[Ip-health] Merck loses Formulation Patent case, court cites KSR

Tue Jun 12 05:03:08 2007

Apparently, Merck has lost the first US post KSR decision on
patentability of a drug formulation.

*  Judge Pauley said:   "Under KSR, 'the combination of familiar
elements according to known methods is likely to be obvious when it
does no more than yield predictable results.' The '340 patent does no
more than combine the predictable results of Davis and Wolfe with the
predictable results of the '072 and '114 patents."

http://biotech.seekingalpha.com/article/37659?source=feed

Merck's Formulation Patent on Pepcid Complete Invalidated by District
Court

Posted on Jun 7th, 2007 with stocks: MRK, PRGO

Aaron F. Barkoff submits: In an opinion released Tuesday, Judge
William H. Pauley III of the U.S. District Court for the Southern
District of New York ruled that Merck's (MRK) patent on the
formulation for Pepcid Complete is invalid as obvious, clearing the
way for Perrigo Co.(PRGO) to sell its own generic version of the
medication. The decision is one of the first pharmaceutical patent
decisions to rely on, and quote extensively from the Supreme Court's
April 30 decision in KSR v. Teleflex (TFX).

The patent-in-suit was Merck's U.S. Patent No. 5,817,340. Claim 1 of
the '340 patent recites a solid oral dosage form comprising
impermeably coated famotidine granules and aluminum hydroxide or
magnesium hydroxide. Pepcid Complete comprises coated famotidine
granules (to inhibit stomach acid secretion) and magnesium hydroxide
(to neutralize stomach acid already present). The coating on the
famotidine granules is important; without it, magnesium hydroxide
would cause famotidine to degrade upon contact. Additionally, the
coating masks the bitter taste of famotidine.

According to Judge Pauley's opinion, two prior art references,
"Davis," and "Wolfe," had previously taught the use of famotidine
with magnesium hydroxide in a pharmaceutical composition. Moreover,
according to the opinion, two prior art patents, the '072 and '114
patents, taught coating of famotidine granules in order to mask
famotidine's bitter taste.

Judge Pauley began his analysis by referring to the "teaching,
suggestion, or motivation" test as follows:

     Until recently, the Federal Circuit had employed an additional
test for determining the obviousness of combining prior art
references." Then, after reviewing the scope and content of the prior
art, he stated: "Under KSR, 'the combination of familiar elements
according to known methods is likely to be obvious when it does no
more than yield predictable results.' The '340 patent does no more
than combine the predictable results of Davis and Wolfe with the
predictable results of the '072 and '114 patents.

Judge Pauley went on to imply that even pre-KSR, he would have found
the '340 patent invalid as obvious, since one of skill in the art
"would have been motivated to use impermeable coating to improve the
palatability of a chewable tablet comprised of coated famotidine and
antacids." Nonetheless, the decision is still informative of how
district courts are applying KSR to pharmaceutical formulation patents.

Ortho-McNeil, a unit of Johnson & Johnson (JNJ), markets Pepcid
Complete in partnership with Merck. Pepcid Complete is an over-the-
counter product intended for the treatment of heartburn, with annual
retail sales of about $90 million. Perrigo reportedly plans to begin
selling its generic version sometime next year, and expects to have
180-day exclusivity when it does.