Patent expiries

Patent expiry does not spell the replacement of the possible monopoly with a situation of competition, for a number of reasons. One of these is the factor of the brand names or trade names with which laboratories identify their products. 

Product Class Leading Brands Company EU Patent Expiry US Patent Expiry... 

Erosion of product lifetimes as a result of greater generic competition means that a product can expect to lose the majority of its market in as httle as 3 months after patent expiry. 

Fig. 11.7 UK sales of enalapril before and after patent expiry (the patent expired in December 1999 ).

Although it was open to Member States to decide not to allow an exclusivity period to run beyond patent expiry. 

Hudson, John. 2000. Generic Take-Up in the Pharmaceutical Market Following Patent Expiry A Multi-Country Study. Jnternational Review of Law and Economics 20 205-221. 

Within the 120 billion worth of proprietary drugs that face patent expiry, there is also 20 billion worth of biopharmaceuticals (e.g., epoetin and insulin). Biogenerics produced in living celllines have not played a role so far, mainly because an unambiguous regulatory framework has not been established yet in the United States. 

For instance, in its 2002 annual report, Barr Laboratories mentions as major highlight of the year Launched and shipped 100 million generic Prozac capsules in first 48 hours of FDA approval. KUDCO, the US subsidiary of the German Schwarz Pharma, launched a generic version of Prilosec (omeprazole) on the day after the patent expiry (Dec. 20, 2002), and matured sales of 150 million until the end of the year, bringing the turnover up by 20% ( ) for the full year, and YULE CATTO, producer of the API for omeprazole, reported a 30% increase of its EBITDA for 2002. 

Financial Muscle. The developmental work for a new API-for-generic has to start 5-8 years before patent expiry of the originator drug. This means a substantial investment in both human resources and R D funding many years before any revenues are generated. 

Within the 120 top 200 proprietary drugs that face patent expiry, there is also 20 billion worth of biopharmaceuticals. Blockbuster biopharmaceu-... 

We are now in a cycle characterized by incremental innovation, not therapeutic breakthroughs, and it is reasonable for industry critics to question the industry on the value of its innovations. A wave of patent expiries, high failure rates of developmental products, pressure to reduce or contain healthcare inflation (prices and expenditures), and access to essential medicines in developing countries have resulted in a global environment of increasing hostility. At this point it is difficult to predict the direction in which the environment will move over the next three to five years. 

The example of Voltarol Retard, cited in the preceding section, is one of a company which has developed an innovative drag, acting to protect its franchise in that product when patent expiry draws near. Every proprietary product eventually loses its patent exclusivity (usually 20 years after the patent was applied for or granted) and it is then open to any other manufacturer to manufacture and sell the same drag, perhaps under its own brand name. It is, of course, necessary to obtain a license to manufacture and market the... 

The decisions regarding the potential for developing other novel inhibitors of gastric acid secretion are likely to be based on therapeutic efiicacy, specificity, lack of adverse effects, longterm tolerability, and safety, as well as commercial issues such as market share, patent expiry, and generic competition (6). Self-medication has... 

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