A new era in India: Patent granted within 9 months of requesting examination

Indian Patent Office (IPO) has now started granting patents under expedited examination system (Rule 24C of the Patent Amendments Rule 2016) within 9 to 12 months.

One such patent granted is IN2885091 for “A PROCESS FOR THE PREPARATION OF APIXABAN“. A request for expedited examination was filed on 24th October 2016 and the same was converted into an expedited request on 21st March 2017. A patent has been granted to Optimus Drugs Private Limited within 9 months of filing of request for examination and 4 months of converting it into an expedited request, on 12th July 2017. The other factual details are as follows:-

 

A new day for computer inventions – Novel hardware not a requirement anymore

The Indian patent office has published the revised guidelines for examination of Computer related inventions (CRIs). The guidelines, while still being silent on the technical effect, do away with the thrust on “novel hardware” feature, which comes as a breather after a long, dry spell.

Also summarized below are the new guidelines, which do not show any tangible shift from what was published earlier.

  • Novelty: For novelty the guidelines state that no matter disclosed before the date of priority is patentable. The guidelines rely on the Manual of patent practise for the same.
  • Inventive step: The guidelines rely on law laid down by Biswanath Prasad Radhey Shyam vs Hindustan Metal Industries Ltd and F.Hoffman la Roche v Cipla for inventive step analysis. Essentially the steps for inventive step analysis are stated to be as follows:-
  1. Identify the “person skilled in the art”, i.e competent craftsman or engineer as distinguished from a mere artisan;
  2. Identify the relevant common general knowledge of that person at the priority date;
  3. Identify the inventive concept of the claim in question or if that cannot readily be done, construe it;
  4. Identify what, if any, differences exist between the matter cited as forming part of the “state of the art” and the inventive concept of the claim or the claim as construed;
  5. Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of inventive ingenuity?
  • Industrial applicability: The guidelines state that the patent specification must disclose a practical application and industrial use for the claimed invention wherein a concrete benefit must be derivable directly from the description coupled with common general knowledge to meet this requirement. Mere speculative use or vague and speculative indication of possible objective will not suffice.
  • Sufficiency: The guidelines state that in cases of patent application concerning computer related inventions (CRIs), Sufficiency requirements are considered as fulfilled if the specification addresses the following:
  •  Each and every feature of the invention shall be described with suitable illustrative drawings.
  •  If the invention relates to “method”, the necessary sequence of steps shall clearly be described so as to distinguish the invention from the prior art with the help of the flowcharts and other information required to perform the invention together with their modes/means of implementation.
  •  The working relationship of different components together with connectivity shall be described.
  •  The desired result/output or the outcome of the invention as envisaged in the specification and of any intermediate applicable components/steps shall be clearly described.
  •  The best mode of performing and/or use of the invention shall be described with suitable illustrations. The specification should not limit the description of the invention only to its functionality rather it should specifically and clearly describe the implementation of the invention.
  • Not Patentability under Section 3(k): The guidelines discuss not patentability under section 3(k)in great length. The guidelines also state to be overriding the chapter of the Manual, containing provisions pertaining to section 3(k) of the Patents Act, 1970. The guidelines state as follows:-  
  • COMPUTER PROGRAMMES
  • The guidelines state that the invention should be analysed in substance to determine if it falls under the excluded category. If, in substance, claims in any form such as method/process, apparatus/system/device, computer program product/ computer readable medium belong to the said excluded categories, they would not be patentable.
  • The exclusion should not be allowed to be avoided merely by camouflaging the substance of the claim by its wording.
  • However, if in substance, the claim, taken as whole, does not fall in any of the excluded categories, the patent should not be denied.
  • The claims in means plus function form shall not be allowed if the structural features of those means are not disclosed in the specification. Further, if the specification supports performing the invention solely by the computer program then in that case means plus function claims shall be rejected as these means are nothing but computer programme per se. 
  • MATHEMATICAL METHODS
  • Method of calculation, formulation of equations, finding square roots, cube roots and all other similar acts of mental skill are, not patentable.
  • Similarly mere manipulations of abstract idea or solving purely mathematical problem/equations without specifying a practical application also attract the exclusion under this category.
  • Mere presence of a mathematical formula in a claim, to clearly specify the scope of protection being sought in an invention, may not necessarily render it to be a “mathematical method” claim.
  • Also, such exclusions may not apply to inventions that include mathematical formulae and resulting in systems for encoding, reducing noise in communications/ electrical/electronic systems or encrypting/ decrypting electronic communications.
  • BUSINESS METHODS
  • When a claim is “business methods” in substance, it is not to be considered a patentable subject matter. 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.
  •  However, mere presence of the words such as “enterprise”, “business”, “business rules”, “supply-chain”, “order”, “sales”, “transactions”, “commerce”, “payment” etc. in the claims may not lead to conclusion of an invention being just a “Business Method”, but if the subject matter is essentially about carrying out business/ trade/ financial activity/ transaction and/or a method of buying/selling goods through web (e.g. providing web service functionality), the same should be treated as business method and shall not be patentable.
  • ALGORITHMS
  • Algorithms in all forms including but not limited to, a set of rules or procedures or any sequence of steps or any method expressed by way of a finite list of defined instructions, whether for solving a problem or otherwise, and whether employing a logical, arithmetical or computational method, recursive or otherwise, are excluded from patentability.
  • COMPUTER PROGRAMMES
  • The computer programmes as such are not intended to be granted patent. The following are essentially not patentable:-
  • Claims directed at “computer programme products” / “Storage Medium having instructions” / “Database” / “Computer Memory with instruction” stored in a computer readable medium.
  • Claims directed at “computer programme products” / “Storage Medium having instructions” / “Database” / “Computer Memory with instruction” stored in a computer readable medium.

Reasons beyond control necessary for condoning delay in submitting response to Examination report

The Indian Patent office while considering a petition filed by Cisco Technologies under rule 137 for condonation of delay in filing response to examination beyond the statutory period, refused to allow such delay as according to the controller all possible reasons as mentioned by the applicant’s agent such as lack of knowledge about the issuance of examination report or lapse on the part of the previous agent in providing true facts/ First Examination Report, are not the reasons sufficient enough to qualify the status of “beyond the control of applicant” as mentioned in section 21(1) of the Act.

The application was therefore considered to be deemed abandoned under section 21(1) as applicant has not refilled the documents within stipulated time period i.e. within 12 months from the date of issuance of first examination report.

The facts of the case are as follows:-

  • The application 2440/DELNP/2006 was filed on May 01, 2006 claiming priority of USA 10/702,167 dated November 05, 2003 through its agent Evalueserve.com Pvt Ltd.
  • Request for examination was made on October 18, 2006.
  • The First examination report were communicated dated July 29, 2010 to the applicant’s address for service on record.
  • After the issuance of FER, Form-13 was filed on June 22, 2011 to incorporate the change in address for service as applicant has transferred the responsibility to prosecute the matter to Mr. Dinesh Jotwani of M/s Aggarwal Associates.
  • The last date to put the application for grant was over on July 30, 2011 and official requirements were not complied.
  • Petition u/r 137 was filed by the applicant dated September 14, 2011 through patent Agent, for delay in filing the response of examination report read with section 81 of the Patent Act, 1970 within stipulated time i.e. 12 months from the date of issuance of first examination report.
  • Response to first objection report was filed on September 26, 2011.
  • Further Form -13 was filed on February 04, 2015 to incorporate the change in address for service as applicant has once again transferred the responsibility to prosecute the matter to M/s K & S Partners.  

To analyze the decision of the Controller it would be essential to read the following to section:-

  • Section 21(1) says ” An application for a patent shall be deemed to have been abandoned unless, within such period as may be prescribed, the applicant has complied with all the requirements imposed on him by or under this Act, whether in connection with the complete specification or otherwise in relation to the application from the date on which the first statement of objections to the application or complete specification or other documents related thereto is forwarded to the applicant by the Controller.” Explanation.-Where the application for a patent or any specification or, in the case of a convention application or an application filed under the Patent Cooperation Treaty designating India any document filed as part of the application has been returned to the applicant by the Controller in the course of the proceedings, the applicant shall not be deemed to have complied with such requirements unless and until he has re-filed it or the applicant proves to the satisfaction of the Controller that for the reasons beyond his control such document could not be re-filed.

The agents argued that the delay was unintentional as applicant was unaware of issuance of Examination report.

The argument that applicants were not informed about the issuance of first examination report was not considered sustainable as according to the controller:

  1. Status of every patent application is freely available on patent office website i.e. http://www.ipindia.nic.in.
  2. At the time of filing of Form-13 dated June 22, 2011, more than one month time was available to the applicants to meet the official requirements.
  3. Petition u/r 137 was filed on September 14, 2011 for condonation of delay in filing the response of examination report whereas response to first objection report was not filed along with the petition. The same was filed on September 26, 2011 delayed by further 12 days.

As per the controller the above clearly shows negligence in part of erstwhile patent agent. It is hard to believe that delay caused was unintentional. The term “unintentional “means where the agent of the applicant/ applicant itself was not aware about the issuance of first examination report and the deadline to comply with the requirements as raised in first examination report. The controller further held that it is negligence not only at the part of erstwhile patent agents but also at the part of applicant as well. If it is to be considered that it was the duty of previous agents to transfer all the previous proceedings to another authorised patent agent for processing instant patent application, then applicant is also duty bound to insure for smooth transfer of all related proceedings form one patent agent to other patent agent.

 

Rules for appointment of IPAB Chairman, Vice-Chairman, Technical Member

In exercise of the powers conferred by section 184 of the Finance Act, 2017 (7of 2017), the Central Government has notified the Tribunal, Appellate Tribunal and other Authorities (Qualifications, Experience and other Conditions of Service of Members) Rules, 2017 on 1st June 2017.

These rules apply to 19 Appellate Tribunal as provided in the schedule of the Rules. Included in this list is also the intellectual Property Appellate Board (IPAB).

The rules provide as follows:-

(1) A person shall not be qualified for appointment as Chairman, unless he, –

(a) is, or has been, or is qualified to be, a Judge of High Court; or

(b) has, for a period of not less than three years, held office as Vice- Chairperson of the Appellate Board.

(2) A person shall not be qualified for appointment as Vice-Chairman, unless he,—

(a) is, or has been, or is qualified to be, a Judge of High Court; or

(b) has, for at least two years, held the office of Judicial Member or a Technical Member, and has a degree in law with at least 12 years of practice at bar or 12 years’ experience in a State Judicial Service.

(3) A person shall not be qualified for appointment as Technical Member (Patent), unless he, –

(a) has, for at least five years, held the post or exercised the functions of the Controller under the Patents Act, 1970 (39 of 1970); or

(b) has, for at least ten years, functioned as a registered patent agent and possesses a degree in engineering or technology or a master’s degree in science from any University established under law for the time being in force.

The Rules also provide that the search and selection committee for the post of the Chairman, Vice-Chairman of the Appellate Board, include –

(i) Chief Justice of India or his nominee- chairperson;

(ii) Secretary to the Government of India, (Department of Industrial Policy and Promotion) -member;

(iii) Secretary to the Government of India to be nominated by the Central Government-member;

(iv) two experts, to be nominated by the Central Government- members.

 

Also, the search-cum-Selection Committee for the post of Technical Member (Patent) of the Appellate Board, include—

(i) a person to be nominated by the Central Government –chairperson;

(ii) Secretary to the Government of India, (Department of Industrial Promotion and Policy) -member;

(iii) Secretary to the Government of India to be nominated by the Central Government – member;

 (iv) two experts, to be nominated by the Central Government – members.

DHC reinstates the agreement between Monsanto Inc and Nuziveedu Seeds

Justice R. K. Gauba of the Delhi high court (DHC) by an order dated 28th March 2017 ruled that Monsanto Technology LLC’s termination of its sub- licence agreement with Nuziveedu Seeds Ltd was illegal and arbitrary.

DHC has reinstated the agreement, however, the trait fee to be paid to the plaintiffs, for the use of the suit patent and trademarks have been directed by the Court, to be in accord with the prevalent local laws, as in force. The court also directed the agreement to be modified according to the format of the GM Technology Agreement Guidelines, 2016 issued by the government.

The facts of the case are as follows:-

  1. Suit for infringement and passing off was filed by Monsanto Technology LLC, Monsanto Holdings Private Limited and Mahyco Monsanto Biotech (India) Pvt. Ltd. impleading three defendants, namely Nuziveedu Seeds Limited, Prabhat Agri Biotech Limited and Pravardhan Seeds Private Ltd., on the groubds that the defendants were continuing to “market and sell” Genetically Modified Hybrid Cotton Planting Seeds inspite of termination of the sub-license agreements between the parties, alleging violation of their intellectual property rights covered by the registered patent (214436), and trademarks BOLLGARD and BOLLGARD II.

  1. The defendant submitted two counter claims. One counter claim prayed for a declaration that the sub-licensing agreements (of 2015) is “valid, binding and in force” and consequently, the defendants being entitled to “all the rights and benefits” thereunder. The other counter claim prayed for revocation of the plaintiffs‟ patent 214436.

  1. The Plaintiffs patent 214436 claims a method for producing a transgenic plant comprising incorporating into its genome a nucleic acid sequence comprising a plant functional promoter sequence operably linked to a first polynucleotide sequence encoding a plastid transit peptide, which is linked in frame to a second polynucleotide sequence encoding a Cry2Ab Bacillus thuringiensis ᴕ- endotoxin protein, wherein said plastid transit peptide functions to localize said ᴕ- endotoxin protein to a subcellular organelle or compartment” (claims 1 to 24) and a nucleic acid sequence comprising a promoter operably linked to a first polynucleotide sequence encoding a plastid transit peptide, which is linked in frame to a second polynucleotide sequence encoding a Cry2Ab Bacillus thuringiensis 8-endotoxin protein, wherein expression of said nucleic acid sequence by a plant cell produces a fusion protein comprising an amino-terminal plastid transit peptide covalently linked to said 5-endotoxin protein, and wherein said fusion protein functions to localize said 5-endotoxin protein to a subcellular organelle or compartment” (claims 25 to 27).

  1. The marks “BOLLGARD” and “BOLLGARD-II” having been registered, in India, under the Trademarks Act, 1999.

  1. Mahyco Monsanto Biotech (India) Pvt. Ltd. entered into sub-license agreements with defendants (2004), and under such sub-license agreements, the defendants received 50 grams of Transgenic Bt. Cotton seeds in consideration of Rupees Fifty Lakhs. The said sublicense agreement also contained an obligation on the defendants to pay a “trait value”.

  1. During the currency of the sub-license agreements of 2004, some dispute arose with regard to the “trait value” and the 2004 sub-license agreements were replaced by new sublicense agreements executed separately in favor of each of the three defendants (sub-license agreements of 2015).

  1. In the meantime, the Central Government in terms of Cotton Seeds Price (Control) Order, 2015, issued a notification via which the maximum selling price of Bt. Cotton Seeds packets were fixed. The MSP for BG I being Rs. 635 per packet, with zero trait value being payable, while the MSP for BG II version being Rs. 800 per packet inclusive of Rs.751 towards seed value and Rs. 49 on account of trait value.(The  intervention of the Central Government by above noted Cotton Seeds Price (Control) Order, 2015, was challenged and such challenges by and large being still sub-judice.)

  1. Licensing and Formats for GM Technology Agreement Guidelines, 2016, were also notified and published by the Government of India. These Guidelines primarily made to ensure non-discriminative licensing to encourage competition and availability of GM cotton seeds to cotton farmers at fair and reasonable prices.

  1. The defendants by their communication informed Mahyco Monsanto Biotech (India) Pvt. Ltd. that the trait value payable under the 2015 Sub-License Agreements stood statutorily modified and that Mahyco Monsanto Biotech (India) Pvt. Ltd. should charge the trait value. This request was turned down and this took the matter to the High Court of Judicature at Bombay.

  1. For the kharif 2015-16 season, Mahyco by further communications called upon the defendants to pay the trait value in terms of 2015 Sub-License Agreements, but such demand was not being complied with. Instead, by their similar communications, the first and second defendant requested the plaintiff to refund the trait fee statedly paid “in excess”, referring to the Government of India price control orders. This demand did not find favour with Mahyco and Plaintiffs alleging breach terminated the agreement. Hence the present suit.

Arguments and finding

 

  • Validity of suit patent:-

Validity of the suit patent was challenged under various provisions of the law like Section 3(f), 3(h) and (j), Section 8, Section 10 (4) and Section 59 (1) etc.

The court held that, whether or not the suit patent is liable to be revoked is a question which would need to be addressed at an appropriate stage only after pleadings in that regard are complete and evidence is adduced on issues thereby raised. No comments were made on such aspect of the dispute.

The court however made a prima-facie finding regarding patentability under section 3(j). The Court agreed with the submissions of the plaintiffs that Section 3(j) of the Patents Act, cannot deprive the patentee of due reward of human skill and ingenuity resulting in human intervention and innovations over and above what occurs in nature. Suit patent involve laboratory processes and are not naturally occurring substances which only are to be excluded from the purview of what is an invention by virtue of the provision contained in Section 3(j). These claims being products or processes of biotechnology are rightly entertained by the Indian Patent office.

  • Protected by the Plant Varieties Act

 It was also submitted by the defendants that impugned acts on the part of defendants are protected by the provisions of the Protection of Plant Varieties and Farmers Rights Act, 2001, by virtue of Section 92, overriding the Patents Act, 1970. The use of any variety as an initial source for the purpose of growing other varieties as is the activity undertaken by the defendants, the limited right of the person claiming ownership of the intellectual property right of such variety is to claim “benefit sharing” under Section 26.

The Court however did not agree with the Defendant and held that the invention which is the subject matter of suit patent is not same as development of a variety within the meaning of Plant Varieties Act. The right to use the genetic material is the subject matter of a patent granted and protected by the Patents Act, in general, and Section 48 thereof, in particular. Section 30 of the Plant Varieties Act is a provision meant only for “researchers” and not for entities such as defendants out to make commercial exploitation and further that it gives, at the most, right to use a “variety” to develop other varieties but not so as to confer the right to use DNA or genetic material.

The contentions of the defendants based on the provisions of the Plant Varieties Act or the import of possible remedy of “benefit sharing” available to the plaintiffs thereunder, or the question as to whether the same would be more efficacious, or extinguishes or erodes the rights conferred by Section 48 of the Patents Act, 1970 has however been left to be addressed at the time of final adjudication

  • Infringement:-

It was also contended that the fact that the defendants’ product comprises of components or genetic material conferring other traits in addition to the DNA construct or nucleotide sequences of the suit patent therefore there is no infringement. However this was considered to be irrelevant, as the presence of other components is immaterial so long as the patented invention is contained within the defendants’ product, this itself being sufficient to constitute infringement.

It was also argued by the Defendants that the claims are directed to a method performed in lab, the biological process adopted by the defendants however is essentially based on the other claims which though submitted with the application under PCT (Patent Corporation Treaty), were withdrawn, the same not being not patentable under section 3(j) and 3(h). The claims were therefore argued to be not infringed.

The court disagreed with the Defendants and accepted the argument of the Plaintiff that infringement by “use” of the patented invention in claims 25 to 27 stands made out because the defendants have admitted that their cotton varieties and hybrid exhibit Bt. trait which would have been triggered only on account of DNA construct or nucleotide sequence on claim nos.25 to 27. The use of the claimed construct was therefore held to be infringement. Court in this respect also relied upon the view taken by the Supreme Court of Canada in Percy Schmeiser vs. Monsanto, (2004) 1 SCR 902, wherein it was argued that ultimately what matters is whether the defendants are taking advantage (in whole or in part – directly or indirectly) of the technical contribution or patented invention of the plaintiffs.

  • Agreement

 The court held that the plaintiffs were duty bound to consider the request of the defendants as made by the communications beginning July 2015, for modification of the terms as to the rate of trait fee payable under the 2015 sub-license agreements for which the mechanism had been agreed upon in the agreement. Since the plaintiffs did not adhere to their obligation under the contract, the demand of payment under the contract terms being not lawful, it apparently being higher than the trait fee permitted by the law in force, the defendants could not have been found to be in default or to have breached their obligations. The termination of the sub-license agreements was therefore held to be prima facie illegal and arbitrary. The parties remain bound by their obligations under the terms and conditions of the 2015 Sub-License Agreements for the period(s) stipulated therein, or till the same are lawfully terminated.

The court also directed that the plaintiffs would be entitled to all the rights under the 2015 Sub License Agreements except as to the rate of trait value payable thereunder and the same has to be in accord with the prevalent local laws prescribed by Cotton Seeds Price (Control) Order, 2015 as indeed of the Licensing and Formats for GM Technology Agreement Guidelines, 2016, both promulgated by the Government of India.

DHC reinstates the agreement between Monsanto Inc and Nuziveedu Seeds

Monsanto Inc, sued Nuziveedu Seeds and its subsidiaries for continuing to sell cotton seeds using its patented technology despite termination of its sub-licence agreement in December 2015.

Justice R. K. Gauba of the Delhi high court (DHC) by an order dated 28th March 2017 ruled that Monsanto Technology LLC’s termination of its sub- licence agreement with Nuziveedu Seeds Ltd was illegal and arbitrary.

DHC has reinstated the agreement, however, the trait fee to  be paid to the plaintiffs, for the use of the suit patent and trademarks, have been directed by the Court, to be in accord with the prevalent local laws, as in force.

The court also directed the  agreement to be modified according to the format of the GM Technology Agreement Guidelines, 2016 issued by the government.

 

Stay tuned for a detailed report of the 96 page order!

DHC maintains the injunction on Cipla for Onbrez

The Delhi High Court (DHC) by its decision dated 9th March 2017 continues to bar Cipla Ltd from selling copies of Novartis AG’s drug Onbrez in India.

The entire controversy is respect of Indacaterol, which Novartis holds a patent for. Novartis markets Indacaterol under the name Onbrez. Indacaterol is a bronchodilator and provides symptomatic relief to persons suffering from chronic obstructive pulmonary disease (COPD). Cipla launched its generic version of the drug, Unibrez, in October, 2004. Cipla changed the name from Unibrez to Indaflo due to an undertaking which Cipla gave in a trademark infringement action filed by Novartis.

An order was passed by Justice Manmohan Singh in January 2015 which restrained Cipla from selling copies of Onbrez (Indacaterol).

An appeal was thereafter filed by Cipla against the order of January 2015. Cipla argued that, Novartis does not manufacture Indacaterol in India. The drug is manufactured by the Novartis in Switzerland and only small quantities are imported catering to a negligible number of patients. Thus, according to the appellant, the respondents are not working the patent in India and consequently, they are not entitled to an injunction.

It was also argued that right under section 48 would be subject to the fact that the patent is worked in India on a commercial scale; that the patent is not used by a patentee merely to enjoy a monopoly for the importation of the article

It was submitted that the non-availability was further aggravated by the fact that the price of the respondents Indacaterol was exorbitant as compared to Indacaterol manufactured, supplied and sold by the appellant. The price of the respondents product was five times that of the price of the appellant‘s product

The Respondent argued that, while public interest considerations may be a relevant factor in certain circumstances such as in the case of life saving drugs, it cannot by itself outweigh the rights of a patentee in the case of infringement of the patent as provided under the said Act.

It was also submitted on behalf of the respondents that the statistics said to have been provided by the appellant with regard to the extent of COPD patients in India is not reliable. References were made to certain articles to suggest that COPD does not include an asthma-like respiratory symptom or chronic bronchitis and, therefore, the number of patients suffering from asthma or chronic bronchitis cannot be considered as part of COPD patients. It was also stated that manufacturing in India is not necessary for the working of a patent. The respondents have patents in several countries and this does not mean that they have to manufacture in each country. All that is required is that the manufacturing facilities must be capable of supplying worldwide depending on the demand.

The Division bench, after considering the arguments of both he parties, held that the injunction granted by the learned single Judge ought not to be disturbed.

The various reasons for the same stated by the bench are as follows: –

  • There is no credible challenge to the respondent‘s patent No.222346. Therefore, prima facie, the respondent is straightaway entitled to an injunction in view of the rights available to it as a patentee under Section 48 of the said Act;
  • The provisions of Section 83 (working and CL ) do not curtail or circumscribe the rights of the patentees under Section 48, except in the backdrop of compulsory licences and ancillary issue;
  • It is not at all necessary that for a patent to be worked in India, the product in question must be manufactured in India. A patent can be worked in India even through imports. All that is to be seen is that the imports are of a sufficient quantity so as to meet the demands for the product. Whether the extent of imports is not sufficient for meeting the demands of COPD patients in India, would be a matter of evidence which can only be thrashed out in the course of a trial.
  • Even though the question of public interest may be a factor in considering the grant of an injunction, it is only one of the factors which needs to be kept in mind.