So, if your inventor deposits some of Factor X, depending on what the claims are, it may still not support the entire breadth of whatever is claimed. However, if the inventor clearly describes how to isolate Factor X (as in Wands), the claim might be enabled.

Furthermore, even a deposited antibody wouldn't allow a POSITA to necessarily distinguish infringing compounds from non-infringing compounds, depending on how the claim is written.

So I'm not sure how depositing Factor X allows the inventor to better satisfy the "super enablement" written description requirement.

Your statement assumes that the absence of patent protection for methods for correlating traits with biological markers will mean less commercially available tests based on the correlations. First, there is no basis in reality for this assumption. We're not talking developing and commercializing a drug here. We're talking about tests. Certainly it takes some amount of time and money to get a test developed and commercialized, but it is trivial relative to a drug. I mean, it costs money to start a coffee shop too. Second, even if the assumption is correct to any degree, is that so bad? Do you know how many crappy tests there are on the market? For every BRCA1/BRCA2 test (which isn't even THAT predictive), there are a hundred that are pure snake oil. Third, do you know where all the correlations are discovered? They're discovered at universities, government agencies, and non-profit research institutes. The discovery underlying the patents at issue in Prometheus v. Mayo was made at CHU Saint-Justine in Montreal. The discovery underlying the patent at issue in LabCorp v. Metabolite was discovered at the University of Colorado and Columbia. The list goes on forever. Do you think that these entities are going to stop discovering these correlations if there is no patent protection available to them? Of course not. Everybody accepts as gospel that Bayh-Dole has been this incredible thing, but where is the evidence? I'm not saying that it's had a negative impact (although some people would), just that it's not had a positive impact. I'd say it's had no impact whatsoever. If you want a guarantee on your investment for bringing a test based on a biomarker correlation to market, the way to handle that is through a regulatory exclusivity scheme. Just as is CURRENTLY done with new chemical entities and orphans. Certainly this would add a cost, namely greater scrutiny as to a test's "efficacy," but again, is that so bad?

The gravy train is coming to an end.

One might wonder just what benefit there is for society to raise the barrier to physicians providing warning information about possible side effects of drugs to patients. Scenario: pharma company patents drug and use thereof. In a separate filing, pharma company claims administering the drug in conjunction with the giving of instructions to discontinue use if hair falls out, etc. Second patent, not claiming the priority of the first patent, expires later. During that interval, a physician prescribing a generic version of the drug would be barred from instructing the patient to discontinue use if the harmful side effect is experienced! Or the physician must obtain a license from the patentee to do so!

And this is good for society?

It is not just a restriction of free speech, it is detrimental to the patient, interfering with the giving of honest advice. That would make allowing such claims hard to justify from the perspective of anyone BUT the patentee (and perhaps his attorney). Who else benefits?

Such a legal limitation reminds of the one-time government restriction on a physician receiving federal funds from discussing abortion with a patient.

Patents are rightly given for inventions, not for restrictions on free speech and interference with patient care.

And how much money was uselessly poured into that sinkhole, attorneys trying proactively to protect their clients' interests as deadlines loomed, filing suggested restriction requirements, hours of time reviewing claim sets, and the like?

Is that waste actionable? NOOOO!

PTO, can you think first, next time, please?

Susan

http://carusbcharger.com