- What is Patent / Tradem ark / Copyright ?
A PATENT for an invention is the grant of a property right to the inventor, issued by the United States Patent and Trademark Office (USPTO). Generally, the term of a new patent is 20 years from the date on which the application for the patent was filed in the United States or, in special cases, from the date an earlier related application was filed, subject to the paym ent of maintenance fees. U.S. patent grants are effective only within the United States, U.S. territories, and U.S. Possessions. Under certain circum stances, patent term extensions or adjustments may be available.
The right conferred by the patent grant is, in the language of the statute and of the grant itself, “the right to exclude others from making, using, offering for sale, or selling” the invention in the United States or “importing” the invention into the United States. W hat is granted is not the right to make, use, offer for sale, sell or import, but the right to exclude others from making, using, offering for sale, selling or importing the invention. Once a patent is issued, the patentee must enforce the patent without aid of the USPTO.
There are three types of patents:
1) Utility patents may be granted to anyone who invents or discovers any new and useful process, machine, article of manufacture, or com position of matter, or any new and useful improvement thereof;
2) Design patents may be granted to anyone who invents a new, original, and ornamental design for an article of manufacture;
3) Plant patents may be granted to anyone who invents or discovers and asexually reproduces any distinct and new variety of plant.
A TRADEMARK is a word, name, sym bol, or device that is used in trade with goods to indicate the source of the goods and to distinguish them from the goods of others.
A service mark is the sam e as a trademark except that it identifies and distinguishes the source of a service rather than a product.
The terms “trademark” and “mark” are com monly used to refer to both trademarks and service marks.
Trademark rights may be used to prevent others from using a confusingly similar mark, but not to prevent others from making the sam e goods or from selling the sam e goods or services under a clearly different mark.
Trademarks which are used in interstate or foreign com merce may be registered with the USPTO.
The registration procedure for trademarks and general information concerning trademarks is described on a separate page entitled “Basic Facts about Trademarks”.
A COPYRIGHT is a form of protection provided to the authors of “original works of authorship” including literary, dramatic, musical, artistic, and certain other intellectual works, both published and unpublished.
The 1976 Copyright Act generally gives the owner of copyright the exclusive right to reproduce the copyrighted work,to prepare derivative works, to distribute copies or phone records of the copyrighted work, to perform the copyrighted work publicly, or to display the copyrighted work publicly.
The copyright protects the form of expression rather than the subject matter of the writing. For example, a description of a machine could be copyrighted, but this would only prevent others from copying the description; it would not prevent others from writing a description of their own or from making and using the machine.
Copyrights are registered by the Copyright Office of the Library of Congress.
The right conferred by the patent grant is, in the language of the statute and of the grant itself, “the right to exclude others from making, using, offering for sale, or selling” the invention in the United States or “importing” the invention into the United States. W hat is granted is not the right to make, use, offer for sale, sell or import, but the right to exclude others from making, using, offering for sale, selling or importing the invention. Once a patent is issued, the patentee must enforce the patent without aid of the USPTO.
There are three types of patents:
1) Utility patents may be granted to anyone who invents or discovers any new and useful process, machine, article of manufacture, or com position of matter, or any new and useful improvement thereof;
2) Design patents may be granted to anyone who invents a new, original, and ornamental design for an article of manufacture;
3) Plant patents may be granted to anyone who invents or discovers and asexually reproduces any distinct and new variety of plant.
A TRADEMARK is a word, name, sym bol, or device that is used in trade with goods to indicate the source of the goods and to distinguish them from the goods of others.
A service mark is the sam e as a trademark except that it identifies and distinguishes the source of a service rather than a product.
The terms “trademark” and “mark” are com monly used to refer to both trademarks and service marks.
Trademark rights may be used to prevent others from using a confusingly similar mark, but not to prevent others from making the sam e goods or from selling the sam e goods or services under a clearly different mark.
Trademarks which are used in interstate or foreign com merce may be registered with the USPTO.
The registration procedure for trademarks and general information concerning trademarks is described on a separate page entitled “Basic Facts about Trademarks”.
A COPYRIGHT is a form of protection provided to the authors of “original works of authorship” including literary, dramatic, musical, artistic, and certain other intellectual works, both published and unpublished.
The 1976 Copyright Act generally gives the owner of copyright the exclusive right to reproduce the copyrighted work,to prepare derivative works, to distribute copies or phone records of the copyrighted work, to perform the copyrighted work publicly, or to display the copyrighted work publicly.
The copyright protects the form of expression rather than the subject matter of the writing. For example, a description of a machine could be copyrighted, but this would only prevent others from copying the description; it would not prevent others from writing a description of their own or from making and using the machine.
Copyrights are registered by the Copyright Office of the Library of Congress.
- What is Schedule M ?
It is Indian Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products as per Drugs and Cosm etics Act 1940.
How many types of options for Patent Certifications ?There are four types and options are there for patent certifications :
Paragraph I / Paragraph II / Paragraph III / Paragraph IV
Paragraph I
- No Patent Filed
- 21 CFR 314.94(a)(12)(i)(A)(1)
- No patents referencing the listed drug in the Orange Book
- Firm is aware of non-listed patent
- Allows for immediate effective date of approval
- Does not mean the patent cannot be enforced
- Patent Has Expired
- 21 CFR 314.94(a)(12)(i)(A)(2)
- Patent listed in the Orange Book
- Cite patent number and provide expiration date
- Allows for immediate effective approval date
- Patent Will Expire
- 21 CFR 314.94(a)(12)(i)(A)(3)
- Listed patent in force at time of subm ission of ANDA
- Cite patent number and provide expiration date
- State intentions not to market until after patent expires
- Allows for approval immediately after expiration of the listed patent
- Patent Challenge - Invalidity, Non-Infringement or
- Unenforceable 21 CFR 314.94(a)(12)(i)(A)(4)
- Intent to market prior to expiration of patent
- Notification provisions apply
- 45-day clock for suit
- Allows for immediate effective date of approval if no suit brought within 45 days
- If suit brought within 45 days, no approval for 30 months or until court decision
- Possible 180-day exclusivity
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