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EDITORIAL
Year : 2017  |  Volume : 7  |  Issue : 1  |  Page : 1-2  

Xtandi versus Indian patent laws: A persepective


Department of Pharmacology, Adesh Institute of Medical Sciences and Research, Bathinda, Punjab, India

Date of Web Publication17-Jan-2017

Correspondence Address:
Aditi Mridul Panditrao
Department of Pharmacology, Adesh Institute of Medical Sciences and Research, Bathinda, Punjab
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2229-516X.198496

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How to cite this article:
Panditrao AM. Xtandi versus Indian patent laws: A persepective. Int J App Basic Med Res 2017;7:1-2

How to cite this URL:
Panditrao AM. Xtandi versus Indian patent laws: A persepective. Int J App Basic Med Res [serial online] 2017 [cited 2017 Jun 28];7:1-2. Available from: http://www.ijabmr.org/text.asp?2017/7/1/1/198496

On November 10, 2016, the Indian Patent Office denied the patent for Xtandi (Enzalutamide), the steeply-priced lifesaving anti-prostate cancer drug on grounds of "lack of inventive step, lack of novelty, and lack of clarity and sufficiency." It was a bold move on the part of the regulatory body, but it has paved way for the marketing of generic versions of the drug in the Indian markets at a fraction of the price of the original drug. [1]

Xtandi (Enzalutamide), a synthetic nonsteroidal-antiandrogen, was developed by chemist M. E. Jung and his research group at UCLA, along with oncologist C. L. Sawyers, as "MDV3100." In 2012, the US Food and Drug Administration approved MDV3100 for treating metastatic castration-resistant prostate cancer under the generic name enzalutamide. In October 2009, Medivation (NASDAQ: MDVN) and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. The companies jointly commercialize Xtandi in the United States, and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing Xtandi outside the United States. In August 2016, Pfizer acquired Medivation and got rights to Xtandi. [2],[3]

In India, Astellas markets the drug for metastatic castration-resistant prostate cancer at a whopping price of $44.77 per pill (Rs. 2750). Four such pills are to be ingested once daily for effective treatment, translating the treatment to roughly $180 per day (Rs. 11,000) or $5014.60 per month (Rs. 3.3 lakh). The average length of treatment is around 8 months which translates the cost up to $40,116 (approximately Rs. 26 lakh). This is much higher than the $26 per pill price Astellas sells the drug for in Japan. [4]

Astellas' justification for the unaffordable cost of the drug is that it wants to appropriate with the cost of innovation and patient benefit. This epitomizes lackadaisical view most pharmaceutical giants adopt in regards to financial versus humanitarian benefits. On top of that, India presents a huge market, prostate cancer being the second most common cancer in males as per the Indian Council of Medical Research and various state cancer registries. [5],[6]

The tragic reality of this situation is that this exorbitantly priced drug is being marketed to a population where most of the people that truly require the drug make just over $4 per day. In such a scenario, the Indian Patent Office's drastic decision is a boon to the patients, as the generic drugs are expected to cost 70% cheaper than Xtandi. [4],[5]

The rejection was a result of pre-grant oppositions that were filed by Indian Pharmaceutical Alliance, Fresenius Kabi, and BDR Pharmaceuticals Limited claiming that it was a new form of a known substance, and not eligible in India under Section 3(d) of the patent act. The grounds of opposition were, broadly, threefold: that the subject matter of the application was not novel, that it did not involve an inventive step, and it did not constitute an invention on account of, inter alia, being hit by Section 3(d). [6]

On the issue of novelty, the Assistant Controller Patents and Designs stated that as the company did not disclose the structure of the drug's compound, it would make the invention novel, and he rejected the argument of the opposing parties. [6]

However, the application was rejected on two principal grounds: it lacked any inventive step and was hit by Section 3(d) and 3(e). As regards the former, the Assistant Controller maintained that the claimed invention did not entail an inventive step over US patent 981 and 257, along with D1, a nonpatented article, which were cited by opponent 1, in as much as it did not entail any nonobvious addition to the compounds envisaged by these documents. Further, claim 3 was found to be obvious in light of US patent no. 578. [6]

This is not the first time a high-profile branded drug has been denied a patent in India under Section 3(d). In regards to anti-prostate cancer drugs themselves, BDR Pharma has earlier launched an affordable version of anti-prostate cancer drug, abiraterone, whose branded version Zytiga is marketed by Johnson and Johnson at $1869 (Rs. 1.25 lakh) for 120 tablets for a month's dose ($62.32 per day - Rs. 4237 per day). [4]

Of course, one cannot forget the case of Novartis being denied a patent for its anti-cancer drug Glivec (imatinib). The patent office argued that the drug's active ingredient was already known before the development of Glivec, and that it was not significantly more effective than the earlier version. Novartis appealed to the Indian Supreme Court and in 2013, the court upheld the decision to reject Novartis' patent on the grounds that the drug was a newer version of a "known substance." Furthermore, the court stated Novartis' claim that the beta crystalline form of imatinib mesylate had 30% greater bioavailability compared to imatinib in free base form did not demonstrate an improvement in efficacy that would make Section 3(d) inapplicable. Gilead Sciences' Sovaldi (sofosbuvir) was denied patent in January 2015 on similar grounds as was Abraxis BioSciences' anti-cancer drug Abraxane (Paclitaxel protein-bound) in June 2014. [7]

There is no denying that Indian laws concerning patents are more stringent than in some other countries, especially for such formulations whose active ingredients have been known before the development of said formulation, when no significant therapeutic benefit is evident. In comparison, US and European patent laws are more lenient. [8] The pharmaceutical industry has also expressed its concerns regarding intellectual property in India. There is an ongoing grievance among the companies over laws and court rulings in India that, in some cases, have made it easier for their generic rivals to sell lower-cost, copycat versions of their medicines. This has given rise to a contentious interplay in an ongoing struggle over access to affordable medicines and pharmaceutical patents. [8] The TRIPS agreement under the WTO charter allows countries to issue compulsory licenses for drugs which are either not being produced in their country or are too expensive. India makes use of this law to the fullest under Section 84 of the Act. Compulsory licenses are routinely given to generic drug companies so that lifesaving drugs can be made available at reasonable prices. [9]

However, being tough on patents could cost India substantially in foreign investment - and that means lost jobs and growth. The country's pharmaceutical sector was expected to grow to at least $50 billion in sales by 2020 from $11 billion in 2012, according to Price Waterhouse Coopers. [8] But for Indians, the Indian policy means affordable health care in the form of generic drugs, even if it does boost the local market more than the foreign. To that end, even US electoral candidate, Bernie Sanders, was very vocal over this issue, where he remarked to the United States Government that they "should use every tool available" for ending the era of pharmaceutical giants charging unreasonable prices. [8]

In conclusion, while it appears that the Indian patent policies are favorable to the common man, they have definite negative impact on the profitability for the pharmaceutical companies endangering India's position in the Global Pharma Market!

 
   References Top

1.
Patent Denied, Price of Prostate Cancer drug May go Down - ET Health World. ETHealthworld.com; 2016. Available from: http://www.health.economictimes.indiatimes.com/news/pharma/patent-denied-price-of-prostate-cancer-drug-may-go-down/55344613. [Last cited on 2016 Dec 02].  Back to cited text no. 1
    
2.
Ramadan WH, Kabbara WK, Al Basiouni Al Masri HS. Enzalutamide for patients with metastatic castration-resistant prostate cancer. Onco Targets Ther 2015;8:871-6.  Back to cited text no. 2
    
3.
Astellas and Medivation Submit Supplemental New Drug Application for XTANDI (enzalutamide) for Chemotherapy-Naive Advanced Prostate Cancer. Astellas Pharma US, Inc.|News Room; 2016. Available from: http://www.newsroom.astellas.us/news-releases?item=137039. [Last cited on 2016 Dec 02].  Back to cited text no. 3
    
4.
Letter T. India - Patent Challenges and Compulsory Licensing; 2016. Available from: http://www.thepharmaletter.com/article/india-patent-challenges-and-compulsory-licensing. [Last cited on 2016 Dec 02].  Back to cited text no. 4
    
5.
Experts Welcome India′s Denial of Patent to Prostate Cancer drug, Xtandi; 2016. Available from: http://www.pharmabiz.com/NewsDetails.aspx?aid=98990 and sid=1. [Last cited on 2016 Dec 02].  Back to cited text no. 5
    
6.
Bajaj R. Patent Office Rejects Patent Application for Prostate Cancer drug Xtandi; 2016. Available from: http://www.spicyip.com/2016/11/patent-office-rejects-patent-application-for-prostate-cancer-drug-xtandi.html. [Last cited on 2016 Dec 02].  Back to cited text no. 6
    
7.
In Major Decision, India Rejects Patent on Gilead′s Hepatitis C drug Sovaldi | RAPS; 2016. Available from: http://www.raps.org/Regulatory-Focus/News/2015/01/15/21090/In-Major-Decision-India-Rejects-Patent-on-Gileads-Hepatitis-C-Drug-Sovaldi/. [Last cited on 2016 Dec 02].  Back to cited text no. 7
    
8.
Anand G. Inside India: India′s Fight against Big Pharma Patents is a Just War; 2016. Available from: http://www.blogs.wsj.com/indiarealtime/2015/03/19/inside-india-indias-fight-against-big-pharma-patents-is-a-just-war/. [Last cited on 2016 Dec 02].  Back to cited text no. 8
    
9.
WTO | Understanding the WTO - Intellectual Property: Protection and Enforcement; 2016. Available from: http://www.wto.org/english/thewto_e/whatis_e/tif_e/agrm7_e.htm. [Last cited on 2016 Dec 02].  Back to cited text no. 9
    




 

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