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Top Adding - Basics Of US Patent Law
United States has the most expansive patent subject matter in the world. US Patent Office has granted patents to living organism, computer software, business methods, new alphabets and countless.
Article 1 Section 1 Clause 8 of the US Constitution empowers the congress to promote the progress of science and useful arts,
Article 1 Section 1 Clause 8 of the US Constitution empowers the congress to promote the progress of science and useful arts,
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
by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries. In furtherance of the power granted by the constitution, the US Congress enacted the first patent act in the year 1790. Though the act was amended several times, the most important amendment came about
; 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
n the year 1952, when congress passed a new patent act codified under Title 35 of the United States Code. Though a few changes were made in 1986, 1996 and 1999, most provisions of the 1952 Act are still in effect.
The US Patent Law is based on the utilitarian reasoning, which is to promote the progress of science and use
The US Patent Law is based on the utilitarian reasoning, which is to promote the progress of science and use
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ul arts in general public interest. An inventor gives an invention to the public and gets exclusive rights over it for a limited period of time. By granting exclusive rights to inventors for a limited period of time, the patent law provides incentive to invent, invest, design around and disclose which in turn encourages p
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ogress of science and technology.
Requirements for Patentability
To be eligible for a patent, an invention should satisfy the requirements of Patentable subject matter (Sec. 101),
a) Usefulness (Sec. 101)
b) Novelty (Sec. 102)
c) Non-obviousness (Sec. 103)
d) Specification (Sec. 112).
Usefulness - An in
Requirements for Patentability
To be eligible for a patent, an invention should satisfy the requirements of Patentable subject matter (Sec. 101),
a) Usefulness (Sec. 101)
b) Novelty (Sec. 102)
c) Non-obviousness (Sec. 103)
d) Specification (Sec. 112).
Usefulness - An in
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ention would be eligible for a patent grant only if it is useful (35 USC Sec. 101). The utility of the invention should be current, substantial and credible. Speculative or future uses are not eligible for the patent. But with regard to genetic inventions, showing of future use is generally allowed. Inventions, which have
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
immoral uses, are not accepted to be useful.
Novelty - Novelty means new. An invention in order to be patentable should be new in the light of that exists at the time of conception of the invention. Section 102 gives a non-exhaustive list of circumstance that denies an invention of its newness.
Non-obviousness - An in
Novelty - Novelty means new. An invention in order to be patentable should be new in the light of that exists at the time of conception of the invention. Section 102 gives a non-exhaustive list of circumstance that denies an invention of its newness.
Non-obviousness - An in
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
ention to be patentable should not be obvious or known at the time of invention. An invention is obvious, if a single prior art reference or a combination of prior art references as a whole, make the invention obvious to a person with ordinary skill in the art to which the invention belongs. The invention should be obviou
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
at the time of conception of the invention and not at the time of contention of obviousness.
As per the Section 103 - Obviousness of an invention will be decided by determining the scope of the prior art, by finding out the differences between the prior art and the claimed invention and by ascertaining the level of ordi
As per the Section 103 - Obviousness of an invention will be decided by determining the scope of the prior art, by finding out the differences between the prior art and the claimed invention and by ascertaining the level of ordi
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
ary skill in the art. Secondary Indicia like commercial success, unexpected results, copying, praise of experts, etc. could also be considered for making an obviousness determination.
Specification - An inventor must file a patent application containing a specification (35 USC Sec. 112). The specification should contain
Specification - An inventor must file a patent application containing a specification (35 USC Sec. 112). The specification should contain
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ritten description of the invention and of the manner and process of making and using it, in such full, clear, concise and exact terms, so as to enable a person with ordinary skill in the art to make and use the invention. The specification should also describe the best mode of carrying out the invention. The written desc
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
ription may contain drawings where and when required to clearly describe the invention. The specification should conclude with one or more claims particularly pointing out and definitely claiming the subject matter of the invention. The claims define the metes and bounds of the invention claimed by the inventor. The inve
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
tor gets rights only over what is defined in the claims.
The basic requirement for patentability is that the invention should fall within the scope of patentable subject matter as defined under Section 101. (35 USC Sec. 101). As per section 101, any new and useful invention or discovery, which is a process, machine, man
The basic requirement for patentability is that the invention should fall within the scope of patentable subject matter as defined under Section 101. (35 USC Sec. 101). As per section 101, any new and useful invention or discovery, which is a process, machine, man
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
facture or composition of matter is patentable. It also includes any new and useful improvements made to an existing invention. An invention generally falls under more than one category.
The courts have construed the terms process, machine, manufacture and compositions of matter very broadly. In Diamond v. Chakrabarty, t
The courts have construed the terms process, machine, manufacture and compositions of matter very broadly. In Diamond v. Chakrabarty, t
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
e United States Supreme Court while upholding the patentability of an oil-eating bacterium stated that everything under the sun made by man is patentable.
Not eligible for Patentability
The statute does not expressly bar any subject matter from patentability, the Courts have held physical phenomenon, abstract ideas and
Not eligible for Patentability
The statute does not expressly bar any subject matter from patentability, the Courts have held physical phenomenon, abstract ideas and
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
roducts of nature to be outside the scope of patentability.
An invention is not considered new or novel if the same were on sale for more than a year before the filing date of patent application. Selling the invention for testing deprived it of the novelty. Even making an offer to sell or making a contract of sale for th
An invention is not considered new or novel if the same were on sale for more than a year before the filing date of patent application. Selling the invention for testing deprived it of the novelty. Even making an offer to sell or making a contract of sale for th
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
e future is fatal to novelty of the invention and it shall not patented.
An invention is not new if it is known or used by anyone in the United States or printed or published in a foreign country. The use should be publicly accessible use and not secret use.
An invention can not be patented, if the inventor had abandone
An invention is not new if it is known or used by anyone in the United States or printed or published in a foreign country. The use should be publicly accessible use and not secret use.
An invention can not be patented, if the inventor had abandone
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
the invention to the public. Taking an invention, which has been dedicated to the public out of the public domain, is against the basic objective of patent law.
An invention is not patentable if it has been patented in a foreign country twelve months before the filing date of the present patent application.
Priority da
An invention is not patentable if it has been patented in a foreign country twelve months before the filing date of the present patent application.
Priority da
.
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
e
As per the Section 102 – For ascertaining the priority, the date of conception would be taken into consideration. The inventor who conceived first and was diligent in reducing the invention to practice would be considered as the first inventor. An invention is not patentable if another person before the applicant has
As per the Section 102 – For ascertaining the priority, the date of conception would be taken into consideration. The inventor who conceived first and was diligent in reducing the invention to practice would be considered as the first inventor. An invention is not patentable if another person before the applicant has
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
invented it. That first inventor should not have abandoned, suppressed or concealed his invention.
Trustman & Co – A Law Firm at Delhi India for patent, trademark, pct application, real estate, debt collection, legal outsourcing, corporate law firm, legal outsourcing LPO
Trustman & Co – A Law Firm at Delhi India for patent, trademark, pct application, real estate, debt collection, legal outsourcing, corporate law firm, legal outsourcing LPO
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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