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Actual - Patenting System - A Historic Perspective
News items flooding from our daily information sources on patents, company law suits, intellectual property rights, and the like would make one believe that the system of patenting is quite young. On the contrary, history of patenting dates back to more than five hundred years.
The present
The present
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
day patent concept was first implemented in England in 1449. King Henry VI of England granted a 20 year monopoly to one, John Utynam, on his stained glass manufacturing process. Though, stained glass manufacturing process was prevalent then, in various parts of England, it was the first st
; 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
te-granted limited monopoly for an industrial practice. By 1552, open letters called Letters Patent were issued under the Great Seal of the King, to officers and friends patronized by the Court. These Letters Patent were issued not only on inventions but on industries, too. For example, the
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
stationers enjoyed a privileged monopoly over publishing industry in England. In 1624, the English Parliament under the directions of Sir Francis Bacon, a great thinker of those times, adopted the doctrine of public interest into patenting. It passed the Statute of Monopolies, recognizing
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
he economic benefits through innovation and awarded patents to protect the rights of the inventors for a term of 14 years.
Immigrants from England in search of new shores of opportunity, traveled to the New World that was already discovered by Christopher Columbus. In 1585, authorized with
Immigrants from England in search of new shores of opportunity, traveled to the New World that was already discovered by Christopher Columbus. In 1585, authorized with
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
a patent from Queen Elizabeth to claim and colonize the “heathen and barbarous lands”, Sir Walter Raleigh, established the first British colony in North America. Along with the colonizers came the patenting system from England to America. The patenting system was followed provincially withi
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
n the various British colonies.
In due course of time, the need to protect the interests of the inventors was constitutionally recognized and included in the US constitution as the Intellectual Property Clause. Over the next fifty years, after the US constitution was framed, the US Congres
In due course of time, the need to protect the interests of the inventors was constitutionally recognized and included in the US constitution as the Intellectual Property Clause. Over the next fifty years, after the US constitution was framed, the US Congres
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
passed the Patent Acts of 1790, 1793, and 1836. These Patent Acts formed the basis for the first legally regulated patenting system. The Patent Act of 1790 was drafted by Thomas Jefferson, the principal author of the Declaration of Independence. The 14 years exclusivity of rights over an i
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
vention was retained in this Act, and it was required to submit s along with the applications. Under the 1790 Act patents were issued only to physical inventions that were put into practice and not on ideas.
The patent application examination extended over several months and the grant
The patent application examination extended over several months and the grant
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
ing happened over even longer durations. Between 1790 and 1793 only 57 patents were issued owing to inefficiency at the level of processing patent applications. As a response to the mounting pressure from the inventors the Patent Act of 1793 was passed to make the patent system efficient. B
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
tween 1793 and 1836, there was an increase in the number of patent applications. To organize and maintain patents for easy cross examination, the Patent Act of 1836 allowed the publishing of patents and made them publicly available through libraries. The availability of knowledge of an inve
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
tion from the published patent documents created interest amongst the public. Due to increasing understanding amongst people of the economic value and advantages of inventions, the number of patent applications increased from 765 in 1840 to 21,276 in 1867. A method for grouping similar pate
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
nts under classes, begun in 1774, was also evolving simultaneously.
In the meantime, in England, the Statute of Monopolies continued to exist for over two hundred years. The Industrial Revolution and the Great Exhibition of 1851 lead to dramatic technological changes that were inefficientl
In the meantime, in England, the Statute of Monopolies continued to exist for over two hundred years. The Industrial Revolution and the Great Exhibition of 1851 lead to dramatic technological changes that were inefficientl
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
addressed by the Statue of Monopolies. With growing concerns over the state of public affairs, the Government introduced the Patent Law Amendment Act of 1852 and the Patent Office was instituted. In a milestone achievement of the Act of 1902, patent documents from 1855 to 1900 were condens
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
d and classified into 1022 volumes in 146 classes. The present day legislation on patenting follows the Patents Act of 1977.
On the lines of international collaboration, the need for worldwide accessibility to intellectual property systems, including patents, was recognized in the Paris Co
On the lines of international collaboration, the need for worldwide accessibility to intellectual property systems, including patents, was recognized in the Paris Co
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
nvention in 1883. The countries entered into the Convention (contracting countries) had accessibility to the IP systems of other countries party to the Convention. Currently there are 171 countries that are party to the Paris Convention. In an effort to provide further international cooper
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
tion, the World Intellectual Property Organization (WIPO) was established in 1967. WIPO is a specialized agency of the United Nations promoting the protection of intellectual property throughout the world. The signing of the Patent Cooperation Treaty in 1970, by various countries, has made
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
it possible to file patent applications to protect inventions in each of the contracting country. Presently, there are 184 member countries of WIPO.
On similar lines, the European Patent Convention of 1973 resulted in the establishment of European Patent Office (EPO) that is responsible fo
On similar lines, the European Patent Convention of 1973 resulted in the establishment of European Patent Office (EPO) that is responsible fo
.
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
r granting European patents. The 32 contracting states have entered into a multi-lateral treaty creating an autonomous legal system for granting European patents.
Presently there are about 200 patent offices including the USPTO in US, Patent Office in UK, and EPO for European countries. Pa
Presently there are about 200 patent offices including the USPTO in US, Patent Office in UK, and EPO for European countries. Pa
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
ent offices like ROSPATENT and SIPO of Russia and China are as recent as 1955 and 1980. The patenting system is fast growing even in countries like Ethiopia, Afghanistan, Angola and Papua New Guinea. Organizations like WIPO and EPO, additionally are promoting IP protection on a global scale
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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