ANALYZE THE MANNER IN WHICH PHARMACARE USED U.S. LAW TO PROTECT ITS OWN INTELLECTUAL PROPERTY

12 May ANALYZE THE MANNER IN WHICH PHARMACARE USED U.S. LAW TO PROTECT ITS OWN INTELLECTUAL PROPERTY

Write an eight to ten page paper in which you:

1. Research three to five ethical issues relating to

marketing and advertising, intellectual property, and regulation of product

safety and examine whether PharmaCARE violated any of the issues in question.

2. Argue for or against Direct-to-Consumer (DTC) marketing

by drug companies. Provide support for your response.

3. Determine the parties responsible for regulating

compounding pharmacies under the current regulatory scheme, the actions that

either these parties or the FDA could / should have taken in this scenario, and

whether PharmaCARE could face legal exposure surrounding its practices. Support

your response.

4. Analyze the manner in which PharmaCARE used U.S. law to

protect its own intellectual property and if John has any claim to being the

true “inventor” of AD23. Suggest at least three ways the company

could compensate John for the use of his intellectual property.

5. Summarize at least one current example (within the past

two years) of intellectual property theft, and examine the effect on that

company’s brand.

6. Analyze the potential issue surrounding the death of

John’s wife and other potential litigants against Pharma CARE as a result of AD23.

7. Specify both the major arguments that John can make to

claim that he is a whistleblower and the type of protections that he should be

afforded. Justify your response.

8. Use at least three quality resources in this assignment.Legal Issues with Compounding PharmaciesYou are a new associate at the law firm of Dewey, Chetum,

and Howe. John, a former researcher at PharmaCARE, comes to your office. He has

concerns about PharmaCARE’s use of AD23, one of the company’s top-selling

diabetes drugs. Two years ago, after PharmaCARE’s research indicated that AD23

might also slow the progression of Alzheimer’s disease, John and his team of

pharmacists began reformulating the drug to maximize that effect. In order to

avoid the Food and Drug Administration’s (FDA) scrutiny, PharmaCARE established

a wholly-owned subsidiary, CompCARE, to operate as a compounding pharmacy to

sell the new formulation to individuals on a prescription basis. CompCARE

established itself in a suburban office park near its parent’s headquarters. To

conserve money and time, CompCARE did a quick, low-cost renovation.CompCARE benefited from PharmaCARE’s reputation, databases,

networks, and sales and marketing expertise, and within six (6) months had the

medical community buzzing about AD23. Demand soared, particularly among

Medicare, Medicaid, and Veterans Affairs patients. Seeing the opportunity to

realize even more profit, CompCARE began advertising AD23 directly to consumers

and marketing the drug directly to hospitals, clinics, and physician offices,

even though compounding pharmacies are not permitted to sell drugs in bulk for

general use. To circumvent this technicality, CompCARE encouraged doctors to

fax lists of fictitious patient names to CompCARE. PharmaCARE sold CompCARE to

WellCo, a large drugstore chain, just weeks before AD23 was publicly linked to

over 200 cardiac deaths.As CompCARE and its new parent company enjoyed record

profits and PharmaCARE’s stock price approached $300 per share, reports started

surfacing that people who received AD23 seemed to be suffering heart attacks at

an alarming rate. The company ignored this data and continued filling large

orders and paying huge bonuses to all the executives and managers, including

John, whose wife recently died from a heart attack after using AD23. John has

come to you with an internal company memo describing the potential problems

with AD23, and information describing the company’s willingness “roll the

dice” and continue to market the drug. Your senior partner has asked you

to write a memo outlining the following issues for review by the senior

partners.Write an eight to ten page paper in which you:1. Research three to five ethical issues relating to

marketing and advertising, intellectual property, and regulation of product

safety and examine whether PharmaCARE violated any of the issues in question.2. Argue for or against Direct-to-Consumer (DTC) marketing

by drug companies. Provide support for your response.3. Determine the parties responsible for regulating

compounding pharmacies under the current regulatory scheme, the actions that

either these parties or the FDA could / should have taken in this scenario, and

whether PharmaCARE could face legal exposure surrounding its practices. Support

your response.4. Analyze the manner in which PharmaCARE used U.S. law to

protect its own intellectual property and if John has any claim to being the

true “inventor” of AD23. Suggest at least three ways the company

could compensate John for the use of his intellectual property.5. Summarize at least one current example (within the past

two years) of intellectual property theft, and examine the effect on that

company’s brand.6. Analyze the potential issue surrounding the death of

John’s wife and other potential litigants against PharmaCARE as a result of AD23.7. Specify both the major arguments that John can make to

claim that he is a whistleblower and the type of protections that he should be

afforded. Justify your response.8. Use at least three quality resources in this assignment.