Biotechnology Industry News
Biotechnology industry news, updates, and press releases

There has been a trend of worldwide harmonization of patent laws. Due to the continuing harmonization, examination of patents in Europe and the United States are very similar.  However, examination standards between the two patent offices can differ. Thus, applicants should be aware of the differences between examination standards since both standards need to be addressed in the single patent application.  This paper will review some of these differences, both major and subtle, that should be considered when drafting a biotech patent for filing in both the U.S. and Europe.

Full details at the Journal of Commercial Biotechnology

Contract research organization (CRO) outsourcing has become a critical strategy for multinational biopharmaceutical companies looking to reduce costs, time-to-market and expanding their pipelines as blockbuster patents expire. Much of the growth in the CRO industry is coming from emerging markets, such as China and India. China's CRO industry began in 1996 and is still relatively young and fragmented. However, it is growing quickly at an annual rate of 30%. Global CRO giants such as Quintiles, PPD, Covance, Parexel and ICON have invested in facilities in China and some Chinese CROs have grown to become global players. This paper will provide a detailed analysis on CROs in China, including the characterization of companies and services provided, recent IPO/M&A deal activity, trends in the sector, and intellectual property and regulatory issues to consider. Readers will be able to obtain a clear picture of China's CRO landscape. This paper should serve as a guide for companies considering outsourcing R&D to China and investors looking for opportunities in China's CRO industry.

 

Full details at the Journal of Commercial Biotechnology

Biosimilars, also known as follow on biologics, are complex biotechnology drugs that are similar, but not identical, to original biologic drug forms, and represent potential lower cost versions that may improve access. Yet biologics and their biosimilar forms have a key safety concern: unwanted immunogenicity. Emerging markets have tremendous interest in biosimilars, but are at a tipping point: they are moving from developing country concerns (e.g., communicable disease) to developed country needs (e.g., cancer therapies) that require biologic drugs. Production, however, is at lower than current Good Manufacturing Practice levels standard in highly-regulated markets. Emerging market public-private partnerships between public agencies, local producers, and global pharmaceutical firms, can incentivize biosimilar production at higher quality levels than required for local markets as well as position themselves for entry into developed markets. Public health goals can be reached while increasing economic opportunities in these markets to benefit global health.

Full details at the Journal of Commercial Biotechnology