NEW THERAPEUTIC ENTITIES
for each of their new molecules and, where possible, for the overall drug products. In particular they use patents, not only as a strategy for becoming the sole marketer and enjoying significant financial returns along the way, but also for driving away competitors. Trailing along the long and winding road to
I
patenting a pharma invention, which involves numerous years of monetary expenditure in clinical research and development (R&D), can ultimately ensure
and marketing authorisation (MA) for the candidate drug. Generic-based pharma industries, on the
other hand, are a different type of (likewise) clever monster. Tey wait until the expiration of
the innovative drug’s patent before legally
manufacturing/marketing generic versions of it, as long as they have complied with local regulations. Tis in turn represents a reduced financial investment—primarily due to the lack of R&D—
nnovative research-based pharmaceutical industries are indisputably clever creatures. Tey seek intellectual property protection
translating into shorter timelines and a lower risk of failure. When a drug’s patent expires, it generally means that
the once-monopolised
product can become more affordable for the bulk of the population, although this is not always the result. But what happens when a third beast is
regulatory approval
introduced: the so-called (and recently coined) new therapeutic entities (NTEs)? Tese specialist pharma products are improved versions of known and/or approved small molecules with established safety and toxicology profiles, which are designed to address specific unmet patient needs. Te nature of the improvement may include drug delivery, combination formulations, modified dosage strengths, manufacturing or reformulation technology, and/or different routes of administration. It is worth noting that
these improved
therapeutic products do not yet have a generally agreed name—as well as NTEs, they are referred to as supergenerics, hybrids or added-value generics, although the US Food and Drug Administration (FDA) does not yet recognise any of these terms. Compared to innovative molecules,
developing NTEs entails a reduced financial investment, as the timelines for R&D are naturally shorter, although they are more expensive to develop than ordinary generics. Te route to commercialisation for NTEs, in general terms, is less of a winding road and significantly less complex, and at least in the US, they are good candidates for exclusivity.
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World Intellectual Property Review Annual 2015
85
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