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October 11, 2007

Necessary Medicine

GlaxoSmithKline is attempting to vaccinate inventors from the examination limits pandemic about to hit, which inexorably will lead to digestive distress and headaches for prosecutors, as well as depression for inventors who cannot adequately protect their inventions. GSK's medication was injected in the Eastern District of Virginia on Tuesday against Jon Dudas as USPTO honcho.

The point, elegantly stated in the GSK complaint, that an inventor has full entitlement, soon to be denied:

An inventor has a statutory entitlement to a patent unless the invention that is the subject of the application for the patent is not new or obvious. 35 U.S.C. 102-103. To obtain a patent, an inventor must file a written application that contains a specification, an oath and "one or more" claims. 35 U.S.C. 111-112. [¶34]

The PTO having gone gonzo, in defiance of legislative expression and CAFC case law:

The Patent Act confines the PTO's powers to regulating internal procedures in practice before the agency. See 35 U.S.C. § 2(b)(2). Section 2(b)(2) does not confer general rulemaking power on the PTO to interpret the Patent Act.

The Federal Circuit has long highlighted that Section 2(b)(2) does not confer on the PTO the power to issue substantive rulemakings. See Merck & Co. v. Kessler, 80 F.3d 1543, 1549 (Fed- Cir. 1996) ("As we have previously held, the broadest of the PTO's rulemaking powers-35 U.S.C. § 6(a) [now 35 U.S.C. § 2(b)(2)(A)] - authorizes the Commissioner to promulgate regulations directed only to 'the conduct of proceedings in the [PTO]'; it does NOT grant the Commissioner the authority to issue substantive rules.") (emphasis in original). The soundness of this conclusion is also confirmed by the proviso that initiates the enumeration of the PTO's rulemaking powers-the PTO can only establish regulations that are"not inconsistent with law." See 35 U.S.C. § 2(b)(2)(A). The Federal Circuit has reaffirmed its continued agreement with the Merck holding as recently as 2003 in Eli Lilly & Co. v. Board of Regents of University of Washington, 334 F.3d 1264, 1269 n.1 (Fed.. Cir. 2003).

[V]iewing Section 2(b)(2) as a whole, as edited by the legislature in. 1999, Congress effectively ratified Merck, confirming the PTO's rulemaking powers purely to internal matters of procedure that would be non-substantive in nature.

What has not been prescribed is proscribed: citing the failure to expand agency rulemaking authority, as evidenced by the patent act flops of the past two years -

Since 1999, Congress has twice proposed, but failed to pass into law, legislation that would have expanded PTO's rulemaking authority.

Causes of action:

1. The final rules' various restrictions on patent application rights are all ultra vires because the PTO lacks the authority to issue substantive rules in this area.
2. The PTO especially lacks the authority to impose the final rules' new restrictions concerning Coninuation Applications.
3. The final rules are beyond the PTO's power because they retroactively change the legal consequences of already filed Continuation Applications and the patent prosecution strategies.
4. The PTO lacks the authority to restrict the number of claims that can be presented in a patent application.
5. Restrictions in the final rules on the rules for Continued Examinations are contrary to the Patent Act.
6. The final rules are procedurally defective in various respects for failure to provide a required notice and a comment opportunity before the proposed regulations were amended in ways that could not reasonably have been anticipated.
7. The final rules are vague and do not put GSK on sufficient notice of how to comply.
8. The final rules work an unconstitutional, ultra vires, and arbitrary and capricious taking of GSK's patent and patnet application property rights.

As prayer for relief, GSK is seeking an immediate preliminary injunction.

Thanks to Gene Quinn at PLI.

Posted by Patent Hawk at October 11, 2007 11:04 PM | The Patent Office


Yippee! Thank you GSK et al. And to K&E for a very well written complaint. If you win, I promise to buy Tagamet for the rest of my life!!!

Posted by: Joyce at October 12, 2007 1:39 PM

Don't you mean: If they DON'T win? :=p

Posted by: T at October 22, 2007 4:58 AM