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Actual - Shouldn't Great Inventions Deserve Iron-clad Patents?
Chemical and pharmaceutical companies spend millions of dollars on research and development, and come up with great inventions, be it on a nove
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
l drug to treat high blood pressure or a new kind of plastic that can resist a bullet; however, they often find that their patents do not stand
; 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
up to a challenge by an infringer who wants to sell a copy-cat product.
Patents are valuable tools in a company’s arsenal to resist competiti
Patents are valuable tools in a company’s arsenal to resist competiti
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
on because it provides an exclusive right up to a period of twenty years. However, often inventors and businesses find out, five or ten years
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
down the road, that the patent does not cover the product that they are selling or does not cover the product the competitor is selling. By th
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
time they realize that the defect, it is often too late to correct it.
Patents are expected to describe the discovery in detail, and end in o
Patents are expected to describe the discovery in detail, and end in o
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
ne or more succinct definitions of the invention, what are called patent “claims”. The “claims” section is an important part of the patent, an
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
d success or failure in the market place rides on the accuracy of the claims. The claims, most often written by lawyers, contain many legal te
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
rms. When the legal terms do not match with the scientific meaning the inventor had in mind, then the patent may not survive a challenge by th
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
e competitor.
Take for example the patent for an extended release drug formulation containing a drug solvent described in the claims as a “sol
Take for example the patent for an extended release drug formulation containing a drug solvent described in the claims as a “sol
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
bilizer”. The patent holder argued that the term covers many different kinds of solvents and not just a surfactant. The infringer argued that
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
the disputed term covers only a surfactant and nothing else. The appeals court ruled, much to the disappointment of the patent holder, in fav
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
or of the infringer saying that the invention was described in the patent with only a surfactant as the solubilizer.
Consider the patent for m
Consider the patent for m
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
aking crisp and flaky cookies. The patent claim stated, as part of the baking step, that the cookie dough is heated to 400 to 800 degrees. Ca
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
n a cookie really survive this intense heat? Wouldn’t it produce a charcoal briquette rather than a crisp and flaky cookie? The judge ruled a
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
ainst the patent holder. The patent could have succeeded had it used “at”, rather than “to”.
To avoid such problems and unpleasant surprises,
To avoid such problems and unpleasant surprises,
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
the patent must be written carefully, keeping in mind that every word used to describe the invention must scientifically and legally correct,
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
and every argument made to obtain the patent must be consistent with the original intent of the inventor.
For a free no-obligation consultatio
For a free no-obligation consultatio
.
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
n, please call Xavier Pillai, Ph.D., a Partner in the law firm of Leydig, Voit & Mayer, Ltd. in Chicago, IL; Phone: (312)-616-5600 or email at
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
xpillai@leydig.com. I help small to medium size chemical and pharmaceutical companies resist competition by securing strong patent protection
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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