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« The Non-obviousness of DNA | Main | Biotech/Pharma Docket »

April 14, 2009



Yeah, Judge Linn is now in Judge Rader's camp on written description as applied to biotech. There's obviously not a uniformity of view on separating written description from enablement in the biotech area.

As I said before, my only quibble with Judge Moore's opinion is that the appellate standard for reviewing the jury verdict of satisfaction of the written description requirement ("substantial evidence") comes very late (and in my opinion, very tardy) in her opinion. By not describing the appellate standard of review earlier in her opinion (as most other Federal Circuit opinions usually do), it's never clear whether Judge Moore is applying a question of law ("de novo") standard (question of law) or "substantial evidence" standard (is the jury verdict legally supported by the evidence presented to them). This also isn't a mere matter of form as it can cause confusion as to what circumstances the holding is (and may not be) applicable.

What claims are the inventors of Ariad and Rochester entitled to? Screening for compounds claims? Those are commercially useless after Merck v. Integra. These inventors deserve some protection for their "progress of useful arts". I am just not sure what that is in light of the strict written description requirements.

Dear SK:

Under current case law, the answer is "Not much, unless" there is some disclosure of a "representative number" of compounds that have the biological effect.

The problem is one of skill sets: the people who make the molecular biological/biotech inventions are typicaly not the people who develop compounds that affect the biological processes identified by the molecular biologists. There are ways for the groups to partner, either between academic departments or with industry. Other discliplines have made those "town and gown" partnerships; in biotech, the start-up model that has existed since the beginning of the industry has taken a different path.

There is a point to be made that these decisions (Rochester and Ariad) are encouraging academics and industry to adopt more traditional roles. It remains to be seen whether that is a good idea.

Thanks for the comment.

Thanks Kevin. Very true. I just hope the academia realize this and do those partnerships early on instead of waiting until the research is about to be published for patent protection.

What claims are the Ariad inventors entitled to?
I think the proper question is "did Ariad actually invent anything at all?"
Looking at the claims what could a (potential) Ariad inventor point to and say "I made that."
Discovering how (or why) a pathway/receptor/gene impacts a disease state is a great scientific achievement but that doesn't make it patentable subject matter. (just my opinion)

Dear IPW:

Under current case law, the answer is that these inventors are not entitled to very much, and certainly not claims that encompass (read: foreclose) molecules not envisioned by the inventors.

The Ariad inventors identified an important biological molecule, NF-kB, that is involved in many responses to the environment etc. for mammalian cells. They certainly enabled the skilled worker to screen compounds for activity in inhibiting NF-kB expression, and they came up with 3 different types of molecules that would have worked to inhibit certain NF-kB-dependent activities in eukaryotic cells. But to do so they needed to identify something that would work, and as of their filing date they had not.

Thanks for the comment.


"It is certainly the case that it [a separate written description requirement] provides a bright line rule for determining what an applicant has invented at the time the application was filed."

Do you really think there is a bright line rule? Written description has been widely criticized as "incoherent" and even as "an unmitigated disaster."

Using your example, if isolation of a cDNA encoding one ortholog of a mammalian protein does enable a reasonably skilled worker to isolate orthologs from all other mammalian species, shouldn't ownership of such greater breadth be warranted? Why should evidence that an inventor envisioned EVERY possible variant of claim language be necessary? More importantly, taking this reasoning to its logical conclusion, couldn't arguments always be made that claims encompass all variants not specifically claimed otherwise?

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