Advice Pool - Legal

As we approach the end of December, it is time to open gifts and start thinking about 2007. So, what can we expect in the legal field next year?

Pre

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

dicting practically anything in the future is a risky endeavor indeed. Okay, I think I am safe predicting the sun will rise tomorrow. After all, I am

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

Examples of combination products may in

hardly going to hear any objections if it does not. When considering the law, predictions of specific events are a bit iffy, but some general trends

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

an certainly be foreseen.

When it comes to the law, everything begins with the Supreme Court. 2006 was a fairly calm year at the court with few revo

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

utionary decisions. The reason? The changing of the guard when it comes to the justices. We have a new Chief Justice and Associate Justice, both who

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

Combination pro

re known for their conservative views. Although 2006 was calm, both justices lived up to their conservative reputations, which gives us a hint of wha

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

is coming in 2007.

The coming year is going to be one of minor and major changes in the case law of the land. With the appointments of Chief Justic

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

Roberts and Associate Justice Alito, the court has shifted to the right. The swing vote on many cases is now Justice Kennedy, who leans to the conse

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

vative side of the scale. This will equate in decisions that reduce the rights of individuals, increases the authority of the federal government and

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

imits the regulation of business. On the hot button topic of abortion, it is more likely that the court will put limits on Roe v. Wade instead of sim

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

ly overturning it, but a complete reversal of the decision is certainly possible.

Moving away from the court system, the other area of law we are li

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

Following aspects would a

kely to see major changes in is intellectual property. Intellectual property law is simply case law and statutes that deal with business assets that

dd to the challenges in developing combination products:

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

re intangible, but valuable. This includes areas such as copyright, trademark and patent law. Forefront in the battle will be the continuing evolutio

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

of how these issues translate to the Internet. One can specifically expect to see a lot of lawsuits involving YouTube.

YouTube, of course, is a sit

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

that allows people to post videos. The site is hugely popular and was recently purchased by Google. With deep financial pockets, it is now a target

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

or litigation on issues related to copyright and trademark infringement. Specifically, the problem is going to be how these rights translate to video

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

Professional from academic institutions, pharmaceutical industries, health care indust

being posted by people on YouTube, which they do not own. For instance, what is the responsibility of YouTube when someone posts a music video or so

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

ething? In practical terms, we are looking at the Napster litigation scenario all over again, but with video this time.

Obviously, the legal arena i

.

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

a huge one. There are many different areas of law and each will be modified in 2007. That being said, a conservative pull back on current law can be

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

Companies that provide selfless information through particip

expected in Supreme Court decisions, and the application of intellectual property law to the net should be the most volatile areas in the coming year

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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