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Patent Claim Please read through the scenario and consider how you would answer the questions at the end.

Patent Claim Please read through the scenario and consider how you would answer the questions at the end.

You have disclosed in the specification of the patent application, some in vitro culture data showing that the compound derived from Fearus tortoisiae has a higher toxicity in prostate cancer cells than healthy control cells. You have also disclosed in a figure, some toxicity in a control batch of kidney cells taken from an individual with a non-cancerous kidney lesion. All cells used were mouse in origin, but widely known to be somewhat predicative of human disease. Also, you have identified a protein on the surface of human neurons, kidney cells, prostate cells and fibroblasts which appear to be a receptor to which the compound binds and is taken into the cells. You have also disclosed the structure of a compound from a crude extract, to be a multi-ringed structure that closely resembles the pattern on the shell of the University of Maryland Terrapin, Testudo.
We claim:
1. A compound derived from the plant Fearus tortoisiae.
2. The compound of claim 1, wherein said compound is capable of selectively killing cancer cells.
3. The compound of claim 2, wherein said compound is capable of killing prostate cancer cells.
4. The compound of claim 1, wherein said compound is capable of treating a condition selected from the group consisting of: cancer, autoimmune disease, neurological disorders, kidney dysfunction and skin disorders.
5. A pharmaceutical composition comprising a compound derived from the plant Fearus tortoisiae.
6. A pharmaceutical composition consisting of a compound derived from the plant Fearus tortoisiae.
7. A method of treating a condition selected from the group consisting of cancer, autoimmune disease, neurological disorders, kidney dysfunction and skin disorders, said method comprising administering a compound derived from the plant Fearus tortoisiae to a patient in need thereof.
The scenario is the following: Your patent agent has drafted the above claims and specification. You are the business director of a small start-up biotech that was started by a scientist from another company with expertise in natural products. You have venture capital, but high costs in labor, facilities and supplies. Since the FDA is now looking at natural products as a class of therapeutics for possible approval, your company appears well-positioned in the market. Your company has found that a crude extract of the toxic plant Fearus tortoisia, (found only on a small patch of woods on the University of Maryland College Park campus) has some anticancer activity in rodent cells, particularly in one prostate cancer cell line. You have not had time to cross check other cell lines, nor to test in human cells. Your initial studies identified a receptor for what appears to be the active ingredient, and you have isolated a compound from the plant, but have not purified the compound completely. You want to apply for a patent as early as possible.
However, you have several concerns:
1. 1. What considerations/questions should the discussion at your board meeting include? Why are these points important? Do you have suggestions or answers to these considerations/questions? Include (but not limited to) at least these points in your discussion:
• Scientific proofs
• Data sufficiency and possible additional tests
• Previous relevant patents
• Timing
• FDA regulations
• Potential revenues vs. R & D costs plus litigation/patent enforcement costs
• Potential markets
• Potential competitors
2. Do you think these claims sufficiently describe your invention? Why or why not? Explain in details.
3. Should they include more (broaden) or less (narrow)? Why? Explain in details.
Write a meeting presentation plan with 600-800 words addressing the above questions/items. Your essay should include a brief introduction setting the scene for the case; an analysis of the situation; questions/considerations and presentation of possible solutions to the questions; and your recommendations which you feel are the best. Please reference any additional sources used.
The essay should be doubled spaced, left justified, and use the APA style format.

 

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