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1) An example of \"Evergreening\" is only choosing organic drug ingredients prol

ID: 1193724 • Letter: 1

Question

1) An example of "Evergreening" is

only choosing organic drug ingredients

prolonging patents by applying for a patent for a drug that contains a 95% change in the chemical structure of a patented product and applying for a patent for it as a new drug.

prolonging patents by applying for a patent for a drug that contains a 95% change in the basic chemical structure of a patented product and applying for a patent for it as a new drug. .

prolonging patents by applying for a patent for a drug that contains a very small change in the basic chemical structure of a patented product and applying for a patent for it as a new drug

Direct to consumer advertising

2)Why did the Supreme Court in India decide against the appeal for an Indian patent by the Swiss pharmaceutical companies application by Novartis for Glivec?

because Indian regulators most likely will not be able to fully protect the patent if approved

because Indian regulators will not be able to allow pharmaceutical companies to sell at high prices

because indian regulators think their own generics are probably higher in quality than the foreign competition

all of the above

a and b

3) Direct to Consumer Advertising by pharmaceutical companies is allowed in which of the following countries?

Australia

japan

New Zealand

Canada

4) orphan drug is a drug with

more than 1 million possible target patients

more than 200,000 possible target patients

less than 200,000 possible target patients

drugs which can only be used for patients that have lost their parents

drugs which work only for patients that like the musical "Annie"

a.

only choosing organic drug ingredients

b.

prolonging patents by applying for a patent for a drug that contains a 95% change in the chemical structure of a patented product and applying for a patent for it as a new drug.

c.

prolonging patents by applying for a patent for a drug that contains a 95% change in the basic chemical structure of a patented product and applying for a patent for it as a new drug. .

d.

prolonging patents by applying for a patent for a drug that contains a very small change in the basic chemical structure of a patented product and applying for a patent for it as a new drug

e.

Direct to consumer advertising

Explanation / Answer

1. ( d ) because, evergreening is achieved by seeking extra patents on variations of the original drug – new forms of release, new dosages, new combinations or variations, or new forms.

2. (c. ) This is because Glivec was already being sold by a lot a of pharmaceutical companies as a generic in India. Further, Novartis failed to prove that the product was a genuine advance over aprevious version. Further, the Indian Parliament, supported by the Supreme Court, has decided that Indian consumers should only pay for expensive patented products when those products represent a genuine advance over older versions

3. (c) New Zealand. Only two countries permit Direct to consumer Advertising, New Zealand and USA.

4. (c) As defined in the United States, any drug developed under the Orphan Drug Act of January 1983 (ODA) is an orphan drug. The ODA is a federal law concerning rare diseases (orphan diseases) that affect fewer than 200,000 people in the United States or are of low prevalence (less than 5 per 10,000 in the community).