Responding to the Patent Cliff - Pharmaceutical Technology

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Responding to the Patent Cliff
As the dreaded patent cliff continues to haunt the pharmaceutical industry, some companies are resorting to desperate measures to delay generic drug entry into the market.

Pharmaceutical Technology Europe

Today, pharmaceutical companies are not only facing immense pressure from the patent cliff, but they are also being increasingly scrutinised in the public eye on how they respond to these challenges. In AstraZeneca's market-abuse case, it was highlighted that the patent system afforded pharmaceutical companies legal protection for the innovative drugs they bring to market. As such, the system was designed to reward innovation and help companies generate revenues to undertake further research (8). However, the authorities stated that they took a dim view on abuses of the patent system as well as other underhand approaches by companies to extend the protection of their blockbuster products and delay generic drug entry.

Therefore, it can be expected that if GSK is found guilty of abusing their market position, the company will face a considerably high fine by the OFT so that the message gets through to other potential offenders in the pharmaceutical industry (6). Similarly, J&J and Novartis will be severely punished by the European Commission if a case against them is proven (7). The cost of pharmaceuticals to the public healthcare system is under tight scrutiny and authorities are keen to ensure that they are getting value for money.

1. C. Harrison, Nature Reviews Drug Discovery 12, 14-15 (2013).

2. PM Live website, "Sanofi predicts end of patent cliff in 2013,", accessed 28 May 2013.

3. Pharmaceutical Field website, "Patent expiry means 2012 is 'marked in red' for Sanofi,", accessed 28 May 2013.

4. N. Neville and J. Rankin, The Guardian website, "GlaxoSmithKline accused of paying rivals to delay generic medicine,", accessed 28 May 2013.

5. Office of Fair Trading website, "OFT issues statement of objections to certain pharmaceutical companies,", accessed 28 May 2013.

6. European Commission, "Antitrust: Commission sends Statement of Objections to J&J and Novartis on delayed entry of generic pain-killer," Press Release, 31 Jan. 2013.

7. European Commission, "Antitrust: Commission opens proceedings against Johnson & Johnson and Novartis," Press Release, 21 Oct. 2011.

8. European Commission, "Antitrust: Commission welcomes court judgment in AstraZeneca case," Press Release, 1 July 2010.


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