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Top Adding - To Crush Your Competition A Strong Patent Is Important -- Learn How And Why
Chemical and pharmaceutical companies protect their investment in research and development and the future of the companies by securing patents on their inventions. Patents help you resist competition. Success or failure of the co
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
mpany often depends on the strength of the patent and the longer the term of the patent, the greater will be its value. A strong patent is one that defines your invention broadly and but at the same time builds in fallback narrow
; 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
nvention.
The United States Patent and Trademark Office receives hundreds of thousands of patent applications each year. In fact, the Patent Office has recently proposed new patent rules to ease the Examiner workload. According
The United States Patent and Trademark Office receives hundreds of thousands of patent applications each year. In fact, the Patent Office has recently proposed new patent rules to ease the Examiner workload. According
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
o one proposed rule, if a patent application is rejected, to be able to present your case again, the patent applicant will be limited to filing one request for continued examination (or RCE). In light of the new rule, unless the 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
tent applicant masters the complexities of patent law, the applicant might end up getting a weak patent instead of a strong one.
Imagine you have filed a patent application where you have defined your invention broadly as well as
Imagine you have filed a patent application where you have defined your invention broadly as well as
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
arrowly in ten succinct sentences in what are known as patent claims. These patent claims will be numbered 1 through 10. Typically claim 1 will represent the invention of the broadest scope, and the higher numbered claims represe
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
t fallback narrow inventions. In our hypothetical, claims 2 to 10 will refer back to claim 1. Thus, claim 2 refers back to claim 1. Claim 4 refers back to claim 3, which in turn refers back to claim 2. Claim 5 refers back to cl
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
aim 1 or claim 4. In this example, say claim 5 refers back to claim 1. Keep in mind that the more number of fallback claims you have, you have a better chance of winning the lawsuit in the event your competitor challenges your pa
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ent.
Now imagine that the Examiner rejects the patent, as it often happens, stating that the invention is not new or is only a minor modification of what is known already. You, as patent applicant, have a chance to respond to the
Now imagine that the Examiner rejects the patent, as it often happens, stating that the invention is not new or is only a minor modification of what is known already. You, as patent applicant, have a chance to respond to the
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
Examiner. You present arguments stating why the invention is new and not obvious and why you should granted a patent. The Examiner rejects your argument. Now, to continue your effort to get a patent, you wish to present new argu
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ents. To do so, you may have to file an RCE (and the fee) along with the new arguments.
The Examiner takes it up again. This time, the Examiner softens a little and says, in a non-final rejection, that invention of claims 4 to 1
The Examiner takes it up again. This time, the Examiner softens a little and says, in a non-final rejection, that invention of claims 4 to 1
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
would be allowable as a patent if you rewrite claim 4 without a reference to claim 1, but continues to reject the broader invention of claims 1, 2, and 3. You now have a choice of taking what the Examiner gave you, that is, claim
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
4 to 10 or alternatively, argue some more. You choose to argue. The Examiner finally rejected your application, repeating what he said before, that is, claim 4 onwards would be allowable if you rewrite it as indicated before. N
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
w, the options you have are very limited. You can rewrite claim 4 as the Examiner indicated, as new claim 1, and obtain a patent with new claim 1. However, you will not be able to get a patent with claims 5 to 10.
The Examiner w
The Examiner w
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
ould refuse to grant claim 5 to 10 because he will say that claim 5 now has been changed in its scope even though you did not change the wording of the claim. The Examiner will argue that original claim 5 referred back to original
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
claim 1. Now, claim 5 refers back to new claim 1, which is of a different scope. The Examiner would indicate that, as the scope of the claim has changed, he would need to carry out further search and examination on claims 5 to 10
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
He would say that the patent law would not allow him to do so since the rejection has been made final already. The only way to get the Examiner moving on this would be if you could file an RCE. However, you have already used up
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
your RCE option. You cannot file another RCE now, and therefore, you cannot get claims 5-10. You will get a patent with just one claim. If an infringer challenges your patent, and proves that your only claim is invalid, your ent
.
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
re patent would be thrown out.
If you had rewritten claim 4 (as new claim 1) when responding to the non-final rejection, rather than when responding to the final rejection as you did, patent law would have allowed the Examiner to
If you had rewritten claim 4 (as new claim 1) when responding to the non-final rejection, rather than when responding to the final rejection as you did, patent law would have allowed the Examiner to
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
arry out further search on claims 5 to 10, and the chances of getting those claims would have been favorable. If you had fallback position of claims 5 to 10 also, you would have a greater chance of winning the case.
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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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