10/30. The Supreme Court denied certiorari in Ferring B.V. v. Barr Laboratories, a pharmaceutical patent case involving the inequitable conduct doctrine. See, Order List [15 pages in PDF].

This lets stand the February 15, 2006, opinion [46 pages in PDF] of the U.S. Court of Appeals (FedCir) which held that a patent enforceable for inequitable conduct.

The Supreme Court wrote in its order that "The motion of Biotechnology Industry Organization for leave to file a brief as amicus curiae is granted. The motion of Pharmaceutical Research and Manufacturers of America for leave to file a brief as amicus curiae is granted. The motion of Washington Legal Foundation for leave to file a brief as amicus curiae is granted. The petition for a writ of certiorari is denied."

The Supreme Court might grant certiorari in another similar case in the future.

Ferring B.V. and Aventis Pharmaceuticals, Inc. filed a complaint in U.S. District Court (SDNY) against Barr Laboratories, Inc. alleging infringement of Ferring's U.S. Patent No. 5,407,398. The District Court granted summary judgment to Barr on the grounds that the patent is unenforceable due to inequitable conduct, and secondly, noninfringement.

The Court of Appeals affirmed on the grounds of inequitable conduct, and did not reach the infringement issue.

The majority wrote that "Inequitable conduct occurs when a patentee breaches his or her duty to the PTO of `candor, good faith, and honesty.´" It added that it includes both affirmative misrepresentations of material facts and failure to disclose material information.

The majority wrote also, quoting from earlier opinions, that "The inequitable conduct analysis is performed in two steps comprising `first, a determination of whether the withheld reference meets a threshold level of materiality and intent to mislead, and second, a weighing of the materiality and intent in light of all the circumstances to determine whether the applicant's conduct is so culpable that the patent should be held unenforceable.´" (Emphasis in original.)

The majority concluded that supporting declarations submitted in support of the application to the USPTO failed to disclose prior relationships between the declarations, that this was material, and that this was intentional.

Judge Pauline Newman wrote a long dissent. She wrote that "``Inequitable conduct´´ in patent practice means misconduct by the patent applicant in dealings with the patent examiner, whereby the applicant or its attorney is found to have engaged in practices intended to deceive or mislead the examiner into granting the patent. It is a serious charge, and the effect is that an otherwise valid and invariably valuable patent is rendered unenforceable, for the charge arises only as a defense to patent infringement."

She continued that "My colleagues, endorsing several novel and unsupportable presumptions of wrongdoing, do injury to the reasonable practice of patent solicitation, even as they defy the rules of summary judgment."

"This is not hyperbole", wrote Newman. "Practitioners from an earlier era well recall the adverse impact on industrial innovation when patents were not a reliable support for commercial investment, based in part on the judicial belief that patents and their practice were seriously flawed. With invalidation of most of the patents that reached the courthouse, the contribution of a diminished patent incentive to the weakening of technology-based investment was a serious national concern, and the impact on the nation's commercial vigor was recognized by government as well as by the industrial and scientific communities."

She wrote that the Federal Circuit was created, in part, to deal with this problem, but now, the majority "on this panel have regressed to that benighted era".

She elaborated that the majority restores "a casually subjective standard, they also impose a positive inference of wrongdoing, replacing the need for evidence with a ``should have known´´ standard of materiality, from which deceptive intent is inferred, even in the total absence of evidence. Thus the panel majority infers material misrepresentation, infers malevolent intent, presumes inequitable conduct, and wipes out a valuable property right, all on summary judgment, on the theory that the inventor ``should have known´´ that something might be deemed material. The panel majority, steeped in adverse inferences, holds that good faith is irrelevant and presumes bad faith. Thus the court resurrects the plague of the past".

Amicus Briefs. The Supreme Court received several amicus briefs. See, amicus brief [27 pages in PDF] of the Washington Legal Foundation (WLF), amicus brief [PDF] of the Biotechnology Industry Organization (BIO), and amicus brief of the Pharmaceutical Research and Manufacturers of America urging the Supreme Court to grant certiorari and reverse.

For example, the BIO wrote that "The decision in Ferring highlights, in dramatic fashion, the unjustifiably low standards for materiality and intent that some panels of the Federal Circuit now apply in an inequitable conduct determination. The court below ruled that an important biotech patent was unenforceable based on omissions in declarations about prior relationships that had no bearing on the validity of the patent or the scientific accuracy of the declarants' testimony. The decision provides no limits on the standard for materiality of information that should be supplied to avoid a finding of inequitable conduct and it infers intent to deceive based on omission alone. The panel decision goes to far and, if permitted to stand, makes the patent application process unpredictable and more costly, and will make the unenforceability of otherwise valid patents uniformly suspect. This is particularly true for the biotechnology industry which suffers from disproportionate levels of patent attacks claiming inequitable conduct."

This case is Ferring B.V. et al. v. Barr Laboratories, Inc., Sup. Ct. No. 06-372, a petition for writ of certiorari to the U.S. Court of Appeals for the Federal Circuit. The Court of Appeals case is App. Ct. No. 05-1284. It heard an appeal from the U.S. District Court for the Southern District of New York.

10/30. Thomas Barnett, Assistant Attorney General in charge of the Department of Justice's (DOJ) Antitrust Division, sent a letter to legal counsel for the VMEbus International Trade Association (VITA) stating that the DOJ will not oppose a proposal by the VITA to implement a policy on the disclosure and licensing of patents.

Barnett (at right) wrote that the VITA's policy "should preserve, not restrict, competition among patent holders".

The DOJ stated in a release that "The policy requires the disclosure of essential patents, commitments to license essential patent claims on fair, reasonable, and non-discriminatory terms, and declarations of the most restrictive licensing terms that patent holders will require."

The letter states that "VITA is comprised of developers, vendors, and users of real-time modular embedded computing systems originally based on the VMEbus computer architecture. This architecture enables engineers to design application-specific computer systems that can be embedded in a wide range of high-performance and mission critical systems such as ultrasound and magnetic resonance imaging machines, semiconductor manufacturing equipment, and industrial control equipment." (Footnote omitted.)

The DOJ release adds that "VITA requested a business review letter from the Antitrust Division expressing its enforcement intentions regarding a proposed patent policy that will impose two requirements on holders of essential patents who participate in VSO standard-setting activities. First, the policy requires that patent holders make early disclosures of patents and patent applications that may be essential to implementing VITA standards once they are adopted. Second, the policy requires that patent holders declare the maximum royalty rate and most restrictive non-price licensing terms they will require from those who must take a patent license in order to implement the eventual VITA standard. These declarations are irrevocable, but patent holders may submit subsequent declarations with less restrictive licensing terms."

This DOJ business review letter was sent to Robert Skitol, of the Washington DC office of the law firm of Drinker Biddle & Reath, the VITA's counsel.

10/27. Robert Kimmitt, Treasury Deputy Secretary, gave a speech in Washington DC regarding the Committee on Foreign Investment in the United States (CFIUS).

He said that "The free flow of capital in open and competitive markets contributes directly to higher productivity growth and efficiency. When capital is free to flow in response to market demand, it is channeled into its most efficient uses." But, he added, "Our open investment policy has always recognized the need to protect the national security".

He continued that "Some countries attempted to thwart takeovers of perceived ``national champions,´´ while other countries raised concerns about the free movement of labor and capital. In the United States, a small number of high-profile transactions sparked a debate in Washington about foreign investment in the United States."

He also argued that notwithstanding the Dubai Ports World case, "we are open for investment". He added that "we must avoid the trap of creeping protectionism".

He continued that the U.S. "intends to lead by example. We must preserve the careful balance between open investment and national security. We know that if we do not preserve this balance, we can expect reciprocal actions from our partners. Already, we can see troubling signs of other nations moving toward protectionist intervention in foreign investment."

He cited four examples. First, "In August, China issued draft regulations governing M&A of domestic Chinese enterprises, reviewing foreign investments in terms of their impact on "economic security."

Second, "Russia justified a proposal to protect 39 industries from foreign control based on what it viewed as U.S. actions in the CFIUS process."

Third, "Mexico's Senate has passed a restrictive investment bill". Finally, "India is considering its own system of investment controls that may cause high hurdles to investment."

10/31. The Progress and Freedom Foundation (PFF) released a short paper titled "A Democratic Voice of Caution on Network Neutrality". The author is Alfred Kahn, who, as former President Jimmy Carter's Chairman of the Civil Aeronautics Board, deregulated the airline industry.

Kahn noted that "The advocates of network neutrality have become distressingly, stridently apocalyptic, rallying all good liberals against" broadband service providers. He asked rhetorically, "Why all the hysteria?"

He argued that "There is nothing ``liberal´´ about the government rushing in to regulate these wonderfully promising turbulent developments. Liberals of both 18th and 20th -- and I hope 21st -- century varieties should and will put their trust in competition, reinforced by the antitrust laws -- and direct regulation only when those institutions prove inadequate to protect the public."

He wrote that "competition is a far better protector of the interest of both consumers and content providers (think radio, television, motion pictures and, now, the Internet) than government ownership or regulation. In telecommunications, cable and telephone companies compete increasingly with one another, and while the two largest wireless companies, Cingular and Verizon, are affiliated with AT&T and Verizon, respectively, some 97 percent of the population has at least a third one competing for their business as well; and Sprint and Intel have recently announced their plan to spend 3 billion dollars on mobile Wi-Max facilities nationwide. Scores of municipalities led by Philadelphia and San Francisco, are building their own Wi-Fi networks. And on the horizon are the electric companies, already beginning to use their ubiquitous power lines to offer broadband--to providers of content, on the one side, and consumers, on the other."

He wrote that if any discrimination occurs, such as in the Madison River Communications case, either the Federal Communications Commission (FCC) or antitrust regulators will stop it.

The House will not meet. It may return from it elections recess on Monday, November 13, 2006. The adjournment resolution, HConRes 483, provides for returning on Thursday, November 9, at 2:00 PM.

The Senate will not meet. See, HConRes 483.

8:30 AM - 1:00 PM. The Department of Health and Human Services' (DHHS) advisory committee titled "American Health Information Community" will meet. The agenda includes a discussion of the Health Information Technology Standards Panel's standards recommendations. See, notice in the Federal Register, October 12, 2006, Vol. 71, No. 197, at Page 60152. Location: Conference Room 800, Humphrey Building, 200 Independence Ave., SW.

10:00 AM - 5:00 PM. The National Science Foundation's (NSF) Advisory Committee for Cyberinfrastructure will meet. See, notice in the Federal Register, October 17, 2006, Vol. 71, No. 200, at Page 61073. Location: NSF, 4201 Wilson Blvd., Room 375, Arlington, VA.

12:15 - 1:45 PM. The Federal Communications Bar Association's (FCBA) Young Lawyers Committee will a brown bag lunch for the volunteers for the FCBA's November 16 auction. For more information, contact fcbavolunteers06 at gmail dot com, Josh Turner at jturner at wrf dot com or 202-719-4807, Katrina Gleber at kgleber at lsl-law dot com or 202-416-1093, or Christina Langlois at clanglois at nualumni dot com or 703-597-2265. Location: Wiley Rein & Fielding, 1776 K Street, NW.

9:30 AM. The U.S. Court of Appeals (DCCir) will hold an en banc rehearing in Rep. John Boehner v. Rep. Jim McDermott, App. Ct. No. 04-7203. See, March 28, 2006, opinion [23 pages in PDF] of the three judge panel of the Court of Appeals, and story titled "Court of Appeals Holds that Rep. McDermott Violated Wiretap Act" in TLJ Daily E-Mail Alert No. 1,339, March 30, 2006. Location: Courtroom 20, 333 Constitution Ave., NW.

9:30 AM - 1:00 PM. The Department of Justice's (DOJ) Antitrust Division and the Federal Trade Commission (FTC) will hold another of their series of hearings on single-firm conduct. This hearing will address tying. The speakers will be David Evans (Vice Chairman of LECG Europe), Robin Feldman (Hastings College of the Law), Mark Popofsky (Kaye Scholer), Donald Russell (Robbins Russell), Michael Waldman (Cornell University), Robert Willig (Princeton University). See, notice. Location: Room 432, FTC Headquarters Building, 600 Pennsylvania Ave.,  NW.

8:00 AM - 2:00 PM. The National Science Foundation's (NSF) Advisory Committee for Cyberinfrastructure will meet. See, notice in the Federal Register, October 17, 2006, Vol. 71, No. 200, at Page 61073. Location: NSF, 4201 Wilson Blvd., Room 375, Arlington, VA.

9:00 AM - 5:00 PM. The Federal Communications Bar Association (FCBA) will host a program titled "Communications Law 101". See, registration form [PDF]. Prices vary. Location: Wiley Rein & Fielding, 1776 K St., NW.

12:00 NOON - 3:00 PM. The DC Bar Association will host a panel discussion titled "DR-CAFTA: The United States-Dominican Republic-Central America Free Trade Agreement A Roundtable with the Ambassadors". The price to attend ranges from $15 to $40. For more information, call 202-626-3463. See, notice. Arnold & Porter, 555 12th Street, NW.

5:30 - 7:30 PM. The Federal Communications Bar Association's (FCBA) Young Lawyers Committee will host an event titled "Comm Law 101 Happy Hour". For more information, contact Chris Fedeli at cfedeli at crblaw dot com or 202-828-9874, or Natalie Roisman at nroisman at akingump dot com or 202-887-4493. Location: Restaurant Kolumbia, 1801 K St, NW.

8:00 - 10:00 AM. The Software & Information Industry Association (SIIA) will host an event titled "Federal Enterprise Architecture: Key Strategies Government Agencies Need to Implement for Aligning IT Operations to Accelerate Business Performance". See, notice. Location: Morrison & Foerster, Suite 5500, 2000 Pennsylvania Ave., NW.

8:30 AM - 4:00 PM. The Department of Justice's (DOJ) Global Justice Information Sharing Initiative Federal Advisory Committee will meet. The deadline to register is October 26, 2006. See, notice in the Federal Register, October 26, 2006, Vol. 71, No. 204, at Page 62122. Location: Embassy Suites Hotel, 900 10th Street NW.

9:00 AM - 5:30 PM. The Information Technology Association of America (ITAA) will host a conference titled "Information Security in the Federal Enterprise". Karen Evans (OMB) will be the keynote speaker. The price to attend ranges from free to $400. See, notice and agenda [PDF]. For more information, contact Patti Coen at pcoen at itaa dot org. Location: Computer Services Corporation (CSC), Executive Briefing Center, 3170 Fairview Park Drive, Falls Church, VA.

12:00 NOON - 2:00 PM. The Federal Communications Bar Association's (FCBA) International Telecommunications Committee will host a brown bag lunch titled "VoIP and Broadband Developments in Europe and Asia". The speakers will be Mark Del Bianco (Law Office of Mark Del Bianco), Christian Dippon (NERA Economic Consulting), Peter Waters (Gilbert+Tobin and Arculli Fong & Ng), Karl Weaver (Newport Technologies), and Jean-marc Escalettes (France Telecom Long Distance USA). RSVP by October 30 to Jennifer Ullman at jennifer dot ullman at verizon dot com or 202-515-2432. Location: Skadden Arps, 11th Floor, 1440 New York Ave., NW.

12:00 NOON - 2:00 PM. The DC Bar Association will host a panel discussion titled "Korea-U.S. Free Trade Agreement -- Negotiations Update". The speakers will include Wendy Cutler (chief U.S. negotiator for the Korea US FTA), Seok-young Choi (Minister of Economic Affairs, Embassy of the Republic of Korea), Demetrios Marantis (International Trade Counsel, Democratic Staff, Senate Finance Committee), Myron Brilliant (U.S.-Korea Business Council), and Mary Patricia Michel (McKenna Long & Aldridge). The price to attend ranges from $5 to $25. For more information, call 202-626-3463. See, notice. Location: D.C. Bar Conference Center, 1250 H Street NW, B-1 Level.

9:00 AM - 4:00 PM. The Federal Communications Commission's (FCC) Consumer Advisory Committee will meet. See, notice in the Federal Register, October 18, 2006, Vol. 71, No. 201, Page 61470-61471. Location: FCC, 445 12th Street, SW.

9:30 AM. The Federal Communications Commission (FCC) may hold a meeting. See, agenda [PDF]. The event will be webcast by the FCC. Location: FCC, 445 12th Street, SW, Room TW-C05 (Commission Meeting Room).

9:30 - 11:30 AM. The Department of State's (DOS) International Telecommunication Advisory Committee (ITAC) will meet to discuss the upcoming meeting of the ITU Radiocommunication Sector's Conference Preparatory Meeting (CPM) for the 2007 World Radiocommunication Conference, to be held on February 19 through March 2, 2007 in Geneva, Switzerland. See, notice in the Federal Register, October 10, 2006, Vol. 71, No. 195, at Page 59580. Location: Boeing Company, 1200 Wilson Blvd., Arlington, VA.

EXTENDED TO DECEMBER 4. Deadline to submit comments to the Department of Commerce's (DOC) Bureau of Industry and Security (BIS) regarding its proposed changes to its Export Administration Regulations (EAR) pertaining to exports and reexports of dual-use items to the People's Republic of China (PRC). Dual use items include certain encryption products, information security products, fiber optic products, computers, and software. See, notice in the Federal Register, July 6, 2006, Vol. 71, No. 129, at Pages 38313-38321. See, notice of extension in the Federal Register, October 19, 2006, Vol. 71, No. 202, at Page 61692.

Day one of a four day a partially closed conference hosted by the Federal Trade Commission (FTC) titled "Protecting Consumers in the Next Tech-ade". The topics to be addressed include "The Changing Nature of Consumer Products, Mobile Devices and Marketing, Data Security and Privacy, Convergence, The Evolving Internet, Payment Systems and Trends, Advertising and Marketing Trends, and Demographic Shifts". The November 9 session is closed to the public. See, notice and conference web site. Location: George Washington University, Lisner Auditorium, 730 21st Street, NW.

Election Day.

2:00 PM. The U.S. Court of Appeals (FedCir) will hear oral argument in Plumtree Software v. Datamize, App. Ct. No. 06-1017, an appeal from the U.S. District Court (NDCal). Location: Courtroom 201, 717 Madison Place, NW.

2:00 PM. The U.S. Court of Appeals (FedCir) will hear oral argument in Thompson v. Microsoft, App. Ct. No. 06-1073. Location: Courtroom 203, 717 Madison Place, NW.

2:00 PM. The U.S. Court of Appeals (FedCir) will hear oral argument in Missiontrek v. Onfolio, App. Ct. No. 06-1271, an appeal from the Trademark Trial and Appeal Board (TTAB). Location: Courtroom 203, 717 Madison Place, NW.

Day two of a four day a partially closed conference hosted by the Federal Trade Commission (FTC) titled "Protecting Consumers in the Next Tech-ade". The topics to be addressed include "The Changing Nature of Consumer Products, Mobile Devices and Marketing, Data Security and Privacy, Convergence, The Evolving Internet, Payment Systems and Trends, Advertising and Marketing Trends, and Demographic Shifts". The November 9 session is closed to the public. See, notice and conference web site. Location: George Washington University, Lisner Auditorium, 730 21st Street, NW.

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