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Top Articles - Patents in India: Law & Procedure
Legislation
The Indian law of patents is enshrined in the Patents Act, 1970. The Act seeks to provide for legal protection for inventions. The rights granted under the Act, are operative in the whole of india.
What is a Patent
A Patent is an exclusive monopoly granted by the Government to an inventor over his invent
The Indian law of patents is enshrined in the Patents Act, 1970. The Act seeks to provide for legal protection for inventions. The rights granted under the Act, are operative in the whole of india.
What is a Patent
A Patent is an exclusive monopoly granted by the Government to an inventor over his invent
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
ion for a limited period of time. It provides an enforceable legal right to prevent others from exploiting an invention. Invention as defined under the Act to mean a new product or process involving an inventive step and capable of industrial application.
Rights conferred by registration
Patents represents one of th
Rights conferred by registration
Patents represents one of th
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
e powerful intellectual property right. The registration of a patent confers on the patentee the exclusive right to use, manufacture or sell his invention for the term of the patent. It means that the invention cannot be commercially made, used, distributed or sold without the patentee's consent. The patent rights can
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
usually be enforced in a court of law.
Who Can Apply For A Patent
An inventor or any other person/company assigned by the inventor can apply and obtain the patent over the invention. A patent is obtained by the inventor or his assignee by filing an application with the appropriate office of the patent office in stip
Who Can Apply For A Patent
An inventor or any other person/company assigned by the inventor can apply and obtain the patent over the invention. A patent is obtained by the inventor or his assignee by filing an application with the appropriate office of the patent office in stip
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ulated forms and fees as required by the Act.
Patent Search
It is prudent to conduct searches as early as possible to avoid spending time and money re-inventing a known matter. A patent is not granted to an invention if it is already available with the public either in the form of published literature or common knowl
Patent Search
It is prudent to conduct searches as early as possible to avoid spending time and money re-inventing a known matter. A patent is not granted to an invention if it is already available with the public either in the form of published literature or common knowl
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
edge.
Patentable Inventions
To be patentable, an invention must, in general, satisfy certain criteria. The invention must be of industrial applicability, must be new and must show an inventive step which could not be deduced by a person reasonably skilled in the field. Above all, its subject matter must be accepted a
Patentable Inventions
To be patentable, an invention must, in general, satisfy certain criteria. The invention must be of industrial applicability, must be new and must show an inventive step which could not be deduced by a person reasonably skilled in the field. Above all, its subject matter must be accepted a
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
s "patentable" under law. As for example, Inventions which are frivolous or claim anything contrary to well established natural laws are not patentable. There are also other specific categories of inventions which are declared as non-patentable.
Patent Specification
The process of patenting typically involves conduct
Patent Specification
The process of patenting typically involves conduct
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
ng prior art searches to distinguish the invention and develop a description that illustrates the best method of working the invention. The description of the invention is called specification. Depending upon the sufficiency of the descrption a specification may be either provisional and complete Specification.
Provis
Provis
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ional and Complete Specification
A provisional specification is often the first application filed in respect of an invention, and usually contains only a brief description of the invention. It need not contain claims. Compared with the provisional, the complete specification contains the full description of the invent
A provisional specification is often the first application filed in respect of an invention, and usually contains only a brief description of the invention. It need not contain claims. Compared with the provisional, the complete specification contains the full description of the invent
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
ion, and the best method of making the invention work. The complete specification comprises a title, field of invention, the background of the invention, the description of the related art, drawbacks of the prior art, the summary of the invention, the brief description of the figures, the detailed description of the pr
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
eferred embodiments, claims and abstract. Complete specification must be filed within 12 months from the date of filing of the provisional specification.
Claims are the most important component in the patent specification as it is the legal operative part which define and determine the legal protection sought for. The
Claims are the most important component in the patent specification as it is the legal operative part which define and determine the legal protection sought for. The
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
extent of patent protection for an invention shall be determined by the terms of the claims. The description and the appended drawings may be used to interpret the claims.
Filing and Prosecuting Patent Applications
The procedure for the grant of a patent starts with filing of the patent application along with the pr
Filing and Prosecuting Patent Applications
The procedure for the grant of a patent starts with filing of the patent application along with the pr
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
esribed fees at the appropriate office* of the patent office followed by filing of request for examination in the prescribed format (present time limit within 36 months), after the publication of the application. Presently, application for patent is not open to open to public for 18 months from the date of filing or d
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ate of priority, though the applicant can request for early publication. The applications are examined substantively and a first examination report stating the objections is communicated to the applicant. Application may be amended in order to meet the objections. Normally all the objections must be met within 12 month
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
from the date of first examination report. If the applicant does not comply with the objection, the application will be abandoned. Upon complying the requirements the application is published in the Official Journal. At that time, opposition can be filed on limited grounds, but hearing is not mandatory. Patent will be
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
granted if the application is found to be in order. Then, the application and other related documents will be open for public inspection. Thereafter, at any time after the grant but before the expiry of a period of one year from the date of publication opposition on substantive grounds is available. The whole process
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
typically takes at least two years.
Duration of a Patent
The term for patents is 20 years from the date of filing of the application for the patent. It is the responsibility of the patentee to maintain an issued patent by paying the annuities until the patent expires. After 20 years term the invention claimed in the
Duration of a Patent
The term for patents is 20 years from the date of filing of the application for the patent. It is the responsibility of the patentee to maintain an issued patent by paying the annuities until the patent expires. After 20 years term the invention claimed in the
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
patent falls into the public domain.
Restoration
Restoration of a patent that lapses due to non-payment of renewal fees can be made within one year of lapse. However, certain limitations will be imposed on the rights of the patentee when the patent is restored.
Remedies For Infringement
It is the sole responsibilit
Restoration
Restoration of a patent that lapses due to non-payment of renewal fees can be made within one year of lapse. However, certain limitations will be imposed on the rights of the patentee when the patent is restored.
Remedies For Infringement
It is the sole responsibilit
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
y of the patentee to see that his patent is not being infringed. It is the patentee's duty to file a suit of infringement against the infringer. The reliefs which may be usually awarded in such a suit are –
i. Injunctons whether interim or final.
ii. Damages or account of profits.
International Patent Protection
i. Injunctons whether interim or final.
ii. Damages or account of profits.
International Patent Protection
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
There is no international or world patent. An inventor has to file an application in each country, where he seeks to protect his invention. However, there are regional and/or International treaties to facilitate the procedure to seek protection like Patent co-operation Treaty (PCT) or European Patent Convention (EPC)
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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