July 11, 2020

Volume X, Number 193

July 10, 2020

Subscribe to Latest Legal News and Analysis

July 09, 2020

Subscribe to Latest Legal News and Analysis

July 08, 2020

Subscribe to Latest Legal News and Analysis

BRIC-a-BRAC: News Items from BRIC Companies January 31, 2014

1.  An interesting article in Pharmaexec.com discusses Russia’s focus on developing a “world class” biopharmaceutical sector.  The article states that IMS Health predicts that Russia’s $16.6 billion in annual prescription drug sales (11th in market size) will rise to $26.6 billion by 2017 (8th in market size).  Specifically, the article discusses ChemRar, a consortia of biotech startups and R & D venture companies funded through a mix of private capital and public funds dedicated to the goal of developing and commercializing innovative medicines with therapeutic potential for Russia (and hopefully the world).  Also discussed is Skolkovo, a publicly funded institution and incubator home to 200 companies that has a broad range of business and policy objectives.  

Finally, the article interviewed key players in Russia’s biopharmaceutical industry and identified four strategic questions it believes will prove critical to Russia’s success.  These questions are: 

a.  “Will government efforts to advance the ‘front end’ of innovation – through new infrastructure, financing of basic research, and tax incentives – be accompanied by the far more essential ‘back end’ of a fair and transparent investment, regulatory and pricing regime based on international standards?

b.  Is there political will to ensure that public health gains a higher profile as a strategic driver of Russia’s future, where medicines — both patent and generic — are recognized as a key part of service delivery within an adequately financed national health care system?

c.  Are the market opportunities in Russia sufficient for the top 10 foreign players to establish world-class R&D operations in the country, effectively transferring to Russia the expertise required to access global knowledge networks and fill the local gaps in financial and human capital?

d.  Can domestic pharma producers build the size and scale to surpass the foreign-based multinationals in Russia and extend that success to international markets, making the transition from copying, distribution and manufacture to an originator of world class innovations?”

2.  On Tuesday, January 28, 2014, the Nigerian government launched the country’s first Intellectual Property Automated Systems (IPAS).  The government believes that the IPAS will make patent registration easier in Nigeria.  The system was launched by Olusegun Aganga, Minister of Industry, Trade and Investment and is considered to be a major milestone in the effort to transform the Nigerian industrial landscape.  According to Mr. Aganga:  

“The introduction of the IPAS will further improve and uplift the integrity and standards of all applications that emanate from Nigeria. 

It will enhance the confidence of both the local and international communities and further encourage local and foreign direct investment in the country.  This is about consumer and investment protection and it is a very good development for the country.”  

To learn more, click here

3.  This week the question was asked whether or not Indian companies have a “chronic data falsification problem” after the United States (US) Food and Drug Administration (FDA) accused Ranbaxy of failing to ensure the integrity of its data.  Specifically, FDA inspectors reportedly found evidence that the company was “over-writing electronic raw data files for ongoing sample sequences until acceptable results were achieved.”

This is the second “offense” for Ranbaxy.  In May 2013, Ranbaxy pleaded guilty to falsifying data.  In fact, in 2013, the US FDA (in warning letters) raised questions regarding the integrity and reliability of data generated by 7 companies.  These companies were Ranbaxy, Wockhardt Limited, Agila Specialties Private Limited, Posh Chemicals Private Limited, Aarti Drugs Limited, Fresenius Kabi Oncology Ltd. and RPG Life Sciences Limited.  To learn more, click here.

©2020 MICHAEL BEST & FRIEDRICH LLPNational Law Review, Volume IV, Number 31


About this Author

Lisa Mueller, Michael Best, Patent application Attorney, intellectual property lawyer,
Partner, Industry Group Chair, Life Sciences

Lisa provides strategic counsel on complex patent issues to clients in the pharmaceutical, biopharmaceutical, biotechnology and chemistry sectors. She brings an in-depth knowledge and extensive experience to her work advising clients on patent protection, freedom to operate and invalidity of blockbuster drugs they aim to produce and distribute.

Lisa’s advice on the full spectrum of global intellectual property portfolio management includes patent prosecution, opposition and other post-grant proceedings