Category Archives: IP Practice in India

SUMMARY JUDGMENT IN INTELLECTUAL PROPERTY DISPUTES UNDER ORDER XIII-A OF CIVIL PROCEDURE CODE

  1. Applicability of order XIII-A of CPC to Intellectual Property Dispute

With the objective of streamlining and expediting the disposal of disputes in litigation, the Commercial Courts, Commercial Division and Commercial Appellate Division of High Courts Act, 2015 (hereinafter referred to as the “Act”) came into effect on October 23, 2015.  The Act provides for the setting up of specially designated Commercial Courts at District level and Commercial Division of High Courts with ordinary original civil jurisdiction to adjudicate on commercial disputes of a certain specified value. “Commercial dispute” includes disputes arising out of intellectual property rights relating to registered and unregistered trademarks, copyright, patent, design, domain names, geographical indications and semi-conductor integrated circuits.[1] “Specified Value” has been defined[2] to mean the value of the subject-matter of the suit, determined in accordance to Section 12 of the Act, which shall not be less than one crore rupees or such higher value to be notified by the Central Government. The value of subject matter in an intellectual property right dispute would be determined by the market value of the said IP right, as estimated by the plaintiff[3].

  1. Amendment of the Code of Civil Procedure

The said Act has amended the Code of Civil Procedure, 1908 (hereinafter to be referred to as “CPC”) to incorporate stricter timelines and procedures. These amended provisions of the CPC are applicable[4] only in respect of commercial disputes of specified value (one crore rupees). One such salient feature of the Act is the inclusion of Order XIII-A in CPC which provides for the mechanism of Summary Judgment in respect of a claim without recording oral evidence. In light of two recent decisions of the Delhi High Court, this article aims to  analyse the said mechanism in respect of intellectual property disputes.

  1. Context of the mechanism under Order XIII-A

Order XIII-A delineates the procedure by which the Court shall, on application of a party, decide a claim without the recording of oral evidence. Previously, suits which had more or less a clear outcome based on merits would still have to go through the entire procedure enumerated under the CPC before the case could be disposed.

The technicalities led to inordinate delays for the parties concerned and the entire docket system was overburdened. To counter this event, the amendment envisages a process for a summary judgment which is on similar lines to summary suits provided in the CPC with the primary difference that application for summary judgment can be in respect of any relief in a commercial dispute while summary suits relate to such relief relating to liquidated demand or fixed sum of debt.

Application to be in respect of a claim or part thereof

Under order XIII-A, the “claim” in an application for summary judgment shall include (a) part of a claim, (b) a particular question on which the whole or part of the claim depends, and (c) counter-claim.[5] For example, in Trade Mark infringement suit, the question of prior user/first use may be a question on which the claim for damages depends either in whole or in part, and such question may be determined in an application for summary judgment.

When and on what considerations:

Under mechanism as provided under Order XIII-A, the application for summary judgment can be made by either party after the service of summons to the defendant and before the framing of issues.[6] Upon consideration and satisfaction of the Court, a summary judgment may be given that (a) the plaintiff/defendant has no real prospect of succeeding on the claim/defence, as the case may be; and (b) there is no other compelling reason as to why the claim should not be disposed of before the recording of oral evidence.[7]

The rationale being that the Court, after hearing both parties to an application for summary judgment, is of the view that there are no material propositions of fact or law on which further evidence needs to be led since the respective rights of the parties are well-established as per the merits of the dispute.

  1. Bright v. MJ Bizcraft

In the case of Bright Enterprises Private Ltd. v. MJ Bizcraft LLP[8], decided by a Division Bench of the Delhi High Court in appeal, a suit was originally instituted before a Single Judge to claim a permanent injunction, restraining trademark infringement and dilution of goodwill by the defendant. The Plaintiffs used ‘PRIVE’ in the hotel business while the Defendants used ‘PRIVEE’ in relation to a nightclub in the hotel Shangri-La Eros. The Single Judge, without issuing summons to the defendant, dismissed the said suit by suomoto invoking Order XIII-A and stating that a plaintiff’s suit with “no real chance of success” ought to be dismissed at whichever stage the Court finds it so. Subsequently, this was appealed by the plaintiffs.

  • No dismissal without issue of summons

On an appeal by the Plaintiffs on the dismissal of their case, the Division Bench held that the principle of audi alteram partem is embedded in the CPC and hence issue of summons is not optional at the instance of the Court when a particular suit has been duly instituted. It was further held that at the stage of admission of the suit, it is only to be seen whether the suit has been duly instituted. It observed that the case of a plaintiff may be weak but that is not a ground for dismissing a suit without granting the plaintiff an opportunity of proving and establishing his case.

  • Window for application and no suomoto invocation

The Division Bench further held that Order XIII-A cannot be suomoto invoked by the Single Judge on inquisition and that summary judgment may only be delivered upon appropriate application being made by either of the parties.[9] Moreover, it was stressed upon by the Court that the window for preferring an application for summary judgment is only after issuance of summons to the defendant and before the framing of issues, and since such proceedings are of an exceptional nature it was the prerogative of Courts to be scrupulous while observing the requirements of Order XIII-A.

  1. Ahuja Radios

In Ahuja Radios v. A. Karim[10], an application for summary judgment was made on the basis of admissions on part of the defendant. The plaintiff was a leading manufacturer and seller of audio equipment under the registered AHUJA mark since 1940. A suit was filed against the defendant for selling counterfeit products under its mark.

The court restrained the defendant from selling audio equipment using the mark AHUJA or other deceptively similar mark and ordered a local commissioner to inspect his premises. The inspection resulted in seizure of a number of products bearing the AHUJA mark, which the defendant admitted were not original. Subsequently in pleadings, the defendant made claims contrary to his initial admitted statements and claimed that such counterfeit products were placed in his premises by the plaintiff immediately before the inspection.

The Court noted that the defendant had no real prospect of resisting the decree of permanent injunction and that the defendant also had little prospect of succeeding in its defence that he was not dealing in the counterfeit products, thereby indicating that there was no compelling reason for the Court to not dispose of the claim for permanent injunction before the recording of oral evidence.

The court passed a decree for permanent injunction in summary disposal of the suit under Order XIII-A on the basis of the admissions of fact by the defendant. Therefore, it is pertinent to note that admission on fact is a relevant criterion for admitting an application for summary judgment.

Conclusion

It is pertinent to note that sometimes disputes in relation to intellectual property rights are pertaining to infringers who do not enter appearance in the proceedings to the suit. Instead of requiring the plaintiff to lead evidence ex-parte, summary judgment under Order XIII-A of the CPC is an efficacious mechanism of disposal of disputes in such cases. The Courts are already passing punitive damages in trademark infringement cases where the offence of infringement is gross and clearly made out and hence, it is submitted that Order XIII-A would find an appropriate application in such disputes.

About the Author: Pratik Das, Legal intern at Khurana and Khurana, Advocates and Attorneys and can be reached at abhijeet@khuranaandkhurana.com

References :

[1] Section 2(1)(c)(xvii) of the Act.

[2] Section 2(1)(i).

[3] Section 12(1)(d).

[4] Section 16(1) and 16(2).

[5] Order XIIIA, R. 1(2).

[6]Ibid, R. 2.

[7]Ibid, R. 3.

[8]2017(69)PTC596(Del).

[9] Order XIII-A Rule 4.

[10] IA No. 5202/2017 in CS(COMM) 35/2017 delivered on May 1, 2017.

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Delhi High Court sought Explanation through Counter Affidavit over Repudiation of Patent application for Xtandi

Xtandi, the wonder drug for prostate cancer, was developed at UCLA, Los Angeles, by the innovation of NIH and Department of Defense grants. The drug was later licensed to Medivation, a biopharma company, which in October 2009 struck a deal with Japanese Astellas Pharma to collaborate on developing and commercializing Xtandi. The two companies now work in partnership to market the drug in US while Astellas Pharma is entrusted with the commercialization of the drug even outside US. The rights to Xtandi were later taken over by Pfizer Inc as a part of Medivation acquisition in August 2016.

In the current scenario, Astellas Pharma, which sells Xtandi in India (a country where most of the people that require the drug make just over $4 per day), is condemned for making the drug available to the Indian metastatic castration-resistant prostate cancer patients at a whopping price of 335,000 rupees or about $5014.60 US Dollars for 112 capsules (a monthly supply), translating to roughly $180 or Rs. 11,000 per day. To this condemnation, the Japanese Pharma giant responded by saying that the cost has been fixed to recuperate the cost of innovation and is commensurate with patient benefit. The blockbuster drug currently nets nearly $3 billion in worldwide sales[1].

The patent application towards Xtandi, titled “DIARYHDANTOIN COMPOUNDS”, was duly filed by UCLA with Delhi Patent Office on December 13, 2007 (Application Number – 9668/DELNP/2007). The application was rejected by the Delhi Patent Office in November 2016. Hitherto, the varsity has been granted patent for this innovation in over 50 jurisdictions across the world since 2007. The rejection of the patent application in India came in the wake of a large array of pre-grant oppositions that were filed by a clutch of companies[2] like Fresenius Kabi on December 12, 2012, BDR pharma on July 24, 2013, Indian Pharmaceutical Alliance, and a few individuals -Mr.Umesh Shah and Ms. SheelaPawar on the following grounds of the Indian Patents Act:

  1. Section 25(1)(e) – Lack of Inventive Step
  2. Section 25(1)(f) – Not inventive (u/s 3(d) and u/s 3(e))
  3. Section 25(1)(g) – Lack of Clarity and sufficiency

The opponents had argued that the claimed compound is not patentable under Section 3(d) of the Patents Act, 1970 as amended by the Patents (Amendment) Act, 2005 as it is a new form of known substances. It was also held that the inventiondid not entail any material improvement in efficacy. Additionally, the Assistant Controller in the case held that the claimed invention did not entail an inventive step over US patent ‘981 and ‘257, inasmuch as it did not entail any non-obvious addition to the compounds envisaged by these documents[3].

For the reasons indicated supra made the Assistant Controller of Patents Designs, Mr. Umesh Chandra Pandey, rejected the invention under Section 25(1) in November 2016 (order by Patent Office). However, now the UCLA (the applicant), represented by senior advocate P Chidambaram, has contended that its application was rejected merely on the ground of opposition by some competitors. The writ petition filed by the UCLA also indicates that even the evidences submitted by UCLA in support of its claims were not considered by IPO and so it has been contested that the application be remanded for consideration of the same[4].

This ongoing attempt of UCLA to get Xtandi (Enzalutamide) patented in India witnessed a development on March 2 when Delhi High Court passed an order in the case of The Regents of the University of California v. Union of India (order), asking the Centre to render an explanation on rejection of patent application (on November 10, 2016).

About the author: Tanu Goyal, Patent Associate at IIPRD and can be reached at: tanu@khuranaandkhurana.com

[1]http://epaperbeta.timesofindia.com/Article.aspx?eid=31808&articlexml=Patent-denied-price-of-prostate-cancer-drug-may-10112016014006

[2]http://www.pharmabiz.com/NewsDetails.aspx?aid=98990&sid=1

[3]http://www.mondaq.com/india/x/576168/Patent/IPO+Rejects+Patent+Application+For+Xtandi+Prostrate+Cancer+Drug

[4]http://www.dnaindia.com/health/report-hc-seeks-reason-for-denial-of-prostrate-cancer-drug-patent-2342983

Fighting with Counterfeit Menace: Montblanc Simplo GmbH vs. Gaurav Bhatia & ors. CS(OS) 2563/2013: Granting Injunctive Relief

Introduction:

It always has been a well known fact that the markets in India are targeted by large number of counterfeit products/goods. Popular brands like LV, GUCCI, Burberry, Armani, Hermes inter alia; are frequently pirated in local commercial markets. Among others, the most popular counterfeit products in market include hardware, software, clothing, watches, writing instruments.

At that backdrop, Indian system is striving hard to deal with the menace caused by the counterfeit products in the market which not only endangers country’s reputation and goodwill but also affect country’s financial market. Indian judiciary has timely made its presence felt by passing landmark judgments with various issues Indian market is facing. Recently, Hon’ble Delhi Court passed orders in one such case which dealt with counterfeit issue.

Facts of the case:

Delhi High Court in its recent judgment dated January 04, 2017 in the matter of Montblanc Simplo GmbH vs.  Gaurav Bhatia & ors. CS (OS) 2563/2013, The Court has restrained an electronic commerce web portal functioning under the Trade name “www.DIGAA.com”. The Defendant’s impugned website was alleged dealing with the manufacturing, selling and advertising of counterfeit Montblanc products which are registered under the Trademark of the Plaitiffs.

Background of the case:

Plaintiff:

A German company incorporated under the laws of the country having its registered office at Hamburg. The registered company named “Montblanc Simplo GmbH” has its work engaged in the manufacturing, distribution and sales of pens & other writing instruments under the registered Trade name MONTBLANC MEISTERSTUCK,. The plaintiff’s company Trademark also include “The Star Device” which is a white stylized six pointed star with circular edges and the “The three ring Device” comprised of three metallic bands located close to the middle of body of pen cap. The plaintiff’s company claims its product registered under proprietors name within India as well as other countries across the world.

In July 2013, the plaintiff through its office in India came to know that the said defendant was selling counterfeit products on a lesser rate from original product of plaintiff. The defendant represented his product as original product of Plaintiff Company. Hence, the present suit was filed.

Submission by the parties:

Plaintiff’s Submission:

  • Plaintiff claimed that his company is losing reputation and trust of his clients because of defendant’s counterfeited products. Plaintiff claimed to be suffering loss and demanded damage worth INR 2,005,000.
  • Plaintiff stated the price of original MEISTERSTUCK CLASSIQUE is INR 30,000 whereas the defendants were selling similar counterfeit product for INR 6,860.
  • Plaintiff in his submission stated that they purchased writing instrument, namely, the MEISTERSTUCK CLASSIQUE from the website defendant was using to sell the products, which were being sold at a discounted price and falsely represented as a product of the plaintiff upon examination that the product was a counterfeit.
  • It was submitted by the plaintiff that the defendant’s product is of inferior quality; also the refill used in Defendants instrument was different than that of original product. Defendant’s instrument has a different color combination than that of plaintiff. Also, the tip of the refill of defendant’s writing instrument has a plastic ball which is different than that of plaintiff’s original product. The serial numbers on the product were also fabricated by the defendant.

The defendants after filing their Written Statement stopped appearing in court and the suit was preceded Ex-parte.

Observation by the Hon’ble court:

  • Court observed some of the consumers complaints filed against the defendant including one customer who purchased counterfeited product from defendant and suffered subsequently lodged a complaint before the cyber cell of Chandigarh Police under section 420 & 406 of Indian Penal Code and section 66A of Information Technology Act.
  • Plaintiff’s brand name MONTBLANC is a well-known mark having goodwill and reputation in its market. It is also proved that public identified plaintiff’s product from its trade dress which includes “The Star Device” and “The Three Ring Device”.
  • Plaintiff also proved on record its notice published in India, and related information from the defendant’s web portal displaying counterfeit products of the plaintiff’s Trademark, They also attached the invoice alongside of the purchased products and photographs of counterfeit products and their warranty card.
  • The court observed that the plaintiff had proved that the defendant was counterfeiting its goods and thereby, infringing its Trademark.

Held:

The Hon’ble Court, in view of the above case granted relief of permanent injunction against the Defendants as sought by the plaintiff  and also passed a restraining order against them to restrain them from Passing-off their counterfeit products as that of plaintiff’s. However, the claim for damages was rejected by the court on the ground that Plaintiffs have not produced sufficient evidence to show the extent of actual damage suffered by the company. Hence, the judgment was in the favor of the plaintiff. Pertinently, it is important to note that in order to claim damages proper and sufficient evidence must accompany to get monetary relief against damages suffered.

About the author: Mayank Srivastav, an intern at Khurana & Khurana, Advocates and IP Attorneys

Export under section 107A of Indian Patent Act, 1970

In the case of Bayer Corporation versus Union of India & ors (W.P.(C) 1971/2014) and Bayer Intellectual Property Gmbh & Anr versus Alembic Pharmaceuticals ltd (CS(COMM) No.1592/2016), High Court of Delhi in the consolidated decision dated March 08, 2017, adjudicated on the issue whether Section 107A of the Patents Act, 1970 permits export from India of a patented invention, even if solely for uses reasonably related to the development and submission of information required under any law for the time being in force, in India, or in a country other than India, that regulates the manufacture, construction, use, sale or import of any product.

Though it’s been almost five years after first compulsory license (in India) was granted to Natco in 2012 against Bayer’s Patent IN215758 covering Nexavar (Sorafenib ), Bayer and Natco are fighting it hard in 2017 as well. One of the terms of Compuslory License was “solely for the purposes of making, using, offering to sell and selling the drug covered by the patent for the purpose of treating HCC and RCC in humans within the territory of India”.

Subsequently, Natco was permitted to export the drug SORAFENIB TOSYLATE not exceeding 15 gm for development / clinical studies and trials. Natco again applied for permission to export 1 Kg. of Active Pharmaceutical Ingredient (API) SORAFENIB to China for the purposes of conducting development / clinical studies and trials, to which Bayer objected.

To better understand the issue at the heart of this decision, it’s important to understand section 48 of the Indian Patent Act, 1970 which gives rights of Patentee and section 107A of the Indian Patent Act, 1970 which lists out activities which shall not be considered to be infringement of Patent.
Both the sections have been reproduced below for convenience.

Section 48:

Subject to the other provisions contained in this Act and the conditions specified in section 47, a patent granted under this Act shall confer upon the patentee—

(a) where the subject matter of the patent is a product, the exclusive right to prevent third parties, who do not have his consent, from the act of making, using, offering for sale, selling or importing for those purposes that product in India;

(b) where the subject matter of the patent is a process, the exclusive right to prevent third parties, who do not have his consent, from the act of using that process, and from the act of using, offering for sale, selling or importing for those purposes the product obtained directly by that process in India.

Section 107A:

For the purposes of this Act,— any act of making, constructing, using, selling or importing a patented invention solely for uses reasonably related to the development and submission of information required under any law for the time being in force, in India, or in a country other than India, that regulates the manufacture, construction, use, sale or import of any product; (b) importation of patented products by any person from a person who is duly authorised under the law to produce and sell or distribute the product, shall not be considered as a infringement of patent rights.

Natco pleaded that export of the Patented invention for the use reasonably related to the development and submission of information required under any law for the time being in force, in India, or in a country other than India, that regulates the manufacture, construction, use, sale or import of any product is squarely covered under section 107A. It also submitted that its intentions were not for commercial purpose. Natco also submitted that grant of Compulsory License does not take away the rights to export the Patented invention for the purposes of section 107A.

Bayer alleged that 107A of Indian Patent Act does not allow exporting of drug even for the purposes of reasonably related to the development and submission of information required under any law for the time being in force, in India, or in a country other than India, that regulates the manufacture, construction, use, sale or import of any product. Bayer tried to draw attention to the fact that language of section 107A does not use the word ‘export’ but uses the word ‘import’. Bayer alleged that absence of the word ‘export’ clearly indicates the purpose of the law was not to allow the export of the patented invention and the words ‘in a country other than India’ should be interpreted only to allow export of the information generated by experiments in India. Patented invention as such cannot be exported from India to generate information to be submitted in other countries. The word selling should be interpreted to mean selling in India and not outside. Bayer alleged that if law intended to allow export, language would have expressly included that as it has included import. In summary, Bayer requested the court to interpret the word sell to mean selling without exporting, i.e. selling in India. Bayer importantly also alleged that exporting under 107A of Patented invention for which compulsory license was granted would result in the abuse of law.

On 5th November, 2014, Natco was permitted export of SORAFENIB for carrying on activities for obtaining regulatory approvals within the meaning of Section 107A of the Act. Bayer preferred appeal against the said order and which was disposed of by expediting the hearing of the writ petition and by prohibiting export till the decision of the writ petition. The hearing of the writ petition commenced on 7th September, 2015 and concluded on 8th July, 2016, when orders were reserved.

Natco had also brought attention to the fact that China requires clinical trials to be conducted in China and do not recognize clinical trials conducted in India. This makes it mandatory for Natco to seek export under section 107A so that it can launch the product in China immediately after term of patent is over.

CS(COMM) No.1592/2016 was filed by Bayer to injunct Alembic from making, selling, distributing, advertising, exporting, offering for sale and in any manner directly or indirectly dealing in Rivaroxaban‘ and any product that infringes Bayer‘s patent IN 211300. Alembic was manufacturing and exporting RIVAROXABAN to the European Union and had made multiple Drug Master File submissions to the United States Food and Drug Administration in the United States of America for the drug RIVAROXABAN. Alembic alleged that exports being effected by Alembic were within the meaning of Section 107A only.

For both cases, court held after referring different dictionaries that selling cannot be interpreted to mean to exclude exporting. Also court found that Patent Act does not require court to do so. Court also brought attention to the fact that even absence of the word ‘export’ in section 48 does not prevent Patentee from restricting third parties from exporting patented invention. Court explained that it’s not the exporting of information is allowed but it’s the Patented invention. The words ‘in a country other than India’ are for the law in force (of country where information is required).
Court also went on to hold that even when compulsory license is granted, Natco as a non-patentee cannot be deprived of making, constructing and selling by way of export a patented invention for purposes specified in Section 107A.

Court gave the liberty Bayer to, if makes out a case of the exports effected or to be effected being for purposes other than specified in Section 107A, take appropriate proceedings therefor.

About the Author: Swapnil Patil, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: swapnil@khuranaandkhurana.com.

India’s time to delve into IP laws

Shireen Shukla, legal intern at Kkurana & Khurana, probes the recent International IP Index report, released by U.S. Chamber of Commerce, where India stood at 43rd position, out of 45 countries.

On 8th February, 2017 U.S. Chamber of Commerce released its 5th annual International IP Index, “The Roots of Innovation,” rating 45 world economies on patents, trademarks, copyright, trade secrets, enforcement, and international treaties with the aim to provide both, an IP report card for the world and a guidebook for policymakers seeking to bolster economic growth and innovation.

It is an undeniable fact that protection of intellectual property serves dual role in the economic growth of a country. Where on one hand it promotes innovation by providing legal protection of inventions, on the other it may retard catch-up and learning by restricting the diffusion of innovations. Therefore a sounder IPR protection in a country encourages technology development and technology transfer from developed to least developed countries. Countries that would demonstrate a commitment to IP laws will only reap rewards.

Often we have seen that major companies and brands invest their money or open their outlets in another country only after seeing the soundness of their IP laws. This proves the role of IP laws and enforceability on the GDP of a country.

GIPC is leading a worldwide effort to champion intellectual property rights as vital to creating jobs, saving lives, advancing global economic growth, and generating breakthrough solutions to global challenges  (Reddy, 2017). The Index ranked the IP systems of 45 countries. Where on one hand United States was ranked number 1, India and Pakistan were ranked 43 and 44 respectively.

Image Source: U.S. Chamber International IP Index: http://www.theglobalipcenter.com/ipindex2017-chart/#

 

Some major facts from the IP Index:

  • A pack of global IP leaders emerged among the 2017 Index rankings, with the U.S., UK, Japan, and EU economies, ranked more closely together than ever.
  • Canada signed the Comprehensive Economic and Trade Agreement (CETA), which raised the bar for life sciences IP protection.
  • Russia introduced new forced localization measures.
  • Japan’s score increased by 10% due to ratification of TPP and accession to the Index treaties.
  • South Korea passed amendments to the Patent Law.
  • Uncertainty around software patentability, Section 3(d) of the Patent Law, and High Court copyright decisions in India continue to present challenges.
  • Indonesia’s Patent Law included a heightened efficacy requirement and outlawed second use claims.
  • South Africa introduced new local procurement policies.
  • UAE created a specialized IPR Court.
  • Indian government issued the National Intellectual Property Rights Policy in 2016.

India announced the much-awaited National IPR Policy in May 2016. This act proved to be a positive attitude to foster the IP laws in India. The Policy is a boon for the IP industry as it provides constructive ways and methods to improve IP administration. The policy has enumerated the importance to educate Indian businesses about IP rights.

The Policy makers realizing the real issue in hand, addressed a number of important gaps in India’s national IP environment, which included the need for stronger enforcement of existing IP rights through the building of new state-level IP cells and investing more resources in existing enforcement agencies; reducing processing times for patent and trademark applications; as well as the need for introducing a legislative framework for the protection of trade secrets

Major developments and landmark judgments in Intellectual property laws since 2015:

  • The Delhi high court on 7 October 2015, barred Mumbai-based Glenmark Pharmaceuticals Ltd from selling, distributing, marketing or exporting its anti-diabetes drugs Zita and Zita-Met,as they tentatively infringed the patent of US-based pharmaceuticals company Merck Sharp and Dohme Corp.
  • In March, 2016, the Delhi High court in the case of Ericcson v. CCI for the first time ever, considered at how IP law interfaced with competition law. It allowed Competition Commission of India (CCI) to continue its investigation into anti-competitive practices by Ericsson regarding use of its SEP’s by other companies such as Micromax and Intex.
  • National IPR Policy in 2016, released last year is entirely compliant with the WTO’s agreement on TRIPS.
  • Examination time for trademarks has been reduced from 13 months to 8 months in the 2016 policy.
  • Bombay HC passed a series of judgments cases (Phantm Films pvt, Ltd. v. CBFC & Anr; Eros International Media Ltd. & Another v. Bharat Sanchar Nigam Ltd.) laid down a strict agenda for the grant of John Doe orders leading to path breaking shift in the John Doe jurisprudence in India. The above-mentioned judgments are focused on balancing the interests of not just copyright holders but also the Internet users and innocent third party providers.
  • The judgment by Bombay HC in Eros v. Telemax, is a pioneer that unwrapped the scope of arbitration of IP disputes arising out of licensing and other commercial transactions.
  • In December 2016, the Delhi High Court in the case of Agri Biotech v. Registrar of Plant Varieties declared section 24(5) of the Plant Varieties Act unconstitutional. The court giving a momentous judgment stated that the section violates Article 14 as it gives unchecked powers to the Registrar. The registrar is not required to be from a legal background in order to grant interim relief to a breeder against any abusive third party act during the period its registration application is pending.This lead to arbitrary use of powers by the registrar.

Beside the above-mentioned developments and progressions, PM Narendra Modi’s “Make in India” initiative also aims to promoting foreign direct investment and implementing intellectual property rights. In these initiatives, the government has decided to improve the intellectual property rights for the benefit of innovators and creators by modernizing infrastructure, and using state of the art technology.

One of the most recent and effective change brought in the trademark rules was on 6th march 2017, where the number of trademark forms have been reduced from 74 to 8 with an aim of simplifying the process of trade mark applications. The new rules promote e-filling of the trademark applications. The fee for online filing of the application is 10 per cent lower than that of the physical filing.

Steps India can take to strengthen its IPR laws:

  • India should implement speedy examination and registration procedures.
  • It should take effective steps to achieve the target of one month (as stated in IPR policy 2016).
  • The number of patent examiners and trademark offices should be increased to improve efficiency and disposal speed.
  • Section 3(d) of India’s Patent Act 1970, relating to restrictions on patenting incremental changes should be amended. Norms relating ever greening should also be revised.
  • A new and revised IPR laws and policies should be implemented so as to make it compatible with IPR laws of WIPO, TRIPS and other major dominant countries like US & UK

Every fiscal year, enormous time and money is being invested on R&D to improve the existing status of the Intellectual property laws in India, to bring it at par with the IP laws of US. We hope by following the above guidelines and following the National IPR Policy, India’s position improves in the next International IP Index 2017.

References :

  1. Prashant Reddy, The Press Release Journalism Around the GIPC IP Index, February 13, 2017, < https://spicyip.com/2017/02/the-press-release-journalism-around-the-gipc-ip-index.html&gt; Last accessed: 28th February 2017
  2. Merck Sharp And Dohme Corporation. v. Glenmark Pharmaceutical, FAO (OS) 190/2013, C.M. APPL. 5755/2013, 466/2014 & 467/2014, (Delhi High Court) (20.03.2015)
  3. Telefonaktiebolaget LM Ericsson v. Competition Commission of India, W.P.(C) 464/2014 & CM Nos.911/2014 & 915/2014, (Delhi High Court) (30.03.2016)
  4. Phantom Films Pvt. Ltd. v. The Central Board of Film Certification, W.P.(L) 1529 /2016, (Bombay High Court) (13.06.2016)
  5. Eros International Media Limited v. Bharat Sanchar Nigam Limited, C.S. No.620 /2016 & O.A.Nos.763 to 765/2016 (Madras High Court) (25.10.2016)
  6. Eros International Media Limited v. Telemax Links India Pvt. Ltd., Suit no. 331 /2013, (Bombay High Court) ((12.04.2016)
  7. Prabhat Agri Biotech Ltd. v. Registrar of Plant Varities, W.P.(C) 250/2009, (Delhi High Court) (02.12.2016)

 

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).

Compulsory Licensing Application against the Patented Drug SAXAGLIPTIN by Lee Pharma

Lee Pharma, a Hyderabad based Indian pharma company, has filed a Compulsory Licensing (CL) Application (in accordance with Section 84(1) of the Indian Patents Act) against one of the patented drug Saxagliptin for treating Diabetes Mellitus. The Patent on Saxagliptin was granted to Bristol Myers Squibb (BMS) in India on 30th April 2007 having number IN 206543 having title “A Cyclopropyl-fused pyrrolidine-based compound” which was assigned to AstraZeneca by way of Deed of Assignment. This is the third instance in India where a compulsory licence has been asked for. Earlier, Natco got its first CL against Bayer’s patented drug Sorafenib while the CL application from BDR against Bristol Myers Squibb (BMS)’s patented drug Dasatinib was rejected by IPO. The application for compulsory licensing against Saxagliptin drug was filed by Lee Pharma dated 29.06.2015 and can be seen here.

Grounds Relied by Lee Pharma for Compulsory Licensing:

  1. That the reasonable requirements of the public with respect to the patented invention have not been satisfied” (Section 84 (1) (a))

The Applicant- Lee Pharma has stated in its CL Application that Saxagliptin is not manufactured in India even after 8 years of grant of the Indian patent by BMS, rather is being imported to India by BMS or AstraZeneca and marketed by Astrazeneca. By citing form 27 filed by BMS with respect to working of patent India for the year 2013, Lee pharma stated in his application that the total number of tablets imported to India was 823,855 and total value was Rs. 654,629/-. Based on above, cost for importing one tablet in India is only Rs 0.80 per tablet whereas the same is being sold at market price of Rs. 41-45/- per tablet.

In an interesting fact, the applicant has further stated that Saxagliptin is one of the four main medicines which are used for the treatment of Type-II Diabetes Mellitus (DM). Further, the applicant has showed that the quantity of the imported tablets is too less to meet the requirements of Indian patients suffering from Type-II DM. They state that there are around 60 million diabetes type II patients, and that ‘even if’ only 1 million out of the 60.1 million were to be prescribed Saxagliptin, 823,855 units (as per Form-27) fall far short of the required amount which is about 0.23% of the total number of tablets required for a year. So there is more than 99% shortage of Saxagliptin in Indian market.

  1. That the patented invention is not available to the public at a reasonably affordable price (Section 84 (1) (b))

As discussed above, the cost of importing one tablet of Onglyza in India is only about Rs 0.80/ per tablet whereas the same tablet is being sold in Indian market by BMS and Astrazeneca at a market price of about Rs. 41-45/- per tablet.  Citing income per capita of an Indian, the applicant showed that the cost of one tablet of patentee’s medicine is more than the whole day earning. Therefore, according to the Applicant, excessive high price of the medicines is a barrier to access of Saxagliptin for the poor patients in India. Thereby the reasonable requirement of public is not being met in terms of reasonably affordable price.

  1. That the patented invention is not worked in the territory of India (Section 84 (1) (c))

The applicant further stated that even after passing a long period of eight years from the date of grant, the patentee has not taken adequate steps to manufacture Saxagliptin in India and make full use of the invention. Pertinently, in earlier Nexavar CL case, the same contention was raised and it was concluded by the Controller that the “worked in the territory of India” means “manufactured to a reasonable extent in India”.

  1. Efforts made by applicant for Voluntary licence (VL): (Section 84(6) (iv))

The applicant earlier requested the patentee to obtain Voluntary License to manufacture and sell the drug in India by writing to them on 02.05.2014. In response to said request for licence, the patentee asked for certain clarifications about the Lee pharma and at the same time disagreed to the applicant’s submission that “the Saxagliptin tablets (ONGLYZA) are not available to the general public at reasonably affordable price and thereby the reasonable requirements of the general public is not being met”. Further, the applicant received a reply from Patentee’s counsel asking for clarifications, manufacturing and marketing details, R&D status and other relevant details for which according to the Applicant, they replied promptly. Applicant sent reminder request to the counsel but did not receive any reply neither from the patentee nor from their counsel.

Another important factor, on which the applicant relied for considering a CL application, is the ability and capability of Lee Pharma to manufacture and cater to the needs of the entire public. Lee Pharma has stated in the Application that it can manufacture 10,00,000 tablets  a day with a price of Rs. 27/- per tablet. Also, the applicant stated that they had already asked for licence from State Government to manufacture Saxagliptin tablets.

Conclusion:

It would be interesting to see the fate of the CL application filed by the Lee Pharma, in view of the fact that this CL application is the third instance prior to which one CL has been granted and one has been rejected. However, it is pertinent to note that the prior two CL applications were for anti cancer drugs (life threatening diseases) while the present application is for Diabetes Mellitus (life management disease). Hence the decision would be noteworthy irrespective of the outcome of CL application which will have a great impact on the Industry regarding Compulsory Licensing practice/filing in India.

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

Recent Patent Litigation Cases (2014-15): India

Patent Litigation in India has steadily increased over last 2-3 years. Dramatic swift has been observed in the innovator’s perspective from the mere aspect of invention to gaining patent protection for their respective invention. Patent owners have adopted aggressive approach towards their patent protection and enforcing their proprietary rights as businesses, are now well-positioned in the realm of patent litigation.  The patent owners are not at all hesitant to challenge the validity of patent rights of their rivals. There has also been gradual increase in the understanding of the complex patent infringement and validity issues.

We will now deal with some of the recent and important patent litigation cases in India.

Merck vs. Glenmark over “Sitagliptin”

In an interesting note, Hon’ble Supreme Court of India on Special Leave Petition filed by Glenmark stayed the Delhi High Court order which passed injunction against Glenmark for the generic drug Sitagliptin till 28th April 2015. Merck Sharp & Dohme filed an application for an ad interim injunction restraining the respondent/defendant Glenmark Pharmaceuticals from using its patented product Sitagliptin (Indian Patent No. 209816) at the Supreme Court. The Delhi high court conclusively held that all the three ingredients (Prima facie, Irreparable injury and balance of convenience) for passing the order of injunction were established by MSD and hence injuncted Glenmark from manufacturing and selling of Zita and Zitamet.

Ericsson vs. Xiaomi

In December 2014, Ericsson had filed a suit against Xiaomi in India for the alleged infringement of the 8 standard-essential patents. The Delhi High Court granted an ex-parte injunction on the sale, manufacture, advertisement, and import of Xiaomi’s devices.

Xiaomi claimed that its latest devices in the Indian market (as of December 2014), the Mi3, Redmi1S and Redmi Note 4G, contained Qualcomm chipsets, which implemented technologies licensed by Ericsson. Xiaomi subsequently challenged the injunction before a Division Bench of the Delhi High Court, which issued temporary orders to allow Xiaomi to resume the sale, import, manufacture, and advertisement of its mobile devices subject to the following conditions:

  • Xiaomi would only sell devices having Qualcomm chips.
  • Xiaomi would deposit Rs. 100 towards royalty for every device it imported to India from the date of the launch of the device in India toJanuary 5, 2015. This amount was to be kept in a fixed deposit for three months during the proceeding of the case.

Novartis vs. Cipla

In another patent litigation case, Delhi High court barred Indian generic drugmaker Cipla from making or selling generic copy of Novartis’s “Onbrez” by giving temporary injunction to Novartis. Citing famous Roche vs Cipla case, the court observed that Novartis has a strong prima facia case and as the validity of the patent is not seriously questioned, there is a clear way out to grant injunction. Further, the court observed that Cipla did not provide any figures about the “inadequacy or shortfall in the supply of the drug.” Earlier Cipla lunched its generic version of Indacarterol in October claiming “urgent unmet need” for the drug in india.

Without going conventional way, Cipla, also approached the Department of Industrial Policy and Promotion (DIPP) to exercise its statutory powers under Section 66 and Section 92 (3) to revoke Indian Patents IN222346, IN230049, IN210047, IN230312 and IN214320 granted to Novartis AG for the drug Indacaterol. Cipla argued on the basis of 3 main points i.e. “epidemic” or a “public health crisis” of COPD, unable to manufacture the same in India by Patentee and high cost of patented drug.

Vringo Vs. ZTE

In January 2014, Vringo and Vringo Infrastructure filed a patent infringement suit in the Delhi High Court against ZTE, over the alleged infringement of its patent IN200572.

In February 2014, the Delhi High court granted an ad-interim ex-parte injunction restraining ZTE from importing, selling, advertising, installing or operating devices that comprise the infringing components. The High court also appointed local commissioners to inspect ZTE’s premises and instructed customs authorities to detain ZTE’s shipments that may contain such devices and to notify Vringo. In March 2014, ZTE appealed against the injunction, which was vacated on August 5 the same year with ZTE being ordered to deposit Rs. 17.85 crore to the court.

The suit is sub judice now. As of August 2014, ZTE had filed for the revocation of IN200572 on grounds of it not being innovative as well as for violating some statutory provisions under Section 64 of the Indian Patents Act.

Reference: http://inpublic.globenewswire.com/2014/09/02/VRINGO+PROVIDES+UPDATE+TO+SHAREHOLDERS+HUG1853040.html

Vringo vs. Asus

In April 2014, Vringo filed a patent infringement suit against AsusTek Computer Inc. in Delhi High Court. As per public updates issued by Vringo to its shareholders, Vringo has alleged the infringement of patent IN223183 entitled “Method and system for providing wireless communication using a context for message compression” by Asus in India.

Asus had claimed that in the context of IN 223183 it was using technology licensed to it by Google. In August 2014, Google filed a request to become a party to the proceedings.

Vringo had requested for an injunction on Asus’ use of the technology in India. The injunction has not been granted yet. No further information about the lawsuit is publicly available.

Reference: http://inpublic.globenewswire.com/2014/09/02/VRINGO+PROVIDES+UPDATE+TO+SHAREHOLDERS+HUG1853040.html

SYMED Labs vs. Glenmark Pharmaceuticals

In another case of SYMED Labs vs. Glenmark Pharmaceuticals, Symed Labs Ltd. had sued Glenmark Pharmaceuticals Laboratories before the Delhi High Court for allegedly infringing two of its patents: IN213062 & 213063. First patent was granted for “Novel intermediates for Linezolid and related compounds” while the ‘063 patent was granted for “A novel process for the preparation of linezolid and related compounds. While declaring the judgment on 9th Jan 2015, the judge convinced that the Plaintiff has got good prima facie case in favour of SYMED. Further the judge decided that protection to the patent processes ought to be granted to the Plaintiff as damages will not be an efficacious remedy. Thus, there will be irreparable loss and injury because of the long uninterrupted use of patents, the balance of convenience also lies in favour of the Plaintiff. Thus the judge granted an ad interim injunction restraining Glenmark from manufacturing, selling, offering for sale, advertising or directly or indirectly dealing in the production of Linezolid manufactured in a manner so as to result in infringement of the Plaintiff’s registered Patents.

Maj. (Retd.) Sukesh Behl & Anr. vs Koninklijke Phillips

In this litigation case, Sukesh Behl made a counter claim for revocation of the suit Patent No. 218255 under Section 64(1)(m) of the Patents Act, 1970 (for short “the Patents Act”) for non-compliance of the provisions of Section 8. Earlier in another suit Koninklijke Phillips sought for permanent injunction restraining Sukesh Behl from infringing its patent and for other incidental reliefs. While delivering the judgement, the judge answered the question of whether the failure to comply with the requirement of Section 8 of the Patents Act would invariably lead to the revocation of the suit patent under Section 64(1)(m) of the Patents Act, the word “may” employed in Section 64(1) indicates that the provision is directory and raises a presumption that the power of revocation of patents conferred under Section 64(1) is discretionary. Citing Chemtura case, the judge hold that the power to revoke a patent under Section 64(1) is discretionary and consequently it is necessary for the Court to consider the question as to whether the omission on the part of the plaintiff was intentional or whether it was a mere clerical and bonafide error. Finally, the judge dismiss the plea of Sukesh Behl for revocation of said patent under section 64 (1)(m).

Enercon vs. Dr. Aloys Wobben

In this land mark decision, Hon’ble Supreme Court of India addressed the multiplicity of patent proceeding cases with respect to Invalidation, opposition and revocation. Dr.Aloys Wobben has filed around 19 infringement suits before the High Court and Enercon India Limited have filed around 23 “revocation petitions” before the Appellate Board, praying for the revocation of the patents held in the name of the Dr. Wobben. The respondents had also filed “counter claims” to the “patent infringement suits” filed by the appellant.  Even though some revocation petitions have been settled by the IPAB, the same issues were being re-agitated by Enercon before the High Court. The Supreme Court of India following rules – firstly, if “any person interested” has filed proceedings under Section 25(2) of the Patents Act, the same would eclipse all similar rights available to the very same person under Section 64(1) of the Patents Act. This would include the right to file a “revocation petition” in the capacity of “any person interested” (under Section 64(1) of the Patents Act), as also, the right to seek the revocation of a patent in the capacity of a defendant through a “counter-claim” (also under Section 64(1) of the Patents Act). Secondly, if a “revocation petition” is filed by “any person interested” in exercise of the liberty vested in him under Section 64(1) of the Patents Act, prior to the institution of an “infringement suit” against him, he would be disentitled in law from seeking the revocation of the patent (on the basis whereof an “infringement suit” has been filed against him) through a “counter-claim”.  Clearly, this judgement laid a smooth road for complex patent litigation practices in India.

It would be interesting to note the developments that would take place in the Patent protection scenario in India and the gradual increase in the patent litigation cases in India.

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

Supreme Court stayed the Delhi High Court order of injunction against Glenmark over the Generic drug “Sitagliptin”

Reportedly, Hon’ble Supreme Court of India on Special Leave Petition filed by Glenmark stayed the Delhi High Court order which passed injunction against Glenmark for the generic drug Sitagliptin till 28th April 2015. The Delhi high court on dated 20th March 2015 set aside an order of single judge bench of Delhi High Court which rejected the injunction application by MSD against Glenmark. This article aims to analyze the Delhi High Court judgment by the Division bench in detail. The detailed judgment can be found here.

Facts of the case:

Merck Sharp & Dohme (hereafter “MSD”) aggrieved by the dismissal of its application for an ad interim injunction restraining the respondent/defendant Glenmark Pharmaceuticals (hereafter “Glenmark”) from using its patented product Sitagliptin (Indian Patent No. 209816) filed an appeal. MSD filed an application before single bench Delhi High Court for permanent injunction, restraining infringement of the patent, damages, rendition of accounts and delivery up. The suit patent relates to a drug which lowers blood sugar levels in Type 2 Diabetes Mellitus (“T2DM”) patients. Glenmark opposed the application for ad interim injunction and relied on documents produced during the hearing. The learned Single Judge rejected the injunction application. Aggrieved by the dismissal of interim injunction Merck sought to obtain an interim injunction against Glenmark seeking to restrain Glenmark from selling its Generic products Zita (generic version of Januvia) and Zitamet (generic version of Janumet, combination of sitagliptin+metmorphin).

Argument advanced by the Appellant (MSD): 

The learned Senior Counsel, Mr. T.R. Andhyarujina for MSD argues, that its drug Sitagliptin is the first in its class of compounds that inhibits the enzyme Di Peptidyl Peptidase-IV (“DPP-IV”). The learned counsel argued that the suit patent is infringed because Sitagliptin and any of its acceptable salts are covered by its claims, thus resulting in the making, using or offering for sale, importing into India etc. of Sitagliptin or any of its salts or any form amounting to infringement of the suit patent. It was further argued that Glenmark, by manufacturing, selling, offering for sale and advertising the pharmaceutical combinations Sitagliptin Phosphate Monohydrate under the brand Zita and Sitagliptin Phosphate Monohydrate and Metformin Hydrochloride under the brand name Zitamet infringes the suit patent and all its claims. It was underlined that Sitagliptin Phosphate Monohydrate cannot be prepared without manufacturing the active ingredient Sitagliptin molecule. Therefore, the use of Sitagliptin claimed by IN 209816 to prepare Sitagliptin Phosphate Monohydrate by Glenmark infringes the suit patent. MSD argued that its non-disclosure of applications (which were not pursued by it) was an inessential detail which should not have clouded the debate on whether Glenmark infringed its suit patent. It was submitted that the subject of the European Patent, and the application No. 5948/DELNP/2005 (filed on 18.06.2004 – in respect of the Phosphoric Acid Salt of a DPP-IV inhibitor that claimed Dihydrogenphosphate salt of Sitagliptin and was abandoned under Section 21(1) on 23.08.2010) could not have been the basis for refusing ad interim injunction. In India, on account of Section 3(d) and the interpretation of the expression “efficacy” by courts, MSD abandoned the phosphate salt application.

The learned counsel for MSD argued that Glenmark’s US Process Patent No. US8334385 is for “Process for the preparation of R. Sitagliptin and its pharmaceutical salts”. It was further contended that this patent clearly admits that Sitagliptin is developed for the treatment of T2DM and is the active free base. It also gives the full description of the process for preparing Sitagliptin freebase in the patent specification which is Scheme 6 in Merck’s patent. The claim of Glenmark’s patent is for a crystalline salt of Sitagliptin. The learned counsel relied upon the disclosures made to the suit patent IN 209816 to state that the basic invention for which patent protection was sought was Sitagliptin “with pharmaceutically acceptable salts thereof”. It is submitted that this is clearly stated in claims 1, 15, 17 and 19. Thus learned counsel stressed that Glenmark”s ZITA (Sitagliptin Phosphate Monohydrate) and ZITA-MET (Sitagliptin Phosphate Monohydrate and Metformin) infringe the suit patent because Sitagliptin is made and used by Glenmark in ZITA and ZITA-MET when it makes salt Sitagliptin Phosphate Monohydrate. It was underlined that the phosphoric acid salt of Sitagliptin was disclosed in the suit patent itself as one of the pharmaceutically acceptable salts.

Arguments advanced by the Respondent:

 The counsel for the respondent argued that the suit patent is obvious and does not involve an inventive step over and above previous disclosures in the prior art. It was further argued that the suit patent is anticipated by prior arts European Patent 1406622 and WO/01/34594.

Further it was argued by the Counsel for the respondent that the suit patent drug Sitagliptin as well as Sitagliptin Hydrochloride are unstable compounds possessing incapability of commercial production and industrial use.

The respondent argued that the claim goes much beyond the limited disclosures in the specification, and thus the claim is overbroad or an impermissible Markush claim that creates a false monopoly. It was also contended that the patent monopoly is too broad to be workable as it includes possibly 4.9 billion compounds and such elastic claims cannot be sustained.

It was argued that the complete specification of the suit patent does not sufficiently and fairly describe the invention and the method by which it is to be performed, since the patent does not describe the preparation of the Sitagliptin free base or Sitagliptin phosphate monohydrate, but only its hydrochloride salt.

Further it was argued that MSD did not comply with its obligation under Section 8 of the Act to disclose patent applications made for the “same or substantially the same invention” – it did not disclose 5948/DELNP/2005 (for Sitagliptin Phosphate Monohydrate), 1130/DELNP/2006 (Sitagliptin Phosphate Anhydrate), 2710/DELNP/2008 (Sitagliptin plus Metformin) or subsequent international applications for these compounds either. It was also argued that such suppression and concealment – contrary to statutory obligations – results in the invalidity of the patent, and at any rate, militates against the grant of an interim injunction that is premised on good faith and complete disclosure.

It was argued by the respondent that the suit patent by the plaintiff’s own admission is different from its product. The only exemplified salt being Sitagliptin Hydrochloride, no other salt can be claimed or covered in the impugned salt patent and the plaintiff, by its own admission equivocally, through several documents admitted that the suit patent is distinct and different from the Sitagliptin Phosphate Monohydrate (SPM) as well as its combinations with Metformin Hydrochloride. Urging that the latter two products are the subjects of separate patents, Glenmark highlighted that this is clear admission that they are not covered by the suit patent. In this respect, the details of the plaintiff’s application, i.e. 5148/DELNP/2005, especially, Claim no.1 and International Patent US 2004027983, again claim no.1 are relied upon. The said salt, i.e. SPM was also claimed to possess tremendous advantages over free base and previously disclosed hydrochloride salt. MSD‟s said patent application no. 5948/DELNP/2005 for SPM was specifically abandoned.

Conclusion:

Considering the arguments advanced by both the parties, the court evaluated the three grounds Prima facie case, irreparable injury and balance of convenience for passing interim injunction as below:

1) The court on the first ingredient held that prima facie case had been established by MSD for the fact that Glenmark uses Sitagliptin free base as the active component in its chemical formulation.

2) The court on the issue of whether the claimant would suffer irreparable injury in the absence of interim injunction or not, held in affirmative. The court rejected the argument of Glenmark that injunction should not be granted as the monetary compensation may be granted. On the contrary court opined that prices may not recover after the patentee ultimately prevails, even if it is able to survive the financial setback (or “hit”) during the interim, which may take some time.

3) On the issue of balance of convenience the court held in favor of MSD. On the issue of price difference between the commercial products by MSD and Glenmark is not so startling as to compel the court to infer that allowing Glenmark to sell the drug, at lower prices would result in increased access. However, the court observed that Permitting Glenmark to operate would not necessarily result in lowering of market prices. Hence according to court the balance of convenience lies in favor of MSD.

The court conclusively held that all the three ingredients for passing the order of injunction were established by MSD and hence injuncted Glenmark from manufacturing and selling of Zita and Zitamet.

About the Author: Meenakshi Khurana, Partner at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: meenakshi@khuranaandkhurana.com

Recent decision of Delhi High Court in the case of GILEAD PHARMASSET, LLC V. UNION OF INDIA & ANR

Recently, the Delhi high court on dated 30th January 2015 set aside an order of the Deputy Controller of Patents and Designs. The impugned order rejected a patent to US drug maker Gilead for its hepatitis C drug “Sovaldi” on dated 13th January 2015. The detailed judgment can be found here.

Facts of the case:

M/S GILEAD PHARMASSET, INC, USA, filed a patent application on 30/05/2003 in USA and the corresponding application was filed in India through PCT on 27/12/2005 vide application no. 6087/DELNP/2005 (“A (2’R)-2′-DEOXY-2’FLUORO-2′-C-METHYL NUCLEOSIDE”). Two Entities, NATCO Pharma Ltd. and Delhi Network of Positive People +IMAK filed applications for pre-grant opposition, under Section 25 of the Act on dated 13 March 2014 and 17 March 2014 respectively. On 13th January 2015, the Patent Office rejected Gilead’s Hepatitis C drug, sofosbuvir (Sovaldi) on the basis of it failing to clear Section 3(d) of Indian patent act 1970 which prevents evergreening of patents and provides that no new form of an existing substance shall be patented unless the new form is more effective than the old one. The copy of the decision made by Controller General of Patents can be accessed here.  Being aggrieved by the order, the GILEAD filed the present writ petition under Article 226 of the Constitution of India.

Arguments advanced by the petitioner:

It was argued by the Counsel for the applicant that while passing the impugned order, Indian Patent Office (IPO) had taken recourse to the material and objections, which were placed on record by the applicants, who had filed their applications to oppose the grant of patent to the petitioner, under Section 25 of the Act. Further it was submitted that this aspect, was clearly demonstrable from the fact that, not only the grounds taken in opposition and documents cited were considered, while passing the impugned order, but even, the typographical errors contained in the applications, filed under Section 25 of the Act, got incorporated in the said order.

It was further contended that the once notice was issued to the petitioner for a hearing under Section 14 of the Act, to consider, whether to grant a patent as requested, IPO should also have heard the petitioner regarding objections raised in the application, under Section 25 of the Act. The learned counsel contended that, while documents in opposition filed by the entities, which had preferred applications under Section 25 of the Act were supplied, no opportunity, was given, to meet the objections raised by them.

Further it was submitted that the impugned order, had created a peculiar situation whereby, while it had returned a finding that the claims presented by the petitioner represented “novelty and inventive steps”, it sustained, the challenge, under Section 3 (d) of the Act, though the applicants, which had opposed grant of patent, had raised objections, on both counts.

Arguments advanced by the Respondent

On the other hand, the opponent contended that the exercise carried out by IPO under Section 14 and 15 of the Indian Patent Act, is quite different, from that, which IPO carries out while hearing applications filed under Section 25 of the Act. Further it was submitted that, while the material and/or objections filed by opponents, which had preferred applications under Section 25 of the Act, was supplied to the petitioner, IPO did not rely upon the same, while passing the impugned order.

Decision of the Hon’ble Court:

The hon’ble court observed that while petitioner’s request for a hearing under Section 14 of the Act was pending, two pre-grant oppositions were filed. Though, the documents filed by the opponents were supplied to the petitioner, no notice was issued to the petitioner with regard to the applications filed under Section 25 of the Act. Therefore, when hearing under Section 14 was finally granted to the petitioner on 24.07.2014, there was no clarity as to the extent and scope of objections, which it was required to meet while pressing ahead with its request for grant of patent. The petitioner, at best, would have prepared itself to rebut the objections raised in the FER. Further the court observed that combining S. 25 and the S. 14 proceedings, if Gilead would have been given an opportunity to be heard on both counts, it could have save not only time, effort but also have avoided the allegation of bias.

 The court accepted the Gilead’s claim and set aside the impugned order given by IPO and remanded for a fresh decision. The court also ordered IPO to fix a date of hearing both for Sections 14 and 25 proceedings and asked to send written communication to all concerned parties including the petitioner.

 Thus it would be interesting to see the decision by IPO after fresh consideration to the facts and circumstances in view of the fact that Gilead has already entered into license agreements with Generic companies of India for the drug “Sovaldi” as per the reported news in September 2014.

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