Interview Questions and Answers on Intellectual Property (IP) Rights
A list of interview questions and answers on intellectual property rights in pharmaceutical industry are given below:
Q. What is Intellectual Property?
Intellectual property (IP) refers to inventions. It is protected in law by, for example, patents, copyright and trademarks, which enable people to earn recognition or financial benefit from what they invent or create.
Q. What is a patent?
A patent is an exclusive right granted for an invention, which is a product or a process that provides, in general, a new way of doing something, or offers a new technical solution to a problem.
Q. What are different types of Patents listed in Orange Book?
Patents that are listed in the Orange Book include:
- Patents that claim the active ingredients.
- Drug product patents which include formulation/composition patents.
- Use patents for a particular approved indication or method of using the product.
Related: Patents and Exclusivity in Pharmaceutical Industry
Q. What are different types of filing certifications for ANDA applicant?
- Paragraph I: that such patent information has not been filed;
- Paragraph II: that such patent has expired;
- Paragraph III: of the date on which such patent will expire, or
- Paragraph IV: 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.
Related: 505 (b)(1), 505 (b)(2), 505 (j) and Para-IV Certification in USFDA Filing
Q. What is NDC Code (National Drug Code)?
Each listed drug product listed is assigned a unique 10-digit, 3-segment number. This number, known as the NDC, identifies the labeler, product, and trade package size.
- The first segment, the labeler code, is assigned by the FDA. A labeler is any firm that manufactures (including repackers or relabelers), or distributes (under its own name) the drug.
- The second segment, the product code, identifies a specific strength, dosage form, and formulation for a particular firm.
- The third segment, the package code, identifies package sizes and types. Both the product and package codes are assigned by the firm.
The NDC Code will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1.
Q. Where you get patent number, patent code & exclusivity?
Patent number, patent code & exclusivity are available in FDA orange book.
Q. What is the official site for checking US Patent?
USPTO – Patent Public Search
Q. Mention few popular sites for patent searching?
Q. How to apply for patent in USA?
In filing a patent application and paying required fees, the USPTO provides forms and an electronic filing tool. You may also wish to find a patent attorney or agent to help draft the required description of the invention and claims, and any required drawings.
For detalis visit UPSTO – Applying for Patents.
How do you stay current with changes and updates to IP laws and regulations?
As a Legal Counsel specializing in Intellectual Property Law, it is crucial to stay up-to-date with changes and updates to IP laws and regulations, both domestically and abroad. You should actively engage in various methods to enhance your knowledge and stay current with intellectual property law developments.
- Continuing Legal Education (CLE) Programs: You can attend relevant CLE programs to expand my knowledge on the latest developments in intellectual property law.
- Legal Publications and Journals: You can regularly read and subscribe to legal publications and journals to stay up-to-date with the latest developments in IP law.
- Online Resources: You can utilize various online databases and resources to keep abreast of the latest developments in IP law. This includes regularly visiting the United States Patent and Trademark Office (USPTO) website, the European Patent Office (EPO) website.
- Networking: You can actively participate in legal and IP-related professional organizations and attend relevant conferences and events.
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