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| home > epc > summer 2002 > what do european pharmaceutical companies need to know in order to get effective ip protection in the us? |
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European Pharmaceutical Contractor
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What factors will affect the granting and enforcement of pharmaceutical patents in the US today? This article looks at the opportunities and pitfalls for pharmaceutical companies looking to diversify into the US market.
This article is intended to examine the considerations that European companies need to bear in mind when applying for patents in the US. Firstly, the general differences between the US patent system and the European system are explained. Then, two important areas that European pharmaceutical companies should be aware of before applying for US patents are analysed. The first is the major changes to examination standards for biotech patents in the US that require applicants to pay greater attention to the utility, written description and enablement requirements when seeking a US patent. The second is the change as to what constitutes infringement following Festo.
Technology, especially biotechnology, is only as strong as its patents. The underlying reason why pharmaceutical progress is dependent on intellectual property protection is the staggering cost of drug development. Perhaps in no other industry can an invention that costs so much to discover and develop be copied or reverse-engineered so inexpensively, at a small fraction of the innovator's research and development costs. Without strong patent protection, pharmaceutical companies could not afford the investment needed to conduct this expensive, high-risk research. So what should pharmaceutical companies be doing to ensure that their patent portfolio is as strong as it possibly can be when applying for US patents?
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
More info >> |
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News and Press Releases |
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Azopharma Announces Plans to Implement XcelodoseTM Technology in the Production of Early Stage Clinical Trial Materials
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today plans to implement Xcelodose technology at its formulations development facility, ApiCross Drug Delivery Technologies. Xcelodose technology is a powder micro-dosing system developed by Meridica. This technology offers a unique powder dispensing system for small-scale capsule filling and ultimately assists in conserving valuable research material as well as reducing various Preformulation activities.
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