Category Archives: pharma

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.

Germany’s Boehringer Repudiated Patent on HIV Drug- Nevirapine

The Indian Patent Office has repudiated Germany’s Boehringer Ingelheim patent on its key HIV drug- Nevirapine, Patent Application Number: 4724/DELNP/2009 entitled “Extended release formulation of Nevirapine”, for a version sold as Viramune XR (extended release), once again forestalling attempts by Big Pharma for “exclusivity” extension on their patented drugs to reportedly block entry of reasonably priced generics.

Boehringer Ingelheim, one of the few family-owned pharma company globally, is working on biosimilars, immuno-oncology and, new treatment options for psychiatric disorders like forms of depression or schizophrenia etc. Globally, it has a strong pipeline in oncology, respiratory, stroke and diabetes prescription medicines – all of which are of importance to the demographics in India, and some of which have already been launched in India. At present, the company has several patented drugs in the domestic market – Xovoltib (afatinib), two biologics Metalyse and Actilyse, Pradaxa anticoagulant, and two diabetes medicines named Trajenta and Trajenta duo.

Some Facts

Boehringer Ingelheim had filed a patent application (application number: 4724/DELNP/2009) in India on extended release of the HIV drug on 20th July 2009, against which, Cipla had filed a pre-grant opposition in 2011, and later on launched its generic version.

Reportedly, the applicant (Boehringer) did not respond to the pre-grant opposition and also did not appear at the hearing fixed for the same on September 15, 2015. N R Meena, deputy controller of Patents & Designs, said in the order, since the applicant did not appear in the hearing fixed under section 25(1) before the controller, and no arguments were offered to rebut the objections raised in the FER (first examination report), and by the opponent, the application for grant of patent is refused.

Objections raised in the First Examination Report (FER)

Some of the below mentioned objections were raised in the first examination report (FER):

  1. Claims1-7, 8-10, 11-14, 15-20 and 21-24 are rejected u/s 3(e) of the Patents (Amended)Act, 2005 as the said claims define a mere admixture resulting only in aggregation of the properties of components thereof.
  2. It is not clear if thecombined agents act together to provide a technical effect that is greater thanjust the sum of the two or more agents alone, or whether the combination is in fact a mere juxtaposition with no interaction of the agents.
  3. Claim 1 and dependent claims thereof do not constitute an invention under section
    2[1(j)] of Patents Act 1970 (as amended in 2005) as the claims lack inventive step in view of following patent documents:
  • US2002/0006439
  • WO00/035419
  • WO2007/047371
  • US2002/0068085

Grounds of Opposition

Some of the grounds of opposition that were raised and relied upon by the opponent in the pre-grant opposition include:

  1. Section 25(1)(e): Obviousness and Lack of Inventive Step

Opponent had presented numerous prior arts to demonstrate obviousness and lack of inventive steps for the claims of the impugned application.

  1. Section 25(1)(f): Not Patentable/ Not an Invention –
  • Claim lack inventive step under Section 2(1)(ja)

The claims of the impugned application falls under section 2(1)(ja) i.e. being devoid of inventive step. The definition of inventive step states that the invention should be a technical advancement over the prior art or it should show economical significance or both and should not be obvious to a person skilled in the art. It was also stated that the alleged invention is neither a technical advancement nor does it give any economic significance.

  • Claims not a invention as per section 2(1)(ta)

The challenged invention falls under Section 2(1)(ta), being devoid of inventive step as according to the definition of ‘pharmaceutical substance’.

  • Claims not patentable as per Section 3(d)

The alleged pharmaceutical product (dosage form) as claimed in the impugned patent application does not provide any additional advantage or therapeutic efficacy over the form(s) known in the prior art i.e. 400 mg immediate release form or 200 mg immediate release form.

  • Claims not patentable as per Section 3(e)

The claimed invention i.e. claims 1 and 2, falls under the Section 3 (e) which clearly states that a substance obtained by a mere admixture results only in a aggregation of properties of components thereof is not patentable. The alleged invention in the impugned patent application is a mere admixture of nevirapine and conventional excipients for extended release for once-daily administration without any demonstration of improvement over the prior art.

Previously, an objection under section 3(e) to the dosage form (pharmaceutical product) in claims 15 and 21 of the original claims was also raised in the First Examination Report.

  1. Section 25(1)(g): the complete specification does not sufficiently and clearly describe the invention or the method by which it is to be performed

Conclusion

After hearing all the parties and considering all facts, the Controller denied patent on HIV drug under Section 3(d) of Indian Patent act.

Please refer to the link (http://goo.gl/uw21Kh) for further information.

About the Author: Sugandhika Mehta, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at:sugandhika@khuranaandkhurana.com.

Delhi High Court Upholds Roche’s Patent Claims on Lung Cancer Drug (Tarceva) against Cipla

A division bench of Delhi High Court on 27th Nov 2015 held that the Indian drug manufacturer Cipla infringed Swiss pharmaceutical company Roche’s patent on Erlotinib hydrochloride, marketed under the name of “Tarceva”.

Roche was granted a patent in India on Erlotinib hydrochloride (Tarceva) in 2007. Roche sued Cipla for patent infringement in January 2008 soon after Cipla announced its intent to launch a generic version of Erlotinib (i.e. Erlocip) at Rs.1,600 per tablet, compared to Roche’s selling price of Rs.4,800 per tablet.

The verdict came on the pleas of Cipla and Roche, both of which had challenged the single judge’s order of September 7, 2012. The single judge in his order had held that Cipla was not infringing Roche’s patent and refused to grant any injunction against Cipla, and it allowed the Indian drug firm to continue selling its generic product, Erlocip. The judge had also refused to revoke the patent of the Swiss company as sought by Cipla.

A division bench of justices Pradeep Nandrajog and Justice Mukta Gupta held that the single judge “erroneously compared the products of Roche and Cipla when he ought to have mapped the claims of the suit patent against Cipla’s product”.

Cipla in its plea had urged that while the patent sought to be enforced was for polymorphs A+B of Erlotinib hydrochloride, the product under manufacture by both Roche and Cipla was polymorph B, which ought to be assumed to be in the public domain and, hence, the Indian company’s activities were non-infringing in nature.

Roche in its plea had contended that the basic patent was not confined to any polymorphic form of Erlotinib hydrochloride and, hence, as long as the compound was present in Cipla’s product Erlocip, it infringes the patent.

The division bench in its decision held that:

“This (the patent claim) is a sufficiently broad claim that is clearly not limited to any polymorphic version of erlotinib hydrochloride, but to erlotinib hydrochloride itself,”. “This compound may exist in several polymorphic forms, but any and all such forms will be subsumed within this patent. Therefore as Cipla’s Erlocip is admittedly one particular polymorphic form of the Erlotinib Hydrochloride compound (Polymorph B), it will clearly infringe IN’774 patent.”

The court, however, refused to issue any injunction against Cipla restraining it from manufacturing the medicine, after observing that the life of the patent granted to Roche was ending in March 2016. However, the Court has directed Cipla to render accounts to Roche and make payment for the patent infringement.

“…keeping in view the fact that the life of the patent in favour of Roche in India would expire in March, 2016 we do not grant the injunction as prayed for by Roche against Cipla (because as noted above there was no interim injunction in favour of Roche and due to said reason Cipla continued to manufacture and sell Erlocip),” held court.

Also, the division bench in its 106-page judgment said that as Cipla “could not establish prima facie that the suit patent was obvious”, its plea for invalidating Roche’s patent on the ground of ‘obviousness’, “fails”. In addition, Cipla had demanded Roche’s patent be revoked under Section 3(d) of the Indian Patent Act that essentially bars incremental innovations unless significant efficacy is proven.

Bringing clarity to Section 3(d), the judges wrote: “We understand Section 3(d) as a positive provision that in fact recognizes incremental innovation while cautioning that the incremental steps may sometimes be so little that the resultant product is no different from the original. The inherent assumption in this is that infringement of the resultant product would therefore be an infringement of the original i.e. the known substance and by no stretch of imagination can Section 3(d) be interpret as constituting a defence to infringement.”

Roche welcomed the decision of the Court which upheld the patent covering Erlotinib hydrochloride (Tarceva) and found Cipla to have infringed it.

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