Source: https://www.patentdocs.org/2008/10/index.html
Timestamp: 2020-07-11 05:20:47
Document Index: 441471682

Matched Legal Cases: ['§ 1', '§ 119', '§ 1', '§ 119', '§ 111', '§ 120']

Patent Docs: October 2008
USPTO News: PTO Seeks Comments Regarding Maintenance Fees Notice
In a Notice published in the Federal Register (73 Fed. Reg. 47534) on Thursday, October 30, 2008, the U.S. Patent and Trademark Office published its burden and cost analysis for proposed continuing information collection relating to maintenance fee submissions, and requested comments to the proposed collection.
The Office breaks its analysis down into terms of costs associated with "burden hours" (correlating to attorney billable hours) and costs associated with PTO-related fees and surcharges. The PTO estimates the total number of burden hours to be 33,426 hours per year, which incorporates a split of time for tasks performed by attorneys (primarily petitions) and paraprofessionals. Those hours correlate to a total cost of $4,632,630 per year (at $310/hour for associates, $100/hour for paraprofessionals). The PTO estimates the total respondent cost burden relating to PTO-based fees and surcharges to be $614,571,323, which includes costs such as filing fees, surcharges for late payments, petition fees, postage costs, and recordkeeping costs (see, e.g., 37 C.F.R. §§ 1.20(e)-(i); 1.17(g)-(f)). The bulk of this estimate relates to payment of the actual maintenance fees.
In the Notice, the PTO requests submission of comments on: (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents (e.g., the use of automated collection techniques or other forms of information technology). A summary of these comments will form part the request for OMB approval of this information collection and will become a matter of public record.
Comments can be submitted by e-mail to Susan.Fawcett@uspto.gov (Include "0651-0016 Comment" in the subject line of the message); facsimile: 571-273-0112 (to the attention of Susan Fawcett; U.S. mail (addressed to Susan K. Fawcett, Records Officer, Office of the Chief Information Officer, Customer Information Services Group, Public Information Services Division, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450) or by the Federal Rulemaking Portal at http://www.regulations.gov. Comments must be submitted on or before December 29, 2008.
Requests for additional information should be directed to Robert A. Clarke, Director, Office of Patent Legal Administration, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450; by telephone at 571-272-7735; or by e-mail to Robert.Clarke@uspto.gov.
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USPTO News: Patent Prosecution Highway Pilot Program Between U.S. and Danish Patent Offices
In a memorandum dated October 20, 2008, the U.S. Patent and Trademark Office announced that it will expand the patent prosecution highway (PPH) pilot program to include the Danish Patent and Trademark Office (DKPTO). The PPH program becomes effective on November 3, 2008 for a term of one year, and is extendable for another year. The DKPTO becomes the seventh patent office to become a participant with the USPTO in a PPH program (along with Europe, Japan, Canada, Australia, Korea and the U.K.). As with the other PPH programs, the PPH pilot program between the US and DK Patent Offices allows applicants to request accelerated examination in one Office (the "Office of second filing" (OSF)), based on claims that were determined patentable in the other Office (the "Office of first filing" (OFF)). On November 3rd, the DK Patent Office will publish the procedures and requirements for filing a request to participate in the PPH (available here).
The memorandum lists several requirements for U.S. applications to enter the PPH pilot program, including:
(1) The U.. application is:
(a) a Paris Convention application validly claiming priority under 35 U.S.C. § 119(a) and 37 C.F.R. § 1.55 to one or more applications filed in the DKPTO; or validly claims priority under 35 U.S.C. §§ 119(a)/365(a) to a PCT application that contains no priority claims; or
(b) a national stage U.S. application under the PCT, where the PCT application validly claims priority to a DK application; or validly claims priority to a PCT application that contains no priority claims; or contains no priority claims; or
(c) a "bypass" application filed under 35 U.S.C. § 111(a) that validly claims benefit under 35 U.S.C. § 120 to a PCT application that validly claims priority to a DK application; or validly claims priority to a PCT application that contains no priority claims; or contains no priority claims.
(2) The DK application(s) have at least one claim that was determined by the DKPTO to be allowable and Applicant must submit a copy of the allowable claims from the DK application(s), along with an English translation thereof and a statement that the English translation is accurate.
(3) All the claims in the U.S. application must sufficiently correspond or be amended to sufficiently correspond to the allowable claims in the DK application(s).
(5) Applicant must file a request for participation in the PPH pilot program and a petition to make the U.S. application special under the PPH pilot program (sample form PTO/SB/20DK available from the USPTO website on November 3, 2008).
(6) Applicant must submit a copy of all the Office actions relevant to patentability from each of the DK application(s) containing the allowable claims that are the basis for the request, along with English translations thereof, and a statement that the translations are accurate.
(7) Applicant must submit an information disclosure statement (IDS) listing the documents cited by the DK examiner in the DK Office action, unless an IDS citing those references has already been filed in the U.S. application.
Questions concerning the Notice or the PPH program can be directed to Magdalen Greenlief, Office of the Deputy Commissioner for Patent Examination Policy, by phone 571-272-8800 or e-mail: magdalen.greenlief@uspto.gov.
Continue reading "Speak No Evil (Don't Even Hint at It): Declaratory Judgment Jurisprudence After Medimmune" »
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Abbott Laboratories v. Sandoz, Inc. (Fed. Cir. 2008)
The Court of Appeals for the Federal Circuit affirmed grant of a preliminary injunction in Abbott Laboratories v. Sandoz on October 21, and also affirmed the District Court's determination that the patents-in-suit were not rendered unenforceable by inequitable conduct during prosecution (although defendant Sandoz will be able to pursue this defense at trial). In coming to both conclusions, the majority decision illustrated nicely the appellate penchant (and prerogative) of deciding where lines are to be drawn when considering equitable issues.
Abbott's patents-in-suit, U.S. Patent Nos. 6,010,718 and 6,551,616, relate to extended release formulations of clarithromycin, the active ingredient in Abbott's Biaxin® XL product. Abbott filed suit after Sandoz file an ANDA having a Paragraph IV certification that Abbot's patents were invalid or unenforceable.
Claim 1 of the '718 patent is representative:
As are claims 1 and 2 of the '616 patent (which is a continuation-in-part of the '718 patent):
The District Court granted Abbott a preliminary injunction "to preserve the status quo" using the conventional four-factor test: whether there was a "(1) likelihood of success on the merits of the underlying litigation, (2) whether irreparable harm is likely if the injunction is not granted, [considering] (3) the balance of hardships as between the litigants, and (4) factors of the public interest." The Federal Circuit reviewed the grant of preliminary injunction based on an abuse of discretion standard. Sandoz alleged that Abbott's claims were anticipated and/or obvious over several prior art references, which the District Court found were not sufficient to establish that the claims were invalid. An interesting feature of the District Court's analysis was a reconsideration of the obviousness question in view of the Supreme Court's KSR v. Teleflex decision, which came down after the District Court originally considered Sandoz's obviousness contentions.
The question decided by the Federal Circuit was not concerned with the merits per se of the District Court's decision on the substantive question of whether Abbott's claims were anticipated or obvious; the panel found no clear error in the lower Court's factual determinations and no errors of law in its legal conclusions. The Federal Circuit also found no error in the District Court's claim construction or determination that Abbott was likely to establish at trial that Sandoz's product infringed at least one asserted claim of the patents-in-suit. Rather, the question before the Federal Circuit was the extent of the showing sufficient to preclude a district court from granting a preliminary injunction based on the likelihood of success on the merits prong of the four-factor test. This discussion was cast in Section VI of the decision, where Judge Newman was joined in her opinion upholding the injunction by Judge Archer, and from which Judge Gajarsa dissented.
Judge Newman (at left) rejected Sandoz's contention, and the dissent's, that a defendant must merely "[raise] a substantial question concerning either infringement or validity" to render grant of a preliminary injunction to be an abuse of discretion. Rather than being merely a question of whether a defendant could show claims were "vulnerable" to an invalidity challenge, at this stage Judge Newman said that sound precedent made the question whether there was a likelihood of success on the merits. In making this determination, the opinion sets forth what Judge Newman termed "the law governing the grant of a preliminary injunction." This precedent includes Supreme Court, "every regional circuit, and controlling Federal Circuit precedent," including Gillette Co. v. Energizer Holdings, Inc., 405 F.3d 1367 (Fed. Cir. 2005); Ranbaxy Pharmaceuticals., Inc. v. Apotex, Inc., 350 F.3d 1235 (Fed. Cir. 2003); Reebok Int'l Ltd. v. J. Baker, Inc., 32 F.3d 1552 (Fed. Cir. 1994); and Smith Int'l, Inc. v. Hughes Tool Co., 718 F.2d 1573 (Fed. Cir. 1983). The opinion characterized a "substantial question" as "more than a scintilla but less than a preponderance of evidence in support of its side," and further noted that there are also equitable factors that "are of particular significance at a preliminary stage," citing University of Texas v. Camenisch, 451 U.S. 390 (1981), and that a court must consider these factors in addition to whether a defendant has raised a "substantial question." The opinion also cited the Supreme Court's decision in eBay Inc. v. MercExchange, L.L.C., 547 U.S. 388 (2006), that patent cases are not deserving of unique treatment" when courts consider these equitable factors in deciding whether to grant a preliminary injunction.
The opinion then sets forth what the dissent characterizes as "a superfluity of citations" to decisions from all the regional circuits and the Supreme Court in support of it thesis that the "likelihood of success on the merits" is the principal criterion used by district courts in deciding whether to grant a preliminary injunction, and by reviewing courts when deciding whether a lower court has abused its discretion. The opinion specifically cites Hybritech Inc. v. Abbott Laboratories, 849 F.2d 1446 (Fed. Cir. 1988); Roper Corp. v. Litton Systems Inc., 757 F.2d 1266 (Fed. Cir. 1985); Pretty Punch Shoppettes, Inc. v. Hauk, 844 F.2d 782 (Fed. Cir. 1988); Nutrition 21 v. United States, 930 F.2d 867 (Fed. Cir. 1991); and Texas Instruments Inc. v. Tessera, Inc., 231 F.3d 1325 (Fed. Cir. 2000) (as well as another dozen cases) as Federal Circuit precedent in support of the "likelihood of success" standard for preliminary injunctive relief, all of which are in accord with the principles the Supreme Court enunciated in eBay, according to the majority opinion. The opinion contrasts this standard with the adequacy of the "substantial question" standard for averting judgment on the pleadings or summary judgment, citing Christianson v. Colt Industries Operating Corp., 486 U.S. 800 (1988).
The dissent takes the opposite position, and Judge Gajarsa (at right) has a number of Federal Circuit opinions in support of the "substantial question" standard. Like the majority opinion, the dissent focuses on the first prong, the need for a plaintiff patentee to show a likelihood of success on the merits for a court to grant an injunction. Judge Gajarsa opines that the District Court abused its discretion because Sandoz had raised enough of a question on the validity of the patents-in-suit to preclude Abbott from satisfying the "likelihood of success" prong of the preliminary injunction standard. He emphasizes that the burden is on the patentee, in view of the "extraordinary nature of the relief" sought (i.e., an injunction) to establish this prong. However, if a defendant "raises a substantial question concerning either infringement or validity, i.e., asserts an infringement or invalidity defense that the patentee cannot prove 'lacks substantial merit,' the preliminary injunction should not issue," citing Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343 (Fed. Cir. 2001). The dissent bases its argument that a showing by a defendant that claims are "vulnerable" is supported by language from Abbott Labs. v. Andrx Pharms., Inc., 452 F.3d 1331 (Fed. Cir. 2006) (quoting Amazon):
In resisting a preliminary injunction, however, one need not make out a case of actual invalidity. Vulnerability is the issue at the preliminary injunction stages, while validity is the issue at trial. The showing of a substantial question as to invalidity thus requires less proof than the clear and convincing showing necessary to establish invalidity itself.
Judge Gajarsa's point is that the District Court imposed a requirement that Sandoz show, by clear and convincing evidence, that the asserted claims of the patents-in-suit were invalid in order to defeat the grant of a preliminary injunction to Abbott, and that this burden was improper at the preliminary injunction stage. The precedential basis for his contention that Sandoz merely needed to raise a substantial question as to validity includes E.I. du Pont de Nemours & Co. v. MacDermid Printing Solutions, L.L.C., 525 F.3d 1353 (Fed. Cir. 2008); Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361 (Fed. Cir. 1997); Tate Access Floors v. Interface Architectural Res., 279 F.3d 1357 (Fed. Cir. 2002); Erico Int'l Corp. v. Vutec Corp., 516 F.3d 1350 (Fed. Cir. 2008); and PHG Techs., LLC v. St. John Cos., 469 F.3d 1361 (Fed. Cir. 2006). Moreover, Sandoz having established to Judge Gajarsa's satisfaction that its claims were vulnerable to being invalidated on obviousness grounds, the burden was on Abbott to show that Sandoz's invalidity contentions lacked "substantial merit."
The differences in opinion, and copious citation of authority by both the majority and the dissent, perhaps suggest that there is a split in the Federal Circuit's jurisprudence that requires the Court to revisit this question en banc (or for the Supreme Court to weigh in on the quanta of evidence required to uphold vel non the likelihood of success on the merits for preliminary injunctions). It is equally likely, however, that these cases illustrate how courts must balance the evidence presented by each party in making a determination of whether the patentee is likely to succeed on the merits. The majority and dissent each assert different opinions on whether Sandoz's obviousness contentions have merit and raise a "substantial question" of invalidity. For the majority, the deficiencies in Sandoz's evidence lead to the conclusion that Abbott is likely to prevail on the merits, and hence the majority upholds the District Court's grant of a preliminary injunction. The dissent, on the other hand, believes Sandoz's contentions have merit, and that granting a preliminary injunction under these circumstances is an abuse of discretion. The perhaps inevitable consequence of this equitable balancing is that the Federal Circuit applies its "abuse of discretion" standard to questions of whether a district court's grant of a preliminary injunction is upheld or overturned by substituting (or imposing) its judgment for the judgment of the district court. It is reasonable to ask, as it has been asked in other contexts, whether the Federal Circuit's mandate justifies this result, and whether its penchant for so extending its plenary authority is contrary to the behavior and outcome in the other regional circuit courts of appeal. It is also reasonable to ask whether this penchant is precisely the kind of jurisprudence that has so motivated the Supreme Court to review, and reverse, the Federal Circuit so often over the past ten years.
Panel: Circuit Judge Newman, Senior Circuit Judge Archer, and Circuit Judge Gajarsa
Opinion by Circuit Judge Newman; dissenting opinion by Circuit Judge Gajarsa
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ACI ITC Litigation Conference
American Conference Institute (ACI) will be holding its Advanced Forum on ITC Litigation from January 27-28, 2009 in Washington, DC. The conference will offer insights into current trends and issues involved in an ITC action, including:
• The fallout from the decision in Broadcomm v. Qualcomm;
• Drafting the Exclusion Order, and working with enforcement agents to ensure it is carried out;
• Preparing arguments to pass the Domestic Industry test, particularly with the growth of licenses;
• Managing documents, foreign witnesses, and minimizing costs;
• Avoiding redundancy in discovery review and expert witnesses;
• Utilizing a Section 337 action as a means to settling, and in conjunction with, other actions in federal court;
• Weighing the financial benefits and competitive edge vs. extreme cost and time constraints of an ITC action;
• Implementing strategies to prepare for a potential ITC action whether initiating or as a potential respondent;
• Collaborating with multiple parties in a Section 337 action under extreme time constraints;
• Controlling extremely high volumes of discovery responses and overcoming the practical challenges such as foreign translations, multiple copies, database management;
• Devising practices for efficiently working with the United States Customs office and other enforcement organizations; and
• Identifying action plans to successfully work with the ITC courts, commission and counsel’s office.
In particular, ACI's faculty will offer presentations on the following topics on January 27 and 28:
• View from the bench: Honorable Judge Paul J. Luckern;
• View from the ITC Commission: Director of the Office of Unfair Import Investigations, Lynn I. Levine;
• Exploring new and developing challenges in ITC litigation;
• Maximizing relationships with the ITC: Initiating an action, working with the staff, and instituting the best practices for a favorable outcome;
• Broadcom v Qualcomm: Updates of the federal appeal, and the overall status of downstream products;
• Enforcement address: George F. McCray;
• Maximizing your relationship with customs: Securing enforcement and to preparing for subsequent product questions;
• Foreign company case study: Preparing a client for an ITC action, and addressing their questions, fears, and challenges;
• Operating in the eye of the storm: Effective strategies for litigating an ITC action;
• Section 337 litigation business advantages: ITC vs. Federal District Court; and
• Passing the Domestic Industry test with the rise of licensing and trademark cases.
An additional pre-conference workshop entitled: "Drafting an ITC Complaint: Developing Strategies and Composing the Necessary Documents" will be offered on January 26th. In this workshop, ACI faculty will instruct attendees on the essentials of drafting an ITC complaint, to ensure that it provides a concise and formidable argument.
The agenda for the ITC Litigation conference can be found here. A complete brochure for this conference, including an agenda, list of speakers, and registration form can be downloaded here.
The registration fee ranges from $2,195 (conference alone) to $2,795 (conference and workshop). Those registering by November 28, 2008 will receive a $300 discount off the registration fee and those registering by December 26, 2008 will receive a $200 discount off the registration fee. Those interested in registering for the conference can do so here, by calling 888-224-2480, or by faxing a registration form to 877-927-1563.
Patent Docs is a media partner of the Advanced Forum on ITC Litigation.
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