Category Archives: News & Updates

Teva held responsible for Induced Infringement of Eli Lilly’s Blockbuster drug ALITMA

In Teva Parenteral Medicines, Inc.; APP Pharmaceuticals LLC; Pliva Hrvatska D.O.O.; Teva Pharmaceuticals USA, Inc.; and Barr Laboratories, Inc. (hereinafter referred to be as Defendants/Appellants/Teva) Vs. Eli Lilly & Co. (hereinafter referred to as Plaintiff/Appelle/Eli Lilly) decided by United States Court of Appeals for the Federal Circuit (CAFC) on January 12, 2017, Plaintiff had filed Hatch Waxman suit against defendant to prevent them from launching generic version of the lung cancer drug whose rights are reserved with the plaintiff. The decision from CAFC came after an appeal from the United States District Court for the Southern District of Indiana in No. 1:10-cv-01376-TWPDKL, Judge Tanya Walton Pratt.

Eli Lilly owns a patent US 7772209 (hereinafter referred to as US‘209) issued in 2010, relating to method of treatment administering the chemotherapy drug pemetrexed disodium (hereinafter referred to as “pemetrexed”) (used to treat certain types of lung cancer and mesothelioma) after pretreatment with two common vitamins—folic acid and vitamin B12 (reduce the toxicity of pemetrexed in patients). Eli Lilly markets pemetrexed under the brand name ALIMTA®.

In 2008-2009, Defendants notified Eli Lilly that they had submitted ANDA seeking approval to market generic version of ALIMTA®. After issuance of US’209 patent, Teva sent additional notice that they had filed Para IV certifications, declaring that US’209 patent was invalid, unenforceable, or would not be infringed. Subsequent to which Eli Lilly alleged Teva of induced infringement. Eli Lilly asserted that Teva’s generic drug would be administered with folic acid and vitamin B12 pretreatments and thus will result in infringement of the 209 patent.

Eli Lilly asserted claims 9, 10 (dependent on claim 1), Independent claim 12, and its dependent claims 14, 15, 18, 19, and 21 of the US’209 patent at trial.

Independent claims 1 and 12 have been reproduced below for reference:

Claim 1:

A method of administering pemetrexed disodium to a patient in need thereof comprising administering an effective amount of folic acid and an effective amount of a methylmalonic acid lowering agent followed by administering an effective amount of pemetrexed disodium, wherein the methylmalonic acid lowering agent is selected from the group consisting of vitamin B12, hydroxycobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-cobalamin perchlorate, azidocobalamin, cobalamin, cyanocobalamin, or chlorocobalamin.

Claim 12:

An improved method for administering pemetrexed disodium to a patient in need of chemotherapeutic treatment, wherein the improvement comprises:

  1. a) administration of between about 350 μg and about 1000 μg of folic acid prior to the first administration of pemetrexed disodium;
  2. b) administration of about 500 μg to about 1500 μg of vitamin B12, prior to the first administration of pemetrexed disodium; and
  3. c) administration of pemetrexed disodium.

It is important to note that current case involves issue of induced infringement i.e. a type of indirect infringement that may be committed under section 271 (b) (dealing with infringement of Patents).

In June 2013, Defendants conditionally conceded induced infringement under then-current law set forth in Akamai Technologies, Inc. v. Limelight Networks, Inc. (Akamai II) which at that time was the subject of a petition to the Supreme Court for a writ of certiorari. The parties’ stipulation included a provision reserving Defendants’ right to litigate infringement if the Supreme Court reversed or vacated Akamai II.

District court had rejected contentions of the defendant that Patent was invalid for obviousness or obviousness-type double patenting and also due to indefiniteness of the term vitamin B12.

Defendants filed an appeal on invalidity. While that appeal was pending, the Supreme Court reversed Akamai II, holding that liability for inducement cannot be found without direct infringement, and remanding for CAFC court to possibly reconsider the standards for direct infringement. In view of that development, the parties in this case filed a joint motion to remand the matter to the district court for the limited purpose of litigating infringement. CAFC granted the motion.

The district court held a second bench trial in May 2015 and concluded in a decision issued on August 25, 2015 that Defendants would induce infringement of the US’209 patent. This was after considering the effect of Akamai V decision, which had broadened the circumstances in which others’ acts may be attributed to a single actor to support direct infringement liability in cases of divided infringement.

Defendants appealed.

Below given factors are taken into consideration while deciding cases of induced infringement:

  • Whoever actively induces infringement of a patent shall be liable as an

Infringer;

  • There cannot be indirect infringement without direct infringement;
  • Patentee needs to prove alleged infringer knew or should have known his actions would induce actual infringements; and
  • Standard of proof required by Patentee to claim relief under induced infringement is ‘preponderance of the evidence’.

It was agreed by parties that Defendants’ proposed product labeling would be materially the same as the ALIMTA® product labeling and consists of two documents: the Physician Prescribing Information and the Patient Information. District court found that both the documents included instructions regarding the administration of folic acid—the step that the district court found would be performed by patients but attributable to physicians.

According to Akamai V, where no single actor performs all steps of a method claim, direct infringement only occurs if the acts of one are attributable to the other such that a single entity is responsible for the infringement. The performance of method steps is attributable to a single entity in two types of circumstances:

  • when that entity “directs or controls” others’ performance, or

 

  • when the actors “form a joint enterprise.”

In Akamai V, CAFC had held that directing or controlling others’ performance includes circumstances in which an actor:

(1) “conditions participation in an activity or receipt of a benefit” upon others’ performance of one or more steps of a patented method, and

(2) “establishes the manner or timing of that performance.”

District court found taking folic acid in the manner recited by the asserted claims is a critical and necessary step to reduce potentially life threatening toxicities caused by the Pemetrexed amounts to receive the benefit of the patented method.

Regarding first of the two pronged test, the court found, based on the product labeling, that taking folic acid in the manner specified is a condition of the patient’s participation in the Pemetrexed treatment. Regarding the second prong, the court found that physicians would prescribe an exact dose of folic acid and direct that it be ingested daily. Hence court held all steps of the asserted claims would be attributable to physicians.

Court further observed that the mere existence of direct infringement by physicians, while necessary to find liability for induced infringement, is not sufficient for inducement but there has to be also specific intent and action to induce infringement. Court went on to find intent on the part of physician for the inducement and held that there was no error in district court’s decision. Some important observations of court have been mentioned below.

CAFC made two important observations as below:

  • The intent for inducement must be with respect to the actions of the underlying direct infringer, here physicians.

 

  • Second, it is not required to show evidence regarding the general prevalence of the induced activity. When the alleged inducement relies on a drug label’s instructions, the question is not just whether those instructions describe the infringing mode,..but whether the instructions teach an infringing use such that we are willing to infer from those instructions an affirmative intent to infringe the patent. Court further observed that the label must encourage, recommend, or promote infringement and it is irrelevant that some users may ignore the warnings in the proposed label.

Court went on to observe a label that instructed users to follow the instructions in an infringing manner was sufficient even though some users would not follow the instructions, but vague instructions that require one to look outside the label to understand the alleged implicit encouragement do not, without more, induce infringement.

On the issue of invalidity on the indefiniteness of the term “vitamin B12”, CAFC hold that a person of ordinary skill in the art would understand the scope of the claim term “vitamin B12” with reasonable certainty. Applying Nautilus (outcome of this decision) in this case did not lead CAFC to a different result from the district court’s conclusion on the question of indefiniteness.

Regarding issue of invalidity due to obviousness, CAFC was not convinced that the district court committed clear error in concluding that Defendants failed to carry their burden of proving that it would have been obvious to a person of ordinary skill to use vitamin B12 pretreatment to reduce Pemetrexed toxicities.

Thus CAFC affirmed district court decision.

About the Author :  Ms. Rashmi Goswami, WOS-C at TIFAC, intern at Khurana and Khurana, Advocates and IP Attorneys and can be reached at swapnil@khuranaandkhurana.com

Obtaining a Certificate of Recognition from DIPP for IPR benefits

“A start-up would now require only a certificate of recognition from the Department of Industrial Policy and Promotion (DIPP) and would not be required to be examined by the inter-ministerial board, as was being done earlier. This is one rapid change that we have brought in,” said  Nirmala Sitharaman, Minister of Commerce and Industry in New Delhi at the ‘Start-up India States’ Conference’ in  2016.

This has been done to improve the ease of doing business by entrepreneurs, when earlier there was a complex and elaborate process of approaching the inter-ministerial board to procure the IPR benefits. After May 16, 2016, Start-Ups have been made eligible for expedited examination of Patent Applications.

This post particularly discusses the procedure of obtaining a ‘Certificate of Recognition’ from Department of Industrial Policy and Promotion (DIPP) before and after filing the Application of Patent.

Procedure to be followed varies depending on whether Start-Up has applied for Patent (and the application is published) or has not applied yet.

Type 1:

The procedure below is only for applicants who have NOT filed the application of patent.

The Application form is available on http://www.startupindia.gov.in/registration.php

Click on Startup India Services > Startup Recognition > Application.

  1. Fill the required information regarding the following ;
      a. Name of the Entity;
      b. Nature of the Entity – Private Limited Company/Limited Liability Company/Registered Partnership
      c. Incorporation/Registered No.
      d. Date of Incorporation/Registration
      e. Address of Registered Office
      f. Details of authorized representative
      g. Details of Directors/Partners
  2. Either of the following supporting documents are required to be filed in the Application for the Certificate.
      a. Letter of Recommendation, in a form specified by the DIPP from an incubator recognized by Government of India  ;or
      b. Letter of support by any incubator which is funded, in relation to the project, from Government of India or State Government as a part of specified scheme to promote innovation ; or

A panel of facilitators has been constituted for providing assistance and support in filing applications for Intellectual Property Rights (IPR), wherein, Department of Industrial Policy and Promotion (DIPP) would bear the facilitation cost. The list of the Incubators is available on ; –http://startupindia.gov.in/uploads/pdf/List_of_facilitators_for_patents.pdf

      c. Letter of Recommendation, in a form specified by the DIPP from an incubator established in post-graduate college in India; or.
      d. Letter of funding from the Government of India or any State Government as a part of specified scheme to promote innovation; or – If the Government of India or State Government has provided funds as a part of any scheme to promote innovation to the applicant, a Letter of Funding by GOI or State Government is admissible as a legit document to be submitted.
      e. Letter of funding of not less than 20 percent in equity by any Incubation Fund/Angel Fund/Private Equity Fund/Accelerator/Angel Network duly registered with Securities Exchange Board of India that endorses innovative nature of the business – If SEBI has funded,  not less than 20% in equity by any above mentioned Funds which endorses the innovative nature of the business of the entity to the applicant, A Letter of Funding by SEBI can be submitted.
      f. Letter of recommendation from Industry association recognized by DEPARTMENT OF INDUSTRY POLICY AND PROMOTION – A Recommendation  Letter can be obtained by any Industry Association or Organisation which is recognized by DIPP.

The list of Industries/Organisations which can provide for the letter of Recommendation  are available on www.startupindia.gov.in .

Click on Information> List of Industry Association/Organisations for Recommendation Letter.

  1. Incorporation or Registration Certificate- Company/ Partnership Incorporation/LLP/ Registration Certificate is MANDATORY to be submitted.
  2. A Brief note or a supporting document regarding the innovativeness of the idea of the product or services offered by the entity.
  3. With respect to tax benefits, note that, if you opt for tax benefits, your application will go to the Inter–Ministerial Board for evaluation, which may take time. If your aim is only to obtain benefits related to IPR, you can refrain from choosing the tax benefits option.

The FORMAT for the above mentioned “Letter of Recommendation,  Letter of Support from Incubator, Letter of Funding from SEBI, Recommendation letter from Industry Association/Organisation”  is available on http://www.startupindia.gov.in/startup-recognition.php

An application for a certificate is processed within a period of 10-25 working days from the date of Application, if accepted, the certificate is available to be procured.

Type 2:

The points below discuss the procedure for obtaining a Certificate of Recognition for applicants who have filed for patent and the same is published.

  1. Visit http://startupindia.gov.in/uploads/pdf/List_of_facilitators_for_patents.pdf and fill in the details requested in the form as mentioned above.
  2. Against Nature of Recommendation, Select “Patent filed and published in the Journal by the India Patent Office in areas affiliated with the nature of business being promoted”.
  3. Against “Supporting document based on the nature of recommendation selected above”, upload journal extract of publication of your patent application.
  4. Upload Incorporation/ Registration Certificate.
  5. Against “Brief note on innovativeness of products /services offered by the entity”, upload a document in PDF format that provides details relating to the nature of business of your company and why products /services offered by your company is innovative.
  6. As mentioned above, with respect to tax benefits, note that, if you opt for tax benefits, your application will go to the Inter–Ministerial Board for evaluation, which may take time. If your aim is only to obtain benefits related to IPR, you can refrain from choosing the tax benefits option.
  7. Submit the application upon self-certification.

PENALTY FOR FALSE REGISTRATION:
If the application is found to be obtained, without uploading the document or uploading any other document or a forged document, the concerned applicant shall be liable to a fine which shall be fifty per cent of paid up capital of the startup but shall not be less than Rs. 25,000/- (Rupees Twenty Five Thousand only).

 

Effect of Union Budget, 2017 on the R&D/ Intellectual Property Practices in India

Union budget that was highly waited for (after demonetization) had gained more attention also due to preponing to February 01, 2017.

As a matter of fact, every year budget has certain impact on various industries including IP industry and R&D sectors. In this article, we will try to analyze possible effects of 2017 budget on R&D/Intellectual Property (IP) Practices in India. Though there were no special funds/incentives proposed for R&D, budget did have certain announcements for indirect effect on the IP practices.

  1. With intent made clear in budget 2015 itself, in 2017 Hon’ble Finance Minister Arun Jaitley proposed that corporate income tax for smaller companies with annual turnover upto INR 50 CR be reduced to 25%.

In 2016, FM had proposed that companies with turnover less than INR 5 CR would have to pay tax less by 1% and new manufacturing companies who do not avail of any exemption would be charged only 25%.

 This move will make sure that medium size companies do not pay more tax as compared to larger companies as observed in 2015-2016, wherein 2.85 lakh companies making profit of less than INR 1 CR had to pay effective tax rate of 30.26% while 298 companies making profit of more than 500 CR paid effective tax rate of 25.90%.

This reduction in tax rate is likely to give smaller companies flexibility to invest saved 5% in R&D activities.


  1. FM also believes pushing digital transactions further would enable small and micro enterprises to access formal credit. He also made clear that Small Industries Development Bank of India (SIDBI) will be encouraged by government to refinance credit institutions which provide unsecured loans at reasonable interest rates to borrowers based on their transaction history. This is likely to give higher chances of eligibility to IP driven companies not having strong collateral.

  2. Focus on startups in 2016 seems to be continued in 2017 as well. Among the schemes announced for start-ups, eligibility for start-ups for expedited examination of Patent Applications was a great move. In 2017, government aiming to heavily utilize technology for pushing initiatives such as SWAYAM (providing opportunities for a life-long learning) and DIGIGAON (providing telemedicines, education and skills through digital technology), start-ups would never want to miss an opportunity to contribute through innovative ideas for the facilitation of implementation of schemes.

  3. In another move to encourage start-ups, in 2016 it was announced that 100% deduction would be available for any 3 consecutive assessment years out of 5 years beginning from the year in which the eligible start-up is incorporated with the condition that total turnover of eligible start-up should not exceed Rs. 25 Crore in any of the previous years beginning on or after the 1st day of April, 2016 and ending on the 31st day of March, 2021. In 2017 budget, period of 5 years has been changed to 7 years.

  4. Research and Development Cess Act, 1986 is proposed to be repealed. Reduction in tax cost to the extent of 5% (R&D cess) on technology imports. Subsequently, service tax at 15% to be paid in full.

  5. On a disappointing note, there seems to be no separate incentive for R&D.

All in all, though there seem to be some encouraging proposals nothing substantial is coming to the way of IP fraternity as was provided in last year budget in the light of Make in India Regime. But this is not totally surprising as on all fronts, budget seems to be a cautious approach (understandable in light of other measures such as demonetization and GST being radical).

Comparative Advertisement: A Perspective

Ms. Sakshi Jhalani, Intern, Khurana & Khurana, Advocates and IP Attorneys looks into the fundamentals of Comparative Advertisement vis-avis Trade Mark Rights in India.

Advertising is indeed a crucial step in determining future of any product. It is the most successful and proven way to attract the attention of the potential consumers in the market. Since, the consumers have a wide variety of products to choose from, often the advertisers resort to a practice of comparing their products from that of the competitors. While this is an acceptable practice, many times in order to gain more pecuniary benefits and mileage, competitors end up using such tactics which either misleads the customers or amounts to denigration of other’s product. Comparative advertisement is a unique practice, where a manufacturer compares his goods or service from that of his competitors for the purpose of promotion and increased sale of his goods.

Comparative advertisement can be divided into two categories, puffery and denigration. Imagine a producer making superlative claims indicating his product is best so as to influence the public into buying it. Now, if the same claim is made through degrading the image of an identifiable competitive product, it crosses the limited scope of puffery leading to denigration of the product. This might not only amount to defamation of the competitor’s product, but also mislead the consumers since most of the time to producers does not have a valid ground to claim that other product is not good.

Though advertisements were considered a part of form of speech but, they did not constitute as ‘free speech’ since it was done merely for the purpose of commercial gain.[1] This position was reversed in the case of Tata Press vs. Mahanagar Telephone Nigam Ltd., where the court held that advertisements is not only profiting the producers but there is a free flow of information in free market economy fulfilling the greater goal of public awareness.[2]By virtue of this judgement, advertisements were held constitutive of ‘commercial speech’ under the ambit of Article 19(1)(a) of the Constitution.

Even though advertisements have been given constitutional protection under free speech, there cannot be blanket protection given to advertisements merely on the ground of public awareness. It needs to be checked that these advertisements are neither deceptive, nor they are disparaging the competitor’s goods. Initially, matters relating untrue or misleading advertisements were governed under Section 36A of the Monopolies and Restrictive Trade Practices Act, 1969 (‘MRTP Act’), which dealt with ‘unfair trade practices’. However, the MRTP Act was repealed by Section 66 of the Competition Act, 2002. But, this did not leave traders remediless since the definition of ‘unfair trade practices’ was incorporated parimateria under Section 2(1)(r) of the Consumer Protection Act, 1986 (‘CP Act’). The scope of CP Act was limited to the extent of providing recourse to the consumers only, it did not include manufacturers, sellers or service providers.

The absence of a proper statutory instrument for advertisers to address their grievances led to the creation of a self-regulatory body called Advertising Standards Council of India (‘ASCI’). The principles laid down by ASCI ensured that this practice of comparative advertisement is conducted in a fair way taking into consideration the interests of all the associated groups involved. It make sure that the manner in which the comparison is laid out is not in a way that provides the producers with an undue advantage over the competitor’s product. It also ensured that the comparisons are accurate and are based on the facts so as to not deceive the potential consumers.

Even though ASCI laid down reasonable and fair guidelines, it lacked effective implementation and faced problems when infringement is caused by the actions of non-members. The problems covering such infringements are better addressed by Section 29(8) and 30(1) Trademarks Act, 1999 (‘the Act’). While Section 29(8) deals with infringement of trademarks when done through advertisements, section 30(1) provides with an exception when such use of marks is done according to the “honest practices” in industrial and commercial matters. When a producer is using the method of comparative advertisement for promoting his/her goods or services, it might lead to dilution, tarnishment or blurring of the trademarks of the competitors. The Act protects the interests of such producers, whose marks are likely to get denigrate because of unfair actions of the competitors.

Honest practices, dilution, disparagement, all these essentials are not clearly defined under the Act, but can be traced through various judgments throughout the course of time. In the case of Reckitt & Colman f India Ltd. vs. M.P. Ramchandram&Anr, the court dealt with the component of puffery as a part of comparative advertisement for the first time. This case involved manufacturers of two clothing detergents ‘Robin Blue’, the plaintiff and ‘Ujala’ the defendant. It was contended by the plaintiff that the defendant in his advertisement, had on purpose used a bottle similar to that of plaintiff’s product. The defendant also mentioned in his advertisement that the plaintiff’s product was inefficient and was uneconomical.[3] The court in this case held relied on the case of De Beers[4] and held that a producer can declare his goods to be the best, or even better than his competitors even if the statement is untrue. But, while making such comparison he cannot state that his competitor’s goods are bad, even if that is true. He cannot make any statement which might lead to disparagement of his competitor’s goods.

Another landmark case that dealt with the meaning of word disparagement is Pepsi Co. vs. Hindustan Coca Cola Ltd. Pepsi Co. alleged infringement of trademark as Coca Cola, vide its advertisement has disparaged the products of Pepsi Co by calling Pepsi “Bacchon Wala Drink”. Further Coca Cola also used a bottle with same colour combination as that of Pepsi with the name “Peppi” written on it. The court while analyzing the meaning of disparagement held that, an advertisement is considered to be defaming if it is undervaluing, bringing discredit or dishonor upon the competitor’s product.[5]

Further clarity is laid down by the court in the recent 2015 judgment of Havells vs. Amritanshu, where the advertisement in dispute dealt with the Hevells’s and Eveready’s LED bulbs. The question in issue was whether for an advertisement to be an ‘honest’ one, does the comparison between the producer’s and the competitor’s product must involve all the features. The Delhi high court in this case held that if an advertiser is highlighting only a special feature of his/her product, that makes it distinct from that of his competitor’s, he/she is allowed to do so as long as the comparison is true. The failure to compare all features of a product while comparing will not amount to disparagement. The court in this case also laid down certain tests to be applies for the purpose of comparative advertising. The tests include, standard used in deciding a case of comparative advertisement, test of ‘honest’ advertising as per section 29(8) and 30(1), and test of a ‘misleading advertisement’.

The status of comparative advertisement in foreign countries like U.K. and USA is more liberal when compared to India. Where the practice of comparative advertisements is a common trend, the producers are generally not allowed to make any superlative claims with respect to their products without providing for any evidence. They are also allowed to compare their products with the competitors’ and mention that the other’s product is not as good as theirs provided they make a valid and reasonable claim. In my opinion, such trend should be adapted in India as well, as making superlative claims about their products without them being true fails the main purpose of protecting the consumers from deceptive practices of traders. Also, if the claim made by the producer with respect to his competitor’s product is true, it should be allowed since, it will provide consumers with a valid reason to choose between a better product, and in long-run promotes healthy trade practice as it will help the competitor to improve the quality of his goods.

About the Author: Ms. Sakshi Jhalani, Intern, Khurana & Khurana, Advocates and IP Attorneys.

References :

[1]HamdaedDawakhana vs. Union of India, AIR 1960 SC 554.

[2](1995) 5 SCC 139.

[3]1999 PTC (19) 741.

[4]1975 (2) AII ER 599.

[5]2001 (21) PTC 722.

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

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

The curious case of drug development

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

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

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

 

Patent Term Extension

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

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

Non-Patent Exclusivities:

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

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

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

Table 1. Scheme of Exclusivities granted by the US FDA

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

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

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

20.11.2005 (CP)

30.10.2005 (NP)

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

20.11.2005 (CP)

30.10.2005 (NP)

8 years data exclusivity

+2 years market protection

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

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

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

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

India

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

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

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

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

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

References:

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

First Symposium of IIPRD in 2017

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

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

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

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

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

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

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

Here is our take:

Details of the Patent Application and important dates:

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

 

04/12/2008

Priority Application Number/ Priority date US61/012,162

 

07/12/2007

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

Application Area:

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

Facts of the case:

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

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

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

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

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

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

Analysis of the rejection decision:

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

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

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

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

Reference:

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

The Mickey Mouse Debate

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

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

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

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

The Debate

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

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

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

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

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

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

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

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

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

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

The Indian Scenario

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

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

References:

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

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

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

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

Claim 1:

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

Claim 6:

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

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

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

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

PATENT INFRINGMENT SUIT BY DOLBY AGAINST OPPO AND VIVO

Anjana Mohan, an intern at Khurana & Khurana, Advocates and IP Attorneys deals with the updates in the Patent Litigation between Dolby International and two Smartphone companies Oppo and Vivo over the patented technology by Dolby.

Dolby filed suits vide Suit no CS(COMM) 1425/2016 and CS(COMM) 1426/2016 against various parties including the two major Chinese companies Oppo and Vivo, and their number of affiliated local entity, at the Delhi High Court alleging patent infringement of its technology and for illegally selling phones with Dolby technology  without paying appropriate royalties for use of its patented technologies.

The defendants had filed applications, without prejudice to their rights and contentions, state that to enable them to continue manufacturing and selling goods with the technology in which the plaintiffs claim patent, that they are ready and willing to deposit in this court the royalty as computed and stated in the plaint. The applicants/defendants offer to deposit royalty in this court at the rate of Rs.32/- per unit manufactured /sold/imported. However the counsel for the Plaintiff contended that they have specified the standard royalty charged by them from all licensees and which is graded as per the volume of manufacturing/sales/imports. It was also contended on behalf of Plaintiff that the royalty at the highest rate would work out to about Rs.38/- per unit and that the defendants should be directed to pay royalty at the said rate directly to the plaintiffs in US Dollars, as is being paid under interim orders in a large number of other suits, a compilation whereof is handed over in the court. It was also contended that the defendants should pay also the arrears of the royalty due with effect from the date the defendants started manufacture/sale/import of the goods with the subject technology.

As per the order on the 27th of October 2016, the court ordered that the defendants should furnish the particulars regarding the manufacture, importation and sale of the products on the 5th of the succeeding month. Moreover, the defendants are required to pay on the 8th of the succeeding month the royalty at the rate of Rs.34/- and in return, would allow the continuance of the importation/sale/manufacture of the goods. The directors of the said companies have agreed to be bound by the undertaking of the court.

Further, after much deliberations/arguments/contentions pertaining to the rate of royalty to be paid interim, the Plaintiffs and Defendants has represented to the Hon’ble Court that the parties have worked out an interim arrangement during the pendency of the suit. They have in Court handed over a draft of the interim arrangement which had been perused and found acceptable by the Court. The said terms envisaged the appointment of a Mediator. The counsels state that this Court may appoint any retired Judge of this Court as Mediator and they would pay lump-sum remuneration of Rs.5,00,000/- for mediation, to be shared equally between the plaintiffs and the defendants. Chief Justice A.P. Shah (Retd.) has agreed to mediate as per the recent order dated 14th December 2016.

In the light of the above it would be interesting to note the final verdict in the matter and thus is much awaited.

References: