement from the Court marks a new shift in patenting of software-related inventions in India. I believe the effect of this observation accompanied by the strong resistance from stakeholders to the draft Guidelines for Examination of Computer Related Inventions (CRIs) has resulted in release of the final Guidelines, which in fact is a watered down version of the draft Guidelines.
The Guidelines mark a paradigm shift in the patent office’s thinking towards the patent eligibility of CRIs. Earlier, in CRIs there was a specific requirement to pinpoint novelty and inventive step in the hardware features and link it to the software or computer programme used in the invention. The new Guidelines have done away with requiring novel and inventive hardware features in computer-related inventions as a condition precedent. The final guidelines specifically point out that a combination of a novel computer programme with a known hardware going beyond the normal interaction with such hardware and affecting a change in the functionality or performance of the existing hardware should not be considered as excluded subject matter. In the guidelines, it has been mentioned that if in substance, the claims, taken as whole, do not fall in any of the excluded categories, the patent should not be denied. Per the guidelines, what is barred from patentability are claims which are directed towards computer programmes per se, namely claims directed at computer programmes, sets of instructions, routines or sub-routines written in a specific language and computer programmes per se stored in a computer readable medium.
The requirements for patentability of claims relating to mathematical methods has also been substantially relaxed. Now, use of a mathematical formula in a claim to clearly specify the scope of protection would not in itself render the claim unpatentable.
On the patentability of business method related inventions, it has been mentioned that mere use of words such as “enterprise”, “business”, “sales”, “transactions”, “commerce” and “payment” in the claims should not lead to the conclusion that the CRI is just a business method. Instead, if the subject matter is essentially about carrying out business, trade, or financial transactions or a method of selling goods through web (such as providing web service functionality), it should be treated as a business method. Further, if the claimed subject matter specifies an apparatus or a technical process for carrying out the invention even partially, the claims shall be examined as a whole.
What tips do you have for helping patentees facing a Section 3(d) challenge to their application? What sort of evidence should they show to prove enhanced efficacy?
KV: After the Supreme Court’s decision in Novartis, in order to avoid falling under the purview of Section 3(d) of the Indian Patents Act, if the substance claimed in invention is not a new chemical entity and is likely to be considered as a known substance, it will be necessary to provide efficacy data to clearly establish advancement over what has been considered the known substance and closest prior art capable of being used for the same function.
Therefore, I suggest that applicants develop efficacy data with respect to the closest prior art or the similar compositions or compounds available for the same purpose.
The examiners tend to insist on such data for standard chemical and pharmaceutical inventions. While for chemical inventions some evidence exhibiting better and improved properties or stability meets the requirement in many cases, for pharmaceutical inventions, the requirement is more stringent wherein evidence establishing enhanced therapeutic efficacy is required.
The type of efficacy data appropriate for showing therapeutic efficacy should relate to the ultimate function of the claimed product, not merely change in properties. The data should clearly reflect the functional improvement of the claimed product with respect to the closest prior art capable of being used for the same function. The change in properties may be admissible, only if such changes ultimately improve the function and are supported by efficacy data.
Further, such efficacy data can be adduced as evidence even at a later stage of prosecution of the patent application, perhaps in the form of an inventor declaration.
What tips do you have for helping applicants meet the Section 8 requirement?
SV: Section 8 casts a duty of disclosure on the applicant regarding corresponding foreign applications. While many consider it as similar to the USPTO’s IDS requirement, I consider it to be a different, more stringent and continuing requirement.
The Section 8 requirement has become an elephant in the room for applicants. However, some practical solutions may help in easing the burden of the requirement to some extent.
My advice to applicants would be that once you have provided details of all corresponding foreign applications in Form 3 even though you are under obligation to regularly update such details, in view of the substantial information required to be given, applicants should file a consolidated Form 3 with all the updated information at the time of filing response to the examination report and file a petition if required by the examiner in this regard. This strategy will be more cost effective than filing a new Form 3 every six months.
Another requirement is under Section 8(2) of the Act. Please be advised that the statutory requirement to submit information under Section 8(2) applies only when the patent office communicates the requirement. Therefore, once the applicant has submitted all the documents and information under Section 8(2) as required by the examiner, there is no further legal requirement to provide other information to the patent office. The requirement under Section 8(2) is based on the requisition by the examiner. However, if after filing of documents and information under Section 8(2) there are developments in any corresponding foreign application wherein claims have been rejected or narrowed down, then the applicant may submit such information voluntarily to show its bonafide.
Further, if the applicant voluntarily submits the information under Section 8(2) before the issuance of office action, the examiner may not raise this requirement in the office action and it may also lead to less prior art citations in the first examination report.
I would also like to inform the readers that English language summaries of office actions, search reports and the like shall suffice, if the documents are originally not in English.
Also, there is no obligation to submit details until grant of patent under Section 8 during the post-grant opposition period (12 months from the date of publication of grant).
Section 8 requirements are a serious issue. If you do not heed the requirements, even otherwise valid patents are prone to third party challenge which can result in invalidation.
What particular practical issues should international patent applicants be aware of?
KV: Applicants entering India via the PCT should remember that substantial amendments to the specification and claims are not permissible. There are limitations on amendments even if supported by the description. Section 59 of the Patents Act does not allow amendments which broaden the scope of the PCT claims. Secondly, if a PCT application contains a large number of claims and the applicant deletes some during the national entry phase, the applicant must pay fees even for the deleted claims. Also, the applicant can only delete claims after national phase entry after filing a formal request along with the prescribed official fee.
Further, a 2013 amendment in Rule 138 of the Patents Rules, 2003 nullified the decision of Madras High Court in Nokia v Deputy Controller of Patents. The amendment takes away the discretionary power of the patent office to extend the period for filing a national phase application under Rule 20(4)(i) by one month (beyond the 31 months deadline from the earliest priority) if the applicant shows good cause.
Another issue which affects prosecution times is that applications are examined by the patent office in the order the request for examination is filed. I suggest filing a request for examination immediately after filing the application. With PCT applications, applications should enter the national phase as soon as possible without waiting for the 31-month deadline, and immediately after entry into national phase file the request for examination and publication. Further, I suggest filing a response to the first examination as soon as possible after issuance of first examination report. Delay in filing of the response results in delay in consideration from the patent office.
Kanchan Vadehra is a partner at Kan and Krishme. She is one of the founding members of the firm and has been instrumental in the firm’s growth.
She has over 20 years of experience in handling patent drafting and prosecution of mechanical, electrics, telecommunications and automotive engineering subject matters.
She is a member of FICPI India, FICPI (International Federation of Intellectual Property Attorneys), APAA (Asian Patent Attorneys Association) and INTA (International Trademark Association).
She works with both domestic and international companies, including Fortune 500 companies, and research institutions. Vadehra has prosecuted more than 3,000 patent applications before the Indian patent office.
Vadehra has often been consulted by the Government of India on new guidelines and rules related to the Indian Patent Act.
She has made presentations on IP law and practices with over 100 institutions and corporate bodies in India and overseas including Japan, Europe and the US.
Sharad Vadehra is the managing partner at Kan and Krishme and also heads the IP litigation department. He joined the profession in 1989, and is amongst the few attorneys in India with both technical and legal qualifications.
Vadehra specialises in intellectual property, media, entertainment, sweepstake and promotions, marketing, commercial disputes and litigation with more than 25 years of experience. He handles such matters for both domestic and international companies, including Fortune 500 companies, and research institutions. He has prosecuted more than 7,000 patent and trade mark applications.
He has spoken on IP law and practice with over 500 institutions and corporate bodies in India and overseas, and is the author of the book Indian Patent Law and Practice published by Chosakai in Japan in Japanese.
The Government of India regularly consults Vadehra when drafting proposed guidelines and rules relating to the Patent Law.
Vadehra, along with other colleagues founded FICPI India in 2009 and is heavily involved with the group, acting as its president. He is one of the founding members of GALA (Global Advertising Lawyers Alliance) and is president of its Asia Pacific branch.
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