Data Exclusivity Drug Regulation Innovation Patent

Ranbaxy finally gets approval for Synriam – Can it keep out the competition?


imagesThe Mint and other Indian media outlets have reported that India’s drug regulator has finally given marketing approval to Ranbaxy for its new anti-malarial drug Synriam. We had previously blogged about Synriam over here, here and here.

The drug is a Fixed Dose Combination (FDC) of “arterolane maleate 150 mg and piperaquine phosphate 750 mg drug”. Arterolane was invented by a global team headed by Prof. Vennerstrom consisted of researchers from University of Nebraska (USA), Monash University (Australia), the Swiss Tropical Institute & Hoffman La Roche. The initial research was funded and co-ordination by the non-profit Medicines for Malaria Venture (MMV), which also owns the Indian patent for the drug – IN 245779.

MMV had reportedly invested closed to $20 million dollars in the project. Ranbaxy and MMV had signed a MoU, almost a decade ago for the development of this drug before parting ways in 2007. Thereafter both parties went their own way but not before MMV gave Ranbaxy a royalty free licence to exploit the patent for Arterolane worldwide. After this split Ranbaxy reportedly invested about $30 million dollars of its money along with a $1 million dollars contribution from the Department of Science & Technology (DST) for carrying out extensive Phase III clinical trials in India under Professor Neena Valecha. The Phase III clinical trials were reportedly successful last year and Ranbaxy had announced the launch of the drug on April 25, 2012 – World Malaria Day.

It has taken more than a year since then for Ranbaxy to get a final go ahead from the Indian drug regulator. The launch of Synriam is certainly a landmark event for the Indian drug industry but it also raises the question of IP protection for the drug in question. Will MMV be ready to licence the drug to other Indian generics willing to manufacture the drug? More importantly will MMV willingly to sue any other Indian company which decides to manufacture the drug without permission? Most importantly though, how does Ranbaxy intend to protect its $30 million dollar investment in the drug, if MMV is reluctant to enforce its patent, especially since India does not have a data exclusivity law which would have otherwise protected Ranbaxy’s investment?

Prashant Reddy

Prashant Reddy

T. Prashant Reddy graduated from the National Law School of India University, Bangalore, with a B.A.LLB (Hons.) degree in 2008. He later graduated with a LLM degree (Law, Science & Technology) from the Stanford Law School in 2013. Prashant has worked with law firms in Delhi and in academia in India and Singapore. He is also co-author of the book Create, Copy, Disrupt: India's Intellectual Property Dilemmas (OUP).

4 comments.

  1. AvatarAnonymous

    Thanks for this information Prashant. New molecules seeing the light of the day is great news. I checked the file wrapper of the Indian Patent 245779. Seems there is no license uploaded or may be the same has not been notified to the IPO as required under s. 69 of the Patents Act. Correct me if I’m wrong. From your previous posts, I’ve known you quite pro-actively look for these things. Have you missed fishing on this one?

    Reply
  2. Prashant ReddyPrashant Reddy Post author

    Hi Anon,

    I did try to check the e-register for this particular patent but the page wasn’t loading – it is usually the Register which reflects whether the patent has been licensed. From what I understand, the Patent Office has not been putting up scanned copies of patent assignment documents submitted to it under Section 69.

    Best,
    Prashant

    Reply
    1. AvatarAntara Kapoor

      The Form 27 for 2012 is also silent on the licence. It actually also states that the patent was not worked due to ongoing clinical trials.

      Regards,

      Antara

      Reply
  3. AvatarJoseph Christie, Ph.D.

    Mr. Prashant Reddy,
    The concluding remarks about Ranbaxy’s modus operandi is NOT conclusive. No wonder they have been running into all sorts of problems, violating the strict protocols of FDA, regarding the manufacture and export of India-made to USA , Your, “Most importantly though, how does Ranbaxy intend to protect its $30 million dollar investment in the drug, if MMV is reluctant to enforce its patent, especially since India does not have a data exclusivity law which would have otherwise protected Ranbaxy’s investment?:”: will NOT elicit a response from Ranbaxy, as has been my experience in getting information on the loudly touted anti-malarial. Here are my letters to key people in this antimalarial launch by Ranbaxy,
    1, To Mr. Raghu Kochar
    Director – Corporate Communications
    Ranbaxy Laboratories India Limited
    Gurgaon, India

    Dear Mr. Kochar:
    Now that the fanfare and hoopla surrounding the launch last month of your combination antimalarial drug Syniram® must have fizzled out, as an educated investor I am writing this investigative enquiry to seek additional information to supplement what has appeared in the printed media and your own communications.
    In your Corporate communications it is stated, “It is indeed gratifying to see that Ranbaxy’s scientists have been able to gift our great nation its first new drug, to treat malaria, a disease endemic to our part of the world. SynriamTM will certainly become the preferred option in the hands of doctors to fight malaria, which every year claims more than half a million lives globally. This is a historic day for science and technology in India as well as for the pharmaceutical industry in the country. Today, India joins the elite and exclusive club of nations of the world that have demonstrated the capability of developing a new drug.”, said Mr. Arun Sawhney, CEO and Managing Director, Ranbaxy.
    The bold-faced parts above are deceptive as well as misleading, and they clearly contradict the following statement from your Company:
    “Ranbaxy Laboratories Limited, India’s largest pharmaceutical company….… Ranbaxy is a member of the Daiichi Sankyo Group. Through strategic in-licensing opportunities and its hybrid business model with Daiichi Sankyo, a leading global pharma innovator headquartered in Tokyo, Japan,…….”
    Notwithstanding these facts, the Hindu reported in it’s article, “Native anti-malaria drug launched” that” The drug, launched by Health Minister Ghulam Nabi Azad in the presence of Science and Technology Minister Vilasrao Deshmukh, has been developed by the company in collaboration with the Department of Science and Technology and supported by the Indian Council for Medical Research…. The company has spent close to $ 30 million on research and development of the drug, of which the Government of India contributed a total of Rs. 5 crore”.
    My comments in the Hindu are produced below:
    “The comments by most readers made me realize how that half-baked or little knowledge is dangerous. Ranbaxy is NOT an Indian company anymore, just like Hindustan Levers or Proctor and Gamble are not, notwithstanding their Indian subsidiaries. As simple as that. This should answer Vekat’s inquiry, “Is Ranbaxy a Indian Pharma Co. now?)” The statement by Raman, that ” Synriam is a two component medication, whose one component is an analog inspired from artemisisnin.” is blatantly false. IT is NOT an analog, which in organic chemistry is a very restrictive word. The only STRUCTURAL COMMONALITY between the plant-derived Artmissinin and the basic component, arterolane , of Synriam® is both of them have an “OZONIDE” functionality. Finally, most of the R&D and chemical synthesis etc of the key ingredient arterolane maleate were, presumably, done at the University of Nebraska, Nebraska, and there are plenty of publications in chemical literature to lend credence to this fact.”
    Besides, excerpts of the following comment by Mr. Babu Tekwani is more to the point that I have raised, and R&D-specific:
    “ I hope the drug is not restricted to use in India only, meets global standards and becomes available in other malaria afflicted countries…. This is a combination of two drugs….and arterolane (not an artemisinine analog as mentioned, but inspired from endoperoxide structure of artemisinin). Arterolane, the new antimalarial component of this combination was ORIGINALLY DESIGNED AND MADE by Dr Jonathan Vennerstrome at the University of Nebraska US. A note acknowledging his contribution and subsequent support by the Medicines for Malaria Venture (a nonprofit PPP at Geneva) was important. MMV support brought Arterolane to stage of clinical trials”.
    Now that Mr. Tekwani has pointed out the pioneering role of Prof. Vennesrstome in the R&D and synthesis of Arterolane, I wonder why Ranbaxy in none of its statements did not mention or acknowledge this fact. All the pronouncements by Ranbaxy, it seems, were meant to inveigle the Indians and more importantly, the Indian Government, by stirring up false jingoistic support for tits new product, SynriamTM.
    The recent Reuters report, “Probe uncovers serious problems with India’s drug regulator” lends another dimension to the question of the Central Drugs Standard Control Organization (CDSCO), which oversees the licensing, marketing and trials of drugs in India. (http://www.reuters.com/article/2012/05/09/india-drugs-idUSL1E8G92K420120509),
    My recent correspondence with Dr Jonathan Vennerstrome is enclosed for your information.

    Sincerely yours,
    Joseph Christie

    2, To the Scientist who made the drug and got the Patent (licensed to Ranbaxy?)
    Professor Jonathan L. Vennerstrom
    College of Pharmacy, University of Nebraska Medical Center
    Nebraska Medical Center
    Omaha, Nebraska 986025

    Subject: Your papers titled, “ Structure-Activity Relationship of the anti-malarial
    Ozonide Arterolane (OZ78)” J. Med. Chem.,2010, 35 (10), pp 481-491
    & “ Identification of an anti-malarial synthetic trioxolane drug development
    Candidate”, Nature, 2004 Aug 19;430(7002):900-4.
    Dear Dr. Vennerstrom:

    I came across your above two interesting publications (only abstracts) on the internet yesterday. As one who was with Parke, Davis& Company in India during the early 1960s, I was fairly conversant with the tropical epidemic, benign tertian or Plasmodium vivax and malignant tertian P. falciparum malaria, since the Company was the leading producer of Camoquin (amadiaquin) and Camoprima ( a camoquin plus primaquin drug).

    I am a retired synthetic organic/medicinal chemist now, having worked both in academia and in chemical industries in the US. I live in Asia (Thailand) now, and the recent news of the Indian drug Company, Ranbaxy Laboratories, launching its “new” anti-malarial drug Syniram® ONLY in the Indian market to start with, came as a pleasant surprise to me. In my Parke-Davis days in mid 60s, Ranbaxy was a mere “mom and pop” company, mostly an imitator of other’s drugs. Thus, the claim by, Mr. Sawhney, it’s CEO, that “This is a historic day for science and technology in India as well as for the pharmaceutical industry in the country. Today, India joins the elite and exclusive club of nations of the world that have demonstrated the capability of developing a new drug.”, piqued my curiosity in the product all the more.

    What struck me most was the fact that very little scientific information was/is available on Syniram®, except the following statement:

    “The new drug, which will be marketed first in India, is developed as a fixed dose combination consisting of arterolane maleate 150 mg and piperaquine phosphate 750 mg drug, in line with World Health Organization recommendations. It is among the best options available today. I applaud the success of R&D at Ranbaxy in the creation of this New Age Cure for Malaria and am sure that innovative drug products will continue to be developed at Ranbaxy-R&D labs, even in the future.”

    Search for information on these two key ingredients naturally led to your above two papers. I would very much appreciate your sending by e-mail the entire papers plus any additional information such as Patents etc. on Arterolane etc.

    Thank you.

    Sincerely yours,
    Joseph Christie, Ph.D.

    I rest my case as far as Ranbaxy is concerned.

    Reply

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