Lecture 7 Patents

What is the role of the patent department

protect and defend the rights of the patent owned by the pharmaceutical

Patent

a reservation of rights on a particular idea or product preventing others from making, using, or selling the patented invention without permission.

True or false: if I own a patent on a product, I am the only one that can produce that product

False! Just because I own the patent doesn’t mean I get to use it

How long does the patent last (if filed correctly?)

20 years with possibility of extension for pharmaceuticals or medical devices dependent on the arena of use

PCT

An international treaty that streamlines the process of filing patents in multiple countries.

metes and bounds of the invention

refers to the boundaries and specific details that define the scope and limits of a patented invention.

reduction to practice

the process of constructing a working model or prototype of an invention to demonstrate its feasibility and functionality.

prior art

refers to any evidence that your invention is already known, which can affect the patentability of an innovation.

What are the conditions to file a patent on the product

novelty, inventive step, and enablement/written art

freedom to operate

the ability to develop, manufacture, and sell a product without infringing on the patent rights of others.

patent infringement

the unauthorized use of a patented invention, which can lead to legal consequences and damages.

invalid patent

where one or more claims made by the patent application are deemed invalid for granting patent rights

PGR

stands for Post Grant Review, a procedure allowing third parties to challenge the validity of a patent after it has been granted.

IPR

stands for Intellectual Property Rights, which encompass the legal rights associated with the creations of the mind, including patents, copyrights, and trademarks.

orange book

a publication by the FDA that lists approved drugs and their corresponding patent and exclusivity information.

Generic drug

A medication that is equivalent to a brand-name drug in dosage form, strength, route of administration, quality, performance characteristics, and intended use, but is marketed under its chemical name or a different brand name after the original patent expires.

ANDA

(Abbreviated New Drug Application) filed with the FDA to obtain approval for a generic drug. Its faster and doesn’t have the same regulation or need to rerun all of the preclinical trials because it relies on innovator data and only requires small studies to prove bioequivalence

When can a generic drug application be filed

five years after the approval of the innovator drug, and four years if the innovator drug is challenged

Bolar Provision

Allows generic manufacturers to begin the FDA approval process for a generic drug before the patent of the brand-name drug expires, enabling them to market the generic product immediately after the patent expiration.

Orange book certification (4 parts)

1. Patent not filed

2. Patent expired

3. the product will be marketed as of the date on which such patent will expire

4. that such patent is invalid or will not be infringed by the manufacture, use or sale of the new drug for which the application is submitted.

Paragraph IV

Certification that a generic drug does not infringe on a listed patent or that the patent is invalid, allowing the generic to enter the market prior to patent expiration.

BPCIA

The Biologics Control and Innovation Act (BPCIA) provides a regulatory framework for the approval of biosimilars, allowing for a streamlined pathway for biosimilar products that are shown to be highly similar to an already licensed biologic.

Sections of the patent application (general)

title, inventors, owners, cited art, figures, abstract, filing date, claims, background