Journal of Commercial Biotechnology

The international community has responded to the call for increased management of biotechnology which may harm the environment through participation in multilateral environmental agreements (MEAs). Some of these agreements contain specific provisions which are at the heart of the foundation, both implicitly and explicitly, for international regulation of biotechnology. The implications of these agreements for biotechnology research are discussed. The membership of countries in the Asia and Pacific region to specific MEAs is discussed in the context of selected economic, political, geographical and agricultural indicators.

Since the first biotech crop was commercialised in 1996, these crops have enjoyed a rapid adoption and are now grown commercially by 8.5 million farmers in 21 countries, an 11 per cent increase from 8.25 million in 17 countries in 2004. Research and development is being conducted in another 45. The billionth cumulative acre of biotech crops was grown in 2005. Notably, last year Iran grew its first crop of biotech rice, the first biotech planting of this important food crop globally. The Czech Republic planted biotech maize for the first time, bringing the total number of European Union (EU) countries growing biotech crops to five with Spain, Germany and the Czech Republic being joined by France and Portugal, which resumed planting biotech maize after four and five-year gaps, respectively. This could signal an important trend in the EU. Although North America leads in the research, more than half of the 63 countries engaged in biotech research, development and production are developing countries. The first generation of such crops focused largely on input agronomic traits, the next generation will focus more on value-added output traits. In the next decade, some studies estimate the global value of biotech crops will increase nearly five-fold to $210bn.

R&D costs in the biotechnology and pharmaceutical industries continue to rocket, as do royalty rates for the relatively few new drugs and technology that successfully complete clinical testing. Several of the issues that led to last year's joint Department of Justice/Federal Trade Commission (DOJ/FTC) hearings are significant within those industries, including (1) recent court decisions reaching inconsistent results or at odds with public agency positions; (2) proliferation of new patent filings; (3) efforts to expand the scope of patents; (4) mergers and acquisitions reducing competition and consumer choice; (5) more restrictive, licenser-oriented licences; (6) patent blocking; and (7) patent settlements with reverse payments. This article discusses the results of studies evaluating the rising costs and declining success rates of new biotechnology and pharmaceutical product offerings, the upward trend in royalty rates and litigation awards, and the implications of the DOJ/FTC hearings.

There was a question as to the value of research tool patents; for instance, whether practising such patents for preclinical research would be within the research exemption of the US Patent Statute. The Federal Circuit in Integra Lifesciences I, Ltd v Merck kgaA held that the preclinical research in issue was not within the safe harbour of the research exemption, breathing life into research tool patents; but vacated the damages award because it appeared to have been influenced by hindsight knowledge that a valuable drug candidate had emerged. Integra is thus good news and bad news for owners of patents relating to discovery tools. This paper is not to be considered opinions of Frommer Lawrence & Haug LLP or any of the firm's clients; and nothing in this paper is to be considered as legal advice, a substitute for legal advice, or as positions/strategies, etc taken/employed in, or suitable for, any particular case or set of facts.

Patent analytical data has proved itself a key enabler in measuring the commercial focus and activity taking place within highly research and development (R&D) intensive industries such as biotechnology. Marks & Clerk has assessed biotechnology patent application and grant records from a range of international patent office and proprietary databases, with a view to gauging the industry's commitment to R&D and the particular areas of biotechnology that are attracting investment. Using this research, this paper seeks to provide a snapshot as to the current ‘state of play’ across the biotechnology sector, looking at strategic trends, technological focus and industry dominance. It also seeks to analyse indicators as to the future commercial development of the industry.