Sunday, May 28, 2006

Does something WITH water inherently arise from something WITHOUT water?

Patently-O noted of SKB v. Apotex on paroxetine: the CAFC reversed that particular decision — finding that the patent was inherently anticipated because PHC hemihydrate “inevitably results from production of” PHC anhydrate.

Patently-O had noted earlier: In concurrence, Judge Gajarsa found that the manufacture of PHC hemihydrate could be "a natural physical process" occurring "under normal climactic conditions and with no human intervention," and thus found that it was an unpatentable process of nature.

In my article entitled Imagine: No More Indecision In Intellectual Property Cases (Intellectual Property Today, August 2005 at page 7), I had written:

As noted above, Ulysses S. Grant said that if he were wrong in his
decision, he could do the other thing. In the paroxetine case (SmithKline
Beecham v. Apotex, 403 F.3d 1328 (CAFC 2005)), there have been a number of false
starts.n11 One reader questioned whether the April, 2005 decision really altered
the law of inherent anticipation, on the basis that it was "inevitable" that
paroxetine anhydrate will form the hemihydrate. Although the various judges in
the case got bound up in the vanishing polymorph (Vonnegut ice-9) issue
presented, one notes the simple chemical reality that an anhydrate contains no water
and a hemihydrate contains water (i.e., this is more than a polymorph issue).
It is not inevitable that an anhydrate will convert to a hemihydrate. If the
anhydrate is kept away from water, it will never form the hemihydrate.
One of ordinary skill knows how to keep things away from water (e.g.,
maintaining anhydrous ferric trichloride purple, protecting alkali metals, using
titanium tetrachloride). While it may be "natural" for an anhydrate to form a
hemihydrate in the presence of water (driven by the thermodynamics of
hydration), it is not inevitable,n12 and, in the absence of water, the
conversion won't happen at all. Presumably, the word "natural" was a
proxy for "water-containing environment." The idea of "inevitability" may now
require elucidation of conditions.

Endnote 12 stated: All thermodynamically-allowed results do not happen at standard
conditions. Thus, no one is worried that diamonds will convert to
graphite, the thermodynamically stable form of carbon at STP.

**Separately, of the current discussion about embryonic stem cell patents involving CIRM and WARF, the article in the August 2005 IPT also noted:

In discussing the absence of the common law research exception from
both the Merck decision and the current patent law reform bill (H.R. 2795),
Joshua Sarnoff and Janice Mueller blamed a lack of vigorous advocacy by the
parties with the greatest interest, academic and research institutions.n13
However, one notes that the only amicus brief filed in the Merck case (by WARF) was
in favor of the patentee (Integra), not in favor of the "researcher" (Merck)

-->Curiously, the proponents of CIRM have not yet discussed research exceptions to patent law.


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