Legal Question in Product Liability in Maryland

New Product Implement Strategy

To Whom It May Concern:

This is hypothetical situation where I might need your help.

XYZV is a drug product with and indication for rheumatoid arthritis. The patent for the product is due to expire in 2008. I'm part of the management team at VXZ Inc. Having examined the market potential for rheumatoid arthritis I wish to have the Company enter the market with a drug product containing the same active ingredient as XYZV. Which issues and strategies might I consider in assessing if this a feasible strategy and how would I implement that strategy?

Thanks for your help regarding this issue.

Have a pleasant day.

Best Regards,

MA


Asked on 4/28/04, 2:12 pm

1 Answer from Attorneys
G. Joseph Holthaus III Law Offices of G. Joseph Holthaus

Re: New Product Implement Strategy

Sounds great. Now you have to deal with the issue of being in management of the protected company. FDA approvals may be a hold up. Capitalization of a production facility is another hurdle. Distribution and marketing costs can be substantial especially where another competing drug may be pending FDA approval status.

Should you want to procede then establishment of a business plan and obtaining financing is your first step. You may want to consider opening a C-corp and filing appropriate holdings. Another business formation may be more suitable depending on various business/cost factors.

Such a plan requires the assistance of an attorney, accounting and marketing team. Contact me should you want to move on with your plan.

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Answered on 4/28/04, 8:58 pm


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