BRIC-a-BRAC: March 14, 2014
1. As a follow-up to our post on Patent Trolls: A View from Europe, on February 28, 2014, Apple Inc. (Apple) won dismissal of the US $2 billion patent infringement lawsuit brought by IPCom GmBH (IPCom) in the District Court of Mannheim, Germany. Specifically, the Court held that Apple did not infringe the two patents asserted by IPCom (although the reason for the decision was not given). IPCom is appealing the decision.
2. Is the road to riches for pharmaceutical companies not paved with biosimilars and the BRIC markets? This is the question examined in an article at philly.com. According to the article, it is becoming clear that only a handful of companies may make substantial profits with biosimilars. In fact, some suggest that biosimilars represent “fool’s gold” for many companies. With respect to the BRIC markets, the article notes that the sales in the BRIC countries, which were expected to spearhead pharma’s emerging markets strategy, are not meeting expectations. The reasons include price controls in China, India and Brazil as well as slowing growth in China and the use of compulsory licensing in India. Russia is struggling to keep investors due to the falling ruble and the Russia-Ukraine faceoff.
3. Will there be a Global Regulatory Supergroup? According to Regulatory Focus (RF), U.S. and international regulators are working to create a new global regulatory organization whose focus would be on leveraging and sharing resources and information among various regulatory authorities. The announcement of the existence of this organization was made on March 6, 2014 by Margaret Hamburg, the Commissioner of the U.S. Food and Drug Administration (FDA), speaking at the Medicines and Healthcare Products Regulatory Agency’s (MHRA) Annual Lecture in London. According to Commissioner Hamburg, “Regulators around the world have begun to collaborate around the formation of an International Coalition of Medical Regulatory Authorities (ICMRA)”. While the details of the ICMRA are still in the early stages, Commissioner Hamburg envisions that the organization will be a “high-level, strategic advocacy and leadership entity”. A full transcript of Commissioner Hamburg’s speech can be found here.