With little known Lee Pharma filing India’s third compulsory licensing (CL), legal eagles and everyone interested or connected to pharmaceutical IP are gearing up for yet another discussion on this topic.
In a battle that is going to look like a David versus Goliath, the Hyderabad-based API maker has chosen to go after an anti-diabetes molecule, saxagliptin, which is covered by Patent No. 206543. Originally granted to Bristol-Myers Squibb in 2007, it later passed on to AstraZeneca in 2014 when the latter acquired BMS’ interests in the companies’ diabetes alliance.
There are some similarities between Lee Pharma’s CL and India’s second CL, filed by another relatively unknown pharma company, BDR Pharma, against BMS’ anti-cancer molecule Dasatinb. BDR Pharma’s CL was rejected because the Controller General (CG) of the Indian Patent Office ruled that it had not fulfilled the basic condition for making a case for a CL, i.e. BDR Pharma had not made too much of an attempt to first get a voluntary license (VL) from the patentee. Though BDR Pharma had sent a VL request to BMS, it did not respond to the latter’s response which was a list of queries, basically inquiring if BDR Pharma had the capacity to produce good quality APIs, etc.
BDR Pharma went ahead and filed a CL application as soon as it was legally permitted; i.e. after a year had passed from its initial request to BMS. When questioned as to why they did not reply to BMS’ queries, to take forward the process of negotiating for a VL, BDR Pharma indicated BMS was using a delaying tactic, referring to an article written by members of the patentee’s legal team recommending that a series of questions to counter a VL request was the best delaying tactic. The CG refused to accept this defence as he contended that the defense attorneys’ article cannot be taken as a reflection of BMS’ stand as it represented many other companies as well and rejected BDR Pharma’s application.
IP analysts are already seeing similar weak links in Lee Pharma’s CL application. As analysed by Balaji Subramanian’s blogpost on Spicy IP, (Compulsory Licence Application filed over AstraZeneca’s Saxagliptin: http://bit.ly/1ftpwKi), in Lee Pharma’s case, it claims it approached the original patentee, once again BMS, in May last year. BMS asked for clarifications, which Lee Pharma claims it provided in November. While Lee Pharma did not receive any further word from BMS, it received an email from the present patentees, AstraZeneca, which it claims it ‘could not open’.
If the CG this time decides to give the benefit of doubt to the CL applicant, then Lee Pharma’s other arguments will be up for scrutiny. There are some grey areas here too, indicating that it will not be an open and shut case.
These grey areas are natural when you consider that we are at the start of what is sure to be a long (and convoluted) journey for pharma IP, litigation on CL, etc. in India. India’s record on CL has been mixed, with the first CL, Natco Pharma’s application for Bayer’s Nexavar, being a success while the second one (BDR Pharma’s application for BMS’s Dasatinib) faced rejection. (Lee Pharma files India’s 3rd CL: http://bit.ly/1LVEOUk)
It is heartening that smaller companies like BDR Pharma and Lee Pharma are showing the confidence to challenge the status quo. According to Lee Pharma’s website, Promoter/Director, A Venkata Reddy seems a veteran in APIs. He started his career in Dr Reddy’s Laboratories, co-promoted Hetero Drugs in 1993, then promoted Genix Pharma three years later and finally started Lee Pharma in 1997. But do smaller companies have the wherewithal to fight these legal battles to the logical conclusion? AstraZeneca is reviewing all legal options and points out that the company “enables affordable access to their medicines in India and elsewhere.” (Have complete confidence in our IP: AstraZeneca: http://bit.ly/1NTEzHO).
The battle between two corporate unequals could be balanced out by support from patient/ health groups and/ or parliamentarians but none of that has happened so far. We’ll have to wait and see how India’s third CL fares at the IPO.