Continuation Rules Would Cause GSK Irreparable Harm

Yesterday, I blogged briefly about the Eastern District of Virginia's injunction preventing the PTO's new continuation rules from taking effect today, November 1st.  But the Court's order was not available yet.  The order has been issued -- click here for a copy -- and it is very interesting.  The Court held that plaintiff GSK had shown a likelihood of success on the merits regarding several issues:

  • That limiting the number of continuations a party can file violates 35 U.S.C. Section 120, which states that later filed applications have the same effect as their parent applications.
  • That the new rules are impermissably retroactive because the limits on numbers of claims and continuations will change the terms of the bargain struck between inventors currently prosecuting their applications and the PTO when those inventors filed their applications, prior to the new rules going into effect.
  • That the requirements for Examination Support Documents ("ESD") are impermissably vague because they do not sufficiently define the paramters of the search required.

The Court also held that GSK would be irreparably harmed by implementation of the rules because GSK has about 2,000 pending applications and GSK's rights in each of those applications would be materially altered by the new rules. 

[Updated with more links after the jump.]

The balance of hardships weighed in GSK's favor.  The PTO's losses were sunk costs -- updating computer systems and training staff.  But if the PTO wins the suit and later implements the continuation rules, the new computer systems and the employee training will still be valuable.  On the other hand, the entry of the continuations rules will materially limit GSK's rights in its 2,000 pending patent applications.

Finally, the public interest is in maintaining the status quo, rather than allowing the implementation of a new set of rules which could be reversed by the Court in a matter of months.

For more on the preliminary injunction and thoughts about whether the PTO will file an emergency appeal with the Federal Circuit, check out:

I will continue to update this post with coverage of the injunction and any appeals throughout the day.

PTO Preliminarily Enjoined From Using New Continuation Rules

This morning, the Eastern District of Virginia held a hearing on SmithKline's motion for a preliminary injunction against the PTO to prevent the new continuation rules from becoming effective tomorrow, November 1st -- click here for the Blog's coverage of the case this morning.  Gene Quinn and John White of the PLI Patent Practice Center Blog, who attended the hearing, are reporting that the Court preliminarily enjoined the PTO from making the new continuation rules effective.  Of course, the injunction is only preliminary so there is no way to tell what the ultimate result will be.  But everyone that was busy trying to file one last continuation today and worried about whether the PTO's e-filing system would crash under the weight of all of the last minute filings, can put down their pens and rest easy.  The deadline may still come, but it is no longer today.

Trick or Treat: Have a Preliminary Injunction to Eat

Usually I post a holiday-related patent on major holidays (which Halloween is in my house).  But in light of today's Eastern District of Virginia preliminary injunction hearing regarding whether to allow the PTO's new continuation rules to take effect tomorrow, November 1, as planned, I thought a post on the continuation rules was more appropriate.  The patent world, and more particularly the patent prosecution world, has been busy analyzing and preparing for the new continuation rules for several months.  For analysis of the new rules check out the Maryland Intellectual Property Law Blog (click here and here) and the 271 Patent Blog (click here).

While most were just probing the rules for loopholes or preparing to comply with them, two also filed suits in the Eastern District of Virginia seeking to enjoin enactment of the new rules -- Triantafyllos Tafas v. Dudas, No. 07 C 846 (E.D. Va.) and SmithKline Beecham Corp./GSK v. Dudas, No 07 C 1008.  Click here for Patent Docs' excellent coverage of the SmithKline/GSK suit.

The two suits were consolidated and a preliminary injunction hearing has been set for today -- click here and here to download the briefs at Patently-O.  Numerous entities have taken sides, filing amicus briefs -- click here for a list of the briefs and links to some of them at the PLI Patent Practice Center Blog.  And for those of you who cannot wait to read the result here shortly after it comes out and who are not busy with legal work or preparing for tonight's trick or treating, click here for the PLI Patent Practice Center Blog's live blogging coverage of the PI hearing.

Update:  Click here for more coverage of the Eastern District of VIrginia cases by the WSJ Law Blog and click here for even more briefing from Patently-O.

Happy Halloween.

Federal Circuit Further Defines Ordinary Observer Test

Arminak & Assocs., Inc. v. Saint-Gobain Calmar, Inc., No. 06-1561, Slip Op. (Fed. Cir. Sept. 12, 2007) (Holderman, C.J., sitting by designation.).*

On behalf of Chief Judge Michel and Judge Gajarsa, the Northern District’s Chief Judge Holderman affirmed C.D. California’s holding that declaratory judgment plaintiffs’ (“Arminak”) “AA Trigger” shroud design for a spray bottle did not infringe declaratory judgment defendant’s (“Calmar”) design patents covering certain design elements of shrouds. The main issue, and one of first impression, was whether the “ordinary observer” for purposes of design patent infringement should be the end-user/purchaser of spray bottles or the industrial purchaser that buys triggers or shrouds for assembly into a finished spray bottle product. The district court held that the ordinary observer was the industrial purchaser and the evidence clearly established that industrial purchasers would not be confused by similarities between Arminak’s and Calmar’s patented shrouds. Calmar argued, however, that the Supreme Court in Gorham Mfg. Co. v. White, 81 U.S. 511 (1871), expressly excluded experts from being ordinary observers and that, therefore, retail purchasers had to be the ordinary observer. But the Federal Circuit noted that did not sell shrouds or fully assembled spray bottles including their respective shrouds to retail purchasers. The parties sell shrouds to industrial purchasers. Industrial purchasers, therefore, are the appropriate population of ordinary observers. The ordinary observer is:

A person who is either a purchaser or, or sufficiently interested in, the item that displays the patented designs and who has the capability of making a reasonably discerning decision when observing the accused item’s design whether the accused item is substantially the same as the item claimed in the design patent.

* This is not an appeal from the Northern District, but I am covering it because Chief Judge Holderman authored the Opinion. Thanks to Dennis Crouch at Patently-O for bringing the case to my attention.

Patents -- Profit or Cost Centers?

Two patent professors, James Bessen and Michael Muerer, have published portions of their upcoming book, Innovation at Risk, online.  The book promises an empirical study showing that the current patent system discourages innovation and suggesting ways to fix the system, presumably to encourage innovation.  The suggested fixes are not fully described online yet, but some of the empirical basis for the problem is and it is generating a fair amount of conversation -- see the New York Times, Wired, Patently-O and Wired GC, for example.  The authors say they have analyzed emperical patent litigation data from 1974 until 1999 (the last for which information was fully available).  Their numbers show that profits/damages from pharmaceutical and chemical patent litigation have generally increased as patent litigation costs have increased and maintained a substantial profit margin -- in 1999, patent litiation resulted in worldwide profits of over $12B (in 1992 USD) with US litigation costs of just over $4B (in 1992 USD).  For all other technology areas, however, patent litigation profits/damages have remained relatively flat while patent litigation costs have increased substantially -- profits have hovered around $2-3B per year (in 1992 USD) while costs have gone from a little more than $2B in 1994 to almost $12B in 1999.

These numbers could be terrifying to a casual reader, and they fit nicely with the current Patent Reform Act efforts in Congress.  But I suspect that much of the increased patent litigation costs come from companies that are bringing questionable cases based upon inflated damages theories or refusing to settle infringement cases against them despite the fact that the facts do not support their case.  One of the most important skills in patent litigation is self-reflection.  You have to be able to take a step back and review your case with a disinterested eye to truly determine your strengths and weaknesses.  An outside counsel who has the ability and the courage to do that for a company is an invaluable asset, who will likely save you far more than he or she will ever cost the company in legal fees.

Federal Circuit Agrees With the Northern District: Preliminary Injunction Holdings Are Not Preclusive

Abbott Labs. v. Andrx Pharm., Inc., No. 06-1101, __ F.3d __ (Fed. Cir. 2007).

While this is not a Northern District case, it is relevant to the Blog because it is an appeal of a Northern District case and because it confirms Judge Coar's ruling (discussed here) that a preliminary injunction holding lacked preclusive effect in the related case Abbott Labs. v. Sandoz, Inc., No. 05 C 5373, 2006 WL 3718025 (N.D. Ill. Dec. 15, 2006).  In this patent dispute plaintiff, Abbott Laboratories ("Abbott"), alleged that defendant's, Andrx Pharmacueticals ("Andrx") sale of a generic form of Abbott's patented extended release antibiotic (clarithromycin, an erythromycin derivative) which Abbott markets as Biaxin XL.  The Northern District held that Abbott had established a likelihood of success on the merits of its infringement claim and that Andrx had not established a likelihood that the patent would be held invalid.  As a result of those holdings, the Northern District issued a preliminary injunction.  In its appeal, Andrx argued that Abbott was precluded from obtaining a preliminary injunction because the Federal Circuit overturned a previous Northern District preliminary injunction for Abbott against another generic antibiotic producer Teva Pharmaceuticals ("Teva").  In that case, the Federal Circuit held that Teva raised a substantial question as to the validity of the claims at issue, sufficient to call Abbott's likelihood of success on the merits into question. 

The Federal Circuit, applying Seventh Circuit law, held that preliminary injunctions would be given preclusive effect only in the "rare instances" that the injunction raised an "insuperable obstacle" to plaintiff's success on the merits.  Because the Court did not find an insuperable obstacle to Abbott's success on the merits, the denial of a preliminary injunction against Teva had no preclusive effect in this case.  As a result, the Federal Circuit upheld the Northern District's preliminary injunction.

The Federal Circuit's reasoning appears to square with Judge Coar's reasoning in the Sandoz case.  In Sandoz, the Court held that preliminary relief holdings have no preclusive effect because they are made on an incomplete record, "inherently tentative" and based upon only "an estimate of the likelihood of success."  Despite the fact that the Federal Circuit's denial of the preliminary injunction lacked preclusive effect, however, the Court ultimately refused to reach a holding inconsistent with the Federal Circuit's without a "substantial showing" on a more complete record.  So, although the Court denied the TRO, it appeared to remain open to a preliminary injunction based upon a more complete record.

You can find more on the Federal Circuit's Andrx case at Patently-O and the Patent Docs.