Medicine in Europe: what are the barriers?

Kushal Vyas, ELC Group, looks at barriers to generic entry in Europe

Access to medicine and return on investment have always been key public policy considerations for governments to balance increasing healthcare cost and promote innovation.

Lifecycle management strategies by brand companies have been successfully challenged and generic companies have subsequently launched products. However, pharmaceutical research on new actives involves relatively less certainty and substantial investment. To promote further research and secure return on investment, various monopolies with specific scope have been awarded to the originator companies.

Exclusivity

Exclusivities are the incentive given for the specific period of time to the innovator companies upon the submission of clinical and other research data for specific types of products. Recent rules now provide protection of eight years data exclusivity plus two years marketing exclusivity plus other additional exclusivities, wherever applicable.

Data exclusivity is the period during which companies cannot rely on innovator’s data to obtain a marketing authorisation for generic application unless licensed by the innovator. Market exclusivity refers to the period during which generics can submit an application referencing the innovator’s products but cannot receive the approval of its product till its expiry. New indication exclusivity (plus-one year) may be received if registered during the initial eight year period and demonstrates significant clinical benefit over existing therapies. It may also be obtained for a new therapeutic indication for a well-established substance based on significant clinical data. Change in class exclusivity (plus-one year) may also be added, for example, OTC switch. Orphan drug exclusivity and Pediatric use marketing authorisation are given separate exclusivity for 10 years.

Supplementary protection certificate (SPCs)

SPC is the ‘Sui generis’ system which provides additional monopoly to compensate time lost for granting MA. Patents are filed in the initial stage of research and its expiry is calculated based on its filing date. However for pharmaceutical inventions, multiple years are lost in gaining regulatory approvals. To compensate, additional monopoly is awarded as an extension to the basic patent, with a maximum of five years. SPCs take effectafter the expiry of patent to which it is attached.The term of SPC is calculated as (date of first MA in the EEA − date of filing of corresponding patent) − five years. The SPC may be extended for 6 months after compliance of an agreed Pediatric Investigation Plan (PIP).

Patents

Patents are territorial rights to exclude othersfrom making, using, selling or importing the claimed invention. In the case of pharmaceuticals, drug substance related patents may be granted with claims covering markush/genus structure, species/specific substance, for example, compound per se, derivatives like salts, esters etc, polymorphs, process for preparation of drug substance, intermediateand so on. Method of treatments patent may be granted to indications and other treatmentrelated patent eligible inventions. Formulation patents are also granted with the product claims or process for its preparation. Patents are applied for invention identified during various stages of product development. There can be multiple patents covering a single product.

Barriers/Strategies

Exclusivities are the primary form of monopoly which restricts the filing or marketing of generic applications. Grant of exclusivity is rejected by the regulatory authorities in few cases, and in very few instances, generic applicants have also tried to challenge such grants. SPC are usually applied for the basic drug patent, however, originators do apply for other types of patents. SPCs are challenged by generics in multiple cases for eligibility, scope, term of protection etc and there are positive outcomes in many instances. Alternatively, depending on the scope of protection, generic companies may also file MA having freedom to operate over the granted SPC.Patents form a third set of barriers for the generic companies. However, each granted patent has specific scope and generics may design specific freedom to operate or challenge strategies.

In summary, generic companies may come up with early launch products by well-designed strategies withcombined input of scientific, regulatory andlegalexperts’inputs against various forms of monopolies. Originator companies usually try to protect all feasible options likely to be explored by generics. By involving early stage research, generics may also come up with inventive feasible strategies with patent protection which gives right to exclude others.

Views provided herein are general. Kindly seek necessary diligence from relevant experts.