Smart Strategizing – Protection by shielding through Patent Evergreening in Pharmaceutical Domain with special reference to Roche v Cipla

17th January, 2013 - 1:20 pm Categories: IP Practice in India News & Updates Pharma/Biotech Patent Litigations 0 Comments

Pankaj Mohanta, an intern at Khurana and Khurana talks about patent evergreening in the pharmaceutical domain. Through this post, he gives special emphasis on the recent landmark case of Roche v Cipla, which created quite a stir in the pharmaceutical industry.

Needless to say, patent evergreening is that territory which falls in a bit of a grey area. With the recent criticisms and mushroom cloud of controversies surrounding this topic has forced the pharmaceutical companies to sweep this method piece under carpet. But perceiving the high value returns in this era of uncertainty with an insight to step a foot into the future, taking chances doesn’t really seem that compromising given the fact that colossal figures have been continually pumped into the R&D departments. The pretty recent patent litigation of Roche v Cipla was one of a kind, where the world got to have the opportunity to witness a one of a kind, call it legal or business strategy. The plaintiff here who happened to be Roche, attempted prohibiting the defendant company Cipla from manufacturing the former’s anti-cancer drug formulation – Erlotinib. This drug’s generic equivalent costs the 1/3^rd the amount of the protected and patented drug formulation available as, over the counter antidote in the markets, thereby running the risk of relatively less adoption or possibly, rejection by the consumers. The plaintiff then sought an interim injunction against the defendants. But the prime hassle arose with the morphed or an altered substitute, here in this case, a Polymorphic Form B belonging from the same class of drug but wasn’t one of Roche’s patented drug, thereby rendering the court to decide in favor of the defendant along with the light of the provision mentioned in the leading statute of Section 3 [d] of the Indian Patents Act, 1970 following a stance that Cipla didn’t infringe Roche’s Indian Patent IN 196774.

The key focus at the heart of any pharmaceutical giant’s agenda, which produces patented drugs on a mass commercial scale is to incentivize and widen its sphere of operability by way of a selective monopolization driven at a speed in order to achieve a protective perpetuation for any given drug formulation of its origin. So, if we speak of a way to safeguard a prolonged scalability for pharmaceutical companies, they might consider patent evergreening as one of those techniques for future medicine which would potentially drive an evolution of smart grid initiatives ushering in a new era of pharmaceutical dynamics paving way for a paradigm shift the way pharmacokinetics, patient healing and enhanced frugality as a viable turnover alternatives interact in the health landscape.

Patent Evergreening – What and how this stuff works?

It is a term which implies a step that aims for perpetuation of a protection over a given patented drug. To be a bit comprehensive on this part, I mean a technique which describes a latency requirement which is often exercised as a strategy by assistance of which pharmaceutical players with patents involving certain drug formulations which are about to hit expiry date tacitly hold the incentive returns from those antidotes by aggressive takeover or buying out their threats or in this case, their competitors or by taking out new patents which are closely associated with the existing ones by working around their innovation and or working out on a formulation having a stark contrast with that of the existing ones effectively devising a new pharmaceutical mixture.

However, this practice may not have gone that mainstream in a given spectrum of priorities of the pharmaceutical companies in the current scenario. But, a matter of fact, having achieved high net returns when there is too much of time and money at stake, this stream definitely demands privileges in intellectual monopolies for which the pharmaceutical companies would just do whatever it takes for them to grab hold of this appealing platform despite an inherent risk of regulations powered by various statutes and bodies that makes sure that a level of hybrid governance is being taken care in this sector. Be it jurisdiction to prescribe, adjudicate or to enforce, it has been sort of a taboo for jurists to openly express about this whilst patent litigations. Here, however, no active patent ingredient over a drug composition is being taken into consideration instead the delivery channels and its general usage.

In this post, I would further focus on the peculiar grey area of patent evergreening which can effectively be crafted as a smart strategy which could potentially be an element in the pharmaceutical domain, for sizing, shaping and seizing the future. However, if the pharmaceutical terrain is mapped for competitiveness, even they are subjected to few conditions of which the companies need to comply and work along, lest to avoid an opportunity paradox and they are: generic arm patents of their own organization and re-inventing around a patented drug that are soon to expire.

Exhibit A – Pharmacogenomics

Object – Apply in a view to looking for extension of protection of the soon to expire patent by patenting a formulation which is established by evidence based facts [both clinical and lab] to prove its efficacy in functioning and delivering results.

This is an eclectic combination of Pharmacology and Genomics. This concept is pretty futuristic and relatively new in application where it aims to arrive at a certain component having desired results whilst customized and tailored to a patient’s genetic makeup.  Variant factors are responsible for a peculiarity of drug responsiveness in a given physiology of a patient’s system which may be affected by lifestyle, age, diet, environment etc. but hitting a factor that remains largely constant which includes a patient’s genetic set up can lead to instantly affirmative, uniform and scalable results with a bonus package of safety and greater efficacy.

The following positive drivers shall tentatively enable the pharmaceutical companies to be at vantage point over others those practice the traditional way & some of those drivers are:

• Enhanced Medications
• Safer Drugs
• Achieving accuracy in drug delivery dosage administration
• Advanced screening for pathophysiology
• Re-engineered Vaccines
• Stable Performance
• Better chances of approval
• Plummet in the expenses for health care

Exhibit B – Data Exclusivity

Object – Apply in a view to looking for extension of protection by way of excluding generic drug manufacturing companies from the data devising methodologies which has value of efficacy, safety and quality that gives a formulation an edge over the existing traditional drugs which are protected and are soon to expire.

Article 39.3 of the Agreement on Trade Related Aspects of Intellectual Property Rights recognizes the need to have an IP regime for protection of test data and analytical insights in the pharmaceutical sectors where the patent protection as a standalone guarding statutes or combination of such regulatory statutes. The data exclusivity evergreening is that form of protection that has the capacity to, in fact, restricting the governments for prohibiting a grant for a compulsory license on patented drugs as the monopoly would anyway prevent other pharmaceutical companies for marketing the generic products. Well, rest assured, this stays as one of the reliable methods for protection while the industry giants sought test data exclusivity in Free Trade Agreements and try fixing it by provisos with their trade counterparts. The European Union by far, has been most friendly to the pharmaceutical players with the maximum protection period of Eight years with an additional Two years of market exclusivity.

Exhibit C – Supragenerics

Object – Apply in a view to looking for extension of protection by innovations which have the feasibility of being patentable by altering them into an enhanced form of the pre-existing products that are soon to expire of that company and release into the over the counter stores in a bit advance.

Hence, the players can attempt in releasing the oxygen by implementing and deploying those above mentioned techniques which are some of the smart strategies, a pharmaceutical company can chalk out in order to hit those guaranteed sweet spots in their domain. By reinventing their offer with a continuous focus on their patent portfolio while keeping a hawk’s eye over the prevalent regulation and compliance, they can effectively secure their valuable market share and yet manage to retain their customers by driving better pharmacological patient centricity.

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