Patent

Patent war intensifies: Glenmark launches generic version of Merck’s Januvia



As reported by Rupali Mukherjee of Times of India, in a move which will transform the landscape of the Indian pharma industry, Glenmark has launched a cheaper generic version of pharma multinational Merck’s blockbuster anti-diabetes drug Januvia (Sitagliptin phosphate). The generic vs. innovator battle earlier restricted to anticancer and anti-retroviral meds has now entered uncharted territory; just when you thought things couldn’t get any murkier! 


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Numbers and market dynamics: 
Owing to obesity and lifestyle changes, India has acquired the dubious distinction of becoming world’s diabetic capital followed closely by China. Emerging markets like India offer huge untapped potential and opportunity for anti-diabetic drug launches. According to this IMS report, the market for non-insulin diabetes treatments has experienced strong growth over the last decade, averaging 9.5% over the past five years. 
Traditionally, therapies for Non-Insulin dependent diabetes was dominated by relatively old and off- patent drugs primarily comprising biguanides (metformin) and sulfonylureas. For majority of type II diabetics, since medications have to be taken daily to achieve glycemic control, drug resistance is a major challenge. Thus there is a therapeutic void which generates demand for novel anti-diabetic product classes. Dipeptidyl peptidase-4 inhibitors (DPP-4) or what is known as “gliptins” offered a new alternative in the treatment pathway. 
Among the DPP-4 inhibitors/gliptins, Merck’s Januvia (Sitagliptin) and Novartis’s Galvus (Vildagliptin) are India’s first patented oral anti-hyperglycemics. In India, Merck’s Januvia was launched in April 2008, few months before Novartis’s Galvus was launched in Sept 2008. Merck and Novartis also partnered with domestic pharma companies to take advantage of local sales force to increase market penetration. Novartis joined forces with domestic generic USV to promote Galvus. Under an India-specific agreement, Merck partnered with Sun Pharma to launch local brand Istamet .In addition Merck also continued to market Sitagliptin in India under the Januvia brand. Januvia is touted as the undisputed leader among the gliptins with the brand accounting for about 80% of worldwide sales for anti-diabetic monotherapy. In India the gliptins market share is estimated at about 500 crore! 
Patent status and launch of generic version by Glenmark 
A very cursory patent check (IPO) reveals that Merck’s Januvia is protected by two patents in India viz. IN209816 and IN219148. IN209816 is a product patent which specifically covers Sitagliptin. IN219148 claims process intermediates used in the manufacture of Sitagliptin. Apart from this, Merck had filed a patent application 5948/DELNP/2005 covering the phosphate salt form and enantiomers of Sitagliptin, but this patent application was abandoned following a pre-grant opposition. Apart from this, Merck is pursuing two patent applications which specifically cover Janumet extended release (sitagliptin+metformin combo). 
According to the Times of India article, a Glenmark official confirmed the launch of generic version of sitagliptin and said “”Glenmark is a responsible company and has launched the products after due diligence and research. Like other branded generics, Glenmark’s Zita & Zita-Met are also branded generics.” Further according to the article, Glenmark states that its product is “non-infringing” on Merck’s drug. 
First of all, the question of infringement should be evaluated against patent claims and not against innovator’s products. Also, one wonders how one can be non-infringing to a product patent? 
Pricing scenario: 
Januvia and Janumet are once daily prescription pills. As per CIMS Asia, a strip of 7 tablets of Januvia (strengths 50mg and 100mg) is priced at Rs. 300. That works out to around Rs. 43/day. Merck has adopted tiered/differential pricing and launched Januvia in India at one fifth of its US price, less than a dollar a day. According to the TOI article, Glenmark has priced its generic version around 30% cheaper than Merck’s Januvia and the overall savings to the patient could be around 5000 Rs./year.Going by the some of the tremendously steep price reductions we have seen for some anti-cancer drugs recently, I would say that the price reduction offered here is modest.Also, as reported here, many experts assert that Metformin, a 50 year old drug still works best for diabetics and has the least side effects. With so many alternative efficacious and affordable therapeutic options available for diabetic patients; I wonder whether the “public interest” factor will feature in this case. 
Conclusion: 
Merck was upset with the generic launch and an official was quoted as saying “We are disappointed in Glenmark’s decision to introduce products that directly infringe upon our intellectual property. We believe our patents for Januvia and Janumet are valid and enforceable and will vigorously defend them.” Coup de grâce for Big Pharma? Another patent war on the cards? Only time will tell. 

Madhulika Vishwanathan

Madhulika Vishwanathan

Madhulika is a registered Indian patent agent and has completed her Master’s in Pharmacology from the Institute of Chemical Technology (ICT), Mumbai. Her interests include issues involving pharmaceutical and biotechnology patent law, regulatory aspects like Hatch Waxman litigation and antitrust law.She is currently working at law firm based out of Memphis, TN.

15 comments.

  1. AvatarAnonymous

    AS correctly pointed out that “ How one can be non-infringing to a product patent?”

    There is a precedent case (Roche vs. Cipla) which says that one can be non-infringing to a product patent if they are making the polymorph or salt which is claimed in the other patent application filed in parallel with the product patent application. I hope you remember the judgement of the case between Roche vs. Cipla dated September 7, 2012 by Delhi High Court for drug Erlotinib.

    This is just my interpretation to the judgement and may be the same judgement can be interpreted in different manner. Please let me know in case I have misinterpreted the judgement.

    I think that Glenmark might have taken the same stand based on the above mentioned judgement by Honorable Delhi High Court.

    Reply
  2. AvatarAnonymous

    glenmark is trying to follow the cipla vs. Roche precedent decision. infringement and claim construction are totally different issues

    Reply
  3. AvatarAnonymous

    Dear Madhulika:

    The Times was not the first to break this news. IN fact, this was reported in Scrip on 28th March itself. A Google search will take you to the Scrip link (which then requires subscription).

    Regards,
    Anon.

    Reply
  4. AvatarAnonymous

    What else can you expect. Copycats will keep copying, moreso when our judiciary as well as Government encourages them to do so. Who is gonna stop them?

    Reply
  5. AvatarAaradhana

    India, please honour patent linkage in the country. It is not all that bad! There are other mechanisms by which you can lower down drug prices in the country. Hope you know that you need innovative drugs in order to combat those life-threatening diseases rampantly proliferating in the country. If there are no innovative drugs, then there are no generics either! I hear that many of those innovative drugs are already not available in India. Specifically, I am told that there is a drug for treating diabetes, which also makes pancreas sensitive to insulin is not available in India. The country has to find a mechanism for lowering drug prices rather than crying foul over the well established concept of patent linkage or throwing up the defense of public interest every now and then.

    Reply
    1. AvatarSunil

      The CEO of BAYER, the German Giant has said that they make Drugs for the Western people and Not for lousy poor Indian or China or South East Asian poor people. So if people in those cannot afford drugs, let them die but help them with drugs? You people in the so call Western Countries should realize that drugs should be made affordable to ALL the people in society?

      Reply
  6. AvatarKen from Japan

    There seems to be some confusion in India between patentability requirements and patent scope.

    The claim is that MSD doesn’t have patent protection on sitagliptin phosphate because of Section 3(d).

    To this, I would say the following:

    1. Yes, sitaglilptin phosphate may not be patentable in India due to Section 3(d). i.e., the phosphate salt may not be patentable in India (which explains why MSD abandoned the patent application)..

    2. No, that does not imply that MSD’s basic patent on sitagliptin doesn’t cover its phosphate salt. Section 3(d) is only about patentabilitiy; it says absolutely nothing about patent scope.

    Reply
  7. AvatarMadhulika Vishwanathan

    Thank you all for your comments

    [email protected] 12:24:

    First of all, the question of infringement should be evaluated against patent claims and not against innovator’s products.

    In this regard I feel that Roche vs. Cipla decision is questionable.

    Even if the generic version uses diff salt/polymorphic forms other than those claimed in the patent, they are all contained within the “product”

    With, Sun Pharma joining hands with Merck it will be one of a kind generic vs. generic battle.

    Reply
  8. AvatarAnonymous

    I mean whats going on with India, in 90s when world offered free trade to India, it grabbed with both the hands and the result is evident “India is among the leading economies in the world today”. But when it came to imlpimentation of what was agreed upon for the “free trade” it is clearly in defying mode.
    One should understand that this attitude is doing no good to India in long run.

    Reply
  9. AvatarSourav Dan

    The Delhi High Court has already refused to grant interim relief to Merck on Glenmark Pharmaceutical’s manufacturing and marketing anti-diabetes drugs Zita and Zita-Met. Merck sells these under the Januvia brand.
    However, the High Court had kept the main petition of Merck pending for filing of evidence and other subsequent legal proceedings before its joint registrar on July 16.

    Reply
  10. AvatarAnonymous

    If this is the way patent jurisprudence is going to evolve in India, it is better that we don’t have patent system in this country.

    Reply
  11. AvatarSam

    Surely the government must make medicines and to sell in country cheaply.Now the people in country to decide to become poor with medicine prices or to die without medicine.Not to look at the world,decide what the people in the country need.

    Reply

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