The Curtain Raiser Formal Guidelines for Examination clarifying Patent Examination Position on Computer Related Inventions in India

The much debated and iterated ‘Guidelines for Examination of Computer Related Inventions’ formally released by the Office of Controller of Patents finally dawns the light upon the much elusive position on Software and Business Method Patents in India. The Indian Software Patent ecosystem for years has been echoing various voices behind the curtains – from the extremities of ‘Software is not patentable in India‘ to techno-legal jargons such as ‘software claims can be patented by restricting with embedded systems’ and ‘if there is a technical effect, software is patentable‘ – all of which silently represent the good, bad and ugly albeit perceptively true picture. It is plausible that the latest Guidelines represent an honest and progressive effort of the Indian patent office to remove these curtains and attempt to elaborately lay down, impressively with examples, the true nature of how the patent office and examiners plan to examine computer related invention, more so for hardcore software and business methods.

Coming straight to the meat of the guidelines: for the first time it is loud and vocal in an official document that ‘Software’ and ‘Business Methods’ – with provisos ofcourse – are indeed patentable in India.

In so far as Software claims are concerned, the guidelines expressly referencing the legislative intent, aim to shrink the doubt on the expression ‘computer program per se‘ by stipulating guidelines allowing computer programs’ patentability in various sections:

Page 12:

“Therefore, if a computer programme is not claimed by “in itself” rather, it has been claimed in such manner so as to establish industrial applicability of the invention and fulfills all other criterion of patentability, the patent should not be denied.”

Page 13:

“a novel computer programme with a known hardware which goes beyond the normal interaction with such hardware and affects a change in the functionality and/or performance of the existing hardware”

Page 13:

“A computer program, when running on or loaded into a computer, going beyond the “normal” physical interactions between the software and the hardware on which it is run, and is capable of bringing further technical effect may not be considered as exclusion under these provisions”

Whereas, when it comes to Business Methods, the age old trick of tying them down to something tangible appears to have been endorsed:

Page10-11:

The claims drafted not directly as “business methods” but apparently with some unspecified means are held un-patentable. However, if the claimed subject matter specifies an apparatus and/or a technical process for carrying out the invention even partly, the claims shall be examined as a whole

Plausibly, the guidelines have attempted to illustrate specific criteria and examples to unfold the grey pixels of software and business method inventions into expressly compared black and white of the patentable vs non patentable.

The caveat though lies in some conflicting illustrations and some generic/broad misplaced guidelines:

Example 8.4 of Page 16 does not appear to be resonating with stipulations of patentable vs non-patentable examples. The example is as follows:

A computer-implemented method comprising: identifying one or more person names in a set of one or more documents, with each identified person name more likely to refer to a single person in a profession than other person names in the document: identifying descriptive language from one or more documents, based on the identified names; and identifying within one or more documents other person names that refer to persons in the profession, based on one or more portions of the identified descriptive language.         

Further, the exclusion of claims directed at ‘Computer Program Product’ is not deriving its basis from the legislation which limits the exclusion to ‘computer program per se’. That said, foreign precedence including the European Patent Office asserts the patentability of Computer Program Products, having matched the other criteria, as specified in the Guidelines for Examination – Part G – Chapter II – 3.6 (link) which reads as:

the computer program itself as well as the physical media carrying the program (see T 424/03), i.e. computer program product claims, such as “data carrier”, “storage medium”, “computer readable medium” or “signal”.

To add to the above, a ghastly stipulation lies in the following example which would not be excluded under Section 3(k):

Method of encoding/ decoding, method of encrypting/ decrypting, method of simulation though employing a mathematical formula.

It is apprehended that something went amiss with that statement, as the literal and plain interpretation suggests that if one devises a new method merely to encrypt data and decrypt it (a new cryptogram for example), that ought to constitute a patentable subject matter if construed novel and inventive by a mathematician, a person skilled in that art – which practically wouldn’t be the case when the examiner draws out such a patent application for assertive review.

In summary, while the Formal Guidelines add an appreciable leaf to the patents office’s chapter of reforms and promoting transparency, it does leave a few stones unturned in being able to absolutely do so, and the part at the end of the introduction section 1.5 spelling out, ‘The guidelines are subject to revision from time to time based on interpretations by Courts of law, statutory amendments and valuable inputs from the stakeholders‘ must be held on to.

The complete ‘Guidelines for Examination of Computer Related Inventions (CRIs)’ can be accessed here while the official order for its release can be accessed here

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

“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

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.

Three Days International Symposium on Strategies for Managing Pharmaceutical, Biotechnology and Chemical Patent Portfolios (United States, European and Chinese Scenario)

We are happy to inform you all that IIPRD and Khurana & Khurana, in association with Sughrue Mion, PLLC, USA, TEE & HOWE IPATTORNEYS, CHINA and MAIWALD, GERMANY are holding an International Patent Symposium covering all major and relevant Pharmaceutical, Biotechnology and Chemical Patent Portfolios in the month of October, 2015 in India. The Three-Days International Symposium would be covering Strategies for Managing Pharma, Biotech & Chemical Patent Portfolios in US, EP & China and is being held from 5’th to 7’th October 2015, at Hotel Hyatt, Vastrapur, Ahmedabad and 7’th to 9’th October 2015, at Hotel Hilton (Andheri East), Mumbai.

IIPRD_Symposium_Image

About the Speakers: The speakers are a unique gathering of Patent Attorneys, Legal Counsels, who have extensive years of experience in their professional fields. These Speakers will put across to the delegates a real insight of Patent Laws & Practices, and Commercial perspectives as prevalent and practiced in Europe, United States, and India.

The speakers include:

  • Mr. Chid Iyer, Partner at Sughrue Mion PLLC, USA
  • Mr. Michael R. Dzwonczyk, Partner at Sughrue Mion PLLC, USA
  • Ms. Aiyda Ghahramani, Associate at Sughrue Mion PLLC, USA
  • Mr. Shackelford, Associate at Sughrue Mion PLLC, USA
  • Ms. Azy S. Kokabi, Associate at Sughrue Mion PLLC, USA
  • Dr. Toby Mak, Partner at TEE & HOWE IPATTORNEYS, CHINA
  • Ms. Yeping DING, Partner at TEE & HOWE IPATTORNEYS, CHINA
  • Dr. Alexander Wittkopp, Managing Partner at Maiwald Patentanwalts GmbH
  • Mr. Vinod Khurana, Senior Partner at Khurana and Khurana, Advocates & IP Attorneys

Please see the complete details including Program Schedule, Topics, Speakers Profiles etc. in a brochure available over here.

If you wish to attend the symposium, please send your nominations to iiprd@iiprd.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

Compulsory Licensing Application against the Patented Drug SAXAGLIPTIN by Lee Pharma

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

Grounds Relied by Lee Pharma for Compulsory Licensing:

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

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

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

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

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

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

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

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

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

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

Conclusion:

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

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

Section 3(D) of Indian Patent Act Strikes Again

India revoked yet another drug patent granted to a German MNC, Boehringer Ingelheim, for its respiratory drug, Spiriva (crystalline tiotropium bromide monohydrate) at a time when the US is putting pressure on Indian government for not providing adequate patent protection to multinational drug companies. In its decision, the patent office held that Boehringer failed to establish any technical advancement or any economic significance for the compound, and the monohydrate crystal form also fails to demonstrate any new therapeutic efficacy and therefore cannot fulfill the requirement of a patentable invention under Section 3(d) of the Patents Act.

Facts and highlights of the case:

  • Boehringer Ingelheim filed a patent application (558/DELNP/2003) for crystalline tiotropium bromide monohydrate in Patent Office, Delhi on 16th April, 2003.
  • A pre-grant opposition was filed by Intermed Labs Pvt. Limited on 05th November, 2007 against the grant of this patent application. The said pre-grant opposition was heard by the then Learned Controller Mr. S.K.Roy. However, the application was recommended for Grant of the Patent on 21st December, 2012 and was allotted the Patent No. IN254813.
  • CIPLA filed a post-grant opposition to Boehringer’s patent, claiming the drug was ‘obvious’, and the crystalline tiotropium bromide monohydrate did not demonstrate any significant change in ‘therapeutic efficacy’.
  • Indian Patent office issued an order on March 2015 to revoke the Boehringer’s patent (IN 254813) covering crystalline tiotropium bromide monohydrate.

This is considered as a landmark case as the patent was revoked after it was granted, with much scrutiny and examination, and after the pre-grant opposition had been dismissed a few years back.

Tiotropium bromide, being a pre-1995 molecule, was not patented in India as the Indian patent law did not provide patent protection for “products” till 1995. However, Boehringer filed a patent application for the crystalline tiotropium bromide monohydrate on the grounds that the monohydrate form is stable under rigorous manufacturing condition and post manufacture, and this specific form exhibits stable particle size distribution make it effective as an inhalable drug.

Cipla had filed an post-grant opposition to Boehringer’s patent in 2013, claiming the drug was ‘obvious’, and the monohydrate crystal form of tiotropium bromide did not demonstrate any significant change in ‘therapeutic efficacy’ as required under Section 3(d) of the Patents Act.

In its decision, the Patent office ordered,

            “The physical stability of the compound during formulation cannot be considered as a sole factor for improvement of therapeutic efficacy of the drug under as required under section 3 (d) of the Indian Patent Act, adding the compound is “a product of mere trial and error” and does not “involve any inventive skill”.

            “The data as submitted by the applicant relating to stability test provided in the reply statement fails to prove clearly the superior properties of the Monohydrate form in comparison with the prior art form, as stability does not have any relation with the therapeutic efficacy”, Assistant controller Ajay Thakur said.

            “In the present case, I would say that the Patentee achieved lowering of crystal growth of the active during the micronization process and such reduced particle size is effective to penetrate the lungs. But this cannot be considered to translate or exhibit enhanced therapeutic activity over the known substance “, Assistant controller Ajay Thakur said.

The Assistant controller further added that,

            “Grant of a patent in other countries cannot be cited as a proof of inventiveness, the fact as clear from the Chinese prosecution, where the Supreme People’s Court of People’s Republic of China upheld the invalidity of Boehringer’s crystalline tiotropium bromide monohydrate patent application reasoning that it lacked ‘unexpected technical effects’ and hence was not ‘creative'”.

Cipla (an Indian Pharma major) has been marketing the generic version of tiotropium bromide monohydrate under the brand name “Tiova” since 2003. The revocation of the patent paves the way for the Indian firm to continue selling its generic version in the Indian market.

Boehringer Ingelheim has a three month window to appeal to the Intellectual Property Appellate Board to seek a review on the order issued by the patent office.

The Section 3(d) was incorporated in the amended Patent Act with the objective of blocking the pharmaceutical companies’ attempt to claim patent right for incremental innovation involving new forms of a known molecule with no significantly enhanced efficacy. MNCs have been constantly trying to circumvent this provision ever since the Patent Act was amended in 2005. In view of the Public interest, the Indian government does not want pharmaceutical companies to unjustifiably profiteer from pharmaceutical substances that involve only incremental innovation.

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

Follow

Get every new post delivered to your Inbox.

Join 328 other followers