Monthly Archives: August 2015

“Well, You have not made out prima facie case for Compulsory License”: Notifies Rajiv Agarwal, Controller General of Patents, Designs and Trademarks, to Lee Pharma!

In a major update for the patent circle (and of course Pharma industry), reportedly, Lee Pharma, a Hyderabad based Indian pharma company, which had filed a Compulsory Licensing (CL) Application on June 29, 2015 in India, against one of the patented drug Saxagliptin of AstraZeneca (used for treating Diabetes Mellitus), has failed to make out prima facie case for the same.  Cognizance of the same has already been taken by Economic times and SpicyIP.  This is the second blog written on the CL filed by Lee Pharma by IIPRD, earlier blog which discusses patent details, grounds of application can be accessed directly by clicking here.

This development has to be recognised as a major one because application by Lee Pharma is the third instance of applying for Compulsory Licensing in India and of earlier two, one was accepted and other was rejected. Of course, this development is also important when Pharma and Patent world wants to see how India is responding to US pressure on amending the patent laws.

It is noteworthy that Controller has not refused CL application for Lee Pharma, rather he has only notified Lee Pharma that it has not made out the prima facie case for the order under section 84. Controller was required to do so by Rule 97 (1). Further according to the rule 97 (1), Lee pharma has one month from the date of notification to request for the hearing, if it wants to proceed with the application and if request for hearing is not made, controller shall refuse the application. According to Rule 97 (2), if request for hearing is made within 1 month from the relevant notification, the Controller shall, after giving the applicant an opportunity of being heard, determine whether the application may be proceeded with or whether it shall be refused.

Though, Economic times claims to have seen the copy of notification given to Lee Pharma by the controller, and also claims that controller has found Lee Pharma’s proposed selling price several times the import cost and only marginally below that of AstraZeneca and controller has also stated that manufacture in India is not a necessary precondition to establish working in India according to the relevant section. It is expected that Lee Pharma will likely exercise the provision for hearing available to it.

So here we are, all eyes on you now, Lee Pharma, the clock is already ticking.

Once the final decision regarding CL application is issued and made public, we will be back here for detailed discussion on the same, as this is something we just can’t afford to miss, right?

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

Advertisements

Yippee..here comes the ‘Trade Marks Agent Exam’

Yes, you all read it right. Long waiting has come to an ending. Here is the link for the notification dated August 20th, which was published at the Indian Patent Office (IPO).

Long (in fact too long) wait for the Trade Mark Agent Exam since 2010 (when it was held last) has come to an end with the announcement for the Trade Mark Agent Exam-2015 from the IPO. The notification gives details regarding who can apply, how to apply, form to be used for applying purpose, and nature of exam. Last date for applying is September 07th, 2015. List of eligible candidates and dates for the written examination and Interview will be posted on official website of the IPO i.e. www.ipindia.nic.in on or before September 11th, 2015. For any further clarification regarding this reader can call on 022-24132735/24132393 or send email at cgoffice_mh@nic.in of the IPO.

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

Denial of Injunction on the grounds of Acquiescence and Delay by Plaintiffs: SRF Foundation v. Ram Education Society

Devina Choubal, an intern at Khurana & Khurana looks into grounds of denial of injunction by analyzing the recent case of SRF Foundation v. Ram Education Society.

FACTS:

‘SRF Foundation’ plaintiff no.1 is a registered non-profit society engaged in several social and community work including running schools such as “The Shri Ram School”. The name/mark “Shri Ram” is used by the Plaintiff No.1 since 1988 having a good reputation. While plaintiffs No.2 is engaged in setting up schools in India and abroad. With this goodwill, the plaintiffs fulfilled its objective to meet the shortage of good schools by entering into an agreement with “Educomp Infrastructure and School Management” to set up five schools under the name of “The “Shriram Millennium School”. “Ram Education Society” defendant opened “Shri Ram Global Pre School” next to the plaintiff no. 1’s school in Gurgaon. The plaintiffs filed for the registration of trademark, thereafter subsequently withdrawn and the defendant instead registered their mark. The plaintiffs being the real brother of the defendant’s trustee wrote emails to his brother to alert the defendant of the reputation and goodwill of the name/mark and to stop using it. However, the defendant continued to use the name/mark “Shri Ram. The plaintiffs advertised stating that the name/mark of the school does not belong to them. Thereupon, the defendant’s lawyer sent a legal notice to the plaintiffs to withdraw the advertisement and to render public apology. The plaintiffs filed a suit for permanent injunction, passing off and account of profits in the Delhi High Court and also filed an application seeking interim injunction. The Hon’ble High Court passed an order with respect to interim injunction which is discussed in detail as below. The complete order can be accessed here

ARGUMENTS BY THE PLAINTIFFS:

  • It was contended by the plaintiffs that the inherent right to use the name “Shri Ram” rests with each member of the Shri Ram family but such a right is subject to restricting oneself to its domain of business and not encroaching upon others rights. They have no objection if the said mark is used by the defendant in other activities or services but not this activity, as they have being using the name/ mark “Shri Ram” for almost 25 years, the reason being they have goodwill in these services, leading to monopoly over the name/mark. Though the plaintiff and the defendant belong to the same family, still the use by the defendant hampers the plaintiff’s reputation. Because of passing off the services of the plaintiffs by the defendant, the public are confused about which school belongs to whom. Thus, there is no bonafide use of the name/mark. The use of “Shri Ram” in the name/ mark causes confusion and is deceptively similar.
  • The plaintiffs further contented that there is a prior use of the name/mark by them, as the name/mark has been used by them extensively for many years before the defendant.

ARGUMENTS BY THE DEFENDANT:

  • There exist parallel rights to use the name/ mark, thus, the defendant is protected under the legacy of the Late Shri Ram Family. The defendant and the plaintiff share a common family name. Therefore, there cannot be a claim of any proprietary right or monopoly by the plaintiffs. The defendant’s schools are “Shri Ram Global School”, “Shri Ram Centennial School”, “Shri Ram Global Pre School” which is distinctive from Plaintiffs, which are “The Shri Ram School” and “Shri Ram Millennium School” in terms of different suffix and logos. Therefore there is a bonafide use of the mark by the defendant and the plaintiffs cannot have monopoly rights over the mark “Shri Ram”. Also it was further contended by the defendant that the name/mark is not deceptively similar or confusing as it can be distinguished because of different logos & suffix, as stated above. It was further submitted that the email dated 28th September, 2011 stated that there is no objection/ admission on the part of the plaintiffs to running of the schools by the defendant. The said email is as follows: – “I want to mention that if you ever wanted to divest or reduce your shareholding, you would then be reduced to minority shareholding in your company. You must remember that the ‘Shri Ram’ brand might then go to wrong outsiders. One would have no control over how they would use this brand.”
  • The defendant did not deny the prior use by the plaintiffs but they rather denied an exclusive proprietorship, being aware about the plaintiffs having established the schools before them. However, the defendant represented by Mr. Anand, after becoming aware of the fact that the name/mark existed before the use by the plaintiffs as the Shri Ram School in Mawana, UP established by the family’s relatives, they argued on the contention of no prior use by the plaintiffs.

Picture2

COURT OBSERVATIONS & JUDGEMENT:

The elements of passing off:-

In order to succeed in an action of passing off, 4 main requirements have to be satisfied by a party who intends to seek the relief of injunction.

  • Prior use;
  • Party who is claiming right must be the proprietor of the mark;
  • Confusion & deception;
  • Delay, if any.

In respect of the first and the second requirement the defendant already approved of the prior use by the plaintiffs though denying the exclusive right over the mark/name. The Hon’ble Judge was brought to notice by the defendant about no such written document existing which tells that the plaintiffs have an exclusive right. However, the plaintiffs have a reputation and no other family member though involved in contribution to education have acquired such goodwill, for the simple fact that the operation of Mawana School started by the Shri Ram family relatives prior to the use by the plaintiffs is limited to the place as pointed out by the plaintiffs and thus considered by the Hon’ble Court.

While in respect of third requirement, it was held that the defendant adopted the trademark even though the plaintiffs has been using it since 23 years, thus, creating confusion by starting school with the name/mark “ Shri Ram” in the same vicinity as that of the plaintiffs. Therefore, the name/ surname being distinctive is protected as per law.

The delay of about 3 years in approaching the court was because the plaintiffs though being aware about the use of “Shri Ram” by the defendant, they did not take any action against them. Thus, there was a delay for a considerable amount of time leading to the applicability of principle of acquiescence. The reason given by the plaintiffs was of proximity of relation between the founding members of the plaintiff and defendant because they are real brothers and the plaintiffs tried to warn and end the matter amicably.

The similarity of marks:-

The Judge observed that the parties have Shri Ram in common and the same was an essential part of their services. It was held in Himalaya Drug Company v/s M/s SBL Ltd. that the essential features of the mark if they are same then the logos are deceptively similar. The mark “Shri Ram” is also used by the defendant like the plaintiffs. Therefore it is deceptively similar.

The admission by the plaintiffs:-

It was further held that the admission made by the plaintiffs cannot operate as an estoppel against the person making it.  As held in Gulabchand vs. Bhaiyalal, AIR 1929 Nag 343. There cannot be an estoppel against the law or statutory provisions. When one is concerned with the statutory right or constitutional guarantee, there cannot be any estoppel against the same.

Bonafide Use:-

It was observed that the “bonafide use” as per the Section 35 of the Trademark Act, 1999 is not to be considered in the present case because the defendant’s school is started in the vicinity of the plaintiffs and they issued licenses and appointed franchises despite warnings from the plaintiffs.

CONCLUSION:-

The Hon’ble Court hel that the defendant to display the disclaimer while continuing the functioning of the schools within 6 months about no connection with the plaintiff’s school. The reason being, the interim injunction of the use of the name/mark would cause hardship to the students and the parents who have already paid fees and taken admission in the defendant’s school. The defendant would be entitled to give bonafide description in the nature that the school is run by Vivan Bharat Ram under the legacy of his grandfather Shri Ram for future schools.

OMG! Over 2.26 lakh patent applications pending with Patent offices in India for approval…Why? Shortage of professionals says Commerce and Industry Minister!

In worrying statistics, Commerce and Industry Minister Nirmala Sitharaman, as reported in a news article dated 31st July 2015, informed parliament in a written reply to the Lok Sabha that as many as 2, 26, 339 patent applications are pending for approval with various Patent offices in India due to shortage of professionals. She also said that pending requests of examinations which are awaiting disposal at different stages of processing in patent offices is used to measure the pendency of application. Therefore numbers of pending patent applications must be much higher than the reported figures.

Based on statistics provided, Delhi patent office tops the list with 83,291 pending requests of examinations. Mumbai patent office is having the least number of pending cases at 28,100. Chennai and Kolkata patent offices are the second and third with 74,390 and 40,558 pending cases for disposal.

A look at Dynamic utility to view ‘Month of Request for Examination for which FER is being issued, (can be accessed at http://ipindiaservices.gov.in/rqstatus/) reveals following statistics:

For the Electrical/Electronics group, Delhi patent office is issuing the FERs for July 2009, while other three patent offices are issuing FERs for the year 2010 with Mumbai patent office being ahead of others issuing FERs for October 2010. For the Biotechnology group, Chennai patent office, which is issuing the FERs for February 2012, is ahead of the pack with Kolkata patent office lying at the bottom of the table issuing FERs for March 2010. For the  Chemistry group, Mumbai patent office is ahead of others by issuing FERs for June 2012 with Chennai patent office at the bottom by issuing FERs for  October 2010. For the Mechanical, Kolkata patent office is  issuing FERs for February 2009 and is the only patent office issuing FERs for the year 2009 and Delhi patent office is ahead of the rest with issuing FERs for December 2011.

While explaining the efforts taken by the government to clear the pendency, Nirmala Sitharaman said that government has approved additional 252 posts of examiners and 76 posts of controllers. This will increase total sanctioned strength of examiners and controllers to 589 and 170 respectively. She further informed of steps taken by the government by sanctioning 263 posts of contract examiners of patents as a short-time measure.

For those who are looking for an opportunity to work with Indian Patent Office as an examiner, applications can be filed online, starting date was July 25th, 2015 and last date of application is August 24th, 2015. Further details regarding advertisement and instructions for filing online application can be obtained at http://recruitmentnpc.in/.

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

Revocation of Valganciclovir patent by Controller of Patents, Chennai

Recently in a matter remanded from IPAB to Controller of Patents, Chennai, a decision of revoking Roche’s patent IN207232 for Valganciclovir was delivered after hearing both the parties. The subject patent was granted on January, 2009 followed which post grant oppositions were separately filed by CIPLA, Matrix, Ranbaxy and Bakul Pharma along with two NGOs Delhi Network of Positive People and lndian Network for People living with HIV/AIDS & The Tamil Nadu Networking People with HIV/AIDS (hereinafter INP+ and TNNP+), wherein INP+ and TNNP+ were allowed by the Apex court to raise all contentions in the form of an intervention cum affidavit before the Assistant Controller and the parties agreed to be heard along with CIPLA, Matrix, Ranbaxy and Bakul Pharma. In the opposition proceedings, the patent was revoked limiting it to single process claim by the Controller of Patents on 30.04.2010 and being aggrieved by this decision, Roche filed an appeal at IPAB challenging the decision. IPAB on 30.01.2014 set aside the Patent Controller’s decision to revoke the patent on technical grounds and remanded it to the Controller for re-consideration.

Issues before the controller:

  • Determining whether the expert evidence was prior art publication or disclosure

Answering the issue, controller observes that the expert evidence is not a prior art document to be relied upon for deciding a case, but it may be considered for understanding the prior art documents, if the evidence covers such prior art documents. The opinion of the expert evidence, if it is based on further laboratory or animal study of a given subject matter, it cannot be considered for concluding such invention because it is later acquired knowledge, but it can be used for understanding the present invention. Therefore, expert evidences cannot be considered as prior publications/disclosures, but it can be taken as opinion on the prior arts.

  • Deciding upon the obviousness of the present invention

The next issue which the controller addressed was whether the present invention was obvious with respect to prior art references. The controller observes that the present invention is obvious against two prior arts US 4957924 and EP 0375329A2.

Claim 1 of the present invention recites,

  1. The compound 2-{2-amino-1, 6-dihydro-6-oxo-purin-9-yl} methoxy-3-hydroxy-1-propanyl-L-valinate or a pharmaceutically acceptable salt thereof, in the form of its (R) or (S)- diastereomers, on in the form of mixtures of the two diastereomers.

Regarding this , the controller states that the monovaline ester of ganciclovir is disclosed in the form of Markush formula in EP ‘329, which covers both monovaline and di-valine ester of ganciclovir where support for the both mono and di-valine ester of gancicloviris is provided in the specification. Thus the disclosure of EP ‘329 is clear and unmistakable direction to the mono valine ester of ganciclovir. Hence, a skilled person working in the synthetic chemistry field can easily arrive at the present invention without further experimentation. Therefore mono valine ester of present invention is anticipated by EP’329. Controller further emphasizes that claim 1 of EP ‘329 clearly and unambiguously discloses as at least one of the substituents is valine residue which indicate the presence of mono valine ester. Therefore, EP’329 undoubtedly disclosed mono valine ester of ganciclovir.

With respect to process claim, controller observes that the synthetic method for preparing mono valine ester of ganciclovir as claimed in independent claim 12 of present invention may not be explicitly disclosed in EP ‘329, but said method is just a general method for coupling acid group in the amino acid with hydroxyl group, which can be adopted for any type of alcohols. Therefore, using EP’329, a person working in the synthetic chemistry can easily prepare ester of ganciclovir with lysine without undue burden.

Further the controller observes that the object of the present invention is to provide a prodrug of ganciclovir with improved oral bioavailability. Controller notes that the solution for poor absorption in the gastrointestinal tract for acyclovir is disclosed in US ‘924 patent. Therefore a person skilled in the art can perceive to prepare mono valine ester of ganciclovir from the teachings of both EP’329 and US’924 references. Thus all the claims including process claim are obvious to a skilled person in the art.

  • Deciding upon the efficacy of substance under the subject patent under section 3 (d)

Deciding upon the efficacy of substance under the subject patent, the Controller observes that the new form L-monovaline ester of ganciclovir molecule has shown improvement in oral bioavailability than bis-valine ester of ganciclovir and ganciclovir, whereas there is no support in the specification pertaining to efficacy. Controller observes that the ester modification of the present invention was made to protect the substance from destruction in the gastrointestinal tract and make the molecule more bioavailable. Thus the controller has ruled that while bioavailability is one of the factors affecting efficacy, it cannot be directly equated to efficacy. Citing Hon’ble Supreme Court of India’s decision on Novartis case, the Controller rules that: “lmprovement in bioavailability of the new form cannot be considered directly related to efficacy. Even any unforeseen property observed in new form, unless such property directly relate to efficacy, it will be considered as inherent property of such substance. Since there is no direct relation shown for the improved bioavailability of new form of ganciclovir in the description with regard to significant difference in the efficacy, and therefore such a new form shall be considered as a same substance. Thus new form of the present case Monovaline ester of ganciclovir is considered as a same substance i.e. ganciclovir because,the difference in enhanced efficacy is not shown in the complete specification.” According to the controller, since there is no direct relation shown for the improved bioavailability of new form of ganciclovir in the description with regard to significant difference in the efficacy, therefore such a new form shall be considered as a same substance. Further regarding process used for preparing present invention, the controller held that the process used to prepare new form is a conventional process as it is already known process as disclosed in EP ‘329. Thus, the Controller rules that the present patent was a ‘mere use of a known process’ which was not patentable under S. 3(d), Patents Act.

  • Locus standi of the two NGOs as “person interested” under section 2(1)(t)

Deciding the locus standi of the two NGOs, as person interested under section 2 (1)(t) of patent act, Controller notes that NGOs would fall under the ambit of persons interested as the criteria of locus standi in post grant opposition is to be viewed in broader perspective to grant quality patent. According to the Controller, the two NGOs are the end users or directly affecting parties, if the patent is granted. Thus it is held by the controller that viewing in to the broader prospective, the two NGOs falls under the purview of under section 2 (1)(t) of the patent act and hence the parties have locus standi to oppose the patent.

Thus hearing all the parties and considering all facts and relevant arguments, the Controller revoked the patent granted for the drug Valganciclovir under section 25(4) of Indian Patent act.

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