Intellectual Property
Pharmaceutical discoveries, and advances in biomedical
research, have created a multi-billion dollar industry.
With stakes so high, it is important for companies to be able
to protect their investments. This is typically done through
the use of patents.
Patents can apply to the method
of synthesizing a drug, the chemical makeup of a new molecule,
or possibly even to certain genetic discoveries.
There are many other potential uses for patents in the field
of pharmaceutical law, as well.
Trademarks and
copyrights also play a role in pharmaceutical law. After all,
just as with any product, brand identification can be a key to
success in marketing and brand loyalty.
Safety and Marketing
Another important area of pharmaceutical law is in product
safety and marketing.
Pharmaceuticals are among the
most highly regulated products in the U.S., and must pass
stringent testing by organizations such as the Food and Drug
Administration (FDA) before they are even allowed onto the
market.
However, these products could still be
misused, even if approved for their intended purpose. As such,
strict laws regarding how these drugs can be marketed both to
individuals and to doctors prevent false and misleading
claims. If, as has often been the case, later research
discovers a product is not safe, other laws are in place to
immediately compel the recall of the product from the
marketplace and prevent its further sale.
Distribution
Of course, many drugs are considered controlled substances in
the EMEA.
As a result, very strict guidelines exist
for which drugs may be sold without a prescription (i.e.,
over-the-counter) and which may only be given if approved of
by a licensed medical practitioner.
Other laws make
it a crime to prescribe medications that are in quantities
that are intended for distribution on the black market or that
would be harmful to the patient. Still others criminalize the
resale of prescription drugs.
Services We can propose :
- Patent and trademark prosecution.
- Intellectual property litigation.
- Corporate finance and M&A.
- Private equity and venture capital.
- Drug pricing and reimbursement strategies.
- Clinical trial agreements.
- Licensing and collaboration agreements.
- Supply, manufacturing and distribution agreements.
- Government relations.
- Labelling, advertising and distribution.
- Product liability litigation and class actions.
- Risk management and competition law.
- Transfer pricing.