US Patent Law Research Articles

Enzo Biochem v. Gen-Probe: complying with the written description requirement under US patent law.

Recent court decisions effectively call for researchers and companies to reduce their biotechnology and pharmaceutical inventions to practice before they can apply for patent protection.

Post-TRIPS Options for Access to Patented Medicines in Developing Nations

This article explores the tension between granting patent protection under the TRIPS Agreements and the availability of medicines at affordable prices to developing countries. A crucial consideration under the TRIPS compulsory licensing option is the ‘adequate remuneration’ paid. A theoretical and empirical analysis shows that the royalties set under past compulsory licenses have been much lower than those that would be established under the ‘foregone profits’ standard of US patent law. To respect comparative advantage in the supply of licensed drugs, the TRIPS language requiring that compulsory licensing be predominantly for domestic supply needs clarification. The multinational drug pricing strategy that best combines equity with coverage of R&D costs is a variant of Ramsey pricing, under which prices are much lower in nations with low ability to pay and/or high price elasticities of demand than in wealthy nations. Statistical evidence on the prices of 15 AIDS drugs in 18 low‐ and medium‐income nations reveals that tendencies toward Ramsey pricing were at best weak. To encourage Ramsey pricing, parallel exports should be barred from low‐income nations, and price controls should not benchmark the prices charged in low‐income nations. Outright donation can also enhance the supply of drugs to low‐income nations. A quantitative analysis shows that when the marginal cost of production is low relative to ‘inventoriable’ average cost, donations can actually enhance a drug producer's after‐tax profits under US tax laws. Minor tax law changes to enhance donation incentives are suggested.

Putting your best mode forward.

Unique to US Patent Law, the best mode requirement presents a delicate balancing act for biotech inventors.

Of submarines and interference: legal status changes following citation of an earlier US patent or patent application under 35 USC §102 (e)

The changes in legal status of issued US patents which may result from the resolution of conflicts with patents of earlier date under 35 USC §102 (e) are reviewed. Some suggestions on how these changes may be tracked are provided. Resolution of these conflicts is often delayed by the existence of submarine patents, i.e., patent applications that have an earlier date but are published much later or are otherwise not known to the initial patentee. Resolution is also complicated by the “first to invent” concept in US patent law. The types of action resulting from the operation of 35 USC §102 (e) are described with reference to specific cases, and include interference, infringement and validity resolution, reexamination, reissue applications and disclaimers.

Biotechnology and Patents

Legal nature, macro and micro economic importance of patents, differences in propensity towards patenting and their consequences. Brief comparison of US and European patent law with regard to patentability of biotechnological inventions. The regime adopted under the EU Biotechnology Directive, especially as regards the patentability of DNA sequences, as well as plants and animals. Addressed were also the issues of prior informed consent in case of the use of biological material of human origin and the implications of early publication of raw sequence data.

Europe bids to pull US patent law into line with first-to-file system

LONDONThe European Commission (EC) and the United States are to reopen talks after more than a decade aimed at eventually harmonizing US patent law with that of most other countries.

Patent issues of genomics research

The interface between the science of genomics and the law of protecting inventions has been fraught with controversy. This paper starts with a basic primer on US patent law followed by a review of the patent issues related to genomics discoveries, in particular, expressed sequence tags (ESTs). Particular focus is placed on the positions expressed by those within the National Institutes of Health and the US Patent and Trademark Office about policy questions and patentability issues for ESTs. The paper concludes with a report on the status of patent law issues related to genomics and discusses those issues yet to be resolved. Drug Dev. Res. 41:205–217, 1997. © 1997 Wiley-Liss, Inc.

United States patent prior art rules and the neem controversy: a case of subject-matter imperialism?

A recent United States patent covering an improvement to the naturally-occurring pesticide in neem tree seed oil might have been rejected as 'obvious' if United States patent law recognized certain forms of prior inventive activity on a par with similar activity occurring within the United States' borders. But the US only recognizes prior 'knowledge, use or invention' as blocking a claim to a patent when those activities take place within US borders, or are evidenced by publications accessible in the US, or, more commonly, by foreign patents. Neither of these last forms of tangible 'prior art' is likely to be available to block patents on biodiversity inventions – most notably because of the fact that most developing nations do not allow patents on pharmaceutical or agricultural inventions, categories subsuming most biodiversity-related advances. Although the United States patent only has direct force within the United States, it is nonetheless highly significant to this global dispute, since the United States and other developed nations stand to be the major markets for the end-products of neem. This paper argues that the border-drawing distinctions in US patent law are archaic, counter to stated policy directives and are disproportionately influencing the developing world's stance towards GATT and its intellectual property rights provisions.