The degree to which patenting, and in particular secondary patenting, protect pharmaceutical products during their lifecycle is often misconstrued.
28.11.12
Productive discourse between those who believe in the fundamental importance of the patent system and those who do not, is hindered by the technical and legal complexity of patent law. A complexity compounded in the pharmaceutical sector by the interaction of the patent system with drug regulatory practice. Misleading characterizations of the pharmaceutical patent system ( including recent references to “extending patents for decades” ) have become an increasingly common part of public debates concerning both access to pharmaceuticals and the incentives to investment in pharma R&D. “Incremental Innovation” is sometimes used pejoratively and patents protecting such innovations dismissed as “evergreening” or “lifecycle management”, alluding to anti-competitive behavior or inappropriate extensions of exclusivity. It is vital in an environment of confusing messages that there is clear understanding of the legal and marketplace reality of the strengths and limitations, of pharmaceutical patenting.
The key point must be the basic legal principle that patents granted on further inventions made in relation to already patented subject matter can never extend the scope or term of patent protection provided by an earlier patent. While a new patent protected term arises for this “secondary” or “incremental” innovation, the scope of the secondary patent is limited to the new invention and its existence does not prevent third parties operating across the full scope of the earlier patent, when that earlier patent’s normal term expires. A classic pharmaceutical example of such an incremental innovation capable of generating secondary patent protection would be a new, inventive formulation of an already marketed and patented drug. Assuming a patent is obtained protecting the new formulation; such a patent would have no effect on the ability of third parties to exploit that drug in any formulation disclosed in the original patent. The new patent in no way forms any extension of the previous patent to the drug but has its own legally unconnected patent life.
It is also important to establish that “incremental innovation” is in no way lesser innovation either legally or scientifically. In a pharmaceutical environment where the scientific and regulatory hurdles to approval of new molecular entities continue to grow, it is vital from a patient perspective that all thetherapeutic potential of existing drugs is fully exploited. Rewarding further innovation on already approved drugs does not extend the patent protection on that drug as first marketed but encourages the development of new formulations, indications or combinations that increases the number of patients who can be treated. As the drug development paradigm shifts to reflect an era of personalized medicine there is a likelihood that first approved indications may indeed be relatively numerically smaller and incremental innovation will be required to spread access into more prevalent indications.
Of course there are well-established legal provisions whereby pharmaceutical patents can be “extended” but only as compensation for on-market patent term lost pending regulatory approvals e.g. the “Patent Term Extension” (PTE) system in the US or the Supplementary Protection Certificate (SPC) in the EU. However the term patent “extension” is to some degree misleading given that while expiry of the on-market patent-protected term may be deferred for up to a maximum of five years, this is in compensation for a loss commonly of ten to twelve years pending marketing approval. In areas of innovation not requiring regulatory approvals; the full twenty years of on-market patent protected term may be obtained however, even when including PTE and SPC adjustments, the maximum on-market patent term for pharmaceutical inventions is capped at 14 years in US and 15 years in the EU. (Note: in certain circumstances an additional 6 months may be added to these capped terms as a reward for clinical trials seeking paediatric approval).
The scope and term of pharmaceutical patents and related intellectual property rights have evolved gradually over many decades as effective incentives proven to drive therapeutic innovation. The justification for these rights has come under particular scrutiny by emerging markets opening up to more innovative drugs. India has notably singled out pharmaceutical incremental innovation to be excluded from patentability, while permitting patents for incremental innovation in other technology sectors. It may well be misplaced perceptions as to the market effect of patents to incremental pharmaceutical innovation on existing drug products that has led a country such as India to introduce this exclusion. Industry must effectively communicate that patents for incremental innovation will drive the targeted development of already approved drugs for the specific needs of both developed and emerging markets and do so without extending earlier patent terms or in any way restricting access to already marketed products.
