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March 06, 2008

Comments

Perhaps Judge Sheridan is taking a side-wise swipe at the absurdity of it all. Maybe he wrote this opinion in the hopes that the CAFC would reverse him. Who knows....

In reality, it's not so much the KSR decision that was wrong (because it didn't really change the law, by itself) but rather the Pfizer v. Apotex decision that shows judges how to brush off secondary considerations in order to find obviousness.

Also, we must accept that the last sentence of Sec. 103(a) has been judicially re-written. It now effectively reads "Obviousness shall not be negatived by the manner in which the PHOSITA perceives the invention."

I agree with Judge Sheridan. The ultimate question was whether the intuitive trial and error performed by Bayer amounted to an "invention" that deserved separate patent protection--which clearly it did not. Spirenone and drospirenone are close enough to warrant that call.

Dear Fowler:

The point isn't whether you (or I) agree with Judge Sheridan in this case - it's having a lay judge using her "common sense" to make the decision.

Thanks for the comment

Kevin, I've felt for a few years now that many of the judges on the CAFC are on the march against second-generation pharma patents, though heaven forfend that they would admit it. KSR, which I view as a response to business method and software patents in the wake of State Street, simply gave them additional weapons to attack second-generation pharma patents. The Norvasc decision last year was merely the most egregious example where the court invalidated a patent that objectively met the Graham tests of non-obviousness. Judge Sheridan, it seems, took his cue from the CAFC and some of the English-major imprecise prose in KSR.

While I have my doubts about the non-obviousness of many formulation patents I've encountered, this case seems like one where objectively the invention wasn't obvious. I hope this decision is overturned on appeal, but I'm also realistic: it will be entirely panel dependent, and looking at the trend, I think down the road we're going to see more, not fewer, decisions like Judge Sheridan's, and more such decisions being upheld rather than overturned.

Did any of you note the cite that the court used to support "its" common sense reading? Here it is: 127 S.Ct. 1732.

And here's the relevant preamble to that cite:
"The syllabus constitutes no part of the opinion of the Court but has been prepared by the Reporter of Decisions for the convenience of the reader." See United States v. Detroit Timber & Lumber Co., 200 U.S. 321, 337, 26 S.Ct. 282, 50 L.Ed. 499.

Dear Jud:

You may be correct, but it's likely to be the result of a less-than-diligent clerk citing a mis-citation in another case (some of the Docs have suggested PharmaStem may be the culprit).

But the issue is the Supreme Court's admonition regarding "common sense" - if that common sense is not grounded in the person of skill in the art, you get cases like this one.

The problem with having judges make this determination is that they are likely to misunderstand the way science and technology advances - not necessarily in a logical fashion, but in fits and starts. The skilled worker would be more capable of understanding (and giving credence to) the patentee's explanation of how the invention was actually achieved - the long section of the opinion on the developmental background. Judge Sheridan expressly refused to give anything more than "little weight" to this evidence, and thus was comfortable applying his version of "common sense" to something he had no basis for having any "common sense" about.

Which doesn't mean it will be overturned on appeal. It is possible that the CAFC will decide that Judge Sheridan was equally less-than-diligent about expressly stating that his decision was grounded in the testimony of Barr's experts but that he was entitled under KSR to make these factual determinations.

The other issue is whether the Judge's application of "common sense" runs afoul of the statutory proscription that "[p]atentability shall not be negatived by how an invention is made."

Thanks for the comment.

Dear Dan:

I think that what's happening is another paradigm shift (here, with regard to how 103 is applied to pharma patents). And, as with other such changes (how the written description requirement of 112 has changed over time), patentees suffer the consequences.

In the Norvasc case, I think the problem was how the invention was claimed. If it had been claimed as a method for producing Norvasc, it might have fared better, since the "advantage" of using the besylate was in manufacuring the product. Viewed from this angle, it is a patentable invention.

Viewed from the "just another pharmacetically-acceptable salt" perspective, however, the Court found it easier to ignore the manufacturing advantages over the "obviousness" of the formulation per se. Ironically, the method claim might have been just as effective, even against foreign competition, since it is unlikely that the besylate could be "swapped out" after production.

Having said that, I agree that the Court's reasoning was outcome-driven at best, but I also agree that second-level patent protection for pharma will be a battleground for a while.

Thanks for the comment.

Kevin,
I agree that the citation was probably sloppy, but that's a symptom, not the problem. The reason I think the CAFC could (and should) reverse this is because the "common sense" to which the mis-citation refers (when it is referenced correctly) is that of one of skill in the art.

"When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103."

A correct citation would lead to use of the correct standard, and the mis-citation is thus easily challenged as:
a) a non-binding reading of the law (because it is a non-precedential citation), and
b) an incorrect reading of the law.

Jud:

Agreed. Let's hope Bayer's lawyers read PatentDocs.

Thanks for rhe comment.

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