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« Could the "New Rules" Nightmare Finally Be Over? | Main | Follow-on Biologics News Briefs - No. 6 »

July 27, 2009

Comments

A good biotech conception case. Was the fact that the adipose-derived stem cells were different from the bone marrow-derived mesenchymal stem cells helpful for patentability?

Dear SKD:

Since the mesenchymal stem cells were in the prior art, if the adipose-derived cells were the same cells then they wouldn't be novel per se, and the claims might be limited to methods for isolating such cells from fat tissue (compare obtaining bone marrow to fat by, for example, liposuction). So I think that the fact that these were distinctly-different types of adult stem cells could make a difference on patentability.

Thanks for the comment.

Thanks Kevin. Because neither the cell surface markers alone nor the ability to differentiate are sufficient to distinguish the stem cells (at least for the USPTO), I was just curious if the adipose "source" was a major reason for patentability. It is some times successful to argue that because the source is different, some of the novel properties that the examiner claims are "inherent" in the prior art cells are not necessarily inherent. From the facts, it is not clear as to why did Hedrick even argue for his finding that these cells were not MSCs for conception?

Dear SKD:

I think Dr. Hedrick's point was that he HAD to be an inventor because the adipose-derived stem cells were patentable ONLY when he had established that they were actually a distinct cell population from the bone-marrow derived mesenchymal stem cells - i.e., if you didn't know/had not established that difference, then you could not have conceived of an adipose-derived stem cell (since the stem cells you obtained from adipose tissue may just as well have come from bone marrow and migrated to fat tissue). Whether or not you think this is likely, his point is that unless you ruled it out you could not have conceived of a patentable invention. The CAFC didn't see it that way.

Thanks for the comment.

It makes sense now. Thanks for the additional explanation.

Kevin,

With respect your statement "Since the mesenchymal stem cells were in the prior art, if the adipose-derived cells were the same cells then they wouldn't be novel per se,.." how do you think the recent Abbott v Sandoz case that held process limitations in product-by-process claims must be met for infringement affects the analysis? If the corollary is true, then the same process limitations must be taught in the prior art as well, which is in direct conflict with In re Thorpe. The paradigm - that which infringes if before anticipates, may not be valid anymore ....

Dear SDK:

The Abbott decision was almost 20 years in the making, and follows the CAFC's penchant for promoting certainty. But I don't think it impacts the inventorship question, and before or after Abbott the existence of the product in the prior art precluded product by process claims to that product (although method of making claims were available for novel methods).

Thanks for the comment.

The comments to this entry are closed.

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