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<< Patent Intelligence Briefings / << Background to and Purpose of EU SPCs

Pharmaceutical Patents Database Significance

Pharmaceutical patents… Are they any different to other patents? Apart from certain specific elements that relate to pharmaceuticals, the answer is no. However, there are characteristics governing the patenting of pharmaceuticals that do set it apart from other forms of intellectual property protection. For example, being granted a patent for a pharmaceutical does not automatically provide the ability to use that period of exclusivity to its fullest extent. Getting the pharmaceutical to a stage where it can start recuperating costs of development and start earning profits is not so straightforward. Hence the creation of the pharmaceutical patent term extensions, SPCs in Europe and Waxman Hatch in USA. Most major countries of significant economic value incorporate either system into their legislation.

It is very important for originating companies to protect their intellectual property, especially when considering the costs of developing new drugs. This has been estimated in excess of $800 million per product. Companies simply cannot afford to lose patent protection prematurely as this could be potentially catastrophic. Research companies usually follow similar paths towards finding the “next” blockbuster. So it is a matter of timing when the patent is filed to protect the invention. Too early and a lot more development will be needed to get to a practical outcome. Too late and other researchers could get there first. So it is important to get there first but also not too early. From experience companies have very few products in the pipeline that could be considered possible blockbusters. To lose out is potentially dangerous, companies have been known to disappear because of the failure of their major efforts.

In the 1960s two companies Pfizer and Ledley dominated the market by virtue of their broad spectrum anti-biotics (Tetracyclines). When their patent protection disappeared, so did their dominance of the market. Pfizer subsequently recovered to reach a similar dominant position more than 40 years later; Ledley never really fully recovered and in the 1970s as a part of American Cyanamid, was acquired by Wyeth.

So this tended to emphasise the important of patent protection as this heralded the emergence of generics, which was not coincidental. It was seen that the main costs in any drug lies in the development; the direct costs of production is generally the smaller element. Therefore the possibility of producing products in the post patent period when only production costs needed to be considered was self-evident. Why the industry did not anticipate this eventuality remains a mystery. Perhaps, as some commentators considered, it was the arrogance of the industry in believing that the brand would hold dominance over the unbranded in spite of the great differentials in price. So, we have seen a surge in generic activity over the past 40 or 50 years that has made it currently the biggest growth area in the industry… And all because of the failure by the industry to recognise in time the significance of patent protection.

The MPA patents database includes patent expiry, filing and SPC dates of all authorised pharmaceutical products marketed in the EU, enabling the expiration of patents on key drugs and generic entry to be checked online.

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EC Regulation 469/2009 Article 20 EU Supplementary Protection Certificates | Pharmaceutical Patent Term Extensions
Pharmaceutical Patent Intelligence | French Generics Market | UK Parallel Imports and Pharmaceutical Patents
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