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In the January, 2006 issue of Intellectual Property Today, attorneys Thomas J. Van Gilder and Carl A. Kukkonen cited to a document on the webpage of the United States Patent and Trademark Office [US

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

PTO] for the proposition that "patent filings have grown from 353,394 to 406,302, an increase of nearly 15%, from FY 2002 to FY 2005." In footnote 3 of their article, they carefully provided the pa

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

e number of the document and the link to the document: See USPTO 2005 Annual Report at 61, http://www.uspto.gov/web/offices/com/annual/2005/2005annualreport.pdf. The interesting, and troubl

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ng, aspect about this is that one will not find in the cited document at the given link the number "406,302".

The number 406,302 did not arise out of thin air. Intellectual Property Today had ment

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

oned the number in its December 2005 issue: The agency received 406,302 patent applications, and 323,501 applications for trademark registration as reported in its fiscal year 2005 Performance

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

and Accountability Report released in November. The magazine eWeek had mentioned the number on January 16, 2006: Last year, the USPTO granted 165,485 patents, up from 99,000 in 1990. Accor

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

ding to the patent office, a record 406,302 new applications were filed last year alone. On January 25, 2006, Bruce V. Bigelow of the San Diego Union-Tribune used it: In November, the pat

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

nt office said it issued 165,485 patents in the fiscal year that ended in September -- and had received 406,302 patent applications, along with 323,501 applications for trademark registration. A

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

dy Holloway of Canadian Business used the number on January 30, 2006: It's easy to see why the patent office is swamped. It received 406,302 patent applications and granted 165,485 of them las

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

year, adding to a database of patents that numbers roughly seven million. On February 20, 2006, Dan O'Shea had used the number in Telephony: During 2005, the agency received 406,302 patent

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

pplications and 323,501 applications for trademark registration, according to the agency's Web site.

As of April 23, 2006, one will find at page 61 of the above-identified link a table stating

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

that there were 409,532 filings in FY 2005. One will not find an explanation of why the previous number of 406,302 is gone. Data that exist only on an internet website can be changed, without expl

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

nation, and thus cease to exist. In this particular instance, we have evidence of the previous information, because so many people cited to it. However, a person looking only to footnote 3 of the

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

rticle by Van Gilder and Kukkonen, and following the link to page 61 might be led to the conclusion that Van Gilder and Kukkonen "got it wrong."

In fact, the "error" of Van Gilder and Kukkonen woul

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

have been referring to a link to a site that was capable of changing the numbers. Those authors who cite to internet websites for numerical data should be aware that such citation may be perilous

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

n the sense that it is not permanent. The situation presents an interesting issue in the way law review cite checking works. If a law review author utilized the 406,302 number and cited to Van Gil

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

der and Kukkonen, the cite would be approved. However, if a law review author utilized the 406,302 number and cited the USPTO document, the cite should NOT be approved.

In this particular case, th

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

re is a secondary sustantive issue as to patent law. The figure of 409,532 (or the previous figure of 406,302) comprises the combination of utility patent applications AND design patent application

.

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

. Typically, in such things as the debate on how high the patent grant rate is, one looks only at utility applications. Taking the previous data as presented, one would find a grant rate of 165,4

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

5/406,302 = 40.7%, miniscule in comparison to the 97% number once alleged by Quillen and Webster, or the 85% number accepted by Lemley and Moore in the article "Ending Abuse of Patent Continuations.

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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