The life sciences industry is under scrutiny. In the US, Congress is discussing radical reform of healthcare provision while the FTC, an antitrust watchdog, continues to investigate reverse-payment settlements; in the EU, meanwhile, the European Commission has recently completed an investigation into competitiveness in the pharmaceutical industry and indicated it might soon take action against individual companies. On a wider level, there are powerful debates worldwide about balancing control and access over genes and traditional knowledge. These challenges come in the context of major changes within the industry, as many blockbuster drugs lose patent protection, the lines between the branded and generic industry become increasingly blurred and new companies develop in emerging markets.
The scope and limits of IP protection define the competitive landscape in the pharmaceutical, biotechnology and related industries, so both innovators and competitors need to know and understand the latest activities of legislators and the courts. That applies to issues ranging from what is patentable, how inventions can be protected and how ownership is determined through to effective branding and the ownership of data.
The chapters in this Life Science Focus 2009 address many of the most pressing IP issues for life science companies worldwide, including: international litigation strategies; how to manage a product's life cycle; the fight over Novartis's patent for Gleevec in India; the regulatory environment for generic companies; patent term extension; and comparative advertising. There are also updates on the patentability of genes and proteins, the regulation of biotherapeutic products and the determination of obviousness. The Focus covers Asia, Europe and the Americas.
While the analysis in these articles is varied and subtle, each highlights the increasingly complex and demanding business of managing an IP portfolio in the life science industry. Thanks to market pressures, greater competition and increased regulatory scrutiny, all businesses – large and small – in this industry need to become even more sophisticated in how they develop, manage and exploit their IP rights. Only those that do so will be successful in the long term.
James Nurton
Managing editor
Managing IP