Delhi High Court sought Explanation through Counter Affidavit over Repudiation of Patent application for Xtandi

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 sales[1].

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 companies[2] 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:

1. Section 25(1)(e) – Lack of Inventive Step
2. Section 25(1)(f) – Not inventive (u/s 3(d) and u/s 3(e))
3. 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 documents[3].

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 same[4].

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, 2016).

About the author: Tanu Goyal, Patent Associate at IIPRD and can be reached at: tanu@khuranaandkhurana.com

[1]http://epaperbeta.timesofindia.com/Article.aspx?eid=31808&articlexml=Patent-denied-price-of-prostate-cancer-drug-may-10112016014006

[2]http://www.pharmabiz.com/NewsDetails.aspx?aid=98990&sid=1

[3]http://www.mondaq.com/india/x/576168/Patent/IPO+Rejects+Patent+Application+For+Xtandi+Prostrate+Cancer+Drug

[4]http://www.dnaindia.com/health/report-hc-seeks-reason-for-denial-of-prostrate-cancer-drug-patent-2342983