Category Archives: Pharma

E- Pharmacy In India (Ban Or No Ban)

‘E-pharmacies’ are in quandary after the decisions taken by country’s two High Court’s over the issue of online sale of medicines. The Hon’ble Delhi High Court deferred the hearing on the matter and extended its interim stay on the online sale of medicines through e-pharmacies. However, the Hon’ble Madras High Court temporarily suspended the ban on online sale of medicines that was imposed last week by a single judge bench of the High Court. The petitioners in both the cases have sought a complete ban on the sale of drugs including prescription medicines and psychotropic substances on internet by online pharmacies (E-Pharmacies) in absence of any regulations notified by the Government of India.

E-Pharmacies (The Convenient Option)

E-Pharmacies made access to medicine highly convenient, all medicines general or specific are available just on one click , a patient need not have to hop from one shop to another in search of a particular medicine. This E- pharmacy industry has become a lucrative sector in the past few years, with surge in cheap data usage and widening reach of e-commerce. It has been estimated that more than 250 online pharmacies have sprung up in India in recent years, cornering Rs1,000 crore of the Indian drug market. Leading Startup Netmeds has recently secured $35 million of funding from Daun Penh Cambodia group. Similar investments have been on rise in other online pharmaceutical companies as well such as LifCare, Pharmeasy,  1mg and others.[1]The sector have been offering services like telemedicine at affordable prices and free delivery of  prescribed medicines by connecting brick-and-mortar pharmacy stores with the consumers through mobile applications. However, the many organizations have been protesting against proliferation of e-pharmacies, the traditional pharmacies see them as competitors eating their pie whereas human rights groups have raised concerns over the unregulated sale of medicines leading to potential health epidemic .

Position in India

Further, on the legal standards the petitions argue the online sale of medicines to be in contravention with the existing legal requirements that are must for the sale, prescription, storage and transportation of medicines . In India, the sale of medicines is mandated only in accordance with the Drugs and Cosmetics Act, 1940 (“DCA”) and Drugs and Cosmetics, Rules 1945 (“DCR”). The fixed retail shops must obtain license under Section 18 of the DCA and Rule 61 of the DCR to carry sale of prescribed medicines. Further, the sale shall be done only against a valid prescription of a medical practitioner in accordance with Section 42 of the Pharmacy Act ,1948. Lastly only a registered pharmacist is authorized to dispense medicines under Rule 65(2) of the DCR and Rule 9.1 of the Pharmacy Practice Regulations, 2015. The petitioners have argued that the ‘e-pharmacies’ have been openly flouting these rules and thus playing with the health of millions of patients.

Recommendations

It cannot be debated that E-pharmacy cannot be equated with normal e-commerce platform. It would be a serious concern if medicines can be bought or sold in a similar manner that of other goods on Amazon or Flipkart. The same was accepted by a sub-committee that was constituted by Drugs Technical Advisory Board (DTAB)  entrusting responsibilities to examine the issue of regulating the sale of drugs over internet under the Drugs and Cosmetics Rules, 1945 (D&C Rules). The sub-committee has also proposed recommendations on the matter and lately these recommendations have been published as ‘Draft-Rules’ by Ministry of Ministry of Health & Family Welfare (MOH&FW). Thus a new Part VI- ‘Sale of Drugs by E-Pharmacy’ has been proposed to be added to the D&C Rules. Though the DRA and DRC were silent on the online sale of medicines,it is imperative to examine the proposed legal structure with existing legal regime governing the pharmaceutical industry.

 

Legal Issues Existing Framework Proposed Rules
License
Section 18 of the DRA and Rule 61 of the DRC makes mandatory for fixed retailers to obtain a license for sale of the medicines.
Proposal to create a National Portal, that shall act as the nodal platform for transacting and monitoring online sale of drugs.
Geographical Restriction
Rule 61 of the DRC impose geographical restrictions at the licensed premises.
Sale of medicines shall take place only in the respective state from where the order has been placed.
Prescription
A valid prescription is mandatory for sale of prescription under Section 42 of the DCA.
The sale of online medicines is to be carried through proposed Electronic Prescription Exchange.
Dispensing medicines by registered pharmacist
Medicines shall be dispensed under the personal supervision of a pharmacist as per Rule 65(2) of the DRC and Rule 9.1 of the Pharmacy Practice Regulations.
The drugs are required to be prescribed by registered medical practitioner and sold through licensed professional only.
Storage and Transportation
Rule 64 of the DRC ensure that the license is granted only after the authority ensures the premises are adequately equipped for storage of medicines and the medicines sold are to be given to the patient by hand.
the e-pharmacy is an intermediary its functions, responsibilities, procedure for registration need to be fixed under DRC.
Patient Confidentiality
Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002; and Pharmacy Practice Regulations, 2015 makes strong provisions for patient confidentiality.
It is critical to ensure personal data of the patients confidential in accordance with the IT Act.
Supervision by Drug Inspector or Drug Controller
The premises where drugs are sold, stocked, exhibited can be inspected by Drug Inspector as per Section 22 of the DCA.
provisions relating to supervision shall be followed as per existing laws.

Conclusion

In a country where almost no-compliance is being followed with respect to sale of prescription drugs by the brick-and-mortar stores, e-pharmacies have a potential to alter the existing practices. Sale through an Electronic Prescription Exchange (EPE) would be a step in containing overuse and unscrupulous of medicines especially ones contributing to antibiotic resistance across the country. It will also provide a check on to rampant mal-practices done by Doctors and Brick and Mortar Pharmacies like passively forcing patient buy medicines from their preferred Pharmacist in the greed of getting commission on sale.

Furthermore, Doctors also prefer to prescribe costlier medicine to generic medicines to gain more commission as a result of which these Brick and Mortar Pharmacies rarely give any discount because they need to pay the doctors commissions for prescribing their medicines leaving the poor patient at the suffering end. In fact, there are various tie-ups entered upon by Private Hospitals and Pharmacies for conducting the above described  mal- practices which everyone of us have experienced at some point of time. Therefore, I strongly advocate the concept of E- Pharmacies however, same can only be  made effective after a proper framework of laws governing the industry. In absence of the same there are huge chances of a greater mis-happening, as sectors of great importance like that of pharmacy cannot be left unchecked and unregulated.

India could also widen the scope of industry by following best practices across the world such as Displaying Internet Pharmacy Logo in UK over all the web-pages and prohibiting advertisement of medicines especially ones stored through computer cache. However, lurking the online pharmaceutical industry for regulations is serious blow to the same cause. The legal mechanism must be put in place at the earliest.

Author: Mr. Shubham Borkar, Senior Associate – Litigation and Business Development  and Gursimran Narula – Intern, at Khurana & Khurana, Advocates and IP Attorneys. In case of any queries please contact/write back to us at shubham@khuranaandkhurana.com or at www.linkedin.com/in/shubhamborkar.

References: 

[1]https://qz.com/india/1494451/delhi-high-court-bans-e-pharmacies-like-netmeds-medlife-1mg/

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Pharma Companies Extend Patent Life With Slight Modifications

Introduction

Pharmaceutical industry is one of the most potential industry which has huge profit margins. Extensive growth and knowledge is required with frequent changes for better technology and results. Starting from early to the final stage there are gigantic chances of the product’s to face success or failure. Apart from these challenges, a large amount is invested to launch product in the market. In this entire process starting from drug designing to manufacturing, IPR plays an vital role. Intellectual Property Rights today are the most strategic and powerful asset of all large and Multinational Companies throughout the world, providing continued global market, economic dominance and profitability. Multinational companies decide mergers and acquisitions on the basis of Intellectual Property Assets. All companies irrespective of their size get their technology Patented/Registered which makes their assets safe for trading license, joint R&D/Production ventures, recognized globally.

Extension of Patent Life by Making Modification in Drugs

Pharmaceutical companies are playing smart by making slight modifications to their existing drugs in order to extend a patent life span which has resulted in calls for the government to not recognize process methods for patenting, and allowing only molecular patents.

Pfizer’s Caduet  is perfect example, It is a pill used for treatment of heart disease. Caduet is a simple combination of the blood pressure drug amlodipine besylate (marketed as Norvasc) and the cholesterol drug atorvastatin calcium (better known is Lipitor). Pfizer developed both Norvasc and Lipitor, with Lipitor holding the post of top selling pharmaceutical in the world for several years. Pfizer’s patent on Norvasc and Lipitor expired in 2007and 2011, respectively, but due to Pfizer’s existing patent on the molecules, no other manufacturers could produce a combination medication containing the molecules. Caduet conveniently entered the market in 2004.

 Another example is Prilosec, when the patent for Prilosec was near expiry, AstraZeneca in order to maintain the monopoly of the blockbuster drug Prilosec launched Nexium which was the same drug with minor changes in design and colour

Pharmaceutical R&D is an expensive and time consuming process which may take 8-10 years to complete. Companies are well aware of the time consumed in review and approval process by regulatory bodies before a new drug gets approval for marketing. So in order to recoup the considerable time and resources invested in the drug development and approval process the pharmaceutical companies depend on exclusivity provisions granted by the regulatory bodies.

There are many official and unofficial methods to extend term of a patent beyond 20 years wherein,

Official methods include provisions by some regulatory bodies such as Data exclusivity, Orphan drug exclusivity, Paediatric exclusivity and the 180-day exclusivity (Hatch Waxman Act, U.S. Food and Drug Administration), Supplementary protection certificate (European Medical Agency), whereas

Unofficial methods include altering or reformulate the existing compound to obtain a new patent by utilising polymorphism, creating combinations, stereo-selective/chiral switches, conversion to NDDS, OTC switching, authorised generics, etc. This article aims at highlighting the strategies used by Pharma giants to extend the term of their patent portfolio in order to maintain their monopoly for extended periods and the regulatory provisions in different countries to check these practices.

However, the Pharmaceutical Association of Malaysia (PhAMA) is arguing with government that modifications do make a difference because different salts carry different pharmacological properties which put forth different effects on patients. Moreover, different salts are patented alone as each carry different properties altogether.

As per PhAMA, nobody is able to predict which salt form is able to provide the desired therapeutic effects and both innovative and generic pharmaceutical companies do file their own patents which are further granted on the basis of novelty, inventive steps and industrial applicability.

After discovering a compound and registering it as a patent, a drug company has 20 years of protection for the patent where it will then carry out pre-clinical trials, and Phases 1 to 3 clinical trials, all which may take 10 to 12 years. After the trials, the company submits the results for product registration and the authority will evaluate the document.

Usage of Patented Technology in Pharma Industry

Pharmaceutical companies are usually at high-risk as once a drug has been successfully created, it is susceptible to being copied by third party through reverse engineering as pharmaceutical compounds can be easily imitated once they have been discovered hence, patent protects the rights of inventor and invention. It third party voids their rights, they are bound to undergo Legal consequences.

Chin says that a strong IP regime is critical for Malaysia to boost its competitiveness, especially to attract foreign direct investment while at the same time encourage technological advancement and innovation.

Conclusion

Since drug development carries unknown risks and extensive research and development which consumes several years. For example, a pharmaceutical company spends some years time getting Federal Drug Administration (FDA) approval for a drug. This means that when the drug comes up in the market, the patent could be good for only a few more years.

Some have considered whether it would be sensible to allow a solid 15 years of patent life after the drug has been cleared by the FDA. However, this is a complicated solution. Presently, drug companies already try to extend the patent life of their drugs as much as they can.

Most of the countries provide a 20-year exclusivity for a patented drug, so that innovator firm remits to undue practices such as evergreening in order to recover heavy costs incurred by them. These practices have become too aggressive with passing time.

Cooperative firms state to understand the pain of people and work for humanity, however are not in any way humanitarian in their approach, even though they pose to be, their sole motive is to hold their monopoly in the market and increase number of patents in their patent portfolios. To check this practice some countries have included certain provisions in their patent laws to extend the overall life of the patent so as to recover some of the time lost during regulatory processes, but in turn innovators firms have found loopholes in laws and even started exploiting these official provisions.

Author: Ms. Deepika Sharma, Sr. Patent Associate at Khurana & Khurana, Advocates and IP Attorneys. In case of any queries please contact/write back to us at  deepika@iiprd.com.

References:

[1]https://www.omicsonline.org/open-access/evergreening-in-pharmaceuticals-strategies-consequences-and-provisions-for-prevention-in-usa-eu-india-and-other-countries-2167-7689-1000185.php?aid=89371

[2]https://www.thestar.com.my/news/nation/2018/11/11/a-strong-ip-regime-is-critical-for-malaysia/

[3]https://www.upcounsel.com/how-long-do-drug-patents-last

[4]https://io9.gizmodo.com/5865283/three-sleazy-moves-pharmaceutical-companies-use-to-extend-drug-patents

[5]http://www.mondaq.com/india/x/387506/Patent/An+IP+Prospects+In+Pharmaceutical+Industry

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)

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.