Category Archives: Pharma

Unboxing The Confusion In Marks Of Pharmaceutical Products

It is not new that the Supreme Court had cautiously laid down the seven principles for determining confusion or deceptiveness in pharmaceutical products. The landmark case of Cadilla held that medicines are boon but if given wrongly it can have life-threatening impact. Thus, there need not be an iota of confusion in the mind of people while buying medicines. The trademark of the pharmaceutical products must be distinctive and not similar or identical. The seven-principle test held that for deciding the question of deceptive similarity, weightage must be given to each of these factors depending upon the facts and circumstances of each case. The factors included are:

a) The nature of the marks i.e. whether the marks are word marks or label marks or composite marks, i.e. both words and label works.

b) The degree of resemblance between the marks, phonetically similar and hence similar in idea.

c) The nature of the goods in respect of which they are used as trademarks.

d) The similarity in the nature, character and performance of the goods of the rival traders.

e) The class of purchasers who are likely to buy the goods bearing the marks they require, on their education and intelligence and a degree of care they are likely to exercise in purchasing and/or using the goods.

f) The mode of purchasing the goods or placing orders for the goods; and

g) Any other surrounding circumstances which may be relevant in the extent of dissimilarity between the competing marks.

The rationale behind establishing these principles was that drugs are poisons, not sweets. Therefore, confusion between pharmaceutical products is are not merely inconvenient but also life threatening. One wrong medicine could cost a person his life. At times, drugs are purchased in critical and pressurized time where there is chaos in one’s life to save his near and dear ones. Many a times; patients are elderly, infirm or illiterate. India has varying degree of infrastructure for supervision of pharmacists and physicians of medical profession in the country due to large variation in linguistics and literacy. Same is the situation with the customers. They may not be able to differentiate between the medicine prescribed and bought which is ultimately handed over to them. There can be accidental negligence as well. The same was supported by McCarthy in Trade Marks, 3rd Edn., para 23.12 which held that the tests of confusing similarity are modified when the goods involved are pharmaceutical products. If the goods involved are pharmaceutical products each with different effects and designed for even subtly different uses, confusion among the products caused by similar marks could have disastrous effects. For these reasons, it is proper to requires lesser quantum of proof of confusing similarity for drugs and pharmaceutical preparations. The same standard has been applied to medical products such as surgical sutures and clavicle splints.

While this is one side of the coin; the other side of the coin was represented by 2015 judgement of Delhi High Court. In Sun Pharmaceutical Industries v. Anglo-French Drugs and Industries Limited, the plaintiff had registered OXETOL on one of its medicinal preparation used for curing bipolar disorder and epilepsy. On the other hand, Respondent had filed for registration of EXITOL under the same class as of the plaintiff, i.e., class 5 for its medicine used in treating constipation.

The main issue held by appellant was that the impugned trademark EXITOL of the respondent was as almost identical to the appellant’s trademark OXETOL and thus it infringed by taking advantage of the financial and human resources invested by the appellant since 2001 without incorporating any cost themselves.

Since both the products fell into class 5 i.e., medicines, therefore the Court took a pragmatic approach. It firstly held that there cannot be any U-turn from Cadilla’s judgement in terms of undermining the aspect of confusion or deceptiveness. However, in judging the deceptiveness, what also must be seen is the material differences between the product. The methods of administering the drug, the shop in which the drugs are sold, the ailment for which the drug can be prescribed are factors that are pivotal for determining deceptiveness. Elaborating on the same, the Hon’ble Court makes comparison of the dissimilarities between the two products-in-dispute in a tabular form. Aspects including different active pharmaceutical ingredients to purpose; from method of administration to visual packaging were compared.

The Division Bench of Delhi High Court upheld the order by Single Judge Bench of the same court and held that a slight semblance in the phonetic pronunciation between two marks cannot automatically satisfy the test of confusion in a person with average intelligence and imperfect recollection. It is necessary that the marks are seen as a whole. The word ‘TOL’ was common in both the marks; however, the prefix was different for both signifying two totally different medicines. Also, both the drugs were Schedule H drugs. Thus, they could only be sold on prescriptions.

Finally, the Court took a progressive view and held it may be a situation that the products-in-dispute fall into the same class and are phonetically similar. However, that cannot be the sole reason to call the marks as confusing. If there are dissimilarities which created no iota of confusion or deceptiveness, then the marks are to be held not infringing one other.

Author: Esha Himadri, Intern at Khurana & Khurana, Advocates and IP Attorneys. Can be reached at swapnil@khuranaandkhurana.com.

References:

[1] Cadila Health Care Ltd. v. Cadila Pharmaceuticals Ltd (2001) 5 SCC 73

[2] Franco Indian Research Pvt. Ltd. v. Unichem Laboratories Ltd. 2005 (30) PTC 131 (Bom)

[3] McCarthy in Trade Marks, 3rd Edn., para 23.12

[4] Sun Pharmaceutical Industries v. Anglo-French Drugs and Industries Limited(2014) 207 DLT 375

[5] Sun Pharmaceutical Industries v. Anglo-French Drugs and Industries Limited(2014) 215 DLT 493 (DB)

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Injunction against Cipla COPD Drug ‘INDAFLO’ Upheld: Delhi High Court

Reportedly, on an appeal filed by Cipla pertaining to COPD drug INDAFLO, the Delhi High court division bench maintained the interim injunction imposed by single judge against Cipla.  As per the order, Cipla has now been restrained from, inter alia, using, manufacturing, importing, selling any pharmaceutical products etc. containing ‘INDACATEROL‘ or ‘INDACATEROL Maleate‘, alone or in combination with any other compound or Active Pharmaceutical Ingredient (API) leading to the infringement of Novartis patent over INDACATEROL.

Background:

INDACATEROL is a bronchodilator and used in the treatment of the patients suffering from Chronic Obstructive Pulmonary Disease (COPD). The drug has been protected and patented by Novartis under Patent no. 222346 and Novartis markets the drug in India through Lupin under the trade name “ONBREZ”. However, Cipla had launched a generic version of the drug with the trade name ‘UNIBREZ’ to which Novartis filed a trademark infringement suit and Cipla agreed to change the trade name to ‘INDAFLO’. Further, Novartis moved to Delhi High Court to seek permanent injunction against manufacturing and selling of INDAFLO and thereby stopping Cipla to infringe its patent over this drug. Hon’ble Single Judge Justice Manmohan Singh passed order for interim injunction against Cipla, until the decision on the application for compulsory license to manufacture and sell INDAFLO is decided by the respective authority.

Being aggrieved by the order of the Learned Single Judge, Cipla filed an appeal challenging the interim injunction.

Arguments and Observations:

Cipla contended and relied on Section 48 (Rights of the Patentees) of the Patent Act 1970, referring to the wordings as mentioned in Section 48 “subject to other provisions in the Act” to be viewed in the light of Section 83 (dealing with General Principles applicable to working of patented inventions) of this Act.

Taking Sections 48 and 83 of the Patents Act, Cipla argued that since Novartis does not manufacture the drug in India and therefore Novartis does not comply with the principles under Section 83. The court rejected this argument stating that Section 83 has no relevance as far as Rights of Patentees as mentioned under Section 48 is concerned.

As per the bench of two judges, Section 83 begins with the words ‘without prejudice to the other provisions contained in this Act’ meaning that Section 83 is without prejudice to any sections in this Act which includes Section 48 as well and further it has been stated that Section 83 belongs to the different chapter of the Act and therefore this does not have an effect on the rights awarded to the patentee under Section 48 of this Act.

Cipla has further argued that since Novartis does not practice the patent in India as it imports the drug in limited quantities and market through Lupin, Cipla should not be restricted to manufacture and sell its generic version. Taking the 2002 case Telemecanique in light, the bench of the two judges rejected the Cipla’s claim, stating that the working of the patent need not compulsorily imply to only manufacture in India, however, the patent can be exercised by even importing the products. However, the court at this stage concluded that on the basis of data submitted by Novartis, sufficient quantities are imported in India since other drugs for treating COPD are also available in the market and also INDACATEROL does not fall in the category of Life Saving Drug.

Cipla further argued on the grounds of “public interest” that Novartis is not importing the sufficient quantity of the drug and also the drug marketed by Novartis is approx. 5 times as expensive as compared to Cipla’s generic version. Cipla argued that pubic interest would not be served in case the injunction is allowed to remain and contended that while granting an injunction “public interest” has to be considered as one of the four aspects (in addition to prima facie case, balance of convenience and irreparable harm and injury).  To which, the court rejected this plea stating that “public interest” is only one of the four factors to be considered while granting an injunction. Further, the bench brought it to the notice that Cipla in this case till now has not even proved that the grant of injunction against Cipla would really harm the public interest. Whereas, Novartis has duly established the validity of the patent and the revocation of the interim injunction in this case, would cause irreparable injury to Novartis under their rights as Patentees as mentioned under section 48 of Indian Patent Act.

Judgment:

Therefore, the bench maintained the interim injunction passed by Hon’ble Judge Manmohan Singh judgment and refused to interfere with the impugned judgment proving to be a disappointment for Cipla in the respiratory drugs market.

About the Author: Ankur Gupta, Lead Operations-Hyderabad, IIPRD and can be reached at: ankurg@iiprd.com

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

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

Here is our take:

Details of the Patent Application and important dates:

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

 

04/12/2008

Priority Application Number/ Priority date US61/012,162

 

07/12/2007

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

Application Area:

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

Facts of the case:

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

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

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

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

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

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

Analysis of the rejection decision:

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

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

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

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

Reference:

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

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

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

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

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

Claim 1:

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

Claim 6:

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

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

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

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

U.S. District Court Confirms Validity of Patent For UCB Pharma’s Vimpat®

UCB Pharma, a Belgian pharmaceutical company, announced on 14th August 2016 that the U.S. District Court for the District of Delaware confirmed the validity of its U.S. reissued patent RE38551 related to anti-epileptic drug Vimpat® (lacosamide). The patent challenge was brought by generic drug makers who had questioned the validity of the UCB’s patent which is scheduled to expire in March 2022.

Vimpat®, one of four key products for UCB Pharma, generated net sales of 379 million euros ($423.7 million) in the first half of 2016. Vimpat® is indicated for use alone or as add-on therapy in the treatment of partial-onset seizures in patients with epilepsy who are 17 years of age or older.

In 2013, UCB had sued numerous generic drug companies, including New York-based generics maker Argentum Pharmaceuticals, after they applied ANDA application to market a generic version of Vimpat® in the United States. In late May, Argentum Pharmaceuticals won an inter partes review of UCB’s patent by the USPTO’s Patent Trial and Appeal Board (PTAB).

The Delaware district court has ruled that UCB’s patent covering the epilepsy drug Vimpat® is valid. The Court upheld the validity of the UCB’s patent after issuing a sealed opinion on the patent. The court’s favorable decision for UCB now guarantees patent protection for Vimpat® until 2022.

Anna S. Richo, executive vice president and general counsel for UCB stated “We are pleased with Delaware Chief Judge Stark’s decision”. “This confirms the strength of our intellectual property for Vimpat®”.

The decision is currently under seal and will be released following an order from the court.

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

India’s First IP Crime Unit Launched in Telangana State

Piracy is one of the major evil Indian IP industry is facing for decades and the same is growing day by day rooting into the system causing irreparable loss to the economic reputation of the country. As per the report by Ernst & Young, Indian films industry has sustained loss of around USD 959 (Rs. 4,411 Crores) million and 5, 71,896 jobs in the year 2008 due to piracy.[1] Further various incidents regarding piracy in the film industry seems to be increasing and recently the incident related to the online leak of movie “UDTA PUNJAB” before two days of its release had made headlines. However Indian Judiciary has taken timely steps to control the piracy by passing John Doe orders wherein identities of the Defendants are not known but the whole site suspected providing the pirated versions is blocked. UDTA PUNJAB is not the only movie which is victim of the piracy, there are numerous movies that falls prey of piracy, some of which are reported while others go unnoticed. Latest incidents of piracy in the Bollywood industry have been in headline every now and then, which palpably is a sheer discouragement to the IPR holder as well as economic system of the country. Even Telangana Film Chamber of Commerce recently claimed that there were 14,000 sites and 89,000 illegal downloads of the movies causing loss in millions of rupees.[2] The issue related to piracy and infringement of IPR in India ultimately impacts its economic reputation which is not at all desirable.

Reportedly, in order deal with the menace of piracy, Telangana Intellectual Property Crime Unit (TIPCU) is launched as India’s first unit to deal with the Intellectual Property Crime. It is set up under the cyber crime wing of the CID to deal with complaints pertaining to online piracy particularly illegal download and spread of movies. Pertinently, TIPCU being first of its kind of state level unit in India seems to be vigilant step by the state government in setting up a special unit dedicated to tackle with the serious and organized intellectual property crime such as piracy, with prime focus on offences committed using an online platform. Modeled upon UK’s Police Intellectual Property Crime Unit (PIPCU), TIPCU’s main task will be to monitor online piracy and recommend blocking of websites providing pirated contents, identify the perpetrators and pursue action. Reportedly, TIPCU’s will also prosecute the pirates and choke their revenue sources. The taskforce is expected to start work in the next few months. It will have representatives from cyber crime police, state IT ministry, internet service providers, the Telugu film industry, legal experts and financial experts.[3] Further TIPCU is also expected to deal with the measure to control illegal online activities, including child pornography. Thus it seems that the horizon of the unit is duly kept wide in order to confront all the wrongs being carried out through online platforms with special focus on piracy. It is a commendable step by the Telangana Government which inculcates deterrence among the wrong doers who indulge in such illegal activities of piracy. Thus units like TIPCU are essential to curb the menace of the Piracy and intellectual property infringement in India, which ultimately helps retain confidence among the authors/creators/ owner towards their Intellectual Property rights in India. Now the actual effective working of the unit is expected to speak louder than words and help clear the menace of piracy issue. Further, it is the need of the hour to have such units throughout India, as the piracy is the issue that is also being faced by the Bollywood as that of the Tollywood. Launch of TIPCU has already set a trend across other Indian states to have such units established which would actively help curbing the menace of piracy in India.

About the Author: Mr. Abhijeet Deshmukh, Trade Mark Attorney, Khurana & Khurana, Advocates and IP Attorneys and can be reached at: Abhijeet@khuranaandkhurana.com

[1] http://www.financialexpress.com/archive/piracy-a-serious-threat-to-indian-film-industry/592752/

[2]http://www.thehindu.com/todays-paper/tp-national/tp-andhrapradesh/tipcu-to-tackle-online-piracy/article8771495.ece

[3] https://www.telanganastateofficial.com/tipcu-telangana-intellectual-property-crime-unit-formed/

Combating Opioid Misuse – COMBAT (Curb Opioid Misuse By Advancing Technology Act of 2016)

The Congress recently introduced a bill on the COMBAT Act (Curb Opioid Misuse By Advancing Technology Act of 2016) to incentivize the development of abuse-deterrent opioids by amending the Federal Food, Drug, and Cosmetic Act to extend the exclusivity period for certain drug products developed or labeled so as to reduce drug abuse, and for other purposes.

Implications on Exclusivity to Certain New Drug Applications (NDAs) –

The COMBAT Act would amend Section 505(c)(3)(E) of the Federal Food, Drug, and Cosmetic Act i.e. 21 U.S.C. 355(c)(3)(E) by adding at the end the following:

(vi) With respect to an application described in clause (iii) or a supplement to an application described in clause (iv), if such application or supplement is approved on or after the date of enactment of the Curb Opioid Misuse By Advancing Technology Act of 2016, the 3-year period specified in each such clause shall be extended for an additional period of 12 months if the person submitting such application or supplement provides documentation to the Secretary demonstrating that the drug that is the subject of the application or supplement—

(I) is approved, in whole or in part, on the basis of one or more new clinical abuse potential studies; and

(II) is approved with labeling that characterizes the abuse-deterrent properties of the drug product.

Implications on Exclusivity to Certain Abbreviated New Drug Applications (ANDAs) –

The COMBAT Act would amend Section 505(j)(5) of the Federal Food, Drug, and Cosmetic Act i.e. 21 U.S.C. 355(j)(5) as following

(1) in subparagraph (B), by adding at the end the following:

‘‘(v) With respect to an abbreviated application described in clause (iv), if such application is approved on or after the date of enactment of the Curb Opioid Misuse By Advancing Technology Act of 2016, the 180-day period specified in such clause shall be extended for an additional period of 60 days if the first applicant submitting the abbreviated application provides documentation to the Secretary demonstrating that the listed drug referred to paragraph (2)(A)(i) and referenced in the abbreviated application—

(I) is approved, in whole or in part, on the basis of one or more new clinical abuse potential studies; and

(II) is approved with labeling that characterizes the abuse-deterrent properties of the drug product.

 (2) in subparagraph (F), by adding at the end the following:

‘‘(vi) With respect to an application described in clause (iii) or a supplement to an application described in clause (iv), if such application or supplement is approved on or after the date of enactment of the Curb Opioid Misuse By Advancing Technology Act of 2016, the 3-year period specified in each such clause shall be extended for an additional period of 12 months if the person submitting such application or supplement provides documentation to the Secretary demonstrating that the drug that is the subject of the application or supplement—

(I) is approved, in whole or in part, on the basis of one or more new clinical abuse potential studies; and

(II) is approved with labeling that characterizes the abuse-deterrent properties of that drug product.

Access copy of the bill here

About the Author: Mr. Tapan Shah, Senior Patent Associate, Khurana & Khurana, Advocates and IP Attorneys and can be reached at: tapan@khuranaandkhurana.com.

IP Workshop held at Hotel Hilton – Jaipur

IIPRD in association with Khurana and Khurana, Advocates and IP attorneys has recently conducted an IP Workshop on 8th of February, 2016 at “Hotel Hilton”, Jaipur. Hereinbelow are the snapshots of activities conducted at the workshop –

As a part of our ongoing Educational and Awareness Programme on IPR, IIPRD takes pride to have successfully completed yet another Programme on IPR – “IP Leveraging and Management” at Hotel Hilton, Jaipur. The objective was to sensitize the Industrialists, Scientists, Educationalists and other attendees towards growing need of effectively leveraging Intellectual Properties.

The Participants include IP practitioners working in law firms as well as IP departments of innovation based companies and representatives of some premium academic institutions and industries. Representatives from IIS University, University Of Rajasthan, IIHMR, Jaipur National University, S K N Agriculture University, Manipal University, Polycon, Awakey, Head Start, S P Biotech, Avis Life Pharma, Rajasthan Patrika, Ayumed Pharma, Startup Labs, Dhewa  Biotech (P) Ltd were a few participants amongst others.

The keynote address and presentation were given by Mr. Vinod Khurana, Founder of IIPRD and Khurana and Khurana, advocates and IP Attorneys, and Mr. Tarun Khurana, a Co-Founder and Partner in IIPRD – an Intellectual Property Consulting and Commercialization/Licensing Firm. Both the IP specialists shared know how on various facets of IP protection and enforcement strategies discussing several case laws and case studies. They illuminated ways to the audience of how IP can be effectively Protected, Managed, and Commercialized.

The Workshop covered the broad areas of Intellectual Property Rights with special emphasis on Patents & Trademarks. It presented an opportunity for academicians, practitioners, consultants and students to exchange ideas and explore emerging issues on IP Leveraging and Management.

Medecins Sans Frontieres (msf) Challenges Pfizer’s Patent Application on Pneumonia Vaccine in India

Médecins Sans Frontières (MSF) also known as Doctors Without Borders, an international humanitarian-aid non-governmental organization, has filed a pre-grant opposition in India to prevent US pharmaceutical company “Pfizer” from getting a patent on the pneumococcal conjugate vaccine (PCV13, marketed as Prevenar 13®).

Prevenar 13® is the world’s largest selling vaccine for infants and toddlers, that helps prevent invasive disease caused by 13 types of Streptococcus pneumoniae. Prevenar 13® contains extracts from thirteen of the most common types of Streptococcus pneumoniae bacteria which are responsible for causing invasive diseases such as pneumonia, blood poisoning and meningitis.  The vaccine works by preparing the body’s defences to fight the infection, without causing the disease.

The patent application (8081/DELNP/2007) filed by Pfizer, if granted, would allow the company to keep controlling the PCV 13 vaccine market until 2026 in India. Pfizer’s patent application covers a multivalent immunogenic composition comprising 13 distinct polysaccharide-protein conjugates, wherein each of the conjugates contains a capsular polysaccharide from a different serotype of Streptococcus pneumoniae conjugated to a carrier protein together with a physiologically acceptable vehicle. Pfizer claimed it should be awarded a patent because the method of conjugating 13 serotypes of streptococcus pneumonia into a single carrier is new but MSF claimed it was not inventive.

MSF said it decided to oppose Pfizer’s patent application “after years of fruitless negotiations” with Pfizer to lower the vaccine’s price for use in its projects. While Pfizer offers the pneumonia vaccine at a discounted rate for $10 per child, a vaccine producer in India, Serum Institute, has announced that it could supply the vaccine to MSF and countries in need for $6 per child.

MSF has filed a “pre-grant opposition”, an administrative process that allows third parties to formally challenge validity of pending patent applications before they are granted, arguing that Pfizer’s claimed method is too obvious to deserve a patent under Indian law, pointing out that an equivalent patent was already revoked by the European Patent Office (EPO) and the validity of South Korean equivalent is currently being challenged.

 “Our pre-grant opposition shows that the method Pfizer is trying to patent is too obvious to deserve a patent under Indian law, and is just a way to guarantee a market monopoly for Pfizer for many years to come,” said Leena Menghaney, Head of MSF’s Access Campaign in South Asia. “India must rebuff demands from pharmaceutical companies, which are backed by diplomatic pressure tactics of the U.S. and other governments, that India change its patentability standards to restrict generic competition.  Pfizer’s unmerited patent application on the pneumonia vaccine should be rejected, opening the door to more affordable versions of the vaccines being produced.”

“This is the first time a vaccine (biosimilar) patent has been challenged in India by a medical organisation, with the goal of millions more children being protected against deadly pneumonia”, MSF further claimed.

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

Indian Patent Office Rejected Compulsory License Application (C.L.A. No.1 of 2015) for “Saxagliptin” Filed by Lee Pharma Ltd.

In an order dated 19th January 2016, the Controller of Patents rejected the compulsory license application of Hyderabad based drug maker Lee Pharma Ltd. to manufacture generic version of AstraZeneca’s anti-diabetic drug Saxagliptin. The Controller of Patents rejected the application on the grounds that substitutes to the drug Saxagliptin are readily available in the Indian market and the Lee Pharma’s claim that requirements of public with respect to the patented invention are not being satisfied has not been proven.

Lee Pharma filed an application under Section 84 (1) of the Patents Act 1970 on 29th June 2015, seeking grant of a compulsory license for manufacturing and selling the compound Saxagliptin (an anti-diabetic drug), which is protected by Patent number 206543 titled “A cyclopropyl-fused pyrrolidine-based compound” granted on 30th April 2007 to Bristal Myers Squibb (BMS). BMS transferred the ownership rights in the Indian patent 206543 to AstraZeneca by virtue of an assignment deed.

While the patent office had heard Lee Pharma’s case in August 2015 and denied a compulsory license, the application was heard afresh after Shri. O P Gupta, the new controller general of patents, assumed office in November 2015. In August 2015, Shri. Rajiv Aggarwal, the then Controller of patents had rejected the compulsory license application. “The applicant has failed to prima facie show that the patented invention is not worked in the territory of India…I am therefore of the view that a prima facie case has not been made out for the making of an order under Section 84,” Aggarwal said in his Aug. 2015 order.

Lee Parma made the compulsory license application on the grounds that the reasonable requirements of the public with respect to the patented invention have not been satisfied, the patented invention is not available to the public at a reasonably affordable price and that the patented invention is not worked in the territory of India.

Lee Pharma submitted that out of all DPP-4 inhibitors presently available in India, Saxagliptin is the latest and the best option for the treatment of Type-II diabetes while the others have side effects, and there is more than 99% shortage of Saxagliptin in the Indian Market, therefore the reasonable requirements of the public with respect to the patented invention under Section 84 (1)(a) were not satisfied by the Patentee.

However, the Controller observed that Lee Pharma’s submission has not demonstrated the reasonable requirements of the public in respect of Saxagliptin and also the exact quantitative requirement of Saxagliptin in India in terms of number of patients requiring it by way of any authentic data or concrete evidence.  The Controller noted that in the absence of any authentic evidence from any statutory authority, it is difficult to conclude whether or not the Patentee is meeting the reasonable requirements of the public in respect of the patented invention.

The Controller further noted that the availability and affordability of Saxagliptin in India could not be determined as Lee Pharma, in their application or in their submissions, has not furnished the details of the reasonable requirements of the public in respect of Saxagliptin, the comparative requirements of Saxagliptin and other DPP-4 inhibitors such as Linagliptin, Sitagliptin and Vildagliptin, or any authentic data/statistics on Saxagliptin prescription by the doctors over other DPP-4 inhibitors.

In addition, under clause (c) of Section 84 (1), Lee Pharma submitted that the Patentee has not taken adequate steps to manufacture Saxagliptin in India and make full use of the invention in India to an adequate extent that is reasonable practicable even after the lapse of a long period of about eight years from the date of grant (30th April 2007). Lee Pharma also submitted that the working of the patented product in the country was hindered by the importation from abroad.

This ground was rejected on the basis that manufacturing the drug in India is not a precondition to establish working in India. The Controller noted that it was difficult to conclude whether manufacturing in India was necessary or not since Lee Pharma failed to show the exact quantitative requirement of Saxagliptin in India in terms of number of patients requiring it.

In the latest order of 19th 2016, Gupta said, “As the applicant has failed to provide evidence along with application or during hearing or by supplementary submissions and failed to satisfy the controller regarding any of the grounds as specified in Section 84(1) of the Act, I am therefore of the view that a prima facie case has not been made out for making of an order U/S 84 of the Act. Therefore, the application for grant of compulsory license by the applicant is hereby rejected.”

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