Xtandi, the wonder drug for
prostate cancer, was developed at UCLA, Los Angeles, by the
innovation of NIH and Department of Defense grants. The drug was
later licensed to Medivation, a biopharma company, which in October
2009 struck a deal with Japanese Astellas Pharma to collaborate on
developing and commercializing Xtandi. The two companies now work
in partnership to market the drug in US while Astellas Pharma is
entrusted with the commercialization of the drug even outside US.
The rights to Xtandi were later taken over by Pfizer Inc as a part
of Medivation acquisition in August 2016.
In the current scenario, Astellas
Pharma, which sells Xtandi in India (a country where most of the
people that require the drug make just over $4 per day), is
condemned for making the drug available to the Indian metastatic
castration-resistant prostate cancer patients at a whopping price
of 335,000 rupees or about $5014.60 US Dollars for 112 capsules (a
monthly supply), translating to roughly $180 or Rs. 11,000 per day.
To this condemnation, the Japanese Pharma giant responded by saying
that the cost has been fixed to recuperate the cost of innovation
and is commensurate with patient benefit. The blockbuster drug
currently nets nearly $3 billion in worldwide
The patent application towards
Xtandi, titled "DIARYHDANTOIN COMPOUNDS", was duly filed
by UCLA with Delhi Patent Office on December 13, 2007 (Application
Number – 9668/DELNP/2007). The application was rejected by
the Delhi Patent Office in November 2016. Hitherto, the varsity has
been granted patent for this innovation in over 50 jurisdictions
across the world since 2007. The rejection of the patent
application in India came in the wake of a large array of pre-grant
oppositions that were filed by a clutch of companies2
like Fresenius Kabi on December 12, 2012, BDR pharma on July 24,
2013, Indian Pharmaceutical Alliance, and a few individuals
-Mr.Umesh Shah and Ms. SheelaPawar on the following grounds of the
Indian Patents Act:
Section 25(1)(e) – Lack of Inventive Step
Section 25(1)(f) – Not inventive (u/s 3(d) and u/s
Section 25(1)(g) – Lack of Clarity and sufficiency
The opponents had argued that the
claimed compound is not patentable under Section 3(d) of the
Patents Act, 1970 as amended by the Patents (Amendment) Act, 2005
as it is a new form of known substances. It was also held that the
inventiondid not entail any material improvement in efficacy.
Additionally, the Assistant Controller in the case held that the
claimed invention did not entail an inventive step over US patent
'981 and '257, inasmuch as it did not entail any
non-obvious addition to the compounds envisaged by these
For the reasons indicated
supra made the Assistant Controller of Patents Designs,
Mr. Umesh Chandra Pandey, rejected the invention under Section
25(1) in November 2016 (order by Patent Office). However, now the UCLA
(the applicant), represented by senior advocate P Chidambaram, has
contended that its application was rejected merely on the ground of
opposition by some competitors. The writ petition filed by the UCLA
also indicates that even the evidences submitted by UCLA in support
of its claims were not considered by IPO and so it has been
contested that the application be remanded for consideration of the
This ongoing attempt of UCLA to get
Xtandi (Enzalutamide) patented in India witnessed a development on
March 2 when Delhi High Court passed an order in the case of
The Regents of the University of California v. Union of
India(order), asking the Centre to render
an explanation on rejection of patent application (on November 10,
It has been a long time since M. Prabhakara Rao, the chairman of Nuziveedu Seeds, was trying to knock down the world's largest seed company "Monsanto Co", in a high-profile conflict over licensing and royalty...
The Patents Act 1970, along with the Patents Rules 1972, came into force on 20th April 1972, replacing the Indian Patents and Designs Act 1911. The Patents Act was largely based on the recommendations of the Ayyangar Committee Report headed by Justice N. Rajagopala Ayyangar. One of the recommendations was the allowance of only process patents with regard to inventions relating to drugs, medicines, food and chemicals.
Traditional Knowledge (TK) is a living body of knowledge that is developed, sustained and passed on from generation to generation within a community, often forming part of its cultural or spiritual identity.
India’s obligations under the TRIPS Agreement for protection of trademarks, inter alia, include protection to distinguishing marks, recognition of service marks, indefinite periodical renewal of registration, abolition of compulsory licensing of trademarks, etc.
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