Litmus Test: Natco's Applications for Compulsory License

Indian Patent Office has finally started proceedings over Natco’s applications for Compulsory License for anti-cancer drugs Tarceva and Sutent to be exported to Nepal under statutory provisions of section 92A of the Patents Act, 1970, also referred as “Doha-style provision.” Natco even reported to offer a five percent royalty to Roche for the generic Tarceva exported to Nepal. Interestingly, the Delhi Patent Office allowed hearing Roche and Pfizer over the issue, which prompted Natco to file an interlocutory petition saying that Roche/Pfizer should not be privy to the compulsory license hearing that takes place between the Patent Office and Natco. No idea which provision allowed Natco to make such an objection?

Reading section 92A, there is nothing explicitly mentioned about hearing will be allowed to patentee or not, but that even does not mean to exclude the possibility for hearing. This can further be supported by the rule 97(1) of the Patents Rules, 2003 which reads as –

If, upon consideration of the evidence, the Controller is satisfied that a prima facie case has not been made out for the making of an order under any of the sections referred to in rule 96, he shall notify the applicant accordingly, and unless the applicant requests to be heard in the matter, within one month from the date of such notification, the Controller shall refuse the application.

The rule clearly allows the Controller to consider evidence to judge a prima case for making an order under section 92A. Now the question is, how the Controller will decide is there a prima case for compulsory license or not? Only by hearing Natco (and may be doing some additional search over Google)? Obviously that will be unfair enough to do that, particularly when Nepal, till date, has made no notification to WTO Council about the importation of Tarceva under Doha-style provision from India. Having an import license from Nepal Drug Authority is not sufficient enough to establish a prima case for making an order for compulsory license under section 92A. In fact, the Controller has made fair and just decision to allow hearing Pfizer/Roche, which will build a transparency and creditability in Indian Patent System.

It would be interesting to know, who approached whom? Whether Nepal Drug Authority approached Natco for supplying the generic Tarceva in Nepal or Natco suggested Nepal Drug Authority to trigger Doha-style provision?

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· Sun Pharma Challenged J&J Drug patent: Sun Pharmaceuticals filed a post-grant opposition against Janssen’s Risperidone extended release version. Read.

· MNCs’ Diabetes Drug Patents Worry Experts: Business Standard reports exclusive story over diabetes drug patents in India. Read.

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Sun Pharmaceuticals Filed Post-Grant Opposition

Mumbai-based Sun Pharmaceuticals Ltd. has filed a post-grant opposition in respect to Indian Patent No. 208191 issued to Janssen Pharmaceutica N.V. against the mail-box Application No. 188/CAL/1995. The opposition was filed on January 02, 2008 with the Mumbai Patent Office, which last year in July (dated July 20, 2007) published the grant of the ‘191 patent under section 43(2) of the Patents Act, 1970. The ‘191 patent relates to sustained-release microparticle of risperidone.

Patent Granted for Antiretroviral Drug Raltegravir

Chennai Patent Office has lately issued an Indian Patent No. 212400 for antiretroviral drug Raltegravir against the mail-box application no. 868/CHENP/2004 claiming priority from US provisional application dated October 26, 2001. Last year in October, Merck’s received the market approval for Raltegravir by the US Food & Drug Administration. Globally marketed as Isentress, Raltegravir (earlier known as MK-0518) belongs to a new class of HIV drugs, integrase inhibitors, and is invented by Italian scientists working at Istituto di Ricerche di Biologia Molecolare P. Angeletti (IRBM), Rome-based drug discovery research center for human viral diseases and cancers.

Patent Granted for Anti-diabetic Drug Vildagliptin

Chennai Patent Office has lately granted an Indian Patent No. 212815 to Novartis for anti-diabetic drug compound Vildagliptin against the mail-box application no. IN/PCT/2001/779/CHE claiming priority from US provisional application dated December 10, 1998. Vildagliptin (earlier known as LAF 237) is second drug in the class of Dipeptidyl peptidase IV (DPP IV) inhibitors to reach to market, after Merck’s Sitagliptin which also received an Indian Patent No. 209816 two months back in December against the mail-box application no. 26/CHENP/2004. Globally marketed as Januvia, Sitagliptin recorded $ 668 million in worldwide sales in 2007 and is projected to reach $2 billion in annual worldwide sales by 2011. Lately, Vildagliptin got approval from European health authorities and is marketed under the brand name Galvus. In July 2007, Bristol-Myer also received an Indian Patent No. 206543 for Saxagliptin against the mail-box application no. IN/PCT/2002/01154/MUM. Bristol is likely to submit an NDA for Saxagliptin this year with the US FDA, possibly the third DPP IV inhibitor to gain market approval.

Gliptins Global Competition, Will Impact India Too II

Drug Name	WO Publication No.	Mail-box Application No.	Status
Sitagliptin	WO03004498	26/CHENP/2004	Patent Granted
Vildagliptin	WO0034241	IN/PCT/2001/779/CHE	Patent Granted
Saxagliptin	WO2001068603	IN/PCT/2002/01154/MUM	Patent Granted
Denagliptin	WO2003002531	1536/KOLNP/2003	Not Known
Melogliptin	WO2005033099	1039/MUM/2003	Pending

Sitagliptin

Starting with Merck’s Sitagliptin, “first-in-class” drug to reach to market and approved by the US Food & Drug Administration (FDA). Earlier referred as MK-0431, Sitagliptin is broadly covered within the markush chemical structure described in WO03004498 and corresponding Indian Patent No. 209816 issued to Merck & Co. against the mail-box application no. 26/CHENP/2004. Marketed as Januvia, Sitagliptin recorded $ 668 million in worldwide sales in 2007 and is projected reaching $2 billion in annual worldwide sales by 2011. Abstract of Sitagliptin mail-box application reads as –

The present invention is directed to compounds which are inhibitors of the dipeptidyl peptidase-IV enzyme ("DP-IV inhibitors") and which are useful in the treatment or prevention of diseases in which the dipeptidyl peptidase-IV enzyme is involved, such as diabetes and particularly type 2 diabetes. The invention is also directed to pharmaceutical compositions comprising these compounds and the use of these compounds and compositions in the prevention or treatment of such diseases in which the dipeptidyl peptidase-IV enzyme is involved.

Vildagliptin

Although Novartis’s Vildagliptin (earlier referred as LAF 237) was competing in parallel with Merck’s Sitagliptin, but later left out in race due to the US FDA concern and subsequent requests for additional safety data. Lately, Vildagliptin got approval by European health authorities and is marketed under the brand name Galvus. Vildagliptin is broadly covered within the markush chemical structure described in WO0034241 and corresponding Indian Patent No. 212815 against the mail-box application no. IN/PCT/2001/779/CHE claiming priority from US provisional application dated December 10, 1998. The abstract of Vildagliptin mail-box application reads as –

This invention relates to compound of formula (IA) or (IB) wherein R' represents hydroxy, C1-C7alkoxy, C1-Cg-alkanoyloxy, or Rs~N-CO-O-, where ~ and Rs independently are C1-C7alkyl or phenyl which is unsubstituted or substituted by a substituent selected from C1-C7 alkyl, C1-C7alkoxy, halogen and trifluoromethyl and where ~ additionally is hydrogen; or ~ and Rs together represent C3-Csalkylene; and R" represents hydrogen; or R' and R" independently represent C1-C7alkyl; in free form or in form of a pharmaceutically acceptable acid addition salt.

Saxagliptin

Bristol-Myer is likely to submit an NDA for Saxagliptin this year with the US FDA, making Saxagliptin possibly the third DPP IV inhibitor to gain market approval. Earlier referred as BMS-477118, Saxagliptin is broadly covered within the markush chemical structure described in WO2001068603 and corresponding Indian Patent No. 206543 issued to Bristol-Myer Squibb against the mail-box application no. IN/PCT/2002/01154/MUM claiming priority from US provisional application dated March 10, 2000. The abstract of Saxagliptin mail-box application reads as –

Dipeptidyl peptidase IV (DP 4) inhibiting compounds are provided having the formula (I) where x is 0 or I and y is 0 or 1 (provided that x = I when y = 0 and x =0 when y = 1); n is 0 or 1; X is H or CN; and wherein R1, R2, R3 and R4 are as described herein. A method is also provided for treating diabetes and related diseases, especially Type 11 diabetes, and other diseases as set out herein, employing such DP4 inhibitor or a combination of such DP4 inhibitor and one or more of another antidiabetic agent such as metformin, glyburide, troglitazone, pioglitazone, rosiglitazone and/or insulin and/or one or more of a hypolipidemic agent and/or anti-obesity agent and/or other therapeutic agent.

Denagliptin

Glaxo suspended the phase III studies for Denagliptin (earlier code name GW823093) due to toxicity problems, which is broadly covered within the markush chemical structure described in WO2003002531 and corresponding mail-box application no. 1536/KOLNP/2003 claiming priority from US provisional application dated June 27, 2001. The abstract of Denagliptin mail-box application reads as –

The present invention relates to novel compounds of formula (I): , their use for inhibiting serine proteases, such as dipeptidyl peptidases, such as dipeptidyl peptidase IV (DPP-IV) and to methods for their production and their therapeutic utility.

Melogliptin

Glenmark’s Melogliptin (earlier referred as GRC 8200) is currently in phase II studies, which is broadly covered within the markush chemical structure described in WO2005033099 and corresponding mail-box application no. 1039/MUM/2003 filed on October 03, 2003. The abstract of Melogliptin mail-box application reads as –

The present invention relates to novel dipeptidyl peptidase IV (DPP-IV) inhibitors of the formula (I), and their analogs, isomers, pharmaceutical compositions and therapeutic uses, methods of making the same.

Gliptins Global Competition, Will Impact India Too

Global market for diabetes drugs exceeds over $21 billion in 2006 and is still expanding rapidly due to the high prevalence of diabetes and lifestyle changes (WHO index) with India estimated to lead in numbers of diabetic population closely followed by China and the US. Such figures not only pushed drug research companies to expand their R&D pipelines for anti-diabetic drug candidates but also fuelled the competitive race among the drug companies to capture this cut-throat yet money-spinning segment and introduce new therapeutically superior drugs before the rivals’ potential drugs. One such area is emergence of new class of oral hypoglycemics which block enzyme dipeptidyl peptidase IV, particularly known as Dipeptidyl Peptidase IV (DPP IV) inhibitors. Also referred as Gliptins, DPP IV inhibitors are emerging drug class for the treatment of Type II diabetes. According to the industry analysts, DPP IV inhibitors has therapeutic and market potential to achieve blockbuster status.

Indian Patent Pipeline

Gliptins global competition is also reflecting in India, with mail-box applications pending with Indian Patent Office for most of the gliptins including Vildagliptin, Sitagliptin, Saxagliptin, Denagliptin and indigenously invented Melogliptin. Drug companies had surely done their homework over India’s diabetes facts & figures, and strategically moved to file patent applications in India. Let’s have a quick patent check for some of the important gliptins pending with/granted by Indian Patent Office.

To be continued …

Patent Circle Building Gravity

Brett Trout of BlawgIT lately posted his Patent Meme mentioning that “there are lots of blogrolls out there, but almost all include non-patent related blogs or patent blogs which have not been updated for months.” Stating, “if only I could have a link to all the important patent law blogs in one place”, Brett listed down his important patent law blogs which also include Patent Circle. This is obviously a great feeling and a sense of pride that fellow US patent attorney recognize Patent Circle as one of the important patent law blogs and includes in likes of Patent Baristas (my favourite), Patent Docs (top-class), Orange Book Blog (not to be missed), Patently-O (extraordinary) and Patent Prospector (best in the class). Thank you Brett for recognizing and including Patent Circle in your invaluable p-meme!

Not only fellow bloggers are recognizing the spirit of Patent Circle, but also India’s leading business newspapers are keeping track of our interesting posts. India’s premier business newspaper Economic Times has lately covered a story on antiretroviral drug Etravirine, which brought into notice by one of our earlier posts. Earlier, another leading business newspaper Business Standard covered a story on global pharma seeking cancer drug patents, which was also moved by one of our earlier post. Even, Business Standard covered an exclusive story on bloggers driving India’s IPR regime and recognized Patent Circle as one of the blog for separating the wheat from the chaff in the flood of intellectual property related information.

We would like to thank all our readers for their support, encouragement and involvement. We are committed to contribute to the area of patents, will continue to bring latest updates, critical analysis and unbiased stories from the world of patents and will keep building presence of India’s first patent law blog on the global platform. We surely appreciate your views, comments and suggestions on any of our posts. Your feedback not only helps identifying our low points but also encourage pushing the envelope to make Patent Circle a reliable and authentic source. If you feel Patent Circle has managed to build a niche and has contributed to add value to your knowledge and information base, please do let us know at chhonkar.varun@gmail.com or seemasingh.patentlawyer@gmail.com.

Ranbaxy Filed Post-Grant Opposition for Valganciclovir

Ranbaxy has filed a post-grant opposition at Chennai Patent Office under section 25(2) of the Patents Act, 1970 against the grant of Indian Patent No. 207232 (read our earlier post) to Roche for Valganciclovir, questioning the validity of the patent on ground of enhanced efficacy under section 3(d). Earlier, during pre-grant opposition period Mumbai-based NGO Lawyers Collective contested the patent grant but the Chennai Patent Office later granted patent without hearing the opposition filed by Lawyers Collective. The ‘232 patent is having priority prior to 1995, which probably makes Valganciclovir a pre-1995 drug compound to be patented in India.

USD 20 billion going off-patent

About 11 leading drugs, including four blockbuster drugs worth USD 29 billion are going off-patent this year in the US reports Reghu Balakrishnan from Financial Express. For full story read A $20 billion American generic market awaits Indian players.

Merck Generic Promotion

Just came across an interesting article about Merck’s promotional strategy to consolidate generic space for Fosamax, before its key indication patent expired. Read The Wacky World of Generics: Fosamax Edition.

Patent Granted for Anti-inflammatory Drug Lumiracoxib

Novartis has received an Indian Patent No. 208639 for anti-inflammatory drug Lumiracoxib against the mail-box application no. 1927/MAS/1998 filed on August 27, 1998 claiming early priority from US provisional application dated August 28, 1997. In November 2006, Lumiracoxib, marketed as Prexige received marketing approval from all European Union countries through a common procedure called MRP, but later on December 13, 2007 the European Medicines Agency recommended the withdrawal for Prexige from all EU market. Earlier, on September 27, 2007, the US Food and Drug Administration issued a not approvable letter for Lumiracoxib, requiring additional safety data. Lumiracoxib, a COX-2 selective inhibitor is broadly covered within the markush compound structure described in the US Patent No. 6,291,523. The corresponding European Patent EP 1 007 505 already been granted Supplementary Protection Certificate in most of the contracting states, running exclusivity till September 2018. The drug is also recalled in Australia, New Zealand, Philippines, and Canada. In January 2006, Novartis received Drug Controller General of India (DCGI) approval to import and market Prexige, but later announced to drop marketing plans for Lumiracoxib in India due to the growing concerns about its adverse side effects.

Patent Granted for Antiretroviral drug Etravirine

United States Food & Drug Administration lately approved a new antiretroviral drug Etravirine chemically 4-[[6-amino-5-bromo-2-[(4-cyanophenyl) amino] -4-pyrimidinyl] oxy] -3, 5-dimethylbenzonitrile marketed by Tibotec Pharmaceuticals Ltd. (a subsidiary of Johnson & Johnson) under the brand name Intelence. Etravirine (clinically known as TMC125) is broadly covered within markush pyrimidine structure described in US Patent Nos. 6,878,717 (indication patent) and 7,037,917 (basic compound patent), and also granted an Indian Patent No. 204028 against the mail-box application no. IN/PCT/2001/00436/MUM filed on April 20, 2001 claiming early priority from US provisional application dated November 10, 1998. Etravirine was designed by Belgian scientists to reduce drug resistance, partly by making a flexible molecule that can fit in the active pocket of HIV’s reverse transcriptase in different ways, even when the shape of that pocket changes because of viral mutations that would defeat other drugs (read).

Adieu to Fosamax, Camptosar Next to go Off-patent

Merck & Co. bids adieu to blockbuster osteoporosis drug Fosamax, which finally runs out patent protection, putting end Merck’s windfall $ 1.9 billion US market. Teva & Barr Laboratories launched the generic versions of Fosamax after receiving final approval from the US Food and Drug Administration and will jointly share 180-day market exclusivity. Under an agreement deal with Merck, Watson will launch an authorized generic to compete and share market space with Teva and Barr. Pfizer’s anti-cancer drug Camptosar worth over $ 500 million US sales is next to lose patent protection for its drug compound Irinotecan hydrochloride on February 20. In October 2007, Dabur Pharma received the tentative approval for generic Irinotecan from the US FDA.

Ignoring not the solution

Just came across an interesting article by D Ravi Kanth ‘Drug Capitalism’ pointing out the concern for affordable drugs to poor consumers, but what really caught my attention is, what Kanth pointed to be moot issue, whether the gap between those who invest billions of dollars to develop new medicines and those who need them most, particularly, the poorest of the poor, is bridgeable.

Undeniably, this is the core issue that need utmost attention across the globe including India, but unfortunately the issue is made diluted by raging politics over ‘Patients or Patents’.

Watson Authorized Generic For Merck's Osteoporosis Drug

Merck’s blockbuster osteoporosis drug Fosamax will lose patent protection tomorrow with the expiration of Orange Book listed US Patent No. 4,621,077, losing significant $ 1.6 billion US market to generic competition. Earlier in January, Merck announced to sign a deal for an authorized generic but did not disclose the name of its partner. Finally, it is Watson Laboratories that will be selling the authorized version of Fosamax. Barr Pharmaceuticals and Teva Pharmaceutical Industries are also expected to launch generic versions Fosamax this week.

Wockhardt Received Patent For Antibacterial NCE

Mumbai-based biotech company Wockhardt has recently received an Indian Patent No. 213142 for antibacterial NCE against the mail-box application no. 3/MUMNP/2005 filed on July 10, 2003. The published abstract of the application (u/s 11A of the Patents Act, 1970) reads as –

The present invention provides agents having high antimicrobial activity for preventing and treating infectious diseases. Thus, the present invention provides novel cyano-(substituted)-methylenepiperidinophenyl oxazolidinone derivatives, processes for making the compounds, as well as antimicrobial compositions containing said derivatives as active ingredients and methods of treating bacterial infections with the said derivatives.

Referring corresponding PCT publication WO2004007489, the antibacterial compounds are cyano-(substituted)-methylenepiperidinophenyl oxazolidinones. Interestingly, Wockhardt is having a strong research pipeline for anti-bacterial drug targets, with few already in clinical trails which include phase II WCK 771 (arginine salt of S (-) nadifloxacin), phase I WCK 2349 (oral prodrug of WCK 771), phase I WCK 1152 (enantiomer of another drug target WCK 919). Wockhardt’s other antibacterial drug targets in preclinical trails include WCK 2370, WCK 2664, WCK 1734, WCK 919 and WCK 1153 (enantiomer of WCK 919).

Merck dropped Melogliptin

Yet another indigenously discovered and invented anti-diabetic clinical drug candidate lost strategic and financial backup from the research-based company with Merck backing out to support co-development and commercialization of Glenmark’s phase II drug candidate Melogliptin (GRC 8200). The decision came after Merck’s decision to re-focus its portfolio and not to invest further in diabetes research and development. Earlier in 2003 and 2004, Novo Nordisk backed out from Dr. Reddy’s phase III anti-diabetic drug Ragaglitazar (DRF-2725) due to risk assessment and phase II anti-diabetic drug Balaglitazone (DRF-2593) due to lack of competitive advantage. Also, in 2003 Novartis discontinued development of anti-diabetic drug (DRF-4158) which Dr. Reddy’s out-licensed to Novartis in 2001. Later Dr. Reddy’s entered into co-development and commercialization agreement with Rheoscience for Balaglitazone, which is currently in final phase of clinical trial. Schwarz Pharma, in 2004, discontinued development of Ranbaxy phase II prostate drug Pamirosin (RBx 2258) whereas last year Medicines of Malaria Venture (MMV) lost interest in Ranbaxy’s phase II anti-malaria drug Arterolane.

Deals Still in Progress

In 2004, Torrent out-licensed a cardiac drug molecule (TRC 4XXX) to Novartis and Glenmark out-licensed an asthma drug Oglemilast (GRC 3886) to Forest Labs.

Cytopia Received Patent for JAK Kinase Inhibitors

Australian-based biotech drug discovery company Cytopia Pty Ltd. has lately received an Indian Patent No. 214081 (the ‘081 patent) for disubstituted pyrazine compounds having protein kinase, particularly Janus kinase (JAK) inhibitory activity. The ‘081 patent is issued against the mail-box application no. 1743/KOLNP/2004 dated November 17, 2004, claiming earliest priority from an Australian provisional application dated May 23, 2002. The published abstract of the Indian application (u/s 11A, the Patents Act, 1970) reads as –

"A compound of the general formula (I) or pharmaceutically acceptable salts, hydrates, solvates, crystal forms or diastereomers thereof is described. A method of treating protein kinase-associated disease states using the compound of formula (I) is also described."

Referring corresponding US Patent No. 7,259,179, the disubstituted pyrazine compounds are used to treat protein kinase-associated disorders which result from aberrant protein kinase activity, in particular JAK activity and/or which are alleviated by inhibition of one or more of these enzymes. Further referring that the term ‘JAK’, ‘JAK kinase’ or ‘JAK family’ refers to protein tyrosine kinases which posses characterizing features of JAK1, JAK2, and JAK3.

Cytopia has few other pending applications with Indian Patent Office for drug targets in same class of JAK inhibitors to treat immune diseases and cancer.

1. 1748/KOLNP/2004 – Protein Kinase Inhibitors
2. 845/KOLNP/2006 – Selective Kinase Inhibitors
3. 616/KOLNP/2006 - Azole-based Kinase Inhibitors

In June 2006, Cytopia signed a licensing deal with Novartis to develop JAK3 inhibitor compounds for the prevention of transplant rejection and the treatment of multiple indications of autoimmune diseases. Under the deal Novartis will pay Cytopia approximately $ 9.5 million over three years including an up front payment and research funding. Over the life of deal Cytopia may also become eligible to receive development, regulatory and sales milestones which could total approximately US $ 205 million if an agreed number of multiple indications are successfully commercialized. Cytopia will also receive royalties on product sales.

Cytopia lately announced that its lead JAK2 inhibitor compound CYT387 demonstrated potent activity in cells isolated from patients with myeloproliferative disorders (MPDs). Till date, none of Cytopia’s JAK inhibitors is in any phase of clinical trials, but Cytopia’s anti-cancer lead drug CYT997 has already received IND status by the US FDA and likely to reach phase II trials. CYT997 belongs to class of cancer drugs known as Vascular Targeting Agents (VTAs) and is modified version of another compound CYT490. The application no. 847/KOLNP/2006 for CYT997 is pending with Kolkata Patent Office and was published in the Patent Office Journal in April last year.

Novartis Strategic Move

In a major development, the Thai Government has decided not to issue a compulsory license on anti-cancer drug Imatinib Mesylate after Novartis strategically agreed to provide free Imatinib to cancer patients’ having a household income less than 1.7 million baht (US $ 51,515) per year under the government-sponsored Universal Health Insurance Programme. The drug will be provided free through the Glivec International Patient Assistance Programme (GIPAP) managed by Max Foundation. Describing the agreement as “win-win situation” for patients and the company, Dr. Vichai Chokevivat, advisor to the public health minister and chairman of the Public Health Ministry’s committee on compulsory license, praised Novartis for its decision. According to Chokevivat, the Universal Health Insurance Programme covers 48 million people of Thailand’s 63 million people. He further pointed out two other healthcare schemes – the social security scheme for employees of private companies and the healthcare scheme for civil servants - could afford Imatinib at market price (3,600 baht per tablet) for their patients. This strategic decision will not only allow Novartis to avoid enforcement of compulsory license, but also continue selling patented Glivec to patients in Thailand who can afford the market price.

Although Novartis made no comment on the deal, but obviously the decision has great strategic value. Firstly, the patent for Imatinib will not be overridden by the compulsory license and secondly, generics will not be allowed in Thailand. The later having the more strategic significance, as it will keep generics off-market till patent expires. Remember, the strategic value of patent protection is to keep competition out of the market. The whole episode will surely bring some praise to Novartis philanthropy and keep Generics note of such strategies, it can surely work out in favour of research-companies and make them poor-patients’ better friends (free drugs hmm … interesting).