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Advice Pool - Patent Litigation Financing
A company or person who invents something new would like to be the sole owner of the invention. Since it is t
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
heir ‘original idea’ they want to reap the benefits and profits. This is applicable on everything from the de
; 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
signs, trademark or brand names, copyrights and so on. These ‘ideas’ are collectively called intellectual pro
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
perty. It is not easy to protect these ‘ideas’ until and unless the government intervenes. That is, the gover
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
nment ensures ‘protection’ by issuing various intellectual protection rights. One such intellectual protectio
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
right is that of patents.
Patent is a government license or legal protection issued by the government. It g
Patent is a government license or legal protection issued by the government. It g
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
ives a person who has invented a product or thing the sole right to make, use or sell it. The individual is t
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
he sole authority to produce it and bring or make changes to it with time. He or she can sue anybody who trie
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
s to use any technology to create the same product. A patent is bound by geographical area. A patent issued t
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
o the person or the inventor helps to recover the cost involved in the making of the product. It also acts as
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
a source to sustain the competition.
Getting a patent is not an easy task. As soon as the inventor decides t
Getting a patent is not an easy task. As soon as the inventor decides t
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
o launch a product, he or she may begin to check for the patented products. After ensuring the innovative qua
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
lity and characteristics of the product, he or she files a patent application. But often the application gets
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
rejected because of the inability to prove the worth or ‘new and different’ in the invention. Hence they hir
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 an experienced, expert patent attorney. The patent attorney will study the pros and cons of the product. He
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
or she will check for similar products and any already filed patent rights. The attorney goes about with the
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
patent application once a convincing, thorough investigation is done on the ‘idea’ or ‘product’. The attorney
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
gets only the contingent amount as fee for the Patent Litigation. There are very few companies that help wi
.
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
th Patent Litigation Financing by giving funds as a non-recourse settlement. In fact, it is found that the co
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
mpanies are more interested in patent infringement litigations, as the recovery chances are relatively better
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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