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« Court Report | Main | Promega Corp. v. Life Technologies Corp. (Fed. Cir. 2014) »

January 12, 2015


I am curious as to how many of these drug innovations are susceptible to challenges under the Court's (ever-expanding) 101 atomic bomb power of rejection, how many of these breakthrough discoveries can be (or will be) simply evaluated as being discoveries of "laws of nature" or mere abstract results of "laws of nature" from "old" methods...

If the advances in development are not claimed, are those same advances now at risk of becoming a roadblock to the fruits of that labor? After all, it appears to be a natural extension of the Court's logic that any new advance from old tools is not patent eligible (mind you, not eligible instead of not novel or not non-obvious); and the Court notably has not provided ANY stopping point for the use of its (quite evidently eviscerating) logic.

Some have called for a restraint in comments (such as the learned Paul Cole), but some (such as myself) have noted that our courts have not engaged that same restraint, and that in truth, the Supreme Court did not provide limits because it does not want to limit its own reach into patent matters.

It would be almost irresponsible not to note that a very extensive risk exists that many or perhaps even all of these drug innovations can be (in the future) deemed by the Court to be innovation undeserving of patent protection. Congratulations to the owners of these innovations that have already obtained patent coverage. Please do not be fooled into thinking that such coverage will be enforceable in this modern day version of "the only valid claim is one that has not yet appeared before us."

Presuming "new drugs" included biopharmaceuticals, you fell into the trap laid every year by CDER with this article! Most every other even expert-level news source also are also victims. Your article is so far off, wrong, in reporting 2014 ‘new’ FDA approvals (only 41), you should consider a major correction, redoing this article.

You obviously used the annual list of ‘new’ NDA and BLA approvals promulgated by FDA (or rather, CDER), the same list cited in an earlier Dec. speech by the Commissioner, etc. But essentially every year, this reporting totally ignores the biologics/BLAs approved by CBER! It only includes relevant/NME CDER approvals, both drugs and biologics. This list is in no way comprehensive concerning ‘new’ FDA 2014 approvals. See my running list of biopharmaceutical approvals at http://www.biopharma.com/approvals.html.

New products and most also clearly containing new molecular entities/NMEs approved with full BLAs by CBER in 2014 that you (and CDER/FDA) omit include:
1) recombinant human papiillovirus (HPV) vaccine, Gardasil 9, from Merck
2) meningococcal group B vaccine, Trumemba, from Pfizer
3) recombinant porcine (pig) Factor VIII, Obizur, from Baxter*
4) recombinant glucagon-like peptide-1 (GLP-1), Trulicity, from Lilly
5) a new combination — Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase - HYQVIA (Gammagard plus Hylenex)
6) recombinant complement C1 esterase inhibitor, Rhucin, expressed by transgenic rabbits (can’t get more novel than this), from Salix Pharmaceuticals, Ltd. (and Pharming Group NV)
7) recombinant Factor VIII, Eloctate, from Biogen-Idec
8) recombinant Factor IX-Fc fusion protein, Alprolix, from Biogen-Idec
9) hyaluronic acid, cross-linked, Monovisc, from Anika Therapeutics

Counting these, FDA likely had a truly record-setting year for 'new' API and product approvals.

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