Patent Docs

ACI Maximizing Pharmaceutical Patent Lifecycles Conference

June 20, 2008

American Conference Institute (ACI) will be holding its 9th Annual Maximizing Pharmaceutical Patent Lifecycles conference on October 15-16, 2008 in New York. At the conference, ACI's faculty will offer presentations on the following topics:

• Clarifying the evolving meaning of 'patent life cycle' for the pharmaceutical business;
• Constructing, adjusting, and executing a pharmaceutical patent life cycle management plan;
• View for the FTC;
• Navigating the complexity of structuring patent settlement options between brand name and generic pharmaceutical patent cases;
• Eye on the bench: Identifying judicial trends in pharmaceutical patent cases;
•
Mastering the intricacies of the 180-day generic market exclusivity;
• Penetrating the complexitites of non-patent/FDA exclusivities;
• Plotting a course into safe harbor for branded pharma;
• View from the FDA;
• Slicing through the complex spectrum of declaratory judgment actions in pharmaceutical patent cases; and
• Factoring the role, challenges, and impact of Orange Book listings and de-listings in patent portfolio management.

Attendees can also elect to attend a branded or generic master class on October 17, 2008. The branded master class, entitled: "Overpowering the challenges in increasing the pharmaceutical patent life cycle through patent extensions," will address the following topics:

• Defining the benchmarks in the drug’s development;
• Determining eligibility for patent term extension;
• Mastering the regulatory review period determinations;
• Calculating the patent term restoration;
• Adjusting the patent term because of delays, glitches, and obstacles in prosecuting patents at the USPTO;
• Calculating the effect of patent term extensions outside the U.S.;
• Obtaining extensions through FDA Pediatric Exclusivity and Orphan Drug Exclusivity;
• Measuring the import of second-generation patents; and
• Incorporating non-US filing strategies into the life cycle plan for pharmaceutical patents.

The generic master class, entitled: "Adding value to Paragraph IV certifications and notice letters," will address the following topics:

• Defining the four types of patent certifications;
• Clarifying the obligations of the ANDA applicant;
• Probing the impact of the declaratory judgment and counter claim provisions;
• Applying the 30-month stay effectively;
• Incorporating the benefits, costs, and impact of the 180-day exclusivity;
• When will forfeiture of exclusivity be triggered?
• Forecasting consequences of inadequate notice letters;
• When should disclosure of technical information about the ANDA and proposed generic product occur?
• Identifying exceptional cases where attorney's fees may be awarded; and
• Illuminating the procedural and substantive requirements of Paragraph IV letters.

The agenda for the Maximizing Pharmaceutical Patent Lifecycles Conference 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 for the conference alone is $1,895 (the registration fee for the branded or generic master classes has not yet been set). Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

Patent Docs is a media sponsor of ACI's Maximizing Pharmaceutical Patent Lifecycles Conference conference.
Docs at BIO: Steve Burrill’s State of the Biotechnology Industry Report 2008

June 19, 2008

By Kevin E. Noonan —

Steven Burrill, President and CEO of Burrill & Co., unveiled his company’s "State of the Biotechnology Industry" report on Wednesday at BIO 2008 in San Diego. Mr. Burrill (below) described developments globally that he anticipates will occur by 2020 and how those changes will impact the industry.

Mr. Burrill’s vision is described on the company website as being "furutistic," but he contends these are just extensions of technology and social trends existing in the present day. For example, he believes that medicine will change focus from passively waiting for disease or disability to appear for doctors to treat, to an extensive (and invasive) medical monitoring system, where medical sensors and diagnostics will become part of the daily routine. Rather than having "family doctors," primary medical care in 2020 will be provided by "wellness centers" staffed by nurse practitioners relying on both diagnostic technology and personal medicine. Individuals will carry a card, or have implanted a chip, detailing their personal genetic variations relevant to disease predispositions and drug susceptibilities/sensitivities, and their diagnosis will be determined while they shop in the rest of the store. Serious diseases (heart disease, cancer) will be treated in specialized medical centers by specialist medical doctors and their staff. And on a daily basis the emphasis will be on medical monitoring and surveillance with regard to drug treatment compliance and "lifestyle" choices such as smoking, alcohol consumption and diet.

Mr. Burrill responded to challenges to his vision by noting that the technology for a good deal of his schema already exists, and that current economic conditions favor trending in this direction. He also noted that the current healthcare system will experience extreme financial stressors by as early as 2013, the date where the amount of Medicare revenues from payroll taxes will be exceeded by expect expenditures, and that a great deal of the current and expected costs on the healthcare system are either outright waste or are devoted to aspects of the system (such as administrative and reimbursement costs) that are not directly related to delivering care. Importantly for his audience, he also mentioned that while the majority of Americans believe that drug costs account for 60% of overall healthcare costs in the U.S., the actual number is just 12%, and that this misconception has significant political consequences for the industry (including his acknowledgement that strong trend for generic drugs can be expected to continue if not accelerate).

The other trend Mr. Burrill described is the ascendancy of India and China as centers of research and development in the biotech/pharma industry. Compelled by a growing middle class population and its attendant demands for a "more and better" life, these governments will continue the present trend of supporting development of "home grown" biotech and pharma industries. Finally, he projected that agricultural biotechnology will play an increased role in addressing the world food crisis, but also used the AgBio industry as an example of how the social and political aspects of introducing biotechnology solutions must be addressed for the industry to remain successful.

The complete report can be purchased from Burrill & Co. ($430 + tax); sales at BIO 2008 include a CD-ROM of Mr. Burrill’s presentation slides.
USPTO News: USPTO Announces Proposed Additional Fee Increases for PCT Applications Filed with US/RO

June 19, 2008

By Christopher P. Singer —

As we reported on Tuesday, the Patent Cooperation Treaty (PCT) has published an amended fee schedule for application filings that is due to take effect on July 1, 2008. In a Federal Register Notice that was published on Wednesday, June 18, 2008, the U.S. Patent and Trademark Office will announce its intention to amend 37 C.F.R. § 1.445(a)(1)-(3) to increase the application transmittal fee (to $415 from $300) and the search fee (to $2,225 from $1,800). The fee associated with a supplemental search would also increase to $2,225 from $1,800. These proposed fee increases follow the recent rate hike of November 2007 (FY 2008), where the search and supplemental search fees were increased to $1,800 from $1,000.

In the Notice, the Office argues that these fee increases are being made to merely offset the estimated average costs to the PTO associated with PCT application processing and preparation of international search reports and written opinions. The Notice states that the estimated average cost of PCT application processing "is slightly over $415.00" while search reports and written opinions have an estimated average cost of "slightly over $2,225.00 for each invention." The Notice also clarifies that this fee increase will impact all PCT applicants filing with the U.S. Receiving Office (US/RO) as the PCT does not account for small entity fee discounts.

Any written comments to this Notice must be received on or before 60 days after publication of the Federal Register Notice (June 18, 2008). Comments should be sent by electronic mail message over the Internet addressed to AC28.comments@uspto.gov. While the PTO prefers comments submitted via the internet, comments may also be submitted by mail addressed to: Mail Stop Comments–Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA, 22313-1450, or by facsimile to (571) 273-0459, marked to the attention of Boris Milef, Office of the Deputy Commissioner for Patent Examination Policy. Comments may also be sent by electronic mail message over the Internet via the Federal Rulemaking Portal. Please see the Federal eRulemaking Portal website for additional instructions on providing comments via the Federal eRulemaking Portal.
Meet the Docs at BIO

June 17, 2008

The Biotechnology Industry Organization (BIO) is holding its annual BIO International Convention this week at the San Diego Convention Center. Founded in 1993, BIO is a nonprofit association seeking supportive biotechnology policies on behalf of more than 1,100 biotechnology companies, state and international affiliates, and related organizations, as well as providing business development services for many emerging biotech companies.

As part of the Convention, more than 1,700 biotech companies, organizations, and institutions will participate in the BIO Exhibition. Patent Docs Kevin Noonan, Donald Zuhn, and Sherri Oslick will also be attending BIO as part of the MBHB contingent. Patent Docs readers who may be attending BIO this week are encouraged to stop by booth #4320 to meet the Docs and talk a little biotech patent law.
Changes to PCT Filing Fees

June 17, 2008

By Christopher P. Singer —

The Patent Cooperation Treaty (PCT) recently published a Notification (No. 189) describing an amended fee schedule which will take effect on July 1, 2008. The new fee schedule modifies the international filing fee as well as the fee reductions for applicants who file electronically. The new international filing fee is set at 1,330 Swiss francs (CHF), which represents a 5% decrease from the current fee of 1,400 CHF. The supplemental "excess pages" fee for applications over 30 pages in length will remain at 15 CHF for each page over 30. The handling fee associated with the international preliminary examination remains at 200 CHF. In addition, the fees will be discounted by 90% (further reduced from 75%) for applicants of certain States (listed here).

Unfortunately, thanks to the weakening of the dollar, the news is not so good for applicants paying fees in U.S. dollars, as the equivalent filing fee will be $1,338 (up from the current fee of $1,263). In addition, the supplemental fee for each page above 30 will increase from $14 to $15. Consequently, the fee for sequence listings filed in compliance with PCT Administrative Instruction section 801 (electronic medium only) will similarly increase by $400 to $6000 (this fee is set at 400 times the supplemental page fee). Further, the handling fee is likely to increase to $201 (up from $171). On a positive note, the reduction in fees for E-filing a PCT application with the US/RO will be further reduced by about 10% from the current schedule.
What the Director’s Letter Didn’t Say

June 15, 2008

By Kevin E. Noonan —

As reported by Patent Docs last week, U.S. Patent and Trademark Office Director Jon Dudas (at right) responded to Congressman Howard Berman’s (D-CA) April letter posing a number of questions raised by Director Dudas’ February testimony before the House Subcommittee on Courts, the Internet and Intellectual Property. Last week’s report recounted the Director’s answers to a number of those questions, including patent application pendency, deferred examination, and Patent Office reorganization efforts.

Director Dudas’ letter also addressed the most explosive question (allegation) in Congressman Berman’s letter: whether senior Patent Office officials, including Director Dudas himself, had acted improperly by meeting with Research in Motion (RIM) regarding re-examination of NTP’s patents during the RIM v. NTP litigation. Director Dudas maintained that there was no impropriety:

Research in Motion (RIM) requested a meeting to discuss whether the United States would participate as amicus curiae in support of a petition for rehearing that RIM was pursuing in the Court of Appeals for the Federal Circuit. The Department of Commerce, led by then-Acting General Counsel Jane Dana, held a meeting on this subject. In attendance were Ms. Dana, Joan Maginnis, Assistant General Counsel for Finance and Litigation of the Department of Commerce, members of the Appellate staff of the Civil Division of the Department of Justice, and Mr. Toupin and John Whealan, Deputy General Counsel for Intellectual Property and Solicitor, from the USPTO. A member of the Commercial Litigation Branch of the Civil Division of the Department of Justice also participated by phone.

The subject of discussion was RIM’S request that the United States support its position in the Court of Appeals for the Federal Circuit that patent infringement not be found when alleged infringement includes acts outside the United States. Citing the USPTO’s policy of not discussing any aspect of a pending USPTO reexamination, Ms. Dana and all other government representatives in attendance refused to discuss or listen to statements, questions, or arguments regarding any matter pending in reexamination. The government did not make the amicus filing that RIM requested.

As stated, the USPTO’s policy prohibits ex parte communications that directly relate to matters pending on reexaminations. This policy does not prohibit contacts with anyone with respect to matters that are not at issue in proceedings before the USPTO. Thus, for example, the USPTO officials regularly meet with patentees and members of the patent bar, even though those parties may be pursuing matters before the Office. In such conversations, consistent with the policy followed during the meeting with RIM representatives, its officials do not discuss particular matters pending before the Office.

While reassuring, this answer does not fully address the allegations, which include that the Office took actions at times calculated to influence the litigation:

• NTP alleged not one meeting, but a series of ex parte meetings with RIM representatives. These allegations were supported by an affidavit from Kevin P. Anderson relating information obtained under Freedom of Information Act requests.

• Documents released under FOIA contain unexplained redactions not accompanied by a claim of privilege (executive, no doubt).

• PTO staff prepared synopses of the reexamination and the patent infringement action for the Director prior to the meeting with RIM representatives (and it is not clear why this would be necessary if all that was discussed was participation in an amicus brief.)

• PTO actions were motivated by political pressure from Congress (whose Blackberry accounts were jeopardized by the litigation), including issuing a reexamination timeline as a result of an improper (according to NTP) request from the Canadian government. This timeline was sent to RIM, but not NTP, prior to a court hearing on whether the damages phase of the litgation should be stayed, and RIM used it to sandbag NTP on the morning of the hearing. (Amazingly, NTP presented evidence that the PTO was working to prepare the timeline before the Canadian government request, allegedly because of ex parte communications between "senior Patent Office officials" and RIM.)

• NTP alleges (and presents evidence in support of its allegations) that RIM had the Office comment not on an amicus brief, but on its brief asking the court not to impose an injunction.

• The PTO issued a 121-page rejection just five business days, and nine calendar days, after NTP responded to an Office Action (resulting in the Action being issued prior to a hearing in the litigation on whether the court would grant NTP an injunction that would have shut down RIM’s business in the U.S.).

And Director Dudas’ answer also expands the scope of the individuals who are now known to have participated in these meetings. Given the penchant for this Congress to exercise oversight sorely lacking during the first six years of this administration, the primary effect of Director Dudas’ answer may be in creating a list of the individuals the committee will subpoena to testify about these meetings, and to give answers to the remaining questions.

For additional information regarding this topic, please see:

• "Director Answers House Subcommittee’s Questions," June 12, 2008
Court Report

June 15, 2008

By Sherri Oslick —

About
Court Report: Each week we will report briefly on recently filed
biotech and pharma cases, and a few interesting cases will be selected
for periodic monitoring.

Sepracor Inc. et al. v. Sandoz, Inc.
4:08-cv-00089; filed June 12, 2008 in the Eastern District of North Carolina

Infringement of U.S. Patent No. 5,698,558 ("Methods for Treating Allergic Disorders Using Optically Pure (-)Cetirizine," issued December 16, 1997), licensed to UCB, following a paragraph IV certification as part of Sandoz’s filing of an ANDA to manufacture a generic version of UCB’s XYZAL® (levocetirizine dihydrochloride, used to treat seasonal and perennial allergic rhinitis). View the complaint here.

Nycomed GmbH et al. v. Teva Pharmaceuticals USA, Inc. et al.
2:08-cv-02877; filed June 11, 2008 in the District Court of New Jersey

Infringement of U.S. Patent No. 4,758,579 ("Fluoroalkoxy Substituted Benzimidazoles Useful as Gastric Acid Secretion Inhibitors," issued July 19, 1988), licensed to Wyeth, following a paragraph IV certification as part of Teva’s filing of an ANDA to manufacture a generic version of Wyeth’s PROTONIX I.V. (pantoprazole sodium injection, used to treat gastroesophageal reflux disease). View the complaint here.

Takeda Pharmaceutical Co. Ltd. et al. v. Barr Pharmaceuticals Inc. et al.
1:08-cv-00339; filed June 9, 2008 in the District Court of Delaware

Infringement of U.S. Patent Nos. 5,464,632 ("Rapidly Disintegratable Multiparticular Tablet," issued December 7, 1995) and 6,328,994 ("Orally Disintegrable Tablets," issued December 11, 2001) following a paragraph IV certification as part of Barr’s filing of an ANDA to manufacture a generic version of plaintiff’s Prevacid® SoluTab (lansoprazole delayed release orally disintegrating tablets, used to treat ulcers, gastroesophageal reflux disease, erosive esophagitis, and pathological hypersecretory conditions, including Zollinger-Ellison syndrome). View the complaint here.

Ethypharm S.A. v. Barr Laboratories Inc. et al.
1:08-cv-00344; filed June 9, 2008 in the District Court of Delaware

Infringement of U.S. Patent No. 5,464,632 ("Rapidly Disintegratable Multiparticular Tablet," issued December 7, 1995), licensed to Takeda, following a paragraph IV certification as part of Barr’s filing of an ANDA to manufacture a generic version of Takeda’s Prevacid® SoluTab (lansoprazole delayed release orally disintegrating tablets, used to treat ulcers, gastroesophageal reflux disease, erosive esophagitis, and pathological hypersecretory conditions, including Zollinger-Ellison syndrome). View the complaint here.

Janssen, L.P. et al. v. Sandoz, Inc.
3:08-cv-02892; filed June 9, 2008 in the District Court of New Jersey

Infringement of U.S. Patent No. 7,160,559 ("Controlled Release Galantamine Composition," issued January 9, 2007) following a paragraph IV certification as part of Sandoz’s filing of an ANDA to manufacture a generic version of Janssen’s Razadyne ER® (formerly Reminyl®) (galantamine hydrobromide, used to treat mild to moderate dementia of the Alzheimer’s type). View the complaint here.

Cytologic, Inc., et al. v. Biopheresis Gmbh et al.
1:08-cv-00978; filed June 6, 2008 in the District Court of the District of Columbia

Review of the decision of the Board of Patent Appeals and Interferences awarding priority of invention to Biopheresis in the interference between U.S. Patent No. 6,379,708 ("Method for Enhancing Immune Responses in Mammals," issued April 30, 2002), assigned to Cytologic and Colorado State University Research Foundation, and U.S. Patent Application No. 09/709,045 ("Method and System to Remove Cytokine Inhibitor in Patients," filed November 10, 2000), assigned to Biopheresis. View the complaint here.

Medicis Pharmaceutical Corp. v. Perrigo Israel Pharmaceuticals, Ltd. et al.
1:08-cv-00539; filed June 6, 2008 in the Western District of Michigan

Infringement of U.S. Patent Nos. 6,765,001 ("Compositions and Methods for Enhancing Corticosteroid Delivery," issued July 20, 2004) and 7,220,424 (same title, issued May 22, 2007) following a paragraph IV certification as part of Perriog’s filing of an ANDA to manufacture a generic version of plaintiff’s Vanos® (fluocinonide cream, used to relieve inflammation and itching caused by certain skin conditions that respond to corticosteroids). View the complaint here.

Eli Lilly and Company et al. v. Teva Parenteral Medicines Inc.
1:08-cv-00335; filed June 5, 2008 in the District Court of Delaware

Infringement of U.S. Patent No. 5,344,932 ("N-(pyrrolo(2,3-d)pyrimidin-3-ylacyl)-Glutamic Acid Derivatives," issued September 6, 1994), licensed to Eli Lilly, following a paragraph IV certification as part of Teva’s filing of an ANDA to manufacture a generic version of Lilly’s Alimta® (pemetrexed for injection, used to treat malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer). View the complaint here.

Forest Laboratories Inc. et al. v. Apotex Inc. et al.
1:08-cv-00336; filed June 5, 2008 in the District Court of Delaware

Infringement of U.S. Patent No. 5,061,703 ("Adamantane Derivatives in the Prevention and Treatment of Cerebral Ischemia," issued on October 29, 1991), following a paragraph IV certification as part of Orgenus’ filing of an ANDA (on behalf of its parent corporation, Orchid Pharma) to manufacture a generic version of Forest’s Namenda® (memantine hydrochloride, used for the treatment of moderate to severe dementia of the Alzheimer’s type). View the complaint here.

King Pharmaceuticals, Inc. et al. v. Lupin Ltd. et al.
1:08-cv-01468; filed June 5, 2008 in the District Court of Maryland

King Pharmaceuticals, Inc. et al. v. Sandoz Inc.
3:08-cv-02802; filed June 5, 2008 in the District Court of New Jersey

The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 7,368,469 ("Use of Inhibitors of the Renin-Angiotensin System in the Prevention of Cardiovascular Events," issued on May 6, 2008), assigned to Sanofi-Aventis and licensed to King Pharmaceuticals, following a paragraph IV certification as part of defendants’ filing of an ANDA to manufacture a generic version of King’s Altace® (ramipril, used to lower cardiovascular risk and to treat hypertension). View the Lupin complaint here.

Daiichi Sankyo Co., Ltd. et al. v. Matrix Laboratories, Ltd. et al.
2:08-cv-02752; filed June 3, 2008 in the District Court of New Jersey

Infringement of U.S. Patent No. 5,616,599 ("Angiotensin II antagosist 1-biphenylmethylimidazole Compounds and Their Therapeutic Use," issued April 1, 1997), following a paragraph IV certification as part of Matrix’s filing of an ANDA to manufacture a generic version of plaintiff’s Azor® (amlodipine and olmesartan medoxomil, used to treat hypertension). View the complaint here.

Centocor Inc. v. Genentech Inc. et al.
2:08-cv-03573; filed May 30, 2008 in the Central District of California

Declaratory judgment of, invalidity, unenforceability, and non-infringement of U.S. Patent No. 6,331,415 ("Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein," issued on December 18, 2001) in conjunction with Centocor’s manufacture and sale of its ReoPro® (abciximab, used for the prevention of cardiac ischemic complications) and ustekinumab (used to treat chronic moderate-to-severe plaque psoriasis) antibody products. View the complaint here.
Conference & CLE Calendar

June 15, 2008

June 16, 2008 – Prior Art & Obviousness 2008: The PTO and CAFC Perspective on Patent Law Sections 102 & 103 (Practising Law Institute) – San Francisco, CA

June 17-20, 2008 – BIO International Convention (Biotechnology Industry Organization) – San Diego, CA

June 18-20, 2008 – Fundamentals of Patent Prosecution 2008: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) – New York, NY

June 23, 2008 – Multilateral Patents (Law Seminars International) – San Francisco, CA

July 1, 2008 – Prior Art & Obviousness 2008: The PTO and CAFC Perspective on Patent Law Sections 102 & 103 (Practising Law Institute) – New York, NY

July 9-11, 2008 – Fundamentals of Patent Prosecution 2008: A Boot Camp for Claim Drafting & Amendment Writing (Practising Law Institute) – San Francisco, CA

July 16, 2008 – Patent Claim Construction Workshop (Law Seminars International) – Seattle, WA

July 24-25, 2008 – Advanced Patent Prosecution Workshop 2008: Claim Drafting & Amendment Writing (Practising Law Institute) – New York, NY

August 11-12, 2008 – Advanced Patent Prosecution Workshop 2008: Claim Drafting & Amendment Writing (Practising Law Institute) – San Francisco, CA

August 10-15, 2008 – Advanced Courses (Patent Resources Group) – Washington, DC

September 11, 2008 – Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) – New York, NY

September 11-12, 2008 – Current Issues in Complex IP Licensing (Law Seminars International) – Philadelphia, PA

September 15-16, 2008 – Biotech Patents*** (American Conference Institute)

September 22-23, 2008 – USPTO Boot Camp: Patent Edition*** (American Conference Institute) – Alexandria, VA

September 22-23, 2008 – FDA Boot Camp*** (American Conference Institute)

September 22-23, 2008 – Patent Litigation 2008 (Practising Law Institute) – San Francisco, CA

October 6-7, 2008 – Patent Litigation 2008 (Practising Law Institute) – McLean, VA

October 15, 2008 – Developments in Pharmaceutical and Biotech Patent Law (Practising Law Institute) – San Francisco, CA

October 23-24, 2008 – Patent Litigation 2008 (Practising Law Institute) – Chicago, IL

November 10-11, 2008 – Patent Litigation 2008 (Practising Law Institute) – Atlanta, GA

November 17-18, 2008 – Patent Litigation 2008 (Practising Law Institute) – New York, NY

***Patent Docs is a media sponsor of this conference or CLE
PLI Patent Litigation 2008

June 13, 2008

Practising Law Institute (PLI) will be holding five sessions of its Patent Litigation 2008 seminar this fall in San Francisco (September 22-23), McLean, VA (October 6-7), Chicago (October 23-24), Atlanta (November 10-11), and New York (November 17-18). Each session of the Patent Litigation 2008 seminar will offer presentations on the following topics:

• Recent developments in patent law and its impact on patent litigation;
• Claim construction and proving infringement;
• Demonstration of a direct and cross-examination of a technical expert contending for obviousness;
• Discovery issues in patent litigation;
• Preliminary and permanent injunctions and declaratory relief in patent cases;
• Section 337 litigation at the ITC and other rocket dockets;
• Opinion letters, representation issues and the impact of the Knorr-Bremse decision;
• Demonstration of a closing argument: Tips from a patent trial lawyer and a jury consultant;
• Prosecuting a patent that holds up in litigation;
• Proving damages and issues to consider in pursuing and defending the damages case; and
• Ethical issues in patent litigation.

A full program for the Patent Litigation 2008 seminar can be found at one of the following links: San Francisco, McLean, VA, Chicago, Atlanta, and New York. The registration fee for each session is $1,495. Those interested in registering for the conference can do at one of the following links: San Francisco, McLean, VA, Chicago, Atlanta, and New York.
Director Answers House Subcommittee’s Questions

June 12, 2008

By Donald Zuhn —

In February, the House Subcommittee on Courts, the Internet, and Intellectual Property held an oversight hearing on the U.S. Patent and Trademark Office. The Subcommittee heard statements from Jon Dudas, the Undersecretary of Commerce for Intellectual Property and Director of U.S. Patent and Trademark Office; Robin Nazzaro, the Director of National Resources and Environment for the U.S. General Accountability Office; Robert Budens, the President of the Patent Office Professional Association (POPA); and Alan Kasper, the First Vice President of the American Intellectual Property Law Association (AIPLA) and a partner with Sughrue, Mion, PLLC. At the time, we reported on the testimony provided by each of these witnesses (see links below).

In April, Representative Howard Berman (D-CA) (at left), the Chairman of Subcommittee on Courts, the Internet, and Intellectual Property, sent Director Dudas a letter requesting that the Director supplement his testimony (see "Congressman Berman Is on the Case"). In particular, Representative Berman presented the Director with eighteen questions regarding, inter alia, Patent Office proposals for reducing the application backlog, the impact of production goals on examiner attrition, and the establishment of regional offices. Representatives Darrell Issa (R-CA) and Bob Goodlatte (R-VA) added six additional questions. The Representatives gave Director Dudas until May 19th to respond.

Earlier today, a copy of Director Dudas’ responses to the Representatives’ questions began to circulate online (see, e.g., "Patently-O Bits and Bytes No. 43" and "Dudas Issues Letter to Congress In Response to Berman’s Questions"). While a portion of the Director’s 26-page letter
focuses on a rather mundane discussion of Patent Office realignment and "reprogramming," the Director did provide some interesting bits of information.

In response to Representative Berman’s question concerning the actions that the USPTO or Congress could take to reduce patent pendency, the Director provided some suggestions that were expected (Applicant Quality Submissions) and some that were less expected (deferred examination). Continuing the Office’s drumbeat on AQSs, the Director labeled the preparation of such submissions a "basic responsibility" of applicants. The Director also listed worksharing (e.g., the Patent Prosecution Highway programs currently being tested with other patent offices) and a number of ways to increase capacity (e.g., creating a Nationwide Workforce via teleworking) as means for reducing patent pendency.

The Director’s most intriguing comments, however, concerned deferred examination, which he proposed implementing via a three-step plan. First, the time period for responding to a notice of missing parts would be extended "within [the Office’s] existing regulatory and statutory authority" from the current two-month extendible period to, for example, a 14-month extendible period. Next, the Director requested that Congress provide the statutory authority to implement a sliding-scale examination fee, in which "the greatest fee is due on filing, or within one year of filing, and lesser fees for later submissions." Finally, the Director proposed that the time period within which a nonprovisional application must be filed to claim the benefit of a provisional application be increased from one year to five years (which also would require a statutory change). With respect to this last proposal, the Director suggested that applicants be allowed to request publication of provisional applications and to collect provisional rights on published provisional applications (both of which would require changes in U.S. patent law).

Further elaborating on the topic of deferred examination in response to a question from Representative Issa, the Director reminded the Subcommittee that:

[i]n the USPTO’s original strategic plan of 2002, the agency proposed three distinct programs which collectively would have reduced the pendency of patent applications to 18 months: (1) deferred examination, (2) competitive sourcing of searches and (3) a 50% increase in fees. When the agency proposed this strategic plan to the public, there was strong and unified opposition to deferred examination from bar associations and patent user groups. In early discussions, congressional staffers advised that no proposal including deferred examination or a fifty percent increase would be acceptable.

Whether one believes that deferred examination (as opposed to the 50% fee increase) was responsible for sinking the Office’s 2002 strategic plan, the Office seems to be returning to deferred examination as a way to reduce the application backlog. Patent practitioners, however, should not discount the possibility that Director Dudas had other motives for providing the Subcommittee with a "history" lesson on deferred examination. In particular, in concluding his response to Representative Issa’s question, the Director noted that:

[t]he USPTO’s experience of proposing deferred examination in 2002 is instructive. The Applicant Quality Submission provision in the Committee passed version of S. 1145 is an even better way to ensure that examination resources are not wasted but are focused on inventions.

On the topic of production goals, the Director refused to acknowledge that examiner attrition was somehow linked to unrealistic production goals. In support of his position, the Director noted that two reports on production goals "made opposing recommendations about the patent examiner production system." Where the 2004 Commerce Office of the Inspector General (OIG) report "seemed to conclude that the production goals are set too low," the 2007 Government Accountability Office (GAO) report "seemed to conclude that the production goals are set too high." The Director contended that because approximately 70% of all FY 2007 examination work was done by examiners with three or more years of experience, and this segment of the examining core has the highest production goals and the lowest attrition rate (i.e., 3.95%, as compared with the 15.5% attrition rate of examiners with 0-3 years of experience), higher production requirements do not necessarily result in higher attrition. The Director noted, however, that the Office was doing some additional analysis on this issue, and would provide the results of this analysis to the Subcommittee by the end of the year.

Finally, in response to Representative Berman’s question on the USPTO’s interest in opening regional offices, the Director informed the Subcommittee that the Office had commissioned a feasibility study, which indicated that the costs of opening such offices would be "significant." The Director noted that the Office had determined that a more financially and strategically prudent solution would be to expand the Office’s teleworking programs.

For additional information on this and other related topics, please see:

• "Congressman Berman Is on the Case," May 14, 2008
• "GAO Testimony Supports POPA’s Position on Examiner Attrition," March 13, 2008
• "POPA President Critical of USPTO During House Subcommittee Oversight Hearing," March 4, 2008
• "More on House Subcommittee USPTO Oversight Hearing," February 28, 2008
• "House Subcommittee Holds USPTO Oversight Hearing," February 27, 2008

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