Patents are an integral part of the Drug Research and Development ecosystem because they not only incentivize innovation but also drive translational research which ultimately benefits society !
Amol Gaikwad, our next pathbreaker, analyzes patents for pharma products, provides opinions on various pharmaceutical technology related matters, and performs patent infringement and validity assessment for pharma companies.
Amol talks to Shyam Krishnamurthy from The Interview Portal about the significance of IP (Intellectual Property) in the pharmaceutical world from the perspective of generic drug companies as well as patent owners.
For students, bringing a drug to the real world requires crossing several technical, legal and regulatory hurdles. But it is immensely satisfying to do your bit for the development of medicines.
Amol, can you take us through your background
I was born and brought-up in a small town in Ahmednagar district of Maharashtra. Growing-up with two siblings meant everything had to be shared and I never really had the luxury of choices.
In my childhood, due to the nature of my father’s government job, we moved to several places. I was not much fascinated about studies and was among those kids in the class who mostly remained quiet and chose not to answer unless prompted for. The best part of my childhood was that I had lots of fun and enjoyed everything that you can think of for a 90s kid, except studies.
What did you do for Graduation/Post-Graduation?
Up until I got my admission for B.Pharm (Bachelor of Pharmacy), there was not even a single graduate in my whole family. Mathematics was my favorite subject in 12th standard and once I even dreamed of becoming an engineer.
I completed my B.Pharm from North Maharashtra University and M.Pharm from Mumbai University. Since I never left home before, it was tough for me to adjust to a new place and new people. I even became home-sick during the first year of B.Pharm. Staying away from home for my education really made me feel responsible towards my family, which made me realize the importance of studies. In situations like those, when you feel like the odds are against you, the most promising mantra for me is to ‘never underestimate yourself’.
Throughout my B.Pharm, I passed the exams with distinction. I even stood first in the Final Year examination in the University and received a Gold Medal. I received the ‘Sir Ratan Tata Trust’ scholarship in B.Pharm second-year. I still remember the joy on my father’s face when I told him about the scholarship. To this day, it has been the most precious moment for me because it was for the first time that I realized the importance of hard work and dedication. Until then, I never received any kind of academic recognition or appreciation, let alone a monetary scholarship. My full one-year expenses were paid with the scholarship amount.
With lots of ambition and zest to do better in life for myself and my family, I decided to pursue M.Pharm (Master in Pharmacy). I studied hard to qualify for the GATE exam (an entrance exam required for M.Pharm admission on merit, now it is GPAT). I qualified the exam with flying colors and got admission for M.Pharm in one of the reputed colleges in Mumbai University.
The best part of my graduation and post-graduation were my friends and mentors. Had they not been there to support me, I wouldn’t have dreamed of achieving a meaningful career for myself. My B.Pharm teacher, Dr. Sunil Bakliwal, supported and encouraged me to push the limits and excel. He guided me on future prospects after B.Pharm, and the efforts that were needed to reach there. I still remember he used to say, “I know you’re going to make it”.
What were some of the drivers that made you choose such an offbeat, unconventional and uncommon career?
Corporate jobs for a M.Pharm candidate in the Pharmaceutical industry are basically offered based on the M.Pharm subject specialization; hence, it is very important to choose your first job based on the department of your liking. Typical career options after M.Pharm are Regulatory Affairs, Formulations Development, API Research, Technology Transfer, Analytical Development, Clinical Development, and Project Management. I did my M.Pharm with Pharmacology as a specialization, so the most obvious choice for me would have been Clinical Development.
How did you plan the steps to get into the career you wanted? Tell us about your career path.
In the final year of M.Pharm, I got in touch with one of my B.Pharm college professors, who was working in a Patent Law Firm in Mumbai. He advised me to consider Intellectual Property (IP) as a career option. It was a totally new dimension to me, something which I never thought of earlier and that I was quite excited about. I started to learn and understand IP and became more fascinated as I kept reading more. I eventually decided to give IP a serious consideration as a career. With that in mind, I joined a correspondence post-graduate diploma course in Mumbai, specialized for IP, Clinical studies, and Regulatory Affairs.
By the end of my M.Pharm, I started to understand more about Pharma-IP activities and job-responsibilities of a Pharma-IP professional. I applied for jobs in various Pharma companies, but it was a challenging to even get shortlisted for an interview.
My first job in IP was at Cipla (2007-2010).
At Cipla, I learned the practical implications of IP in Pharma. I also understood why IP is important for the growth of Pharma business and how differences in IP laws across different countries makes IP more complicated to understand. I was fascinated to participate in IP related discussions with my colleagues, and listening to their perspectives on IP was an amazing source of my learning. I realized that quick learning, adaptability to new challenges, and proactiveness in learning the ever-changing IP regulations is the key to succeed in the IP profession.
After about 6 months of my tenure at Cipla, I was offered a company sponsored IP course in a renowned IP institute in Mumbai. I immediately accepted it. It was a great opportunity to learn the fundamentals of IP from the fraternity across different industries and get to know their IP perspectives.
In Cipla, I learned about the fundamentals of patents, patent searching (a patent search is a search of issued patents and published patent applications for an invention), patentability criteria, patent drafting, patent filing, patent prosecution, and attorney communication. The work was mostly focused on anti-HIV medicines, inhalation products, which Cipla is a pioneer in. I was fortunate to get exposure to complex products like metered dose inhaler (MDI), dry powder inhaler (DPI), and nasal spray products. One of the most interesting learning experiences for me was related to MDI/DPI inhaler device patents and industrial designs.
I worked extensively on Indian Patents, studied Indian Patent Act, and became an Indian Patent Agent in 2010.
But, i wanted to learn more about IP than what I was getting exposed to in Cipla. This desire for learning led me to join Zydus Cadila in Ahmedabad in 2010. At Zydus, on top of honing my existing IP skills, I learned about ANDA filing (generic drug application in the United States) strategies such as including Paragraph I to IV certifications, Patent linkage in the US, patent infringement analysis, importance of case laws across different countries, litigation management, and document production procedure (e-discovery) in patent infringement cases. I worked extensively on topical products like ointments, gels, creams, liposome-based, and nano-particle based products. I enjoyed doing patent non-infringement analysis and proposing non-infringing formulation strategies for simple to complex products for regulated markets like the US and Europe. For the first time, I got an opportunity to work on non-English countries like Mexico and Brazil. Several patents were granted to Zydus which I dealt with by filing satisfactory responses to the office actions. I received the “Best Performer” award for two consecutive years. The recognition really encouraged me to go further and accept more challenges.
After 2-years of my sprint in Zydus, I got an opportunity to work in Wockhardt’s IP department. I was excited to join Wockhardt for two reasons, first – I was going to handle relatively significant responsibilities than my previous assignments and second – I was moving closer to my hometown and going to spend more time with my parents.
In Wockhardt (2012-2014), I learned about business development and regulatory affairs, patent litigation management, patent invalidation, opposition proceedings, label carve-outs, label reviews, drafting and reviewing patent certifications, patent infringement analysis, and patent invalidation. I worked on invalidation of patents related to composition-of-matter, method treatment, and formulation. After a year at Wockhardt, I received ‘Wock-Star’ award as a token of appreciation for my work. Once again, my colleagues and mentors at Wockhardt were my primary source of learning and experience.
In 2013, I got selected for a Patent Expert training course conducted by the Japan Patent Office. I stayed in Tokyo for a month and got to interact with participants from different countries. The participants and faculty exchanged thoughts on different aspects of IP in their countries during the course. It was really an enriching experience for me. It was for the first time I got an opportunity to share India’s IP policies on an international level. The influence of the training was so much that I started to aspire for the next level of my IP career.
In pursuit of IP exploration and learning, I got an opportunity to move to Bangalore in 2014 and work for a US based company, Novel Labs Inc. (2014-2016). At Novel, I worked on opioid, controlled substances, and abuse-prone drugs like codeine, methylphenidate, and morphine etc. I feel fortunate because there aren’t many Indian Pharma companies working on such products. I worked extensively on patent evaluation of different abuse-deterrent technologies, injectable, and ophthalmic products. One of the significant projects I worked on was the development of a novel abuse-deterrent technology.
In 2015, I got an opportunity to visit Novel Lab’s R&D center in New Jersey, US. During the visit I got a closer view of Pharma R&D functionality, operation flow, and high-security vaults built to store abuse-prone medicines. I interacted with several scientists, exchanged our thoughts on IP and research related topics. I keenly observed their working style and attitude towards work, and I noticed that their dedication, smart-work, transparency, and mutual respect towards each other are some of the traits I could follow to advance my career.
In 2017, Lupin acquired Novel Laboratories and as a result, I got transferred to Lupin’s R&D center in Pune. In Lupin, I got end-to-end exposure to complex projects like biologics (monoclonal antibodies). I worked on product identification, patent landscaping, patent evaluation, patent strategy development, regulatory submissions, litigation management, and regulatory approval. I got opportunities to discuss various IP and litigation matters with overseas patent attorneys. I participated in high-level discussions and learned how to present my work to higher management.
I proposed high impact patent invalidation strategies for some of important products and participated in developing IP strategies for in-house and innovative brand products. I also explored new dimensions of IP for the US, Europe and new regions like Australia and Japan.
How did you get your first break?
While my other M.Pharm colleagues were getting placed in different Pharma companies, I was struggling to get interview calls for IP. But I knew the importance of the first job and knew that I had to be patient. One wrong decision, and it could be a disaster, so I decided that until I get a break into Pharma-IP, I would do teaching job for a living. I joined a Pharmacy college in Chembur, Mumbai as a lecturer. I worked there for a month. My patience soon paid off when I got an interview call from Cipla for IP (Intellectual Property), and I got selected as a Patent Trainee.
What were some of the challenges you faced? How did you address them?
Starting off with a corporate career is always a challenge for a fresher. On my first day at work, I felt almost like an alien. My major challenges were professional communication skills and etiquettes. I realized that things in the corporate world were quite different than I thought earlier, things here move really fast, and I must keep myself updated with it. To adapt to the corporate world, I had to work harder. Fortunately, all my colleagues at Cipla were helpful and cooperative. They helped me to settle down and supported me to get along with the corporate flow.
Where do you work now? Tell us about your role as patent Analyst.
One fine day, I got a message on LinkedIn about a job opening at IPD Analytics (IPD), a company that provides life cycle insights (patent analysis) for pharmaceutical products. I had been using IPD services since I was working in Wockhardt and already had a very high impression of IPD as a company. Currently, almost every Indian pharma company doing business across the world is subscribed to IPD Analytics services.
Ever since I started my career in IP, I had never worked for any Patent Consulting Firm. I had always handled IP matters from a generic pharmaceutical company’s perspective. But I always wanted to experience the other side of the industry that belongs to patent owners and brand/Innovator companies. IPD gave me the platform I was looking for.
On the very first day of my job at IPD Analytics, we received a message directly from the company’s Managing Director (MD), Howard Krass, conveying his best wishes and support for our onboarding and our career at IPD. I was completely blown away by that because I never experienced such a gesture during any of my previous employments. Moreover, up until then, I never even got an opportunity to talk to such a high-level person, let alone receive good wishes on the first day at office. I straightaway knew that this is going to be an exciting phase in my career.
At IPD, my work profile is quite different from what I had been doing for more than past 10 years. Even before starting to work, I was confident that I would figure out what needs to be done and quickly learn the required skills. After I joined IPD in 2019, my senior and mentor, Dr. Arvinder Singh guided and helped me to get accustomed with work and the company culture. I paid maximum attention in the beginning to understand the nature of work. With careful attention and my decade long expertise in the Pharma IP domain, I could quickly learn the nature of work. Within a year after joining, not only did I start to handle responsibilities to my own satisfaction, but also meet company’s expectations. My 12+ year experience, IP expertise, and technical understanding of a variety of pharma products have helped me serve my job responsibilities satisfactorily at IPD.
The best aspects of IPD are the people and work culture. Every suggestion and every thought is valued here, irrespective of the level or designation. The work culture is amazing. With expert IP professionals around, here I learn something new every day. I work closely with IP attorneys from countries like the United States, Europe, Australia, Japan, Korea, Brazil, and Mexico who are amongst the renowned IP experts in their countries. A part of my job is also to train new joiners. I feel proud in carrying forward the legacy of my mentors and managers and I always make sure that I convey company values and culture, alongside technical training, just the way I experienced.
At IPD, I do patent analysis for pharma products, provide opinions on various pharmaceutical technology related matters, and do patent infringement and validity assessment for several countries. I participate in discussions with IP and business leaders of Pharmaceutical Companies around the globe and advise them on patent, regulatory, and technical matters. An interesting part of my job is to analyze ongoing patent litigation, predict all the possible outcomes, provide loss of exclusivity (LOE) for products (meaning when the product can go generic) in different countries based on patent analysis, and participate in new product development discussions.
My day at work typically starts by handling patent and technical queries from my colleagues, attending the project meetings, reviewing patent analysis done by my colleagues, and planning future activities. Most of my time goes in talking to my India colleagues and guiding them on patent analysis for different countries. Reviewing patent analysis is the most critical part and I always consider this as an opportunity to expand my IP knowledge and patent analysis skills.
The most amazing part of working at IPD is the never-ending learning possibilities. My best learning resource throughout my career has always been people, and at IPD, it always feels like there is so much to learn from every one of them.
Can you tell us the benefit of your work to society?
Our subscribers around the world, ranging from a mid-sized pharmaceutical manufacturer to a multi-national brand/innovator company, refer to our services for selecting and developing pharmaceutical products. At IPD, we transform complex patent analyses for a vast range of pharmaceutical products into a concise and simple format understandable to anyone who even does not have IP background. I feel that, through my work, by removing the barriers in understanding of their IP complexity, I’m doing my bit for the development of medicines.
What has been your most memorable work ?
I feel extremely satisfied when I see a patent analysis or a patent litigation update which I contributed to is published for our subscribers around the world. I would like to mention my contribution for Japan and Korea patent projects. The major challenge was the language. I was working closely with our Japanese and Korean colleagues and there was no margin for error. I could not give an excuse of inability of language understanding and hence I cannot handle it. With support of my colleagues, we were able to figure-out the most simple and easy ways of handling the project and we were able to successfully complete it much before than we all expected.
Advice to students ?
My journey so far has taught me to never underestimate yourself. No matter where you stand today, you have the potential to achieve the unexpected. Knowledge and courage can make everything possible.
One should develop a constant learning attitude. Always strive for more than what you are expected to do by others. Take responsibilities of tasks which you feel uncomfortable in handling (for example, by volunteering yourself for a project which you have not been trained to deal with) and put all your efforts (like developing new skills) to complete it.
Set smaller goals for yourself and act to achieve those goals. Be ambitious, challenge yourself, believe in yourself that you can do it. And as one of my mentors once said to me…I know you’re going to make it…
Pursue further challenges in my career. Learn an international language, probably Japanese, as it has always been close to my heart.