Philip Brooks' Patent Infringement Updates

Bayer Files Patent Infringement Lawsuit Against Teva

The following is excerpted from a Thursday, July 02, 2009 press release at Webwire:

Bayer Schering Pharma AG, Germany and Bayer HealthCare Pharmaceuticals Inc. together with Schering Corporation have filed a patent infringement lawsuit in the U.S. Federal Court in the District of Delaware against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd.. The lawsuit concerns Teva’s application to the FDA for approval to market a generic form of Levitra®, Bayer Schering Pharma’s therapy for the treatment of erectile dysfunction, prior to patent expiration. The patent at issue in the suit is Bayer Schering Pharma’s U.S. Patent No. 6,362,178, expiring in 2018. In the US, Levitra® is marketed by Schering-Plough and GlaxoSmithKline.

See the full press release here.

CRESTOR PATENT INVALIDITY EVIDENCE UNCOVERED BY ARTICLE ONE PARTNERS COMMUNITY

The following is excerpted from a July 1, 2009 Article One Partners press release:

Article One Partners, LLC has discovered new prior art impacting the validity of AstraZeneca’s Crestor U.S. drug patent, in closing out another round of Patent Studies. The Article One community uncovered premier validity evidence which can show the Crestor patent to be invalid, as verified by independent outside counsel, Darby & Darby, and an independent expert. CRESTOR® (rosuvastatin calcium) is a prescription drug for treating high cholesterol. The discovery of this patent invalidity evidence can impact the industry litigation to market generic rosuvastatin drugs. The prior art (further detailed below) was provided by an Article One community Advisor with the username Columbo, who will receive a monetary award.

JSA Technologies Study Uncovers Two Key References

In addition to the Crestor Study, Article One’s JSA Technologies Study for U.S. Patent No. 6,963,857 uncovered a broad range of prior art references, including two references that each separately can show the patent to be invalid under the strongest level of invalidity evidence, called anticipation. The JSA patent involves transferring funds from a second account to a first account with the accounts on separate networks and servers—such as transferring funds onto university student ID cards. Two Advisors, with usernames Ramesh and Patented, identified the evidence and will share the monetary reward. 

Article One already has begun to license the proprietary collection, with law firm Davis Wright Tremaine, LLP first to license. The JSA Study uncovered new dramatic invalidating prior art that extensive traditional prior art searches didn’t produce. With so many Article One Advisors using different approaches, a wide variety of highest quality references were found—providing two separate paths to invalidity under “102 anticipation,” including a U.S. patent, and obscure publications about a product offered in 1997. The patent has been asserted in litigation against Informed Decisions Corp./Cashnet and has been described by JSA as being widely licensed to universities.

Crestor Study & Industry Impact

Nine generic drug manufacturers have submitted Abbreviated New Drug Applications with Para IV certifications (ANDAs) to the U.S. Food and Drug Administration (FDA), seeking approval to market generic versions of Crestor. AstraZeneca countered with litigation for patent infringement against these nine drug companies, with court cases proceeding in the discovery phase, in the District of Delaware.

The Article One community uncovered references that are crucial for an invalidity position for the U.S. patent to Crestor. This includes references that can teach the claim elements, why the lead molecule would be selected, what results could be expected from substitutions to the lead molecule, and why a person of ordinary skill at the time would have applied the teachings to create the claimed invention. The references can form a clear, convincing invalidity position as verified by the independent outside counsel and expert referenced above. Both the Crestor and JSA Study proprietary collections of prior art are available for license from Article One. 

“The U.S. Patent Office does high quality work, but its resources are limited to fully research the validity of all the patents it issues. With the public bearing the burden of this limitation by paying monopoly pricing, Article One provides a counter-balance through citizen’s review of granted patents,” said Cheryl Milone, Article One Partners founder and CEO. “This Patent Study related to AstraZeneca’s Crestor drug is a perfect example, where the public has provided information to potentially correct an improper patent grant. This citizen review is having a tremendous impact. Earlier this month, the U.S. Patent Office moved forward with a re-exam of Merck’s Singulair U.S. patent based directly upon relevant prior art discovered by the Article One community. Not only do the Advisors eliminate monopoly pricing but they receive premium compensation for doing so.”

Article One also has announced the closing of additional Patent Studies: Opana ER-Penwest; Effexor XR-Wyeth; Lotrel-Novartis; Prevacid-Takeda; Lipitor-Pfizer; Angioplasty Stent-Wall; Keyboard-RIMM; and Wireless Transmissions-Wi-Lan. Studies which are closed indicate that the Article One prior art collections do not form an independent basis for an invalidity position related to the subject patents at this time. Advisors continue to send in validity evidence for closed Studies to earn profit sharing points. In the event that further submissions are relevant to a validity position, Article One will compensate the Advisors with the applicable stated reward of up to $50,000. Closed Studies also contain state of the art collections for the Study patents. These Article One proprietary collections are available for license to interested parties. 

China's Guidebook for Pharmaceutical Patent Protection

Research and Markets announced today, June 22, 2009, in a Business Wire press release:

The addition of the "China's Guidebook for Pharmaceutical Patent Protection" report to their offering.

China is expected to become the fifth largest drug market in the world by 2010 with a growth rate of 20-25 percent per annum in next three years. As China joins the World Trade Organization (WTO) and integrates more completely into the global economy, it will further open the door to a lucrative drug market for overseas pharmaceutical companies, which attracts more and more overseas pharmaceutical manufacturers and producers to enter such drug market and seize a larger part of such drug market. However, the Chinese social environment for the protection of intellectual property right is complex. The locally produced generics and copy products dominate the Chinese drug market. It is estimated that about 97 percent of the drugs produced by local companies are generics or counterfeits.

Facing such complex social environment and market, most overseas and multinational pharmaceutical companies fear that their imported drugs and pharmaceuticals produced in China will be imitated or copied, in turn, their intellectual property will be infringed and benefit will be violated. What reason incurred such fear of overseas and multinational pharmaceutical companies? Why did Eli Lilly & Company fail in its litigation of patent infringement dispute case in China? Why can Pfizer win in an administrative proceeding against the Patent Reexamination Board of the China State Intellectual Property Office (SIPO) for its Viagra patent? Lack of knowledge of the Chinese intellectual property right system and legislation institution, the cultural difference between China and Western countries as well as the language barriers incurred such result.

Guidebook Highlights

China's Guidebook for Pharmaceutical Patent Protection provides a comprehensive and thorough knowledge of the Chinese patent system relating to pharmaceuticals, the detailed administrative, civil and criminal judicial pathways for protections of patent right, and the design for composition of optimized protection strategies.

• The organization structure of patent authorities and judicial system;

• A comprehensive and thorough knowledge of the Chinese patent system and the relevant laws and administrative regulations relating to pharmaceuticals;
• The patentable subject matter relating to pharmaceuticals in China;
• Administrative protection for patent right;
• Civil judicial procedures and remedies for patent right;
• Criminal punitions for infringement of patent right;
• Design for compositions of optimized protection strategies;
• Case studies and comparative analyses of patent infringement disputes.

See the full press release here.

2nd Annual Pharmaceutical Congress on Paragraph IV Disputes

The Center for Business Intelligence is hosting the above-titled conference in Philadelphia, PA on October 22-23, 2009.

Paragraph IV litigation is reaching an all-time high with almost $85 billion in product sales that potentially could be affected by pending litigation and more than twenty-five drugs going off patent before 2012.  Today’s pharmaceutical companies, both brand and generic, have much at stake in this costly, complex and constantly changing area of patent litigation.  CBI’s 2nd Annual Pharmaceutical Congress on Paragraph IV Disputes brings both sides of the issue together for two days of presentations and panel discussions to discuss litigation strategies, statutory guidelines, current cases and their landmark decisions.

 Confirmed Sessions Include:

    Inequitable Conduct and Exceptional Cases – What Does Recent Case Law Tell Us?

        * Inequitable conduct and recent Federal Circuit decisions
              o Aventis Pharma v. Amphastar Pharmaceuticals and Teva 
        * Exceptional cases
              o What makes a case exceptional?
              o Assess Takeda v. Apotex and Alphapharm and prior “exceptional” case examples

        Anthony J. Viola, Partner, Edwards Angell Palmer & Dodge LLP

    Analyze FTC Enforcement Activity and Reverse Payment Policy Initiatives

        * Evaluate continuing development of antitrust litigation
        * Analyze pending reverse payment policy and evaluate the force(s) behind it
        * Discuss authorized generics and their impact on competition
        * Understand the FTC’s findings in their report on FOB market entry and pioneer/FOB competition

        Saralisa Brau, Deputy Assistant Director, Health Care Division, Federal Trade Commission

Learn more and register here.

Pfizer Sues Mylan Over Patents for Top-Drug Lipitor

The following is excerpted from a June 15, 2009 article by Phil Milford and Susan Decker at Bloomberg:

Pfizer Inc., the world’s biggest drugmaker, sued rival Mylan Inc. asking a judge to prohibit sales of a generic version of its cholesterol-fighting medicine Lipitor until 2017.

In federal court papers filed today in Wilmington, Delaware, lawyers for New York-based Pfizer contend a Mylan affiliate has applied to the U.S. Food and Drug Administration for permission to sell copies of Lipitor, the world’s best- selling drug, before three Pfizer patents expire.

Pfizer officials have said they’re looking for cooperative ventures with other pharmaceutical makers to increase generic sales as patents expire. Lipitor logged $12.4 billion in revenue last year, $7.7 billion of it in the U.S.

Ranbaxy Laboratories Ltd., India’s biggest drugmaker and majority owned by Japan’s Daiichi Sankyo Co., settled a lawsuit filed by Pfizer and plans to enter the market in November 2011. Pfizer already is suing Apotex Inc. and Teva Pharmaceutical Industries Ltd. to prevent them from selling copies of the medicine before then.

Read the full article here.

Developments in Pharmaceutical and Biotech Patent Law 2009

PLI is hosting the above-titled conference in New York City on September 17, 2009 (along with groupcasts in Boston, Philadelphia and Pittsburgh and a live webcast) and in San Francisco on October 14, 2009.

This year’s program is totally new! Pharmaceutical and biotech patent law is an important and rapidly changing practice area and the program is designed to give you the information you need to maintain your practice edge.

Technological innovation, Federal Circuit appellate oversight, Congressional action and Supreme Court decisions have all driven significant changes in the law. Several different perspectives on many of the most pressing issues will be offered from experienced in-house and outside counsel.

Do not miss this opportunity to fully understand the impact of appellate decisions and the pending patent legislation on your pharmaceutical and biotechnology patent practice.

What You Will Learn

• The patentability of pharmaceutical products post-KSR v. Teleflex from the Federal Circuit and District Court perspectives
• Inequitable conduct in biotechnology and pharmaceutical patent cases; recent Supreme Court and Federal Circuit developments
• Section 112 developments regarding enablement and written description requirements: the impact of U.S. Patent and Trademark Office (USPTO) Written Description Guidelines
• Cutting-edge issues impacting your pharma and biotech patent prosecution practice
• Patent misuse and other issues in pharma and biotech licensing
• At the intersection of antitrust and pharma and biotech patent cases: unique issues that can arise and strategies to avoid antitrust liability

Faculty

Co-Chairs

    David K. Barr, Kaye Scholer LLP
    Daniel L. Reisner, Kaye Scholer LLP

Speakers

    Karen I. Boyd, Turner Boyd LLP
    Jennifer Gordon, Baker Botts L.L.P.
    Timothy R. Holbrook, Professor at Law, Emory University School of Law
    Lisa A. Schneider, Sidley Austin LLP
    Gerald Sobel, Kaye Scholer LLP
    Darryl L. Webster, Senior Patent Counsel, Wyeth
    Cynthia H. Zhang, Ph.D., Director, Intellectual Property, Gilead Sciences Inc

Program Attorneys

    John M. Mola, Practising Law Institute

More information and registration are available here.

 

"Reverse Payments" in Pharmaceutical Patent Settlements

The Oxford University Press recently published [June 2008] a case study that was co-authored by Senior Economist John Bigelow of the Princeton Economics Group, Inc. The case study described an attempt by the Federal Trade Commission to challenge so-called "reverse payments" made by Schering-Ploughto two generic drug manufacturers. A PEG team led by Dr. Bigelow worked with counsel for Schering to defend the company against FTC allegations that it was per se illegal for Schering to include payments to two generic manufacturers in settlements of patent litigation involving its potassium chloride product, K-Dur 20.

The FTC enforcement action was one of a series the agency had taken against settlements in the pharmaceutical industry that embody payments made by the patent-holder/brand manufacturer to the alleged patent infringer/generic manufacturer. The FTC describes these as "reverse payments" and "payments for delay" because, in the Schering case, as in others, the brand and generic manufacturers agreed to a future date at which the generic would enter the market. The agency alleged that the brand manufacturer protected its monopoly position by paying two potential competitors to delay entering the market.

The Supreme Court declined to take the case, leaving an unresolved problem for policy makers where patent litigation settlements with reverse payments and negotiated entry are concerned. This problem arises from the four lessons the Schering-Plough case teaches:

1. The parties to litigation have a socially beneficial incentive to settle costly and risky patent lawsuits.
2. Economic logic teaches that such settlements could include combinations of payments and delay that would injure competition.
3. Economic logic also teaches that the ability to include payments and negotiated entry in settlements can be essential to achieving pro-competitive socially beneficial settlements.
4. Antitrust inquiry may be incapable of reaching reliable conclusions about the merits of the underlying patent litigation.

Simple rules, either those that per se forbid reverse payments and negotiated entry or those that would grant them a blanket safe-harbor are likely to be unwise. The chapter calls for a program of research that would equip policy makers and enforcers to distinguish between pro-competitive and anti-competitive settlements.

The case studyis: John P. Bigelow [Princeton Economics Group] and Robert D. Willig[Professor of Economics and Public Affairs at the Woodrow Wilson School of Public & International Affairs at Princeton University] , "'Reverse Payments' in Settlements of Patent Litigation: Schering Plough, K-Dur, and the FTC." Case 9 in The Antitrust Revolution, 5th edition, John Kwoka and Lawrence White (ed.s); Oxford University Press, 248 - 75, June, 2008.

I worked with Dr. Willig on the economic issues affecting patent damages in the Polaroid v. Kodak patent infringement case for instant camera and film.

Mylan Settles Patent Dispute with Schering-Plough Over Clarinex

From the April 9, 2009 issue of The Pittsburgh Tribune-Review:

Mylan Inc. announced a patent litigation settlement with Schering-Plough concerning its generic version of the Clarinex allergy medication, a case pending in federal court for 2 1/2 years.

Under the settlement, Canonsburg-based Mylan can market its generic Desloratadine tablets in the 5-milligram size in the United States beginning July 1, 2012, with U.S. Food and Drug Administration approval.

No further settlement details were made public.

Jon Leibowitz Named Chairman of the Federal Trade Commission

From a March 3, 2009 FTC press release:

President Barack Obama designated Jon Leibowitz as Chairman of the Federal Trade Commission by a White House Order dated March 2, 2009.

Leibowitz became a Commissioner of the FTC on September 3, 2004, resuming a long career of public service. He was formerly the Democratic chief counsel and staff director for the U.S. Senate Antitrust Subcommittee from 1997 to 2000, focusing on competition policy and telecommunications matters. Leibowitz was chief counsel and staff director for the Senate Subcommittee on Terrorism and Technology from 1995 to 1996, and for the Senate Subcommittee on Juvenile Justice from 1991 to 1994. He also served as chief counsel to Senator Herb Kohl from 1989 to 2000, and he worked for Senator Paul Simon from 1986 to 1987. In the private sector, Leibowitz served as vice president for congressional affairs for the Motion Picture Association of America from 2000 to 2004, and worked as an attorney in private practice in Washington from 1984 to 1986.

Leibowitz graduated from the New York University School of Law and is a Phi Beta Kappa graduate of the University of Wisconsin. He is a member of the District of Columbia Bar and has co-authored amicus briefs before the U.S. Supreme Court on issues ranging from gun control to the census.

The following is from a February 23, 2009 Bloomberg News Service item at APP.com:

On the FTC, Leibowitz has championed the agency’s efforts to prevent brand-name drug companies from paying manufacturers of cheaper, alternative medications to keep their products off the market.

The FTC has filed numerous lawsuits against drugmakers to challenge these so-called “reverse payments” that occur in drug-patent settlements. After a federal appeals court ruled against the FTC in one case, the agency sought legislation to make it easier for antitrust enforcers to challenge these arrangements, which the FTC argues costs consumers hundreds of millions of dollars in higher drug prices.

Bill To Ban “Reverse Payment” Settlements Introduced

David Fischer posted the following at his Antitrust Review blog:

Yesterday [February 3, 2009], Senators Kohl and Grassley introduced a bill “to prohibit brand-name drug manufacturers from using pay-off agreements to keep cheaper generic equivalents off the market.”  They titled their bill ”The Preserve Access to Affordable Generics Act” (S. 369).  It is similar as the “The Preserve Access to Affordable Generics Act” (S. 316) that was introduced in the last Congress.  That bill did not reach the Senate floor.

A comparison of the findings [sections of S. 316 and S. 369] appears to show that over the last two years 1) prescription drugs are now a lower percentage of national health care spending , 2) a significantly larger share of the prescription drugs prescribed are generics and they make up a significantly larger share of prescription drug expenditures , and 3) generic drugs cost even less now (as compared to their brand-name counterparts).

See the full post here.

According to The Library of Congress' Thomas system the latest major action: 2/3/2009 Referred to Senate committee. Status: Read twice and referred to the Committee on the Judiciary.