Update from India on Xtandi (Enzalutamide) for cancer treatment

In January 2016, KEI and the Union for Affordable Cancer Treatment petitioned the US the Department of Health and Human Services or the National Institutes of Health to use the federal government rights in the patents on the prostate cancer drug enzalutamide, to remedy the excessive and discriminatory price in the United States. 

The basic science that led to the development of the drug for prostate cancer was by researchers from various academic units of the University of California who then licensed the chemical compound’s patent to pharmaceutical company Medivation Inc. of San Francisco. Medivation received FDA approval in 2012 to market enzalutamide as a prostate cancer medication. Medivation and its sub-licensee, Astellas Pharma Inc. of Tokyo, are now selling the drug under the brand name Xtandi. The license agreement did not address the issue of affordable pricing and by granting an exclusive license and seeking patents on the drug, the University of California encouraged monopolistic pricing of the drug. In 2016 Pfizer completed the acquisition of Medivation.

The KEI/UACT petition regarding Xtandi (Enzalutamide) is available here: http://keionline.org/sites/default/files/Xtandi­March­In­Request­Letter­14Jan2016.pdf.

High prices are not charged in the US alone. Japan’s Astellas Pharma sells the drug in India at Rs 3.35 lakh (over 5000 USD) for a pack of 112 capsules which is 28 days’ supply. According to KEI generic competition for enzalutamide could easily drive the price per pill at well less than $.50 per pill, or $2 per day. For more information on pricing see http://keionline.org/node/2662

The patent claims on the the compound in question (9668/DELNP/2007 eq. PCT/US2006/011417) were challenged by generic companies (Indian Pharmaceutical Alliance, BDR Pharmaceuticals Limited and Fresenius Kabi Oncology Ltd) in India The patent rejection order came in November 2016. Claims, Oppositions and decision are available on the Patent Opposition Database now at https://www.patentoppositions.org/en/search?utf8=%E2%9C%93&query=Enzalutamide+
If the patent had been granted in India then the drug would have been under monopoly till 2026. It would have also been a big blow for patients in India who are awaiting more affordable generics and to the global movement for increasing access to affordable cancer drugs that KEI and Union for Affordable Cancer Treatment (UACT) have been fighting for in the US.

In an effort to prevent the marketing of potentially affordable versions of enzalutamide, the University of California – the original applicant of the patent – through its regents (board) has now filed a petition before the Delhi High Court [The Regents of the University of California versus Union of India and Ors, WP (Civil) No. 1163 of 2017].

While it is clear that there is a commercial intent of the licencees (Medivation/Astellas/ Pfizer) in acquiring patent rights in India, the writ is filed in the name of the regents of the University of California, perhaps to portray this matter before the Indian courts to the media as a struggle for recognition of academic research rather than commercial interests.

Appeals against rejection of patent claims are usually filed before the Intellectual Property Appellate Board.

The University of California has not filed an appeal before the IPAB and instead challenged the rejection before the Delhi High Court, using the loophole that the Intellectual Property Appellate Board (IPAB) lacks quorum and is non functional at the moment – as the government has delayed the appointment of the technical member (patents) and the chairperson. The writ is pushing to get the patent application remanded back to the patent office for re-examination as they can then put pressure to get it granted. This tactic has been used before.

In 2015, citing procedural infirmities, Gilead’s filed a writ to get its patent application on sofosbuvir remanded back to the patent office for a fresh hearing and managed to reverse the earlier rejection order.

Similarly 18 months after the hearings in relation to the oppositions and examination of 9668/DELNP/2007 were completed; the licensees through Regents are now claiming as the main ground for the writ that the Controller did not give them an opportunity address certain documents at the hearing.  Would they have raised it if the patent had been granted?

New developments

The matter is now posted to July 20th for hearing. the University of California counsel through their Senior Advocate made a representation that it should be listed in May itself, since only 10 years of patent term were left and 50 patents had been granted worldwide, and all they were seeking was a remand back to the IPO. The Union Counsel said a remand back was unacceptable to the government since it defeated the purpose of the Act.

The Court orally observed that a writ court cannot designate precious time to seeing whether a private commercial interest can be protected, and has listed it for July 20 2017.

The Court earlier in the day accepted an undertaking by the DIPP that they would appoint the Chairperson and Technical Member Patents on a writ filed by one of the pre-grant opponents in the enzalutamide matter. Effectively, the only ground of Pfizer through Regents – that the IPAB lacks quorum – would be rendered meaningless if the appointments are made. The next step for Pfizer – through the University of California – would be an appeal to the IPAB.

 

 

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