Monthly Archives: January 2013

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

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 1/3rd 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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Two International Symposiums on Patent Portfolio Management Strategies for Pharma and Biotech Industry, (i) for R&D Scientists and IP Professionals, and (ii) for Business Development and Licensing Professionals (running concurrently)

About the Symposiums: These Symposiums feature presentation of all important patent issues, as mentioned in the brochure, related to two different groups i.e. Business Development and Licensing Professionals on one hand and R&D Scientists & IP Professionals on the other hand. Both these symposiums for different groups would run concurrently in the different Conference Halls at two different halls of Hotel Hilton. Workshop will provide an opportunity to receive first-hand information including recent judgments on various issues from the experts in the fields.

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About the Speakers: The speakers are a unique gathering of Patent Attorneys, Legal Counsels, and also include experts from the Commercial domain for Business Development Group, who have extensive years of experience in their professional fields. These Speakers will put across to the delegates a real insight of Patent Laws & Practices, and Commercial perspectives as prevalent and practiced in Europe, Japan, United States, and India.The speakers include:

  • Chid Iyer, Partner at Sughrue Mion PLLC, USA
  • Michael R. Dzwonczyk, Partner at Sughrue Mion PLLC, USA
  • Steven M. Coyle, Parter at Cantor Colburn LLP, USA
  • Jeffery Arnold, Partner at Cantor Colburn LLP, USA
  • Leslie-Anne Maxwell, Ph.D., Counsel at Cantor Colburn LLP, USA
  • David E. Rodrigues, Ph.D., Partner at Cantor Colburn LLP, USA
  • Toshio Nakamura, Patent Attorney at Fukami Patent Office, Japan
  • Satsuki Ichikawa, Partner and Patent Attorney at Nakamura & Partners, Japan
  • Thomas Friede, European and German Patent Attorney at Bardehle Pagenberg
  • Wolfgang Bublak, Partner at Bardehle Pagenberg
  • Vinod Khurana, Sr. Partner at Khurana & Khurana, India
  • Tarun Khurana, Partner at Khurana & Khurana, India

Venue and Dates:

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Please see the complete details including Program Schedule, Topics, Speakers Profiles etc. in a brochure available over here.

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Divisional Application

Pankaj Mohanta, an intern at Khurana and Khurana Advocates and IP Attorneys gives us an overview and analysis of divisional application.

BACKGROUND:

A divisional patent application is generally a fair basic patent application which differs from the parent application comprising of data, analysis, results and insights about a particular invention from a previously filed application. The object herein lies about balancing the mutual dependency over the insight driven analogies whilst retaining the identical time bound priority rights where it may still retain the parent application’s filing date.

Much care and attention has to be brought into serious consideration while bringing about a unity of invention while an application is being filed. The construction shall be effective enough to connect the dots so as to eliminate the chances of missing out such a scenario where the Invention’s unity is being inherently jeopardized. The plurality of inventions has been long an issue over the matter concerning divisional applications. There shall be only one application for a given invention, if not, then, there rises a need to file multiple applications in the form of divisionals each dedicated to hook exclusively one invention along with them respectively. If we scan a bit into the sole objective of doing so, we might come across a purposive reason behind such a rationale. It is often strikingly double binded where one of its prongs would represent the financial while the other prong would represent the administrative aspect of such a step. The applicant cannot escape the bunched and varied fees for several inventions by mere filing up one patent application, while closely related ones might be considered by the Controller.

The lack of unified invention, calls for filing divisional applications and is powered by the Article 4G of the Paris Convention.

OVERVIEW:

The applicant, who, here in this matter happen to be Bayer Animal Health GMBH had filed an application back then in the year 1999. This application was duly directed at the Delhi Patent Office bearing an application number – 1427/DEL/1999. Later, this application was retained as a divisional application of 371/DEL/1997.

The application was thoroughly checked and an FER was issued on 2nd day of July in the year 1999. Then, there existed a provision of Section 5 [1] [b] of the leading statute which implied that the claimed invention was not patentable under that provision. Well, scrutinizing a bit of the matter, we would certainly come across the fact that it was a pharmaceutical product having a chemical product base derivative. But, the representatives and the agents for the applicant did not respond back to the issued Office action, thereby rendering the application abandoned under Section 21 [1] as a resultant of non compliance.

Later, new radical changes were brought about in the form of fresh amendments where after being introduced into force enabled chemical substances to be patentable, seeing this, the appellants filed another application for that same invention as a divisional patent invention application of that of the parent or the earlier main application. The divisional application was examined and an FER was issued on the 20th of September, 2007 rendering that application invalid and which didn’t met the necessary criterias fulfilling the requirements of the Section 16 of the leading statute. This time, the appellants responded to this and in their response they stated that the Examiner did not interpret the provisions of Section 16 correctly. To this, another FER was issued based on the same objection on 8th October, 2008. Now, in this Office action, they did not miss out about expressly mentioning the fact that the applicant’s filed application could not be considered as a divisional since Section 16 as the provision per se, exclusively necessitated the need for having plurality of invention for filing such a divisional application.

The appellants thereafter requested for a hearing stating that their present applicant should not have been rejected under the current prevailing laws and provisions and so as the invention was not patentable under the law existing earlier, the original parent application couldn’t be proceeded further hence the present application shouldn’t be rejected, as stated by the appellants.

Their hearing was reviewed and after doing so, the Deputy Controller declined the contention of the applicants wherein they claimed to seek for filing a divisional application even if their parent application did not contain about multiple invention and their embodiments. To this matter, the Deputy Controller probed in and sketched out few findings relating to this case and they are:

  • Divisional Application, in absolute sense, is meant for multiple inventions
  • Disclosure which has been undertaken in one parent application
  • The priority of rights and claims are not specific to a particular invention matter
  • Claims in parent application are identical to that of the instant application
  • Claims in that parent application did not disclose more than one invention
  • Fresh application was filed as divisional to protect the same invention
  • The appellant could not restore the parent application which was not patentable then for the filing since the statute did not provide for that.

After the post amendment, the Controller General of Patents, Designs and Trademarks, he however addressed to all the head offices referring to the new changes bearing a message body which directed them as a communication meant for clarifying about any divisional application filed under the said provisions of Section 16 having claims of the priorities and rights which were not allowed under Section 5 of the then act before 01/01/2005 shall be allowed in accordance with the leading statute of the Patents Act, 1970 which remains firm as amended by the Patents [Amendment] Act, 2005. Not just this, but he also further directed that it shall be ensured that the divisional applications abandoned as per the instructions number – 3/2005 should be reviewed.

FACT BASED ANALYSIS:

There contains a double faceted aspect to this matter from which my analysis has been derived and based upon. The one that sets out instructions while the other stresses on the provisions of the law in the statute which has to do all about the divisional applications. Prior to 01/01/2005, the law provided that the applications having details in the form of disclosures, claims, priorities and rights which might have plurality of inventions while one of those multiple inventions in the application which may have related to a product which was not patentable under the earlier act can very well in the current scenario having the statute as amended, be processed as a divisional application which meets all the criterias which are provided for a proper grant. Also, it shall be taken care while deducing whether an application could be treated as a divisional. Meanwhile, mere re-filing and submitting the same claims and priorities that formed a part earlier in the parent application whilst attempting to make it seem like a divisional application would render that latter application standing invalid. Hence, regardless, Section 16 of Patents Act, 1970 still stands as the only slab according to which the application has to specifically satisfy the objective provisions that are enlisted  as conditions basing on which an application could be treated as a divisional patent application, provided it meets the requirements. Thus, the appellant here in this case who wished to have their application entertained as a divisional application at the Controller office with the priority date of that of their parent application, is largely non apparent on the face that it is impugned and leaves no room for it to be treated as  divisional for that matter to begin with.

CONCLUSION:

The technology dynamics and all its allied industries are undergoing through a state of continuous transformation in any given array of discipline in a linear progression and so does the statutes governing their regulation striving to streamline the compliance factor. The complexity in the patent regime over the Intellectual Property ecosystem carries the sole object to provide an unprecedented clarity in every possible corner while striking a balance for the interests of enhancing monetization, driving commercialization, securing better protectability and taking the pulse for innovation in a scale of continuum where they believe that things are necessary to pro activate as they navigate their journey to the future.