LSIPR 50 2016: Barack Obama and Stephen Ostroff
Name: Barack Obama
Organisation: US government
Position: President
President Barack Obama is the 44th president of the US and was first elected in 2008. After being re-elected in 2012, he is serving his final term, which ends in January 2017. Obama was born in Hawaii in 1961 and moved to Chicago in the 1990s. He earned his law degree from the University of Chicago Law School, studying from 1992 to 1994.
One of Obama’s best known policies is his healthcare reform act, often called ‘Obamacare’. The law is officially called the Patient Protection and Affordable Care Act 2010. The aim of the bill is to enable Americans to afford better quality health insurance.
As a part of Obamacare in 2009, the administration signed into law the Biologics Price Competition and Innovation Act. This landmark piece of legislation provides a regulatory approval pathway for biosimilar products, but it was not until this year that the Food and Drug Administration approved the first biosimilar application, for Sandoz’s Zarxio (filgrastim-sndz), a biosimilar version of Amgen’s Neupogen (filgrastim).
In 2014, market intelligence company EvaluatePharma released a report called “World Preview 2014, outlook to 2020”, in which it discussed the impact of future patent expirations in the biological industry. It reported that from 2014 to 2020, “$250 billion of worldwide drug sales are at risk from patent expiries”. The consensus in the report was that biosimilar products will continue to have a “softer landing” post-patent expiry. It also commented that research and development is expected to grow at a “modest” rate of 2.4% a year from 2013 to 2020.
In 2015, the House Judiciary Committee voted to pass the Innovation Act. This bill, which aims to reduce litigation by so-called patent trolls, has yet to be passed by the Senate. Some commentators have criticised the bill by suggesting that it does not clearly distinguish between a patent troll and a genuine inventor and therefore would make it more difficult for individuals and small businesses legitimately to protect their intellectual property. Should this bill be enacted, it would be yet another example of IP-related legislation stemming from the Obama administration.
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