How do patent laws affect drug development in the pharmaceutical industry and why? 3 Answers as of June 02, 2015

How do patent laws affect drug development in the pharmaceutical industry?

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Banner & Witcoff, Ltd. | Ernie Linek
Drug development is very expensive - some estimates are over 1 Billion dollars to create and market a new drug. Patent protection allows the drug maker a limited time to recoup some of those costs - as nobody else can make, use or sell the patented drug until the patent expires - 20 years after the filing date. FDA delays for approval to sell the drug can be added to the patent lifetime - up to five years more. Without patent protection in a given country - anyone can make and sell the drug there.
Answer Applies to: Massachusetts
Replied: 6/2/2015
Sebby Law Office
Sebby Law Office | Jayne Sebby
A drug can not be patented until it is in final development. It will also need to be approved by the FDA and any other agency that might regulate any component of the drug. If you haven't already, check out the U.S. Patent and Trademark web site. It provides a great deal of basic patent information.
Answer Applies to: Nebraska
Replied: 6/1/2015
Law Office of Kirk Buhler
Law Office of Kirk Buhler | Kirk A Buhler
Generally the patent office examines patent applications for novelty over prior inventions. When they evaluate a drug they determine if the combination of ingredients or the method making the dug is an obvious or non-obvious combination. if it is a non-obvious combination or method then they will issue a patent. The owner of the patent then can enforce their issued patent from people (or companies) that infringe on the issued claims. The "patent laws" just determine how the invention is examined. They don't really affect the "drug development" except to only issue novel drugs or processes.
Answer Applies to: California
Replied: 6/1/2015
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