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If you buy or sell on eBay, or are a BlackBerry user, the odds are that you are aware of the potential impact of patent law on your day to day living. The lawsuit of MercExchange against eBay has the potential to disrupt about a third of e

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

Bay's business if a permanent injunction were granted. The threat of such an injunction against it caused the Canadian company RIM to settle with NTP for $612.5 million in order to keep its BlackBerry buiness going.

By June of 2005, ther

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

Examples of combination products may in

was legislation introduced in the US House of Representatives to reform some of the perceived difficulties. For example, Lamar Smith introduced H.R. 2795. Because powerful interest groups had divergent viewpoints on the injunction issue

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

the proposed legislation went no where.

The US Patent Office [USPTO] itself is proposing some changes to fix perceived problems. In January 2006, the USPTO presented proposed changes, and solicited comments, upon rules which would limit

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

patent applicants to no more than one continuing application.

For all the talk about problems with the US patent system, and proposed solutions, certain topics are not being discussed. Since about 1991, the Patent Office has been run on

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

Combination pro

fees it collects from users. HOWEVER, in that time period, Congress has been diverting some of the fees the USPTO collects to general revenue. In recent years the diversion has represented approximately ten percent of all the user fees p

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

id to the PTO. [see for example Heath W. Hoglund, 83 JPTOS 725]. HR 2795 did not address fee diversion, and as such would have left the USPTO with its 10% yearly shortfall.

Similarly, the USPTO's proposed change has nothing to do with 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 fee diversion. In fact, it proposes to limit the number of continuation applications that can be filed, so a result will be a decrease in the fees taken in by the USPTO.

But the USPTO is facing a desparate situation. With the strangu

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

ation from fee diversion, the backlog of unexamined applications has increased.

Limiting the number of continuation applications is supposed to address the problem. However, one may question whether this tactic is of sufficient scope to

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

esolve the problem.

I had written in Intellectual Property Today in Nov. 2005, based on numbers I got from the PTO for FY2004:

About 7% of applications were "second" continuations. As a result, the USPTO is evaluating the possibilit

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

of limiting continuations. One notes that the combination of RCEs/R129s/CPAs comprises 14% of the applications, with true continuations under Rule 1.53 amounting to 8%. Divisionals comprise 5% and continuations-in-part 4% of the ap

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

Following aspects would a

plications. The single most predominant form, a continued examination of an application, comprises 45% (14/31) of these examples of re-work.@ Dudas noted that the average time spent on each case is 19.7 hours. Although some of the

dd to the challenges in developing combination products:

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

re-work may arise from overreaching by patent applicants, some may be caused by the insufficiency of 19.7 hours, on average, to allow examiner and applicant to come to a meeting of the minds on proper claim scope. Deciding what is new

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

and non-obvious is not an easy job, as a recent episode in the study of Civil War history illustrates.

The number for FY 2005 is even smaller: 5.8 % (21,800/376,000).

Thus, even if the USPTO got its wish, there are not enough "

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

second" continuations to outlaw that would impact the growing number of unexamined applications.

There is a further issue. Examination of a first or second continuation application is easier than examination of a previously unseen applic

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

tion. The examiner has read the case and understands a lot of what is going on. Issues have been joined. The March 2006 newsletter of the Patent Office Professional Organization [POPA] noted that examiners usually process such cases m

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

Professional from academic institutions, pharmaceutical industries, health care indust

re quickly. Curiously, academics Lemley and Moore, in writing about ending abuse of continuations, denied this obvious inference, and suggested examiners would forget what they had learned in the two years that might pass between initial

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

application and continuation. [One notes that Lemley himself did forget about the problems associated with the multiple continuations used in the Axel patent, when he praised the Axel patent in "Patenting Nanotechnology" in 2005, although

.

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 district court in the Axel case had (ironically) cited Lemley's "Ending Abuse" for depicting the evils associated with the sort of thing Axel and Columbia University had done in keeping the patent alive.]

At the end of the day, intere

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

Companies that provide selfless information through particip

ted observers of the patent system will need to keep their eye on the ball to identify what are, and are not, problems with the patent system. Reform is needed, but one needs to ensure that the reform will actually solve the real problems

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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