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Exclusive Interview with Dr Mahalaxmi Andheria, Vice President- Intellectual Property Cell,Panacea Biotec Ltd

This section is an initiative by Origiin, which introduces latest innovations and valuable expert opinions on protection, exploitation of Intellectual property, by Intellectual Property experts to provide inspiration to the readers and also make our readers aware about the emerging technologies, products and innovations. This section also aims at bringing out the importance of patent protection and the way such innovations make difference in evolution of technological progress. 

In this issue, we are extremely happy to publish interview of Dr Mahalaxmi Andheria, Vice President- Intellectual Property Cell,Panacea Biotec Ltd. Dr. Mahalaxmi Andheria brings with her an experience of more than 15 years from the Pharma& Biotech Industry. She has been actively involved in Formulation R&D for 5 years before she decided to switch to IPR and thereafter IPR has been her primary area of focus. In her present association with Panacea Biotec since the last 10 years, she has been instrumental in managing the IPR Department consisting of specialists in diverse fields including biological (vaccines and biosimilars), pharmaceutical &synthetic chemistry area. She has established a seamless collaboration with Business Development and R&D expanding the horizon of her department beyond traditional IPR, broadening the outlook into portfolio planning, strategizing innovation and through creative participation in collaborations.

In addition, Dr. Andheria actively engages in dialogue with policy makers in an effort to contribute towards the development of a robust and balanced National IP Policy in India.Dr. Andheria is a PhD in Pharmaceutics from ICT (former UDCT, Mumbai) and a post-doctorate from University of Cincinnati, USA.

Here are the excerpts of the exclusive interview with her:

Origiin: It is a great pleasure for us to interact with you and publish your thoughts in this interview.

Dr Mahalaxmi: It is my pleasure too. Thanks for contacting.

Origiin: You have been associated with IP for the last 15 years for some of the most respectable pharmaceutical organizations like Sun Pharma and Panacea Biotec in the core areas of IP. How fulfilling the experience has been?

Dr Mahalaxmi: It has been the most enriching experience for me. I am glad to be in this field of IPR, which is an integral part of Organizations like Sun Pharma and Panacea. IPR is a diverse and very interesting field, especially the area of innovation, protection and enforcement and strategizing early market entry path. It gives an opportunity to collaborate with R&D and Business Development departments and contribute in product development from idea generation until commercialization.

Origiin: What are your thoughts on IP workforce available in the market currently? Are they ready to perform all type of IP tasks such as searches, drafting the application, prosecution and litigation?

Dr Mahalaxmi: Current IP workforce available in market is more competitive, skilled and literate professionals. This can be attributed to early stage education in IPR, on line and post graduate certificate courses in IPR, increased awareness & a competitive environment in this domain. There is opportunity and expertise available in this field to handle patent landscape, patent search, patent drafting and prosecution. However, the expertise in patent challenges, especially invalidation of patents and effective management of patent litigations is still limited and this skill set needs to be developed. IP Valuation and Management is another area that needs better understanding & experts.

Origiin: How important is IP valuation and IP audit for a pharmaceutical company?

Dr Mahalaxmi: IP Valuation and IP Audit are two most important aspects of IP Management for an Innovation based Pharmaceutical Company. Strategic deployment of IP assets enables companies to improve their competitive advantages in the market place. IP valuation is an important tool to analyze company’s intellectual assets related to strategic market valuation and growth projections, gain increased market share, earn high profitability and create high perceived value during licensing and strategic partnerships. IP Audit on other hand help in patent life cycle management, enforcing and defending IP rights, systematic review and associated risk mitigation of the IP assets, which enables earn revenues for the enterprise.

Origiin: The patent policy pursued by India enabled it to become a big international player in the generic drug market. Would you like to say anything with regard to this?

Dr Mahalaxmi: The harmonization process from the beginning of Rajgopala Ayyangar Committee in 1950’s till date, has revised the IP Law to suit the Pharma Industry in India. India discontinued the product patent system and only process patents were allowed with the 1970 patent policy. The outcome was that India emerged as a major player in the International generic drugs market, especially in the area of generic AIDS drugs, wherein India became the most affordable exporter to Africa. India is now known as the ‘Pharmacy of the Developing World’.

This was essential then, during the Industrialization phase, for economic growth. Now for sustaining this growth and for our future, it is important to promote innovations and research & development and I would say that we have now rightly moved on to a more progressive patent policy with the 2005 patent amendment, retaining the right balance of protection and affordability. The next decade growth and development of Indian Pharma Industry will be interesting to watch out for.

Origiin: Indian Pharma industry is in favour of ‘compulsory licensing’ of drugs to improve access of essential medicines to the Third World, which does not go well with the western Pharma world. What is your say with regard to this?

Dr Mahalaxmi: Too much has been written and debated on this most controversial topic of Compulsory License (CL) which opened up a plethora of (unwanted) questioning and criticism on India’s patent policies. I just hope that this does not lead to a cascading reverse outcome for future CL applications in India, a glimpse of which we have already seen in the Dasatinib CL matter. My personal view is that, if used discretely and with proper justification and within the ambit of the governing laws and procedures, then it can be an effective tool for a developing country like India, to foster innovation and to promote generics. It is a flexibility provided under TRIPS so it’s only a question of effectively utilizing it in the right way. I think it just got hammered too much and was given too much attention, which resulted in a negative aura around the word ‘Compulsory License’ in India. It only reminds me of the telling statement made by Justice Prabha Sridevan while upholding India’s first CL Order of Nexavar® that “Compulsory Licensing is Not a Bad Word”.

Origiin: Panacea Biotec known to be one of the largest vaccine manufacturing companies in India. Its Inactivated Polio Vaccine (eIPV) has a great commercial value. How innovation is channelized while designing these drugs for the benefit of the society?

Dr Mahalaxmi: There is no short cut to Innovation. It is a systematic and focused approach with an objective of developing safe, effective, affordable and sustainable products, for example Vaccines in this case, for the benefits of society. At Panacea, innovation is inbuilt. It is the focus and essence of our business. Our vaccine research is channelized towards helping people in the developing world to fight the diseases of importance with high quality and cost effective vaccines developed through in–house proprietary research, state of the art research facilities and ultra-modern techniques and scientific skill sets. In certain projects we operate through technology licensing and joint venture partnership routes. It goes without saying that all of these meet the requirements of National Regulatory Authorities and WHO Guidelines. Early consultation and collaboration with policy makers in developing countries help us to identify and develop essential vaccines which meet the requirements of quality, safety and affordability. Vaccine design, quality development and availability at reasonable price are our core areas.

Origiin: What is your take on recent rise in patent settlement cases in India?

Dr Mahalaxmi: Patent settlement and pay-for-delay tactics are major causes of concern in the US Pharma scenario, effectively blocking generic drug competition and availability of low-cost medicine to the public. Unfortunately, such a trend is emerging in India too. There could be some relief though as the Competition Commission of India (CCI) has taken this seriously and have issued notices to some of the companies who have chosen this path. CCI should ensure that patient access to critical drugs is not compromised and take necessary actions to stop such practices to delay launch of low cost generics in case of settlement. Additionally, such out of court settlements leave the validity issues of patents undecided midway. Hence patent settlements should be well scrutinized by relevant authorities.

Origiin: Would you like to give any advice to young aspirants trying to carve a niche for themselves in IPR?

Dr Mahalaxmi: IPR is a very interesting field. It requires specialized skill set and will keep you stimulated and motivated all the while. Develop both technical and legal skills by enrolling to requisite degrees courses. This field requires a lot of reading, searching skills, analytical mind, and a whole load of patience. Once you master it, it’s very fulfilling and enriching, and it gives immense satisfaction to be part of the team which is responsible for innovation and revenue generation for a company. Definitely, there is scope and good future in this filed.

Origiin: Thank you so much, for your valuable inputs and your time spared for Origiin. I am sure our readers will thoroughly enjoy it. Wish you best wishes for all your future endeavours.