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Answers - The Patent Office's Proposed Rules For Disclosing Prior Art Increase Patent Applicant's Burden
Chemical and pharmaceutical companies protect their huge investment in research and development and the future of the companies by securing patents on their inventions.
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
Success or failure of the company often depends on the strength of the patent in its ability to resist competition.
Recently, the United States Patent and Trademark
Recently, the United States Patent and Trademark
; 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
Office proposed changes to the way prior art documents would be submitted, with a view to reduce Patent Office Examiner’s workload and shorten the time it takes to obta
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
n a patent. These changes, however, could drastically limit the company’s ability to secure strong patents unless competent counsel is employed.
The present rules req
The present rules req
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
uire that patent applicants must submit copies of prior art, that is, other patents and publications disclosing information pertinent to the invention being patented.
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
There is no limit on the number of such documents that can be submitted to the Patent Office, and there is no duty to explain what these documents teach. This enables
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
he patent applicant to submit twenty, thirty, or even one hundred or more documents without having to comment on what these documents teach, and, under the present rule
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
s, the Patent Examiner must consider them all before granting the patent.
If the proposed rule changes become law, patent applicants can no more submit unlimited numbe
If the proposed rule changes become law, patent applicants can no more submit unlimited numbe
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
r of documents. The submission would be limited to twenty documents. If the inventor or his lawyer submits more than twenty documents, he must explain to the Examiner
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
in writing, identifying those parts of the documents that pertain to the invention he is attempting to patent.
The obligation of the patent applicant does not stop th
The obligation of the patent applicant does not stop th
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ere. If the patent applicant comes to know of new documents after the Patent Examiner has completed his examination, then he needs to submit that document to the Paten
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
t Office and provide, in addition to an explanation, why this new document is being submitted and how this document teaches more than documents previously disclosed to
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
he Patent Office.
In addition, under the new rules, there is a duty to update the disclosure and explanation continues until the patent application matures into a pate
In addition, under the new rules, there is a duty to update the disclosure and explanation continues until the patent application matures into a pate
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
nt. Every time the patent applicant attempts to redefine his invention, he must point out how each of the documents submitted so far do not disclose the redefined inve
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
ntion.
The immediate effect of the new rules would be to increase the attorney’s fees for securing a patent, as the rules would require the patent attorney to review e
The immediate effect of the new rules would be to increase the attorney’s fees for securing a patent, as the rules would require the patent attorney to review e
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
ch of the documents thoroughly before submitting it to the Patent Office. More importantly, every statement or explanation provided to the Patent Office could constitu
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
te potential ammunition that a competitor could use defeat the strength of the patent.
Even more importantly, if the patent applicant selected and disclosed twenty doc
Even more importantly, if the patent applicant selected and disclosed twenty doc
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
uments selected from among his collection of many documents, the competitor might accuse that the patentee deliberately and intentionally withheld an important document
.
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
The competitor would argue that the patent was procured fraudulently, and therefore, the patent should be thrown out.
The proposed rules are complex and have heighte
The proposed rules are complex and have heighte
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
ned the duty of patent applicants for disclosing prior art documents. Needless to say that competent counsel is vital to insure the strength and vitality of the patent
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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