“. . . .6. What are the criteria for determining whether a patent for a human drug product is eligible for patent extension?

The term of a patent which claims a human drug product, a method of using the product or a method of manufacturing the product will be extended from the original expiration date if it satisfies six conditions.

First, the applicant must show that the patent has not expired.

Second, the applicant must establish that the patent has not previously been extended.

Third, the patent owner or its agent must submit an application for patent term restoration that includes details about the patent and the activities undertaken to secure FDA approval.

Fourth, the applicant must establish the product was subject to a regulatory review period before its commercial marketing or use.

Fifth, the applicant must show that the product either represents the first permitted commercial marketing or use of the product after such regulatory review period or, in the case of a product manufactured under a process patent that primarily uses recombinant deoxribonucleic acid (DNA) technology, represents the first permitted commercial marketing or use of a product manufactured under the process claimed in the patent.

Finally, the applicant must submit the application for patent term restoration to PTO within 60 days of FDA approval of the commercial marketing application. . . .”

Note that the most important requirement for getting a five-year patent extension is that the drug NOT have been PREVIOUSLY approved for some other indication, disease or condition.

Thus, I believe Merck’s compound qualifies.

FDA recites no “due to FDA’s delay” requirement among the six it considers.

FDA will reduce the five years if Merck is deemed not to act swiftly enough — but that should not be a problem, here:

“. . . .[E]ach phase of the regulatory review period is reduced by any time that the applicant did act not act with due diligence during that phase. The reduction in time would only occur after an FDA finding that the company did not act with due diligence. . . .”

SOURCE:

http://www.fda.gov/CDER/about/smallbiz/patent_term.htm

I guessed it would be closer to $900 million, back in early April 2008 — and if the 23 percent downturn persists (but gets no worse) for all of 2008 — it will be more like $850 million fall-off in income:

http://shearlingsplowed.blogspot.com/2008/06/pretty-good-guess-here-at-2008-equity.html

Namaste

Yep — new monthly Vytorin/Zetia IMS scrips were released last night by Schering-Plough, once again on a back-water page of its website — with no front page reference, link or mention.

All new graphics — take a look here:

http://shearlingsplowed.blogspot.com/2008/06/may-2008-cholesterol-franchise-scrips.html

Perhaps the most important development to emerge from this new data is that the IMS numbers (now on file with the SEC) indicate the overall Cholesterol marketplace in the United States EXPANDED by about 1.3 percent in May 2008 — but with its essentially flat May 2008 scrips, the Merck/Schering-Plough Joint Venture effectively lost market-share to competitors’ drugs (albeit at a lower rate than in January through April 2008).

I guess the only thing surprising, here — is that they (Merck and Schering) just keep playing the same old games — So, I propose a game of “New Rules” (a la Bill Maher):

[You make those "new rules" up, below!]

Namaste