Protecting IP assets

Amit Aggarwal
Co-founder, Effectual Knowledge Services

Rohit Aggarwal
Senior Manager, Effectual Services and
leads the LifeSciences team.

Ishita Rustagi
Manager with LifeSciences, Effectual services.

Worldwide, overall technology is flourishing exponentially, specifically in areas of Information Technology, Biotech & Pharmaceutical sciences, Automobiles. Intellectual Property (IP) is emerging as one of the most fundamental economic forces, where strong IP protection can encourage innovations across various industries. To encourage the pharmaceutical or biotech sector to create new drug molecules, therapy, medical devices and other technologies, there is a strong need to protect rights of manufacturing, sales and distribution of the innovative products/processes. The team at Effectual Knowledge Services talks about Challenges and Strategies faced by the Pharmaceutical industry related to IP.

Worldwide, overall technology is flourishing exponentially, specifically in areas of Information Technology, Biotech & Pharmaceutical sciences, Automobiles. Intellectual Property(IP) is emerging as one of the most fundamental economic forces, where strong IP protection can encourage innovations across various industries. To encourage the pharmaceutical or biotech sector to create new drug molecules, therapy, medical devices and other technologies, there is a strong need to protect rights of manufacturing, sales and distribution of the innovative products/processes .

For pharmaceutical it takes between 10 and 15 years to develop a new medicine and can cost approximately $2.56 billion for bringing a product to market. Thus, it is important for pharmaceutical scientists to have a better understanding of patent fundamentals. It is imperative to accelerate drug development process and at the same time apply different strategies to extend the life time of the patent to gain economic incentives.

In pharmaceutical industry, generally two types of protection needed: first one is for creating new molecule, composition, or medical device; and second one is formulation of expired or near to expire molecule or composition. Majority of big-size pharmaceutical companies are increasing their business by creating new molecules, composition or medical devices, whilst the others are enhancing businesses by developing generics and biosimilars.

Pharmaceuticals - Challenges and Strategies
Filing patents in pharmaceutical domain is cumbersome activity as the process required investment of huge amount of money and time, however the risk of infringing their inventions is more likely. The other major challenge is reduced life of pharmaceutical patents because of the need to fulfill all criteria of clinical trials to assure safety and efficacy to regional regulatory bodies such as US FDA. The companies are continuously putting immense efforts to reduce the long time span required for clearing various clinical trial stages.

The high cost involved in R & D means the majority of pharmaceutical companies apply for patent protection during research stages and before clinical trials. The early patenting activity reduces the life of the patents as well as shortens the time available for product marketing. Therefore, the average effective patent life for pharmaceuticals is just 11.5 years, which is much lesser than the ideal 20 years protection.

To overcome the challenges, pharmaceutical companies should consider obtaining patents for the broadest possible scope during the R & D process. The companies can later target to file 'Methods of use' and 'Formulation' patents during the clinical trial stages or when the product's use is clearly defined.

In US, the pharmaceutical companies can apply for a term extensions to balance the reduced patent life. Though, the term extensions do not always equal the actual time lost. The patents can only be extended for half the time period that was consumed for the regulatory approvals and for a maximum patent term of 14 years.



The pharmaceutical companies can also target to develop orphan drugs to treat a rare medical condition referred to as an orphan disease such as Tourette's syndrome. There are governments and patient organizations such as EURORDIS providing economic incentives such as an extended period of market exclusivity to encourage development and marketing of orphan drugs.

Another approach is filing of "label patents" covering methods or products recited in the FDA-approved drug label. The label patents cover repurposed drugs targeting new patient population, new disease area, or new dosage forms, dosing regimens. The patent term for such new patents is 20 years from date of filing, which can significantly extend the period of exclusivity for the repurposed drug. Additional patent protection can also be taken for new routes of administration for known drugs. For example, migraine treatment drug Imitrex (Sumatriptan) by GSK - the patent directed to the original compound expired in 2006, the company later obtained patents directed to Imitrex formulations for intranasal delivery and took FDA approvals.

Trade secret is also becoming an increasingly useful tool for pharmaceutical industry particularly in the US. The period of protection conferred by a trade secret can be indefinite. Trade secret entails significant risk, but can aid in speeding up the process of drug development.

Pharmaceutical industry can focus on implementing artificial intelligence (AI), machine learning, and programmed logic in healthcare inventions. AI -based systems allow better diagnosis, cure and treatment of debilitating conditions. This can help in accelerating the process of developing pharmaceuticals and identifying the patients who are most likely to benefit. Recently in 2018, the AI-powered bionic pancreas secures approval of the FDA to conduct clinical trials for fast acting insulin to cure diabetes Type-1. The device monitors a person's food intake and the rise in blood sugar levels and releases insulin automatically in accordance with it.

Smart Medical Devices Market size is projected to experience significant growth from 2017 to 2024. Europe smart medical devices market is foreseen to gain significant industry revenue share over the forecast period. As per the Reflection and Orientation Paper, in 2016 European Union contributed USD 43.5 million for the innovation of wearable medical devices, hence, driving the business growth. Asia Pacific is the fastest growing region due to soaring population and demands for novel products which positively impacts the demand for innovation in the region. Artificial intelligence market finds its potential application in drug discovery, as AI plays a vital role in drug identification, discovery, screening, and design.

It is interesting to note that in the recent decades, stem cell technologies and personalized regenerative medicine has become increasingly recognized and shows a great potential in enhancement precision medicine. For example, a patient's own cells can be isolated and differentiated to produce the tissue of interest. Some approaches involve stem cells production for engineering tissue and returning the tissue to the patient. Chimeric antigen receptor (CAR) T-cell therapy has changed the way cancer was treated earlier. It uses patients' immune cells to target tumours. Patent filing activity in this area has increased significantly since 2015, with major focus on United States and China market. However, despite of significant research in this area, the technology remains nascent and has a lot of scope of innovation leading to patent protection opportunities.

Conclusion
Despite the challenges, there have been several recent accomplishments in the pharmaceutical sector. Continued efforts to build clinical trial design expertise and infrastructure and efforts toward research prioritization will support the future growth of the pharmaceutical industry.

Patents are vital to protect IP owners from significant revenue loss and to safeguard the pharmaceutical industry's development and innovation in the future. Future priorities are to continue to improve the understanding of developing robust patent system.