Category Archives: IP Litigation

GROUNDLESS THREAT OF PATENT INFRINGEMENT

Introduction

Infringement proceedings involve high costs of litigation in defending the same with the possibility that any temporary injunction granted in the due course thereof would lead to revenue loss, loss of employment and several other impediments to the business. Moreover, embroilment in infringement proceedings or the mere possibility thereof leads to disrepute of the business. Thus, keeping in mind the serious effects and consequences associated with infringement proceedings for which no person should unnecessarily be subjected to baseless threats of infringement, groundless threats of Infringement has been kept as a civil wrong or offence.

Groundless Threat of Infringement

Groundless threat, also connoted to as unjustified/wrongful threat is a threat whereby the owner or any person (depending on the statute) threatens another with legal proceedings without basing the threat on any reasonable basis. IP laws provide protection to the victims of unjustified threats, by preventing the person(s) making the threats from doing the same. Examples of such provisions in IP statutes include Section 60 of the Copyright Act, 1957, Section 142 of the Trademark Act, 1999 and Section 106 of the Indian Patents Act, 1970.

Relief under Patents Act, 1970: –

The Court has the power to grant relief in cases of groundless threat of patent infringement under Section 106 of the Indian Patents Act, 1970. The scope of this provision includes a threat given by any person (who is entitled to or interested in a patent or not)  to any other person by circulars or advertisements or by communication, oral or in writing with proceedings for infringement of a patent. It is important to note that a mere notification of the existence of a patent does not constitute a threat of proceeding within the meaning of this section. The person aggrieved thereby may bring the suit praying for the following reliefs:

  • a declaration to the effect that the threats are unjustifiable;
  • an injunction against the continuance of the threats; and
  • such damages, if any, as he has sustained thereby.

 

LG Electronics India Pvt. Ltd. v. Bharat Bhogilal Patel & Others[1]

 

In this case the plaintiff approached the Hon’ble Delhi High Court on the premise that complaint preferred by Defendant No. 1, Bharat Bhogilal Patel, against the Plaintiff before Defendant No.2, Customs Office, on the basis of which said Customs department is acting upon and interdicting the goods imported by the plaintiff without approaching the Court in accordance with Patents Act, 1970 amounts to groundless threats. The defendant claimed to have obtained a patent in respect of “Process of manufacturing engraved design articles on metals or non-metals”.

Upon receiving show cause notice from defendant no. 2 Customs department, the plaintiff requested for the documents pertaining to the impugned patent and on perusing the same, found that the claims of CS(OS) No.2982/2011 Page No.3 of 10 the impugned patent allegedly lacked novelty as well as any inventive step. Accordingly, plaintiff filed revocation petition before the Intellectual Property Appellate Board (IPAB) challenging validity of the impugned patent. The Customs department continued interdicting the consignments of the plaintiff despite having been informed of the pendency of revocation proceedings. Subsequently, the case came up for hearing and the Court passed interim order in favour of plaintiff, staying the operation of complaint of Defendant No. 2 the Customs office.

Clause 4 of IPR (Imported Goods) Enforcement Rules, 2007: –

“It is pertinent to mention that while the mandatory obligations under Articles 51 to 60 of the TRIPS dealing with border measures are restricted to Copyright and Trade Marks infringement only, the said Rules deal with Patents, Designs and Geographical Indications violations as well, in conformity with the practice prevailing in some other countries, notably EU countries. While it is not difficult for Customs officers to determine Copyright and Trade Marks infringements at the border based on available data/inputs, it may not be so in the case of the other three violations, unless the offences have already been established by a judicial pronouncement in India and the Customs is called upon or required to merely implement such order. In other words, extreme caution needs to be exercised at the time of determination of infringement of these three intellectual property rights”.

Order passed by the Court: –

The Court explained the role of Customs officer in view of clause 4 of IPR rules and under para 95 of the judgement, “I do not agree with the statement made in the written statement by the Defendant No.2 Custom department that unless the stay orders are passed in the Revocation petition, they can proceed with the complaint filed by the owner of patent despite of any merit or demerit in the Revocation proceedings”.

The Court further explained the aspects of groundless threat and stated that “the custom shall act on the notice of the court, therefore if any proprietor or the right holder issues a notice to the custom officials and the custom officials act upon the same by causing restricting the imports of consignments of any party without the determination (prima facie or otherwise) of the factum of infringement of patent by the appropriated designated authority which is civil court under the governing law, then such notice by the right holder to the third party which is customs and the actions thereof by the customs either in the form of notice to that party or otherwise calling upon the party to explain its stand which no such position exists in law are all unnecessary illegal threats to that party”.

Conclusion

From the above discussion, it is clear that complaint to Customs and show cause notice sent by Customs Authority without adjudication of quantum of infringement by Civil Court amounts to groundless threat of patent infringement in light of clause 4 of aforesaid IPR (Imported Goods) Enforcement Rules, 2007.

Authors: Avadhi Joshi and Pratik Das, Legal Interns, Khurana & Khurana, Advocates and IP Attorneys and can be reached at info@khuranaandkhurana.com

References :

[1] 2012 (51) PTC 513 (Del) available at https://indiankanoon.org/doc/48055807/

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Enzo Biochem Inc. v. Applera Corp. – A case pertaining to Doctrine of Equivalents

On August 02, 2017, the United States Court of Appealsfor the Federal Circuit ruled in favor of Applera Corp.and Tropix Inc.in the matter of Enzo Biochem Inc., Enzo Life Sciences Inc., Yale University v. Applera Corp., Tropix Inc. The Court affirmed that the district court accurately interpreted proper construction of claims in U.S. Patent No.5,449,767 (“the’767 patent”) and correctly analyzed Enzo’s doctrine of equivalents argument. In over thirteen years of litigation between the parties, the Court has considered this present infringement action on three separate occasions.

Background

Technology as disclosed in the ‘767 patent pertains to use of nucleotide probes to detect presence of a particular DNA or RNA sequence in a sample or to identify anotherwise unknown DNA sequence. According to the ’767 patent, many procedures employed in biomedical research and recombinant DNA technology rely on use of radioactive labels such as isotopes of hydrogen, phosphorus, carbon, oriodine. The ’767patent also notes serious limitations and drawbacks pertaining to use of radioactive materials that include, elaborate safety precautions, expensive use and purchase, and short shelf-life. As an alternative to use of radioactive labels, the’767 patent elaborates on a series of novel nucleotide derivatives that contain biotin, iminobiotin, lipoic acid,and other determinants attached covalently to pyrimidine or purine ring. Further, the ’767 patent asserts that the use of modified detection approach provides detection capacities equal to or greater than procedures which utilize radio isotopes, and also overcomes other limitations and drawbacks pertaining to use of radioactive labels.

The disputed languageof claim 1 involves following limitation:

“wherein A comprises at least three carbon atoms and represents atleast one component of a signaling moiety capable ofproducing a detectable signal . . . .”

Procedural History

In 2004, Enzo filed a suitag ainst Applera alleging infringement of six patentsincluding the ’767 patent. After multiple years of litigation in 2012, an appeal to the federal court regarding invalidity issues decided on summary judgment, Enzo I, 599 F.3d 1325 (Fed.Cir.2010). The jury found Applera infringed the claims at issue and awarded $48.6million in damages. In appeal, Applera argued that the district court erred in its claim construction because claims of the ’767 patent only cover indirect detection and alternatively, if the claims cover direct detection, they are invalid for lack of written description andlack of enablement. The Federal Court agreed with Applera and reversed the district court’s claim construction, Enzo II, 780 F.3d 1149, 1150 (Fed. Cir. 2015). The Court concluded that the inventors were claiming only indirect detection and thus, held that “the district court erred in construingthe disputed claims of the patent-in-suit to cover bothdirect and indirect detection”. The Court then remanded the case to the district court to determine whether accused product infringes under proper claim construction. The district court agreed with Applera and rejected doctrine of equivalents argument raised by Enzo. Hence, Enzo Appealed.

Opinion of the Court

Firstly, the Court discussed scope of Enzo II and concluded that the district court correctly interpreted Enzo II. According to the Court, the district court rightly referred to specification of the ’767 patent and opined that specification does not support inclusion of direct detection.

Secondly, the Court discussed doctrine of equivalents. According to Enzo, Applera infringes claims under doctrine of equivalents and the district court “misconstrued” its expert declaration and improperly drew inferences in favor of Applera, rather than Enzo. Further, Enzo asserted that scope of equivalents focused on a particular subset of direct detection.

According to the Court, the district court rightly explained that the patent “describes its method of indirect detection as a superior means of detection as compared to direct detection, with ‘detection capacities equal to or greater than products which utilize’ direct detection”. The Court explained that “the specification provides additional support that claim 1 covers only indirect detection”.

The Court relied on Dolly, Inc. v. Spalding & Evenflo Cos., 16 F.3d 394, 400 (Fed. Cir. 1994), according to which “the concept of equivalency cannot embrace a structure that is specifically excluded from the scope of the claims” and noted that the same principle applies in the present case. “Including direct detection as an equivalent of indirect detection would render meaningless the claim language on which decision in Enzo II was based”. Thus, direct detection cannot be an equivalent of indirect detection in relation to these patent claims.

Conclusion

The doctrine of equivalents is generally considered when a product or process does not literally infringe a patented invention but the product or process contains elements identical or equivalent to each claimed element of the patented invention. Further, an analysis of role played by each element in context of function, way, and result of the claimed element and the product or process is required. In the present case, the court excluded direct detection from the scope of claims by referring to specification of the patent application even when the claims expressly did not exclude direct detection. Thus, the present case is an instance of difficulties pertaining to analysis of doctrine of equivalents and indicates proving doctrine of equivalents as unfeasible.

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.

Can non-compliance of mandatory provisions under the patents act, 1970 land you behind the bars?

Technically YES.

The Patents Act, 1970 (hereinafter referred to as the “Act”) is a piece of legislation, penalties under which are largely civil in nature, such as fines, award of monetary damages, injunction, loss of patentee rights including compulsory licensing, abandonment of application or revocation of a patent.

However, violation of certain provisions, such as Section 39 attracts liabilities as set forth in Section 40, and Section 118 of the Act.

In 2002, the foreign filing license (FFL) requirement was introduced in the Act. This requirement required that any inventor / applicant who is a resident of India should file or cause to be filed a patent application for his/her own invention first in India; and only after a period of six weeks after the date of filing of the patent application, a filing could be done in a country outside India. Such a requirement clearly indicates that any Applicant (including inventor) who is a resident of India and desirous to file a patent application firstly outside India is required to U/S 39 to seek a Foreign Filing License (FFL) prior to filing the patent application in any foreign jurisdiction. The principal intent behind FFL is to allow the Indian Patent Office (IPO) to track applications which may be of national importance and/or of sensitive nature, such as atomic energy, defense or national security. It is to be noted that there is no provision under the Act to seek a FFL retrospectively, which makes adherence to the provisions of Section 39 and related Sections that much more critical and important.

Under Section 39: “Residents not to apply for patents outside India without prior permission.—(1) No person resident in India shall, except under the authority of a written permit sought in the manner prescribed and granted by or on behalf of the Controller, make or cause to be made any application outside India for the grant of a patent for an invention unless—

(a) an application for a patent for the same invention has been made in India, not less than six weeks before the application outside India; and

(b) either no direction has been given under sub-section (1) of section 35 in relation to the application in India, or all such directions have been revoked.

(2) The Controller shall dispose of every such application within such period as may be prescribed: Provided that if the invention is relevant for defence purpose or atomic energy, the Controller shall not grant permit without the prior consent of the Central Government.

(3) This section shall not apply in relation to an invention for which an application for protection has first been filed in a country outside India by a person resident outside India”.

It is also important to note that, the scope of Section 39 with respect to “Residents” is not limited to citizens of India or people (citizens of India or elsewhere) living in India. The term “resident” in law is construed to be broader than the term “citizen.” The term “resident” is not defined anywhere in the Patents Act of 1970. The lack of a definition for the term “resident” in the Act necessitates that this interpretation be made from the definition of “resident” as given in the Income Tax Act, 1961. According to the Indian Income Tax Act, an individual is termed as a ‘Resident of India’ if he stays for the prescribed period during a fiscal year i.e. 1st April to 31st March, either for: 182 days or more; or Has been in India in the aggregate for 365 days or more in the previous 4 years. Thus, the scope of who is a resident, while not defined in the Act, can be found in Section 6 of the Income Tax Act, 19611.

Violation of directions under Section 39 attracts civil liabilities under Section 402 of the Act.  Briefly, under the said Section, contravention of Section 39 would result in the application deemed to have been abandoned, and if granted, shall be liable to be revoked under Section 64, sub-clause (n). The language of the provision clearly suggests that non-compliance of Section 39 would severely prejudice the interests of a patent applicant or patentee. A plain reading of the statute suggests that there is no option provided to the applicant to remedy the deficiency, and there are no judicial precedents established by the higher judiciary which may allow any such relief to the Applicant.

More importantly, violations of directions under Section 39 also attract criminal liabilities under Section 1183 of the Act, in which the term of imprisonment may extend to 2 years or a monetary fine imposed on the inventor, in addition to abandonment of the patent application or revocation of the patent even if it is already granted.

It is to be noted that judicial proceedings under Section 118 are to be initiated by the Controller. However, since the Controller has no powers to pass any order of imprisonment, the matter is to be sent to the Courts for formal proceedings.

The language of the said Section, particularly in reference to the word “shall” suggests that judicial proceedings are to be mandatorily initiated and that the Controller has no discretion in the matter. It is up to the Judge’s discretion to pass an order of fine, imprisonment or both. While there is no prior case of prosecution under Section 118, it is important for an Applicant to assume strict compliance in order to avoid unnecessary judicial proceedings.

Therefore, it is in the interests of the Applicant to not only be aware of the provisions of Section 39, 40, and 118, but also take timely action to be in compliance. The said Sections assume more relevance in the present context as many foreign companies have R&D centers in India, research findings of which are filed as patent applications first outside India.  Another common scenario is Indian citizens carrying out research abroad which can lead to generation of patents, or conversely, foreign citizens in India carrying out research. In any of the instances, it is likely that the foreign patent attorney may not be aware of the particular provisions as discussed herein and may inadvertently not only prejudice patentee rights, but also expose the applicant to court proceedings.

Thus, it is always recommended that, in the case of doubt over the residency status of an inventor, it is always safer to first file a patent application in India or to obtain written permission from the Controller of Patents for the grant of foreign filing license and thereby, safeguard the inventor from criminal consequences of Section 118 of The Indian Patents Act of 1970.

ABOUT THE AUTHOR:

Dr. Amitavo Mitra is a Patent Agent and Sr. Patent Associate at Khurana and Khurana, Advocates and IP Attorneys. Views expressed in this article are solely of the author and do not reflect the views of either of any of the employees or employers.

Queries regarding this may be directed to amitavo@khuranaandkhurana.com or swapnils@khuranaandkhurana.com

1Section 6 of Income Tax Act, 1961: (1) An individual is said to be resident in India in any previous year, if he- (a) is in India in that year for a period or periods amounting in all to one hundred and eighty- two days or more; or (b) having within the four years preceding that year been in India for a period or periods amounting in all to three hundred and sixty- five days or more, is in India for a period or periods amounting in all to sixty days or more in that year.

Explanation.- In the case of an individual,- (a) being a citizen of India, who leaves India in any previous year 4 as a member of the crew of an Indian ship as defined in clause (18) of section 3 of the Merchant Shipping Act, 1958 (44 of 1958 ), or] for the purposes of employment outside India, the provisions of subclause (c) shall apply in relation to that year as if for the words” sixty days”, occurring therein, the words” one hundred and eighty two days” had been substituted; (b) being a citizen of India, or a person of Indian origin within the meaning of Explanation to clause (e) of section 115C, who, being outside India, comes on a visit to India in any previous year, the provisions of sub- clause (c) shall apply in relation to that year as if for the words” sixty days”, occurring therein, the words 5 one hundred and eighty- two days”] had been substituted.]

(2) A Hindu undivided family, firm or other association of persons is said to be resident in India in any previous year in every case except where during that year the control and management of its affairs is situated wholly outside India.

(3) A company is said to be resident in India in any previous year, if- (i) it is an Indian company; or (ii) during that year, the control and management of its affairs is situated wholly in India.

(4) Every other person is said to be resident in India in any previous year in every case, except where during that year the control and management of his affairs is situated wholly outside India.

(5) If a person is resident in India in a previous year relevant to an assessment year in respect of any source of income, he shall be deemed to be resident in India in the previous year relevant to the assessment year in respect of each of his other sources of income.

(6) A person is said to be” not ordinarily resident” in India in any previous year if such person is- (a) an individual who has not been resident in India in nine out of the ten previous years preceding that year, or has not during the seven previous years preceding that year been in India for a period of, or periods amounting in all to, seven hundred and thirty days or more; or (b) Hindu undivided family whose manager has not been resident in India in nine out of the ten previous years preceding that year, or has not during the seven previous years preceding that year been in India for a period of, or periods amounting in all to, seven hundred and thirty days or more.

2 Section 40 of Patents Act, 1970: “Liability for contravention of section 35 or section 39.—Without prejudice to the provisions contained in Chapter XX, if in respect of an application for a patent any person contravenes any direction as to secrecy given by the Controller under section 35 or makes or causes to be made an application for grant of a patent outside India in contravention of section 39 the application for patent under this Act shall be deemed to have been abandoned and the patent granted, if any, shall be liable to be revoked under section 64”.

3 Section 118 of the Patents Act, 1970: “Contravention of secrecy provisions relating to certain inventions.—If any person fails to comply with any direction given under section 35 or makes or causes to be made an application for the grant of a patent in contravention of section 39 he shall be punishable with imprisonment for a term which may extend to two years, or with fine, or with both”.

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

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:

Interplay of section 51 and 52 of the Copyright Act, 1962: Delhi High Court judgement

This article enunciates the recent, much awaited, and landmark judgment delivered on September 16, 2016 by Hon’ble Delhi High Court throwing light on the important provisions of the Copyright Act, 1962. This case tries to draw the line between the rights of the author, publishers of the work and competing rights of society.

The case was between THE CHANCELLOR, MASTERS & SCHOLARS OF THE UNIVERSITY OF OXFORD & ORS. Vs. RAMESHWARI PHOTOCOPY SERVICES & ANR. In this case, five plaintiffs THE OXFORD UNIVERSITY PRESS, CAMBRIDGE UNIVERSITY PRESS U.K., CAMBRIDGE UNIVERSITY PRESS INDIA PVT LTD., TAYLOR & FRANCIS GROUP U.K., and TAYLOR & FRANCIS BOOKS INDIA PVT. LTD. filed a suit against RAMESHWARI PHOTOCOPY SERVICE and UNIVERSITY OF DELHI for the relief of permanent injunction from infringing the copyright of the plaintiffs in their publications by photocopying, reproduction and distribution of copies of plaintiffs‘ publications on a large scale and circulating the same and by sale of unauthorised compilations of substantial extracts from the plaintiffs‘ publications by compiling them into course packs / anthologies for sale. Amongst other arguments, defendant replied with claiming that their activities fall under section 52 of the Copyright Act, 1962 and hence do not constitute infringement.

The article does not intend to discuss all the arguments on the behalf of the plaintiff, defendant and views of the judges on the same. Instead, this article intends to discuss effect of the judgment on the interplay between section 51 which declares certain acts as infringement of copyright and section 52 of the act which allows certain acts to be done without falling within the purview of infringement. Article also intends to discuss the scope of educational use allowed under copyright act in light of this landmark judgement.

In September, 2012, University of Delhi (DU) was ordered by the court to examine the proposal to obtain a license from Reprographic Rights Organisation such as IRRO for preparing course packs was passed. By the same order, court also ordered defendant No.1 to maintain proper accounts of sales and to file a fortnightly statement before the court. In reply, DU submitted that question of obtaining licenses arises only if their activity causes infringement of the plaintiffs’ right. Court accepted the contention of the DU and decided on whether activities of defendant fall under infringement.

Vide order dated 17th October, 2012, the defendant No.1 was restrained from making, selling course packs / re-producing the plaintiffs‘ publications or substantial portions thereof by compiling the same either in a book form or in a course pack, till the final disposal of the application for interim relief.

Later, in order to decide whether activities of defendant fall under section 51 or not and if so did they fall under section 52 or not, court observed as below:

Did the activities of defendant fall under section 51?

The court concluded that activities of defendant fall under section 51 and observed as below:

The defendant No.2 University thus, though entitled to issue the books, published by the plaintiffs and purchased by it and kept by the defendant No.2 University in its library, to whosoever is entitled to issuance of the said books from the library, per Section 14(a)(i) and Section 51(a)(i) would not be entitled to make photocopies of substantial part of the said book for distribution to the students and if does the same, would be committing infringement of the copyright therein.”.

Did the fall under section 52?

Court had to decide whether reproduction of material fall under section 52 (i) and while doing that court had to decide whether activities allowed so as not to constitute infringement also cover institution and more than one pupil and whether interpretation of term ‘instruction’ should be restricted to lecture or not. Court held that institution providing instructions to more than one pupil fall under activities allowed under section 52. Moreover court also held that instruction cannot be limited to the term lecture in classroom.

Can section 52 be interpreted as independent of the section 51 or it is proviso or exception to section 51?

Once the acts listed in Section 52 are declared as not constituting infringement of copyright and the reproduction of work resulting from such acts as not constituting infringing copy, it follows that the exclusive right to do the acts mentioned in Section 52 has not been included by the legislature in the definition in Section 14; of copyright, once that is so, the doing of such act cannot be infringement under Section 51 and the question of taking the same out by way of proviso or exception does not arise.

Are defendants liable for infringement?

Section 51 prescribes that copyright is infringed inter alia when any person does anything exclusive right to do which has been conferred by the Act on the owner of copyright. It follows, if there is no exclusive right, there is no infringement. Section 52 lists the acts which do not constitute infringement. Thus, even if exclusive right to do something constitutes copyright, if it finds mention in Section 52, doing thereof will still not constitute infringement and the outcome thereof will not be infringing copy within the meaning of Section 2(m).

Ultimately, court held defendants not liable of infringement.

Court observed that if students were not having access to course packs provided by the defendants, it would not have resulted students buying books, rather it would have resulted in students sitting in libraries taking notes by hand. That would have been injustice in the age of modern technologies. Court also held that declaring acts of defendants as infringement would result in such interpretation of law that results in regression of the evolvement of the human being for the better.

However this judgement did not deal with the cover-to-cover copying of the books as that was not a fact in issue. We will have to wait till we get verdict dealing with such issue.

Further, as consequences of this judgement, with free licensing of photocopying the books, publishers are more likely to invest less in Indian markets. However, some IP experts are also of the view that there would not be any such effect. Let time reflect the real effects.           

About the Author: Ms. Divya Choubey and can be reached at: swapnil@khuranaandkhurana.com

Federal Circuit Rules 180-Day Post-Licensure Notice is Mandatory in Biosimilar Litigation

In Amgen v. Apotex (No. 2016-1308), the US Court of Appeals for the Federal Circuit on July 5, 2016 affirmed a district court’s ruling that a biosimilar applicant must provide a reference product sponsor with 180 days’ post-licensure notice before commercial marketing of a biosimilar product begins, regardless of whether the applicant provided the § 262(l)(2)(A) notice of USFDA review.

            In Amgen v. Apotex, the Federal Circuit rejected Apotex’s contention that the 180-day pre-marketing notice requirement does not apply to biosimilar applicants who participated in the “patent dance” procedure of the Biologics Price Competition and Innovation Act (“BPCIA”), expanding on its decision in Amgen v. Sandoz that the 180 days notice provision under § 262(l)(8)(A) is mandatory in all circumstances, whether or not the applicant engages in the patent dance.

Background:

            The biologic product at issue is Amgen’s Neulasta® (pegfilgrastim). Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF) analog filgrastim. Pegfilgrastim treatment that can help patients make white blood cells after receiving cancer treatment. After Apotex filed a Biologic License Application (BLA) seeking FDA approval to market a biosimilar version of Neulasta® (pegfilgrastim), the parties began the BPCIA’s patent information exchange process, known as the “patent dance”, and as a result, Amgen concluded that two patents U.S. Patent Nos. 8,952,138 and 5,824,784 will be infringed by Apotex’s biosimilar version of Neulasta®. Those infringement claims are being litigated in the U.S. District Court for the Southern District of Florida, although the ‘784 patent has been dropped since it expired.

            Apotex sent Amgen a letter on April 17, 2015, stating that it was “providing notice of future commercial marketing pursuant to § 262(l)(8)(A), though Apotex lacked an FDA license.” Amgen sought a preliminary injunction to “require Apotex to provide … notice if and when it receives a marketing license from FDA and to delay any commercial marketing for 180 days from that notice.” The district court granted that motion, citing the Federal Circuit’s decision in Amgen v. Sandoz that notice cannot be given before the biosimilar product is approved. Apotex appealed.

What is Biosimilar Patent Dance:

            The US Biosimilars Act sets forth several requirements for biosimilar applications, including the so-called “Patent Dance” which describes the process by which the biosimilar applicant and the reference product sponsor (“RPS”) exchange patent-related information for resolving any patent disputes before a biosimilar product can enter the US market.  This procedure has strict timing and sequencing requirements and involves several rounds of information exchanges between the reference product sponsor and the biosimilar applicant. Some of the key steps of this process include:

  • Within 20 days after the FDA has accepted its abbreviated application, the biosimilar applicant must provide the reference product sponsor with confidential access to the biosimilar application and relevant manufacturing information for the proposed biologic.
  • Within 60 days of receiving these materials, the reference product sponsor must provide to the biosimilar applicant: (1) a list of patents it believes are infringed, and (2) identify which, if any, of these patents it would be willing to license to the biosimilar applicant.
  • Within 60 days of receipt of the patent list, the biosimilar applicant must provide the reference product sponsor a statement describing, on a claim-by-claim basis, the factual and legal basis as to why each patent is invalid, unenforceable, and/or not infringed. Within this same 60 day period, the biosimilar applicant may provide to the reference product sponsor a counter list of patents that the biosimilar applicant believes could be subject to a claim of patent infringement.
  • Within 60 days of receiving these materials, the reference product sponsor must provide a reciprocal statement describing, on a claim-by-claim basis, the factual and legal basis that each patent will be infringed, as well as a response to any statement regarding validity and enforceability.
  • The parties then have up to 15 days to negotiate in good faith to arrive at a list of patents, if any, that should be subject to a patent infringement action.

– If the parties reach agreement, then the reference product sponsor must bring an infringement action within 30 days for each patent on the negotiated list.

– If the parties do not reach agreement, the biosimilar applicant must notify the reference product sponsor of the number of patents it will provide in a second list, and the parties then simultaneously exchange within 5 days of this notice a list of patents that each party believes should be the subject of the infringement litigation. Within 30 days after this exchange, the reference product sponsor must bring an infringement action on all the patents on the simultaneously exchanged lists.

The Federal Circuit’s decision in the Amgen v. Apotex case:

            Two provisions of the BPCIA were at play in the Federal Circuit’s decision.  First, under § 262(l)(2)(A), the biosimilar applicant initiates the statutory “patent dance” by providing a copy of its biosimilar application and information about how its product is manufactured.  Second, under § 262(l)(8)(A), the applicant must provide a notice to the innovator 180 days before the first commercial marketing of the biosimilar product.

            In Amgen v. Apotex, Apotex argued that it had followed the patent dance procedure and made its (2)(A) disclosures to Amgen, and that the (8)(A) notice of commercial marketing is only mandatory if the applicant failed to provide the information required by (2)(A).

            The Federal Circuit rejected this argument and upheld the district court’s grant of an injunction to Amgen.  The court held that (8)(A) is mandatory in all circumstances, whether or not the applicant engages in the patent dance.

            The Federal Circuit looked to the text of the law, finding that the “language of (8)(A) is categorical”, and there is “no other statutory language that effectively compels a treatment of (8)(A) as non-mandatory.”  The court further noted that § 262(l)(8)(A) “contains no words that make the applicability of its notice rule turn on whether the applicant took the earlier step of giving the § 262(l)](2)(A) notice that begins the patent dance (i.e. information-exchange) process,” and stood by its holding in Amgen v. Sandoz that the statute is “‘a standalone notice provision’ not dependent on the information-exchange processes that begin with (2)(A).” The court held that “the (8)(A) notice must be a notice given after FDA licensure of the biosimilar product, not before, and that pre-licensure notices are of no legal effect for purposes of (8)(A)”. The court explained that the 180 days period gives the reference product sponsor a period of time to assess and act upon its patent rights.

            In sum, the Federal Circuit concluded that a biosimilar applicant must provide a reference product sponsor with 180 days’ post-licensure notice before commercial marketing begins, regardless of whether the applicant provided the (2)(A) notice of FDA review.

The Federal Circuit’s order can be found at the following link:

http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/16-1308.Opinion.6-30-2016.1.PDF

About the Author: Antony David, Senior Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: antony@khuranaandkhurana.com.

Division Bench of Delhi High Court passed an interim order in Glenmark v. Symed (July 2015)

The High Court of Delhi has passed an interim order wherein the  Justices have made it clear that the appellant (Glenmark) may use any other process which may be a development of Glenmark process / Upjohn process so long as it does not infringe the patented processes of the respondent (Symed).

Background:

Symed Laboratories Ltd. is an Indian bulk drug manufacturer based in Hyderabad. Among other drug products, it manufactures Linezolid, an antibacterial used to treat skin and blood infection including pneumonia. Symed owns two process patents (IN213062 and IN213063) for the manufacture of intermediates for linezolid. The product patent for the drug is owned by Pfizer. Symed has sued a number of Indian manufacturers of Linezolid for patent infringement including Glenmark, Optimus Pharma, Alkem Laboratories Limited (Symed has now entered into a settlement with Alkem), Mankind Pharma Limited and Sharon Bio-Medicine Ltd.

The Delhi High Court had granted an ad interim injunction on 19 January 2015 restraining the Defendants, through their officers, directors, agents and distributors 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 Symed’s registered Patents IN213062 and IN213063 till the disposal of the suit.

The grant of interim injunction had been predicated on four criteria:

  • That there is a prima facie case in favour of the plaintiff;
  • That the plaintiff is likely to suffer an irreparable injury if the defendant is not restrained;
  • That the balance of convenience lies in favour of the plaintiff; and
  • That public interest would not be dis-serviced by the grant of the injunction.

However, the injunction against Glenmark was vacated by the Delhi High Court consisting of Justice Badar Durrez Ahmed and Justice Sanjeev Sachdeva within 2 weeks of the Single Judge’s decision. The other defendants in this case have not been as lucky and continue to suffer the injunction.

While setting aside the January 19 order, the court noted: “It was incumbent upon the single judge to prima facie come to a finding that the active pharmaceutical ingredient (API) of both Glenmark and Symed were identical.”

“This (prima facie finding) does not appear to have been done. In these circumstances, we are vacating the interim order and modifying the same by directing appellant (Glenmark) to maintain accounts and file same in court..,” the Bench said and listed the matter for further hearing on 16 March 2015.

It was also noted by the Court that the single judge did not go into the point regarding applicability of section 104A of the Patents Act 1970 as per which in suits alleging infringement of process patents, the defendant (Glenmark) has to prove that its process is different from that of the plaintiff.

Symed Labs Ltd. vs Glenmark Pharmaceuticals Ltd. on 17 July 2015

In the very recent decision, the Delhi High Court has ordered that Glenmark shall use its process which is virtually identical to the Ujohn process as indicated in the expert report of Prof. Steven W. Baldwin (filed by Glenmark). The Court noted that the expert report indicates that the appellant (Glenmark) process and the Uphohn process are different from the process of preparation of Linezolid, which is employed by the respondent (Symed).

It has been agreed by both the parties that the appellant (Glenmark) shall manufacture Lineolid through its process indicated in the expert report which does not infringe upon the patented process of Symed as indicated in the report. The learned counsel for the respondent (Symed) has accepted the report to the extent that the process shown as the Glenmark process which is virtually identical to the Upjohn process does not infringe the patented process of Symed for production of Linezolid. The learned counsel for the appellant has also stated that they have not and shall not use the patented process of Symed numbered as IN213062 and IN213063.

Paragraph 24 of the report of Prof. Stephen W. Baldwin reads as under:

24. The two claimed intermediate compounds discussed above (PHPFMA and CHFA) do not appear in the Glenmark process for making Linezolid. Moreover, the reaction conditions involved in the various Glenmark process steps would not produce either of these claimed comounds, even as trace inpurities

[CHFA (N-[3-Chloro-2-(R)-hydroxprophy1]-3-fluoro-4-morpholinyl-anlaniline) : PHPFMA (N-3 [Phthalimido-2-(R)-hydroxprophyl]-3-fluoro-4 (morpholinyl) aniline]

While both the parties have accepted the above extracted paragraph No.24 of the report, the Justices have made it clear that the appellant (Glenmark) may use any other process which may be a development of Glenmark process / Upjohn process so long as it does not infringe the said patented processes of the respondent.

Dr. Singhvi, the learned senior Advocate stated on behalf of appellant (Glenmark) that the appellant has already been and will continue to take declarations from sellers of Linezolid to the effect that the seller does not violate anybody’s registered patent and will also in future specify in the declaration b the seller that he does not violate Symed’s aforesaid two patented processed, adding that in the event the respondent initiates legal proceedings against a seller for infringement of the aforesaid two patents, the appellant, on a request being made, would supply the aforementioned declaration.

About the Author: Antony David, Senior Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: antony@khuranaandkhurana.com

Parallel Imports

A company sets different price for its products for different countries as per the requirements. Parallel Imports come about when there is a Currency and Tax Difference between two countries as stated above, encouraging people to import products from one country and sell it off in the other country to earn profit (For example: a person importing iphones from USA at lower price and selling those iphones in India after breaking the codes or selling magazine editions of one country into other at higher price). Now when we deal with Parallel Imports, the concept of ‘Principle of Exhaustion’ comes into consideration. It says that once the protected goods are sold to a consumer or buyer, the IP Rights associated with the same gets exhausted.  It is also known as ‘Exhaustion Doctrine’ or ‘First Sale Doctrine’.

What now needs to be clearly understood is that the Trademarks have a particular Goodwill coupled to it and Parallel Imports may injure them if the products are not of satisfying quality standards in the Imported Country. The main benefit of parallel import is that it encourages competition, and Trademarked or Genuine goods are available to consumers at different prices.

Parallel Imports basically constitute import of Non-Counterfeit or Genuine Goods from one country to another without the permission of the IP owner. The products are indeed legal, but are unauthorised because they are imported without the permission of the Proprietor. The products thus imported are often termed as Grey Products (and not black, owing to the fact that they are Genuine). The Parallel Imports cases are closely related to Trademarks and Copyrights and also equally to the International Trade Market, practically observed when people import goods (for example books or mobile phones) which have Trademarks and Copyrights attached with them.

Parallel Imports Related to Copyright

Earlier the definition of ‘infringing’ copy under Sec 2(m) of Indian Copyright Act was not broad, but since the Amendment, the meaning has been broadened which now clearly states “Provided that a copy of a work published in any country outside India with the permission of the author of the work and imported from that country shall not be deemed to be an infringing copy”[1].

Parallel Import Related to Trademark

Sec 30(4) of the Indian Trademarks Act very evidently states that “Sub-Section (3) shall not apply where there exist legitimate reasons for the proprietor to oppose further dealings in the goods in particular, where the condition of the goods, has been changed or impaired after they have been put on the market.” This section allows the Trademark owner to control the circulation of goods.”[2]

The two major issues that are often discussed regarding the Parallel Imports and Trademarks in India are Whether Parallel Imports make up Infringement under Section 29 of the Trademarks Act and Whether India recognises the principle of ‘International Exhaustion of Rights’ under Section 30 of the Trademarks Act.[3]

Samsung Electronics Company Limited & Anr. .(Plaintiffs) Vs. Kapil Wadhwa & Ors (Defendants).

Plaintiff no. 1 is a company incorporated under the laws of Korea and plaintiff no. 2 is a company under the Indian companies’ act, plaintiffs also informed about their business in India which has been initiated since 1995 when the plaintiff No. 2 was formed. It has a registered trademark “SAMSUNG” under which it carries business worldwide. In March 2011, plaintiffs received information from market sources that defendants were distributing, retailing and selling grey market printers of the plaintiffs in the market and not the ones supplied by the plaintiff No. 2.

Plaintiffs preferred an IA No.7774/2011 under Order XXXIX Rule 1 and 2 CPC which came up for hearing on 11.05.2011 and then on 03.06.2011. The  court ordered “The Defendants, their partners, and all others acting for and on their behalf are restrained from importing, exporting distributing, selling, offering for sale, advertising, directly or indirectly dealing in grey market ink cartridges/toners, or any other products of the plaintiffs under the mark SAMSUNG amounting to infringement of  plaintiffs registered trademarks.”

Defendants filed written statement and an application which is IA No.10124/2011 under Order XXXIX Rule 4 read with Section 151 CPC seeking vacation of interim order passed on June 3, 2011.

Hearing the parties on 8.7.2011, the court was pleased to pass an order partially modifying the order dated 3.6.2011 passed in the local commissioner application and the goods were released to the defendants with few directions. Arguments raised by the defendant was that “It is a settled law that the import, sale or resale of genuine printers by the defendants does not amount to infringement, dilution and passing off. The plaintiffs cannot impose restriction on sale or resale of genuine products originating from the plaintiffs. The present acts of the defendants are permissible under Section 30 of the Act of 1999.”

The defendants went into appeal and appeal was partially allowed. Impugned judgment and order dated February 17, 2012 is set aside insofar the appellants have been restrained from importing printers, ink cartridges/toners bearing the trade mark Samsung/SAMSUNG and selling the same in India. The counsels for Plaintiffs (Respondents) submitted before the Court, that an ordinary customer, who is provided with the warranties and after sales service by the Defendant (Appellant) may form a bad impression of product of Plaintiffs (Respondents), which can lead to damage of reputation of Plaintiffs (Respondents). The Division Bench while setting aside the order of the Learned Single Judge directed the Appellants/Defendants to prominently display in their showrooms that the products sold by them have been imported from abroad and that the Respondents (Plaintiffs) do not give any warranty qua the goods nor provide any after service and that the warranty and after sales service is provided by the appellants personally. 

Hindustan Lever Ltd. vs. Briju Chhabra

In the above mentioned case, the Plaintiff (Hindustan Lever Ltd) is the Registered Proprietor of the Trademark ‘LUX’. The Defendant used to import LUX soaps manufactured in Indonesia into India without the permission of Hindustan Lever Ltd when the imported LUX soap was for sale only in Indonesia (as indicated on the soap). It was argued by Hindustan Lever Ltd that such import of soap into India amounts to Infringement of its rights and that there shall be no guarantee that the product will be genuine. The High Court of Delhi agreed with the submissions of the plaintiff and ruled in their favor, since it was of the view that if the Imports had not stopped, then the plaintiff could suffer a huge loss due to defendant’s act of misrepresentation.

International Laws on Parallel Imports

Since the ‘Paris Convention’ and the ‘Berne Convention’ are silent on the issue and are not explicitly prohibiting the same, every country has resorted to having their own method of managing Parallel Imports. According to the TRIPS Agreement (Article 6), “for the purposes of dispute settlement under this Agreement, subject to the provisions of Articles 3 and 4, nothing in this Agreement shall be used to address the issue of the exhaustion of intellectual property rights.”[4]

Countries on parallel imports

Australia: it permits the parallel import of certain products except books, cars, however software CD’s and music CD’s can be imported.

USA: Parallel import is legal in USA. It was made legal by establishing a legal precedent. “In the case of Kirtsaeng v. John Wiley & Sons, Inc., the US Supreme Court held that the first-sale doctrine applies to copies of a copyrighted work lawfully made abroad, thus permitting importation and resale of many product categories.”[5]

Hong Kong: Parallel importation is legal or permitted in Hong Kong under the trademark and copyright before the amendment came in July 6 of 2007.

Japan: “Japan‘s intellectual property rights law prohibits audiovisual articles marketed for export from being sold domestically, and such sale of “re-imported” CDs are illegal.”[6] 

Conclusion

From what can be understood, the main detriment of Parallel Import is that it promotes Free Trade and encourages competition, other than facilitating Trademarked or Genuine goods to be available at different prices, allowing the consumers to have an option to buy genuine goods at a cheaper price. What can also be understood is that if Parallel Imports are done away with, the manufacturers will have their own business monopolies, leading to goods being available at higher prices. Also consumers must note that Parallel Imports may assure lower priced products but they may not get the quality, service or satisfaction which they had in mind while buying the particular product, also another known fact being that Parallel Imports leads to a huge loss of revenue to the Trademark Holder due to the import of ‘grey goods’.

The Government definitely here must intervene in this matter so as to maintain a balance between the interests of the Consumers and Trademark Holders, so that no one is at a higher risk. Whereas obtaining an Interim Injunction with an Anton Piller order is still the most effective option when it comes to ways of tackling Parallel Imports.

Ultimately the bottom line is that the decision on whether to allow Parallel Imports is a choice between quality control and price control; between the economic rights of trademark owners and consumer access; between trade monopolies and free trade.[7]

References

  1. Jain Sneha, “Parallel Imports and Trademark Law”, JIPR, Vol. 14, Jan 2009.
  2. http://cis-india.org/a2k/blogs/parallel-importation-of-books
  3. http://www.mondaq.com/india/x/208942/Trademark/Customs+Circular+Parallel+Imports+Are+Legitimate
  4. http://www.worldtrademarkreview.com/Intelligence/IP-Lifecycle-India/2015/Articles/Parallel-import-issues-under-Indian-trademark-law
  5. http://copyright.lawmatters.in/2011/02/what-is-international-exhaustion.html
  6. http://www.trademarksandbrandsonline.com/article/the-legality-of-parallel-imports
  7. https://indiancaselaws.wordpress.com/2013/08/21/kapil-wadhwa-v-samsung-electronics/

http://www.indiankanoon.com

[1] Section 2(m) of Indian Copyright Act (amended Section)

[2] Section 30(4) of the Indian Trademarks Act, 1999.

[3] Article on Parallel import issues under Indian trademark law by; Ashutosh Kane & Sakshi Pande

[4] Article 6 of TRIPS Agreements

[5] http://www.wikipedia.com

[6] Ibid

[7] http://www.lexology.com/library/detail.aspx?g=50598d06-63bb-455a-baea-aea8cb1d8920

About the Author: Mr. Kapil Prajapati, interns at Khurana and Khurana, Advocates and IP Attorneys.