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What Do European Pharmaceutical Companies Need to Know in Order to Get Effective IP Protection in the US?

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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By Hilton Lord, Partner at Marks & Clerk

Hilton Lord graduated from Oxford University in 1983 with an Honours Degree in Biochemistry. He spent his first three years in the patent profession with Wellcome, where he was responsible for drafting the original Zidovudine (AZT) patents.

He then moved on to the city firm of Marks & Clerk (the chartered patent and trade mark agents) where he became a Partner in 1992. Hilton specialises in pharma and biotech, and represents a variety of clients, from Japanese pharma giants through to British universities and domestic start-ups.

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