Patent Docs

Court Report

August 3, 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. Barr Pharmaceuticals, Inc. et al.
5:08-cv-00362; filed July 30, 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 Barr’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.

Astrazeneca Pharmaceuticals LP et al. v. Handa Pharmaceuticals, LLC et al.
3:08-cv-03773; filed July 28, 2008 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 4,879,288 ("Novel Dibenzothiazepine Antipsychotic," issued November 7, 1989) and 5,948,437 ("Pharmaceutical Compositions Using Thiazepine," issued September 7, 1999) following a Paragraph IV certification as part of defendants’ filing of an ANDA to manufacture a generic version of AstraZeneca’s Seroquel® XR (quetiapine fumarate, used to treat schizophrenia and bipolar disorder). View the complaint here.

Endo Pharmaceuticals Inc. et al. v. Impax Laboratories Inc.
1:08-cv-00463; filed July 25, 2008 in the District Court of Delaware

Infringement of U.S. Patent Nos. 5,662,933 ("Controlled Release Formulation (Albuterol)," issued September 2, 1997) and 5,958,456 (same title, issued September 28, 1999) following a Paragraph IV certification as part of Impax’s amendment of their ANDA (adding additional dosage forms) to manufacture a generic version of Endo’s Opana® ER (oxymorphone hydrochloride, used to treat moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time). View the complaint here. [NB: Endo previously asserted these patents against Impax in January, as we reported here.]

Brigham and Women’s Hospital Inc. et al. v. Teva Pharmaceuticals USA Inc. et al.
1:08-cv-00464; filed July 25, 2008 in the District Court of Delaware

Infringement of U.S. Patent Nos. 6,211,244 ("Calcium Receptor-Active Compounds, issued April 3, 2001), 6,313,146 (same title, issued November 6, 2001), 6,011,068 (same title, issued January 4, 2000), and 6,031,003 (same title, issued February 29, 2000), licensed to Amgen, following a Paragraph IV certification as part of defendants’ filing of an ANDA to manufacture a generic version of Amgen’s Sensipar® (cinacalcet hydrochloride, used to treat secondary hyperparathyroidism in patients on dialysis, and hypercalcemia in patients with parathyroid carcinoma). View the complaint here.

Novartis Corporation et al. v. Teva Parenteral Medicines Inc. et al.
1:08-cv-00459; filed July 24, 2008 in the District Court of Delaware

Declaratory judgment that Teva’s Paragraph IV notices were improper, null, void, and without legal effect, that the Court therefore has no subject matter jurisdiction over the claims surrounding the patents at issue, that Teva’s notices did not trigger the 45-day period for filing an infringement action under the Hatch-Waxman Act, and that Teva must serve new Paragraph IV notice upon Novartis if and when the FDA accepts Teva’s ANDAs. Also, infringement of U.S. Patent No. 4,939,130 ("Substituted Alkanediphosphonic Acids and Pharmaceutical Use," issued July 3, 1990) following Paragraph IV certifications as part of Teva’s filing of two ANDAs to manufacture generic versions of Novartis’ Zometa® (zoledronic acid injection, used to treat patients with multiple myeloma and patients with documented bone metastases from solid tumors). View the complaint here.
Conference & CLE Calendar

August 3, 2008

August 5, 2008 – Intellectual Property Due Diligence and Audit Bootcamp (West Legalworks) – 1:00-2:00 PM (EDT)

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 21-23, 2008 – 2008 Annual Meeting (Intellectual Property Owners Association) – San Diego, CA

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

September 23-24, 2008 – Biotech Patenting (C5) – London, England

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

October 7-8, 2008 – Global Patent Litigation*** (American Conference Institute) – New York, NY

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

October 15-17, 2008 – Maximizing Pharmaceutical Patent Lifecycles*** (American Conference Institute) – New York, NY

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

October 28-29, 2008 – Pharma/Biotech IP Due Diligence*** (C5) – Amsterdam, Netherlands

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

November 19-20, 2008 – Paragraph IV on Trial*** (American Conference Institute) – New York, NY

***Patent Docs is a media partner of this conference or CLE
Teva and Dr. Reddy’s Settle Coreg® Suit

August 1, 2008

By Sherri Oslick —

Earlier this week the litigation between Teva Pharmaceutical Industries Ltd. and Dr. Reddy’s Laboratories Inc. over generic Coreg® was dismissed without costs and without prejudice based on a settlement between the parties.

As we reported previously, the suit was originally filed in the District Court of New Jersey on June 21, 2007 against Dr. Reddy’s for infringement of U.S. Patent Nos. 6,699,997 ("Carvedilol," issued March 2, 2004), 6,710,184 ("Crystalline Solids of Carvedilol and Processes for Their Preparation," issued March 23, 2004), 7,056,942 ("Carvedilol," issued June 6, 2006), and 7,126,008 (same title, issued October 24, 2006) based on defendants’ filing of an ANDA to manufacture and sell a generic version of GSK’s Coreg® (carvedilol, used to treat congestive heart failure and high blood pressure). Dr. Reddy’s ANDA was approved by the FDA in September, 2007, at the end of GSK’s pediatric exclusivity period.
USPTO News: EFS-Web 1.4 Enhancements Coming Soon

August 1, 2008

By Christopher P. Singer —

The U.S. Patent and Trademark Office sent out an e-Commerce update on July 31, 2008, notifying EFS users of enhancements that will be introduced with EFS-Web 1.4 (to be released on August 17, 2008). For one, users will be able to launch their e-mail programs in EFS-Web and send Acknowledgement Receipts and Pre-Acknowledgement Receipts to any desired address (such as a dedicated docketing e-mail address). The USPTO website lists several other enhancements including:

• BIS Statement on Login Screen: Registered e-Filers must check the checkbox indicating that they have read and accepted the terms of the BIS (Bureau of Industry and Security) Statement on the Login screen prior to authentication (see the EAR (Export Administration Regulation) section of the FAQ found here for more information).

• Sequence Listing Enhancements: Enhancements will allow for uploading one sequence listing (.txt) file up to 100 MB per submission as a separately uploaded file (because it is in text format). Sequence listing files that exceed 100 MB can be submitted on compact disc via Express Mail. EFS-Web will also display a warning if the sequence listing does not conform to the ST.24 or ST.25 format.

• View Saved Submissions by Customer Number: Registered e-Filers will be able to view Saved Submission packages created for new applications that are associated with their Customer Numbers.

• PAIR Button: Registered e-Filers will be able to launch their e-filed applications in Private PAIR with a click of the PAIR button on the Last 40 Acknowledgement Receipts screen.

• Delete Button on the Attach Document Screen: e-Filers will be able to delete unwanted files prior to Upload and Validate.

• Practitioner Registration Status Warning: Registered practitioners will receive a warning to contact the Office of Enrollment and Discipline (OED) if their registration status is not active to practice before the USPTO.

• National Stage Enhancements: When filing a National Stage application under 35 U.S.C. § 371, e-Filers will be able to edit the PCT Number and International Filing Date on the Application Data Screen. EFS-Web will warn applicants if the PCT Number and Filing Date are mismatched.

• First Action Interview Warning on the Attach Document Screen: e-Filers requesting enrollment in the First Action Interview (FAI) pilot program must check a checkbox to confirm compliance with FAI eligibility requirements.

• Fee Codes: Since priority documents are now free of charge, the 8007 Fee Code will be removed from the PCT Calculate Fee screen. The 1708 and 1463 Fee Codes have been added to the PCT Calculate Fee screen. The 1814 Fee Code (Statutory disclaimer) will appear under the "Miscellaneous Patent Fees" and "Post Allowance & Post Issuance Fees" categories.
West Legalworks IP Due Diligence CLE

August 1, 2008

West Legalworks will be offering an "Intellectual Property Due Diligence and Audit Bootcamp" audio webcast on August 5, 2008 from 1:00-2:00 PM (EDT). Lisa Brownlee, author of Intellectual Property Due Diligence in Corporate Transactions: Investment, Risk Assessment and Management, will provide an overview of the IP due diligence process, from the memorandum of understanding/letter of intent through the transaction document. In particular, Ms. Brownlee will address the following topics:

• Defining the purpose and scope (due diligence vs. audits)
• The IP team – training, timing, and coordination
• Confidentiality obligations
• Special IP-related data room procedures
• The IP due diligence checklist

• Level of detail of request
• Standard and customized requests
• Coordination with the general/corporate request

• Independent IP searches
• IP due diligence results and report

• Definition of rights
• Ownership
• Third party rights
• Protection/registration
• Exploitation
• Enforcement/disputes

The registration fee for the webcast is $165. Those interested in registering for the webcast, can do so here.
JEC Holds Hearing on Drug Pricing; GPhA Lobbies for Follow-on Biologics Pathway

July 31, 2008

By Donald Zuhn —

Last week, Senator Amy Klobuchar (D-MN) (at right) convened a hearing of the Joint Economic Committee (JEC), a bicameral Congressional Committee composed of ten members from both the Senate and the House of Representatives, to examine rising pharmaceutical prices and the impact of such price increases on the pharmaceutical market and patient medical bills. During the hearing, entitled: "At What Cost?: Egregious Price Increases in the Pharmaceutical Drug Industry," the Committee heard statements from Senator Charles E. Schumer (D-NY), Chairman of the JEC, and Senator Klobuchar, as well as testimony from the parent of a young patient, the CEO of Minnesota Children’s Hospital, and Madeline Carpinelli, a Research Fellow from the PRIME Institute at the University of Minnesota (which researches policy issues related to pharmaceutical economics). According to the JEC website, the hearing was convened for the purpose of exploring the causes of recent price increases for rare disease therapeutics and the negative impact on affected families’ fiscal stability and access to care.

Senator Schumer (at left) opened the hearing by offering one example of what he believed was an egregious increase in price — he noted that the drug Matulane, which is used for treating Hodgkins Lymphoma, cost less than $70 per dose in late 2004, and then just six months later, jumped to $5,568 (an 8000% increase). The JEC Chairman also noted that this astounding price increase was "not for a groundbreaking new drug [but rather was] for a drug that was put on the market in the 1960s." Concluding that the creation of a regulatory pathway for follow-on biologics was "an important development for American consumers," Senator Schumer stated that he believed the next Administration would make the establishment of such a system a priority, and asserted that "[g]enerics and market competition works."

Ms. Carpinelli provided some of the most interesting testimony. She noted that her analysis of drug prices between 1988 and 2008 showed "that certain drug products have experienced extraordinary price increases that are well beyond what would normally be expected in a competitive market" (see table entitled "Huge Drug Price Increases"), and further, that the number of branded drug products showing extraordinary price increases (i.e., a price change of more than 100% at a single point in time) had been rising sharply in recent years (see chart entitled "Extraordinary Price Increases are Becoming More Common"). Ms. Carpinelli explained that while brand name drug prices rose an average of 7.4% between 2006 and 2007 (as compared with a 2.9% rate of inflation over the same period), certain brand name drugs saw price increases that far exceeded the 7.4% average. She pointed out, for example, that the price of Ambien rose 27.7% in 2007. However, Ms. Carpinelli found that the increase in Ambien pricing paled in comparison with the 500% to 10,631% price increases observed for a handful of other branded drug products (interestingly, the 10,631% price increase was for a branded off-patent drug).

While noting that the "pharmaceutical market is extremely complex and vexing to most observers," Ms. Carpinelli suggested that extraordinary increases in drug pricing were likely the result of a drug company’s "unique position in a market with respect to intellectual property, legal status, barriers to entry, [or] product features that offer a competitive advantage." She also informed the JEC that "[t]he number and magnitude of these extraordinary price increases also raises the possibility that antitrust issues may be present." Ms. Carpinelli, however, did not discount the possibility that the intellectual property and exclusivity status of these drug products may have facilitated the extraordinary price increases. For example, she noted that some of the large price increases were associated with old drugs for which a patent covering a new use or new dosage form had been issued, thereby providing a period of market exclusivity for the drug product.

In response to the JEC hearing, the Generic Pharmaceutical Association (GPhA), which represents manufacturers and distributors of finished generic pharmaceuticals and bulk active pharmaceutical chemicals, issued a press release stating that "the availability of a workable pathway that provides timely patient access to safe, affordable and life-saving biogeneric medicines would save consumers and the health care system billions of dollars." The GPhA noted that while generics represent 65% of the total prescriptions dispensed in the U.S., they only account for 20% of all dollars spent on prescription drugs. GPhA President and CEO Kathleen Jaeger asserted that "safe and affordable biogenerics would allow [patients] to improve their lives while reducing their health care costs." In support of her assertion, Ms. Jaeger cited a study commissioned by Insmed that estimates $67 billion to $108 billion in cost savings over 10 years, and $236 billion to $378 billion in cost savings over 20 years, for generic versions of the top twelve biologics covered by patents that have expired or will soon expire (see "Dr. Robert Shapiro Discusses Follow-on Biologics Report"). She also cited a Pharmaceutical Care Manufacturers Association (PCMA) study that estimated $14.9 billion in cost savings over a 10-year period for certain biopharmaceuticals in the top 200 Medicare Part B reimbursed categories, and an Express Scripts report estimating $71 billion in savings over 10 years for products in four therapeutic categories: interferons, erythropoietin, growth hormone, and insulin. Ms. Jaeger concluded that such cost savings could not be ignored, and necessitated the creation of a "workable approval pathway for biogenerics — one without lengthy and overreaching market exclusivity provisions or patent extensions that simply result in an empty promise to patients."
Patent Reform Critic Says Legislation Would Be Costly and Counterproductive

July 30, 2008

By Donald Zuhn —

In an article posted on the American.com website (the online version of The American magazine) on Tuesday, Dr. Aparna Mathur (at right), a Research Fellow at the American Enterprise Institute for Public Policy Research, argues that now is the time to begin lobbying against the patent reform bill that was taken off the Senate calendar in April (see "Courting Trouble on Patents"). Dr. Mathur, who co-authored an economic analysis of the apportionment of damages, post-grant opposition, and inequitable conduct provisions of the patent reform bills with Dr. Robert Shapiro (see "BIO CEO Provides Update on Patent Reform and Follow-on Biologics Legislation – Part I"), argues that if "controversial" patent reform legislation were passed by the next Congress, it "would do more harm than good, while leaving the basic contours of the problem unchanged."

In her "Memo to Congress," Dr. Mathur clearly sides with patent reformers who "allege that the USPTO is guilty of issuing low-quality patents that violate the criteria of ‘novelty, non-obviousness, and utility,’" rather than the critics who have been seeking significant revisions to the Patent Act. Dr. Mathur points to U.S. Patent No. 5,443,036, entitled "Method of Exercising a Cat," as but one example of a patent that "violat[es] the criterion of obviousness" and "fails the novelty test."

According to Dr. Mathur, the problem with the Patent Office’s issuance of low quality patents is that such patents are difficult to challenge. While a bad patent can be challenged via reexamination, Dr. Mathur notes that such proceedings are not very effective since only 10% of reexaminations result in patent revocation. And while the alternative to reexamination — patent litigation — is often more effective, it is also quite costly (with estimates ranging from $500,000 to $3 million in costs per suit).

Dr. Mathur contends that a third option that would be created by patent reform legislation — post-grant opposition proceedings — would impose costs that far outweigh its benefits. She asserts that "[i]n a litigious society like the United States, the demand for lawyers and paperwork would drive up costs and make the opposition proceeding extremely expensive." Pointing to her patent reform study, Dr. Mathur states that "an opposition system in the United States would increase the costs of patent validation by nearly $16 billion over 10 years."

A post-grant opposition system would also "strike at the heart of what the patent system is designed to protect: the incentive to innovate and invest" by resulting in a higher probability of patent revocation. In her study, Dr. Mathur estimated that a post-grant opposition system, if implemented, would result in a 2.8% probability of patent revocation, whereas the current reexamination system only results in a 0.02% probability of patent revocation. Thus, Dr. Mathur concludes that "[a]n opposition regime could significantly reduce investment in R&D and slow the pace of innovation." More importantly, Dr. Mathur argues that a post-grant opposition system would not fix the "main problem" with U.S. patent system — the issuance of low-quality patents. Dr. Mathur asserts that only the USPTO can fix that.
FDA Makes Changes in Erythropoietin Labeling

July 30, 2008

By Kevin E. Noonan —

The Food and Drug Administration posted a notice on its website today that further restricts prescription of two erythropoietin drugs (Amgen’s Epogen®/Aransesp® and Johnson & Johnson’s Procrit®) to cancer patients. The notice is part of the FDA’s ongoing safety review of these drugs, and is a "follow-up" to a January 3, 2008 Official Communication.

In the notice, the FDA announced that it will require what it terms "safety-related" changes in how these drugs are labeled. The changes include replacing the Package Insert with a Medication Guide, and modifying particular sections of "the Boxed Warnings, Indications and Usage, and Dosage and Administration" portions of the package insert. Specifically, the hemoglobin level at which the drugs should not be administered to cancer patients has been changed. While the changes were developed by the FDA with Amgen’s input and cooperation, the Agency and the company could not agree on the wording of a warning statement that these drugs are not intended for use in myelosuppressed patients where cure is the expected outcome, and statements relating to hemoglobin levels used to trigger initiation and termination of dosing.

The new labeling recommends that treatment should not be initiated until a patient’s hemoglobin level falls to 10 grams per deciliter, and clarifies language suggesting that treatment be continued until hemoglobin levels of 12 grams per deciliter are produced. The labels also recommend that the drugs not be used as "adjuvant" therapy, in combination with chemotherapy after surgical resection. The FDA also decided to disregard a recommendation from its Oncologic Advisory Committee that these drugs not be used for certain types of cancer.

As reported today in The New York Times (see "Amgen Told to Reword Drug Label"), this is the first time the FDA has exercised its new authority under revisions to the Food, Drug and Cosmetic Act to mandate these types of labeling changes; previously the Agency was limited to negotiating with a drug manufacturer to accept a label change. The changes were motivated by studies that suggested that the use of these drugs to treat anemia associated with chemotherapeutic treatment could be deleterious. Despite this, Aransesp® has retained its traditionally strong sales; second quarter 2008 sales are reported to be $825 million. And according to the Times this performance exceeded expectations on Wall Street.

The company has five days to appeal and fifteen days to submit supplemental labeling in compliance with the FDA’s changes to the label.
TauRx Therapeutics and University of Aberdeen Present Data on Potential Alzheimer’s Drug

July 30, 2008

By Christopher P. Singer —

In a July 29, 2008 presentation at the Alzheimer’s Association International Conference on Alzheimer’s Disease (ICAD 2008) in Chicago, scientists involved in a collaboration between the University of Aberdeen and TauRx Therapeutics discussed data demonstrating that their candidate drug, rember, appears to slow the progress of the Alzheimer’s disease. According to a press release from the University of Aberdeen as well as TauRx’s website, rember is a small molecule Tau Aggregation Inhibitor that targets the tangles (aggregates of abnormal fibres of tau protein) that form in nerve cells in the brains of Alzheimer’s patients.

The data presented by the scientists indicated that patients receiving the therapeutic experienced an 81% reduction in cognitive decline over one year, and did not experience a significant decline in their mental function over the course of 19 months. Brain imaging data performed by TauRx was said to suggest that the drug had the most significant effect in the regions of the brain thought to be critical for memory function and where the tangle density is typically high.

Dr. Claude Wischik, TauRx’s Executive Chairman, and a Professor at the University of Aberdeen, characterized the Phase 2 clinical results as representing the first real hope that it may be possible to arrest progression of Alzheimer’s disease. Following up on this promising clinical data, TauRx is planning to begin a Phase 3 trial next year. If the Phase 3 trial confirms the Phase 2 findings, the drug could be available by 2012.
Deputy Director Peterlin Announces Resignation

July 29, 2008

By Kevin E. Noonan —

The U.S. Patent and Trademark Office announced today that Margaret Peterlin, Deputy Undersecretary of Commerce for Intellectual Property and Deputy Director of the USPTO will resign from her post some time in August.

Deputy Director Peterlin (at left) has been a controversial figure in the Office, in part because she apparently lacked qualifications long thought to be required for senior Patent Office management positions, and for her association with several of the controversial "new rules" packages promulgated by the Dudas regime. She survived a court challenge to her appointment mounted by Greg Aharonian, noted intellectual property crusader; David Lentini and David Pressman, both patent attorneys and authors; and Steven Morsa, an inventor (see "Margaret Peterlin Gets to Keep Her Job").

This challenge, based on the provisions of 35 U.S.C. § 3(b)(1) that the person holding Ms. Peterlin’s office must be a "citizen of the United States who has a professional background and experience in patent or trademark law," was dismissed by Judge James Robertson of the U.S. District Court for the District of Columbia, who ruled last December that the provisions of the statute did not confer a private cause of action with regard to Ms. Peterlin’s alleged lack of statutory competence for her position. The Court also held that, although the Administrative Procedures Act (APA) provided a cause of action, the patent statute was sufficiently vague about the standards for her position, and consideration of what qualifications might satisfy the standard were sufficiently subjective, that the decision of whom to appoint to the Deputy Director position was properly "committed to agency discretion by law."

Deputy Director Peterlin was often the official face of the Office, testifying successfully before Congress on major policy initiatives, including the worksharing (see "Lunch with Commissioner Doll") and telecommuting (see "Deputy Director Peterlin Testifies at House Hearing on Teleworking") initiatives. But she also made some missteps in that role, including granting an interview with a Wall Street Journal reporter about the now-enjoined continuation and claims rules the day before they were published in the Federal Register, something that seemed in violation of the spirit if not the letter of the APA (see "Patent Office Announces That New Continuation and Claims Rules Will Be Published . . . Tomorrow").

The Patent Office press release announcing her departure was predictably effusive in its praise of Deputy Director Peterlin, saying that she "strategically positioned the USPTO as a leader in such important policy debates as patent modernization legislation, in which the USPTO played a lead role in forming and communicating the Administration’s position." Director Dudas (at right) called her "instrumental" to the Office’s success during her tenure, pointing to her "insistence on data-driven decision-making" that "greatly improved the USPTO’s business operations." Perhaps in answer to her critics, Director Dudas also said that she "has tremendous understanding of IP issues and helped the Administration promote smart IP policies both on Capitol Hill and with IP offices around the world."

Deputy Director Peterlin in her own valedictory said she was "proud of the strides the agency has made and, for the first time in the USPTO’s history, we are on track to meet 100% of our goals," those goals including "helping the organization reach a new level of excellence through effective delegation, continuous process improvement, transparency of operations and increased employee engagement."

While it has been reported elsewhere that at least part of the motivation for her departure includes the impending birth of her first child later this year, her decision to leave the Office now may also reflect an acknowledgement by the Deputy Director and the Administration that the time is almost over for achieving many of the "goals" they have had for U.S. patent law, including patent "reform" legislation and the numerous rules packages in limbo either in the courts or within the Administration, and that there is little more they can expect to do before the new President is inaugurated in January. Having strongly objected to many of these policy goals, we wish Deputy Director Peterlin well, but cannot honestly say we are sorry to see her go.

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