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Conference & CLE Calendar

May 1, 2011

May 3-4, 2011 – Paragraph IV Disputes*** (American Conference Institute) – New York, NY

May 18-19, 2011 – Forum on Freedom to Operate (C5) – Munich, Germany

May 23-25, 2011 – 6th International Judges Conference on Intellectual Property Law (Intellectual Property Owners Association) – Brussels, Belgium

June 2, 2011 – EPO Opposition & Appeals — The Case Law (Patent Resources Group and Management Forum) – Chicago, IL

June 3, 2011 – European Patents — The Case Law (Patent Resources Group and Management Forum) – Chicago, IL

June 7-8, 2011 – Biosimilars*** (American Conference Institute) – New York, NY

June 8, 2011 – Biotechnology/Chemical/Pharmaceutical (BCP) Customer Partnership Meeting (U.S. Patent and Trademark Office) – 10:00 am – 4:00 pm (EDT)

September 18-20, 2011 – Accelerating Intellectual Property and Innovation in South Africa (South African Department of Science and Technology) – Cape Town, South Africa

***Patent Docs is a media partner of this conference or CLE
USPTO Announces Agenda for Next BCP Customer Partnership Meeting

April 29, 2011

The U.S. Patent and Trademark Office has announced the agenda for the next biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting to be held on June 8, 2011. The proposed agenda is as follows:

Morning Session

• Greetings, TC Update, and Overview (10:00 – 10:30 am EDT): Jackie Stone, George Elliott, and Remy Yucel, Directors, Technology Center 1600

• Microsoft v. i4i Ltd.: How potential changes in the evidentiary standard for an invalidity defense could affect patent prosecution and litigation (10:30 – 11:15 am): Garth M. Dahlen, Ph.D., Esq., Birch, Stewart, Kolasch & Birch, LLP

• Break (11:15 – 11:30 am)

• COPA (Clearing the Oldest Patent Applications) (11:30 am – 12:15 pm): John Barlow, SPE, Technology Center 2800

• Expedited Examinations (Track 1, PPH, Green Tech, AE, and to Make Special) (12:00 – 1:00 pm): Bennett Celsa, QAS, Technology Center 1600

• Lunch (1:00 – 2:00 pm)

Afternoon Session

• Current Sequence Listing Process for Nucleic Acids and Polypeptides (2:00 – 2:45 pm): Joe Woitach, SPE, Art Unit 1633

• Break (2:45 – 3:00 pm)

• Common Issues Examiners Face Regarding PLTs and Plant Utility Patents (3:00 – 3:45 pm): Anne Marie Grunberg, SPE, Art Unit 1638/1661

• Closing Remarks/Discussion (3:45 – 4:00 pm): Jackie Stone, George Elliott, and Remy Yucel, Directors, Technology Center 1600

The meeting can be attended in person at the USPTO's Auditorium in Madison East, 600 Dulany Street, Alexandria, VA, or viewed online here (select the "enter as guest" option). The Patent Office asks that non-USPTO employees login using their e-mail addresses. Additional information regarding the BCP customer partnership meeting can be found here.
European Patent Reform Suffers Another Setback

April 28, 2011

By James DeGiulio —

In March, it appeared that patent reform leading to a unified European Union (EU) patent was on its way to being enacted, after the European Parliament pushed the latest European Commission proposal through despite a dissenting minority of member countries (see "European Parliament Approves Enhanced Cooperation Procedure to Create Unified EP Patent System"). However, this view appears to have been too optimistic, as the European Court of Justice has ruled that a separate patent court would violate European Union law by taking powers away from courts in EU countries. The Court of Justice is primarily concerned that the proposed patent court would not have sufficient checks and balances on its power.

The main selling point of the unified EU patent has been a reduction in costs. While the unified EU patent would decrease application costs, the unified patent court was proposed to reduce duplicative patent litigation costs and provide a forum of specialized patent judges. Unless the EU patent can be enforced by bringing just one suit, rather than separate suits throughout Europe, the benefit of the lower application costs may not be sufficient to warrant an overhaul of the current system. It is not clear whether some countries will cite the lack of a single court as a reason to back out of the unified patent plan, and whether some will see the application savings as reason enough to keep supporting it. However, without a clear patent enforcement mechanism, EU patent holders would have fewer assurances that their intellectual property is secure.

The European Court of Justice ruling can be satisfied if the Court of Justice receives appellate jurisdiction over the new proposed unified EU patent court. However, many are opposed to such a solution. The Court of Justice currently has the authority to rule on EU trademark issues, and has frustrated EU attorneys by providing inconsistent rulings over the years on simple matters of trademark law. The proposed patent court, separate from the Court of Justice, was an attempt to address that concern. Industry representatives have made it known that they would rather maintain the current system than evoke a system where patent questions go to the Court of Justice.

Despite the European Court of Justice ruling, the European Commission continues with its plan to create a unified EU patent, rolling out its latest proposal on April 13, noting that a unitary patent would still drastically reduce the cost of applying for patents. However, the Commission is now weighing new ideas that comport with the Court of Justice ruling and that would meet the goals of the reform. Most of the latest plans fail to put patent matters in front of a specialized patent court or do not solve the problem of disparate enforcement across EU countries.

For additional information regarding this topic, please see:

• "European Parliament Approves Enhanced Cooperation Procedure to Create Unified EP Patent System," March 1, 2011
• "Several EU Members Push for Unified Patent System," December 30, 2010
• "Europe Takes Step Closer to Single EU Patent and Patent Court," February 24, 2010
USPTO News Briefs

April 27, 2011

By Donald Zuhn —

USPTO Announces Postponement of Track 1 Examination (Again)

On April 21, USPTO Director David Kappos sent a message to Patent Office employees, notifying them that "[t]he Track One expedited patent examination program, scheduled to go into effect on May 4, 2011, is postponed until further notice." Last Friday, the Intellectual Property Owners Association (IPO) made the text of that message available. Director Kappos also addressed the postponement of the Track One (or prioritized examination) program on his Director's Forum blog on Friday. Today, the USPTO issued a press release again announcing that the Track One program has been postponed. According to the release, the program, which was scheduled to go into effect on May 4, has been postponed "until further notice due to reduced spending authority in the Full-Year Continuing Appropriations Act, 2011." The Office noted that "[w]ithout the resources to hire a sufficient number of examiners to implement Track One, we must postpone the effective date of the program until we are in a position to implement it successfully while ensuring there will be no adverse impact on non-prioritized examination applications." The release states that a new start date for the program will be announced "as soon as circumstances permit," and that the Office will provide the new date "via a Federal Register notice."

USPTO Extends Patent Prosecution Highway Pilot Program with DPMA

Last week, USPTO Director David Kappos authorized an extension of the Patent Prosecution Highway (PPH) pilot program with the German Patent and Trade Mark Office (DPMA) that was begun on April 27, 2009 (see "USPTO Begins Pilot Program with the German Patent Office"). The PPH pilot permits an applicant having an application whose claims have been allowed in the DPMA to fast track the examination of an application in the USPTO, or vice versa, such that the latter application is examined out of turn. In particular, an applicant receiving a ruling from the USPTO (or the DPMA) that at least one claim in an application is patentable may request that the DPMA (or USPTO) fast track the examination of corresponding claims in the corresponding application in that office. According to a notice regarding the extension of the USPTO-DPMA PPH, both offices have agreed to continue the pilot program for an additional two years to April 26, 2013, at which time it will be determined whether and how the program should be fully implemented.

The USPTO has established PPH programs with fifteen Offices. Currently the USPTO has PPH programs (full or pilot) in place with the Japan Patent Office (JPO), the Korean Intellectual Property Office (KIPO), the United Kingdom Intellectual Property Office (UK IPO), the Canadian Intellectual Property Office (CIPO), IP Australia (IP AU), the European Patent Office (EPO), the Danish Patent and Trademark Office (DKPTO), the Intellectual Property Office of Singapore (IPOS), the German Patent and Trade Mark Office (DPMA), the National Board of Patents and Registration of Finland (NBPR), the Hungarian Patent Office (HPO), the Russian Federal Service for Intellectual Property, Patents and Trademarks (ROSPATENT), the Spanish Patent and Trademark Office (SPTO), the Austrian Patent Office (APO), and the Mexican Institute of Industrial Property (IMPI).

USPTO Updates Registration Exam

Earlier this month, the USPTO announced that it would be updating its registration examination as of April 12, 2011. The updated exam will be based on the Manual of Patent Examining Procedure (M.P.E.P.) Edition 8, Revision 8, as well as the following materials:

• Examination Guidelines Update: Developments in the Obviousness Inquiry after KSR v. Teleflex (75 Fed. Reg. 53643)
(see "USPTO Updates Obviousness Examination Guidelines")

• New Interim Patent Subject Matter Eligibility Examination Instructions (August 24, 2009 Memorandum)

• Interim Guidance for Determining Subject Matter Eligibility for Process Claims in View of Bilski v. Kappos (75 Fed. Reg. 43922)

• Interim Guidance for Determining Subject Matter Eligibility for Process Claims in View of Bilski v. Kappos (July 27, 2010 Memorandum)

• Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. § 112 and for Treatment of Related Issues in Patent Applications (76 Fed. Reg. 7162)
(see "USPTO Promulgates Guidelines for Applying 35 U.S.C. § 112, 2nd Paragraph").
VentureSource Reports 35% Increase in 1Q Venture Funding

April 26, 2011

By Donald Zuhn —

Last week, Dow Jones VentureSource reported that investors put $6.4 billion of venture capital into 661 deals in the first quarter of 2011, which constituted a 35% increase in funding and a 5% increase in deals as compared with the same period last year. VentureSource noted that corporations provided $448 million of the $6.4 billion raised by venture-backed companies and were responsible for three of the ten largest deals of the first quarter.

In the healthcare sector, the VentureSource report indicated that while funding rose 21% to $1.6 billion, the number of deals dropped 6% to 148 in the first quarter of 2011 over the same period last year. Of the industries making up the healthcare sector, biopharmaceuticals collected 53% ($849 million) of healthcare funding and was responsible for 41% (61) of the sector's deals, which constituted a 15% increase in capital and a 13% drop in deals. The information technology sector matched the healthcare sector's $1.6 billion in funding in the first quarter.

Earlier this month, the National Venture Capital Association (NVCA) released its own report on venture funding, which indicated that $5.9 billion had been invested in 736 deals in the first quarter (see "NVCA Reports Modest Gains in First Quarter Venture Funding"). The NVCA report also noted that $1.4 billion had been invested in 164 first quarter deals in the Life Sciences sector (which like VentureSource's healthcare sector consists primarily of biotech and medical device companies).
USPTO Satellite Offices on Hold

April 25, 2011

By Donald Zuhn —

On Friday, USPTO Director David Kappos addressed the impact of budgetary constraints on some of the Patent Office's plans for the coming year. He did so on his Director's Forum blog, where the Director (at right) noted that following enactment of the budget for FY 2011 on April 15, the Office's total spending authority through the end of the fiscal year (i.e., September 30, 2011) had "been limited to $2.09 billion." "Given this level of spending authority," he explained that the Office would "have to make significant reductions for the current fiscal year." Stating that the USPTO had "not come by these decisions lightly," and that he "recognize[d] that these measures will create new challenges for our ability to carry out our agency’s mission," Director Kappos listed a number of USPTO initiatives and policies that would be postponed, suspended, or reduced "[e]ffective immediately and until further notice."

As we noted last week, one of the programs that will be postponed is the Track 1 (or prioritized examination) portion of the Enhanced Examination Timing Control Initiative (see "USPTO News Briefs," April 21, 2011). The opening of the USPTO satellite office in Detroit is also being postponed, "as well as consideration of other possible satellite office locations." Office personnel will certainly feel the impact of the FY 2011 budget, with all hiring being frozen, employee training being reduced, all overtime being suspended, and "all other non-compensation-related expenses, including travel, conferences and contracts" being reduced. In addition, the Director noted that IT projects will be "scaled back," and that funding for Patent Cooperation Treaty (PCT) outsourcing will be "substantially reduced."

The Director's post was preceded by a somewhat more detailed e-mail message the Director sent to USPTO employees. The Intellectual Property Owners Association (IPO) made the text of that message available on Friday. In the e-mail, the Director notes that the Office's $2.09 billion spending limit means that the Office "will be unable to expend the additional $85-100 million in fees that we will be collecting during this fiscal year — funds that we had anticipated being able to use to fund operations this year."

It appears that only patent operations are to be affected, as the trademark side of the Office will be "unaffected and will maintain normal operations."

In view of the budget problems highlighted in the Director's e-mail and blog post, it certainly is a case of what a difference a week — or in this case two weeks — makes. On the heels of the December 2010 announcement of the Detroit satellite office (see "USPTO News Briefs," December 21, 2010), and the Office's indication that it was looking at other locations for satellite offices (as well as provisions in the America Invents Act that would provide for the establishment of three or more satellite offices; see "'Reform' at the U.S. Patent and Trademark Office"), several groups had begun lobbying for satellite offices in their "backyards." On April 6, the Austin American-Statesman reported that House Judiciary Chairman Lamar Smith (R-TX) and Reps. Lloyd Doggett (D-TX), John Carter (R-TX), and Michael McCaul (R-TX) had written to Secretary of Commerce Gary Locke and Director Kappos formally asking them to consider Austin for a regional office. The article noted that Silicon Valley had also begun a lobbying effort to secure a satellite office, and that Denver and Atlanta were considered to be contenders. A Law360 article (subscription required) on April 14 noted that the Silicon Valley effort was in full swing, with Director Kappos meeting with IP insiders in a town hall event to discuss plans for modernizing the Patent Office. The USPTO has posted a draft of the Director's address on its website. While the draft does not mention satellite offices, the Law360 report notes that attendees indicated that the Director had said that Silicon Valley met several of the Office's key considerations. However, with the spending limits imposed on he Office by the FY 2011 budget, satellite office lobbying — like satellite office consideration — is now on hold.
Panel Discussion on AMP v. USPTO This Thursday

April 25, 2011

The Intellectual Property Law Association of Chicago (IPLAC) Biotech Committee and the John Marshall Law School Center for Intellectual Property Law will offer a panel discussion entitled: "Gene Patents . . . Statutory Subject Matter?" on April 28, 2011 from 1:00 to 2:30 PM (CDT) at the John Marshall Law School in Chicago, IL. The panel discussion will focus on the Association for Molecular Pathology v. U.S. Patent and Trademark Office case, which was argued before the Federal Circuit on April 4, 2011. Panelists will include Dr. Hans Sauer, Associate General Counsel for Intellectual Property for the Biotechnology Industry Organization (BIO) and Adjunct Professor of Law at the Georgetown University Law Center; Joshua D. Sarnoff, Associate Professor of Law at the DePaul University College of Law; Patent Docs author Dr. Kevin E. Noonan, Partner with McDonnell Boehnen Hulbert & Berghoff LLP and Adjunct Professor at the DePaul University College of Law and The John Marshall Law School; and Kevin Collins, Professor of Law at the Washington University School of Law.

Patent Docs readers may recall that Dr. Sauer and Prof. Sarnoff participated in a public radio discussion of the AMP v. USPTO case back in June 2009 (see "Gene Patenting Debate Continues"). Dr. Sauer was also of counsel on BIO's amicus brief in support of reversal (see "BIO and AUTM File Joint Amicus Brief in AMP v. USPTO"). Prof. Sarnoff, meanwhile, authored an amicus brief on behalf of the American Medical Association et al. in support of plaintiffs-appellees and affirmance. Dr. Noonan co-authored an amicus brief for the Intellectual Property Owners Association (IPO) (see "IPO Files Amicus Brief in AMP v. USPTO"), appeared on "60 Minutes" in April 2010 to discuss the AMP v. USPTO case (see "'60 Minutes' and 'Newshour' Take Different Approaches to Covering Gene Patenting Story"), and has written extensively on gene patenting and the AMP v. USPTO case in this space. Prof. Collins has written and presented on diagnostic method claims (see "Patenting Information").

The registration fee for the panel discussion is $10 (students), $20 (IPLAC members), or $30 (non-IPLAC members). IPLAC is an Accredited CLE Provider, and it is anticipated that the program will be eligible for 1.5 hours of CLE credit. In addition, Patent Docs will be providing lunch for attendees. Those interested in registering for the panel discussion should contact Paul Reinfelds at PREI@Lundbeck.com or Donald Zuhn at zuhn@mbhb.com to reserve a spot.
Biotech/Pharma Docket

April 24, 2011

By James DeGiulio —

Pozen Secures Injunction Blocking Par's Generic Treximet

Earlier this month, Pozen obtained a preliminary injunction blocking Par Pharmaceutical from marketing a generic version of Pozen's migraine drug Treximet until an infringement suit over the drug is resolved. The dispute between the parties began in November 2008 when Pozen brought suit in the U.S. District Court for the Eastern District of Texas against Par and the generic drugmakers Alphapharm, Teva, and Dr. Reddy's (see "Court Report," November 23, 2008). All four defendants had submitted ANDAs seeking to market generic versions of Treximet. Pozen claimed that the generic drugmakers infringed U.S. Patent Nos. 6,060,499; 6,586,458; and 7,332,183. In April 2010, Teva was dismissed without prejudice from the consolidated litigation. The case against the other three defendants was tried on October 12-15, 2010, and a decision is still pending. However, in early 2011, Par received approval from the FDA to market its generic version of Treximet, allowing Par to launch its product once Pozen's three years of regulatory exclusivity expires on April 15. After Par refused to reveal whether it planned to launch at-risk, Pozen then asked the court for a preliminary injunction until the court issues a final decision.

In an April 14 opinion, Judge Leonard Davis granted a preliminary injunction ordering Par not to make, use, sell, offer to sell, or import into the United States a generic version of sumatriptan and naproxen sodium. Judge Davis focused his analysis on two asserted claims of the '458 patent, finding that Pozen had sufficiently shown that it was likely to succeed against Par on the merits of its infringement claim. The court also rejected Par's arguments that it raised a substantial question regarding the enforceability of the '458 patent. The injunction will remain in effect until a final decision is issued in the pending patent litigation.

Wyeth and Orchid Enter Licensing Agreement in Effexor XR Suit

Wyeth has entered into a licensing deal with Orchid Chemicals & Pharmaceuticals, thereby ending the parties' patent infringement litigation over Effexor XR. The dispute between Wyeth and Orchid began in July 2009, when Wyeth filed suit in the U.S. District Court for the District of New Jersey against Orchid after its submission of an ANDA for a generic extended release version of venlafaxine HCl (see "Court Report," July 12, 2009). Wyeth asked the court to declare that Orchid had infringed U.S. Patent Nos. 6,274,171; 6,403,120; and 6,419,958 and enjoin the generic drugmaker from making or selling its proposed generic. Orchid responded by asserting that that patents were invalid. In October, Wyeth was ordered to produce its prior Effexor patent settlement and licensing agreements after the court decided the agreements might be relevant to Orchid's patent misuse defense. Wyeth has filed at least sixteen suits over Effexor XR since the drug was approved, and has settled with eleven generic companies to date.

On April 14, Judge Freda L. Wolfson signed an order approving the settlement. Under the settlement, Orchid agreed not to manufacture its generic product until the expiration of the three patents at issue, except as permitted by a confidential licensing agreement. The settlement requires each party to bear its own court costs. Further details of the agreement were not revealed.

Takeda Agrees to Dismiss One Actos Infringement Suit against Apotex

After filing its complaint just one month ago, Takeda Pharmaceutical has requested a voluntary dismissal of its patent infringement suit against Apotex, centered around Apotex's efforts to manufacture a generic version of the diabetes medication Actos. On March 22, Takeda brought suit against Apotex in the U.S. District Court for the Southern District of Florida, claiming that Apotex's ANDA infringed U.S. Patent Nos. 5,965,584; 6,329,404; 6,166,043; 6,172,090; 6,211,205; 6,271,243; and 6,303,640 (see "Court Report," March 27, 2011) Apotex sought approval for generic pioglitazone tablets to be used for both monotherapy and in combination with a diabetes drug. Takeda also alleged willfull infringement and inducing infringement, claiming Apotex was likely to advertise the Actos name on its website, thus inviting customers to follow the Actos treatment systems but substitute the Apotex version of the drug.

On April 13, Judge Ursula Ungaro entered an order dismissing the case without prejudice, based on Takeda's request and notice of voluntary dismissal. Takeda did not disclose its reasoning for requesting dismissal, but both parties are currently litigating a nearly identical infringement suit in the U.S. District Court for the Southern District of New York.
Court Report

April 24, 2011

By Sherri Oslick —

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.

Genentech, Inc. et al. v. Glaxo Group Ltd. et al.
2:11-cv-03065; filed April 12, 2011 in the Central District of California

• Plaintiffs: Genentech, Inc.; City of Hope
• Defendants: Glaxo Group Ltd.; GlaxoSmithKline LLC; Human Genome Sciences, Inc.; Lonza Biologics PLC; Lonza Biologics Inc.

Infringement of U.S. Patent No. 7,923,221 ("Methods of Making Antibody Heavy and Light Chains Having Specificity for a Desired Antigen," issued April 12, 2011) based on defendants' manufacture and sale of their Benlysta® (belimumab, under development for the treatment of seropositive patients with systemic lupus erythematosus) and Arzerra (ofatumumab, used to treat chronic lymphocytic leukemia) products. View the complaint here.

Nautilus Neurosciences, Inc. et al. v. Wockhardt USA LLC et al.
2:11-cv-01997; filed April 8, 2011 in the District Court of New Jersey

• Plaintiffs: Nautilus Neurosciences, Inc.; APR Applied Pharma Research SA
• Defendants: Wockhardt USA LLC; Wockhardt Ltd.

Infringement of U.S. Patent Nos. 6,974,595 ("Pharmaceutical Compositions Based on Diclofenac," issued December 13, 2005), 7,482,377 ("Pharmaceutical Compositions and Methods of Treatment Based on Diclofenac," issued January 27, 2009), and 7,759,394 ("Diclofenac Formulations and Methods of Use," issued July 10, 2010) following a Paragraph IV certification as part of Wockhardt's filing of an ANDA to manufacture a generic version of Nautilus' Cambia® (diclofenac potassium, used for the acute treatment of migraine attacks). View the complaint here.

Purdue Pharma L.P. et al. v. Ranbaxy Inc. et al.
1:11-cv-02401; filed April 8, 2011 in the Southern District of New York

• Plaintiffs: Purdue Pharma L.P.; P.F. Laboratories, Inc.; Purdue Pharmaceuticals L.P.; Rhodes Technologies
• Defendants: Ranbaxy Inc.; Ranbaxy Pharmaceuticals Inc.; Ranbaxy Laboratories Ltd.

Infringement of U.S. Patent Nos. 7,674,799 ("Oxycodone Hydrochloride Having Less Than 25 PPM 14-Hydroxycodeinone," issued March 9, 2010), 7,674,800 (same title, issued March 9, 2010), and 7,683,072 (same title, issued March 23, 2010) following a Paragraph IV certification as part of Raxbaxy's filing of an ANDA to manufacture a generic version of Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain). View the complaint here.

Purdue Pharma L.P. et al. v. Impax Laboratories, Inc.
1:11-cv-02400; filed April 8, 2011 in the Southern District of New York

• Plaintiffs: Purdue Pharma L.P.; P.F. Laboratories, Inc.; Purdue Pharmaceuticals L.P.; Rhodes Technologies; Board of Regents of the University Of Texas Systems; Grunenthal GmbH
• Defendants: Impax Laboratories, Inc.

Infringement of U.S. Patent Nos. 6,488,963 ("Hot-Melt Extrudable Pharmaceutical Formulation," issued December 3, 2002), 7,674,799 ("Oxycodone Hydrochloride Having Less Than 25 PPM 14-Hydroxycodeinone," issued March 9, 2010), 7,674,800 (same title, issued March 9, 2010), 7,683,072 (same title, issued March 23, 2010), and 7,776,314 ("Abuse-Proofed Dosage System," issued August 17, 2010) following a Paragraph IV certification as part of Impax's filing of an ANDA to manufacture a generic version of Purdue Pharma's OxyContin® (controlled release oxycodone hydrochloride, used to treat pain). View the complaint here.

Takeda Pharmaceutical Co., Ltd. et al. v. Impax Laboratories, Inc.
3:11-cv-01610; filed April 1, 2011 in the Northern District of California

• Plaintiffs: Takeda Pharmaceutical Co., Ltd.; Takeda Pharmaceuticals North America, Inc.; Takeda Pharmaceuticals LLC; Takeda Pharmaceuticals America, Inc.
• Defendant: Impax Laboratories, Inc.

Infringement of U.S. Patent Nos. 6,462,058 ("Benzimidazole Compound Crystal," issued October 8, 2002), 6,664,276 (same title, issued December 16, 2003), 6,939,971 (same title, issued September 6, 2005), 7,285,668 ("Process for the Crystallization of (R)- or (S)-Lansoprazole," issued October 23, 2007), and 7,790,755 ("Controlled Release Preparation," issued September 7, 2010) following a Paragraph IV certification as part of Impax's filing of an ANDA to manufacture a generic version of Takeda's Dexilant® (dexlansoprazole, used for the treatment of all grades of erosive esophagitis, maintaining healing of esophagitis, and treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease). View the complaint here.

Celgene Corp. et al. v. Mylan Pharmaceuticals Inc.
2:11-cv-01882; filed April 1, 2011 in the District Court of New Jersey

• Plaintiffs: Celgene Corp.; Novartis Pharmaceuticals Corp.; Novartis Pharma AG
• Defendant: Mylan Pharmaceuticals Inc.

Infringement of U.S. Patent Nos. 5,908,850 ("Method of Treating Attention Deficit Disorders with d-Threo Methylphenidate," issued June 1, 1999), 6,355,656 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 12, 2002, with a reexamination certificate issued March 27, 2007), 6,528,530 ("Phenidate Drug Formulations Having Diminished Abuse Potential," issued March 4, 2003), 5,837,284 ("Delivery of Multiple Doses of Medications," issued November 17, 1998), 6,635,284 (same title, issued October 21, 2003), and 7,431,944 ("Delivery of Multiple Doses of Medications," issued October 7, 2008) all licensed exclusively to Novartis in certain fields of use, following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Novartis' Focalin XR® (extended release dexmethylphenidate hydrochloride, used to treat attention deficit hyperactivity disorder). View the complaint here.
Conference & CLE Calendar

April 24, 2011

April 27, 2011 – 27th Annual Joint Patent Practice Seminar (Connecticut, New Jersey, New York, and Philadelphia Intellectual Property Law Associations) – New York, NY

April 29, 2011 – Ethics in the Practice of Intellectual Property Law (John Marshall Law School Center for Intellectual Property Law) – Chicago, IL

April 27-29, 2011 – Patent Strategies Summit*** (International Quality & Productivity Center) – Palo Alto, CA

May 3-4, 2011 – Paragraph IV Disputes*** (American Conference Institute) – New York, NY

May 18-19, 2011 – Forum on Freedom to Operate (C5) – Munich, Germany

May 23-25, 2011 – 6th International Judges Conference on Intellectual Property Law (Intellectual Property Owners Association) – Brussels, Belgium

June 2, 2011 – EPO Opposition & Appeals — The Case Law (Patent Resources Group and Management Forum) – Chicago, IL

June 3, 2011 – European Patents — The Case Law (Patent Resources Group and Management Forum) – Chicago, IL

June 7-8, 2011 – Biosimilars*** (American Conference Institute) – New York, NY

September 18-20, 2011 – Accelerating Intellectual Property and Innovation in South Africa (South African Department of Science and Technology) – Cape Town, South Africa

***Patent Docs is a media partner of this conference or CLE