Biotech and Pharma Patents - Spring 2004-DiGiglio

Biotech and Pharma Patents - Spring 2004-DiGiglio - Biotech...

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Biotech and Pharmaceutical Patents CLASS ONE b Section 1: Issues in Biotech Patent Law 1. infringement – same product, regardless of how made (one panel of federal circuit) 2. infringement – same process (another panel of the federal circuit) law has to catch up to the technology; biotech claims have become much narrower – much narrower on the scope of molecular claims and on the doctrine of equivalens. Life and death issues; not just money, but also related to health care, which is something people take very seriously. People are concerned with BVH in milk, irradiated food, and genetically engineered corn and bacteria. The world of patents is the opposite side of this. Patents give or withhold life – by saying that there is a patent on a particular lifesaving patent. If someone has AIDS or believes that there is a medicine that will treat their child, themselves, or their friends b they care about getting the drug now, not about whether money they pay will be used for future research. Patents act as a barrier towards getting drugs. AIDS in Africa b huge pressure towards bringing in patented lifesaving drugs for free. Why cant drug makers just make profits from patents in Europe and North America. Why is there a paucity of AIDS drugs in Africa? - costs - patents - access to healthcare a. costs, geographic barriers b. political barriers (warlords stockpile and hoard drugs and food) c. social/cultural/religious barriers to healthcare d. stigma of being sick – embarrassment; shunned if you have AIDS (social barriers to treatment) e. legal barriers 1. patents 2. The FDA Thalidomide – FDA had problems with the drug and had questions about the data – it was on the market especially in Europe, and led to many birth defects. By the time the additional testing was completed, there was a huge population of women who gave birth to “thalidomide babies,” born with children instead of arms. Ephedrine – had to be recalled; phen fen – approved for patients who were clinically obese, but got over prescribed, and has led to many products liability suits. Phen fen – side effects overcame the benefits of use; had to be recalled. generic – delivers the bioequivalent in a similar pharmaceutical manner recoup money - exclude others from copying investment for each drug on the market – 800 million per drug, out of 5000 drugs, only five actually have human tests, and only one makes it onto the market. Of those that make it on the market, 3/10 actually make money
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b Canada has laws that limit the price of drugs; we don’t. US bears most pharmaceutical costs; consumers pay for most of this. This is why people want to pass laws where we can import cheaper drugs from Canada. b
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Biotech and Pharma Patents - Spring 2004-DiGiglio - Biotech...

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