Patent Docs

Fabry Patients Sue Genyzme for Damages Caused By Fabrazyme Rationing

March 10, 2011

By James DeGiulio —

Since 2009, we have been tracking the story surrounding Genzyme's enzyme replacement drug Fabrazyme, which started with a problem at Genzyme's manufacturing facilities and led to nationwide shortages of the drug. These shortages prompted Fabry patients to petition the Department of Health and Human Services to exercise march-in rights under the Bayh-Dole Act, which in December 2010 was denied (see "HHS Denies Request to Exercise Bayh-Dole 'March-in' Rights for Fabrazyme"). Now, rather than looking to the government for aid, Fabry patients are instead looking to the court system for relief as they have brought suit against Genzyme and Mt. Sinai Medical School for their rationing of Fabrazyme to Fabry patients. Fabrazyme, the only approved FDA treatment for Fabry disease, is currently being rationed by Genzyme until completion and regulatory approval of new manufacturing facilities, expected in the first half of 2011. Genzyme currently rations patient access to 50% of the FDA approved dosage and does not approve new patients for Fabrazyme treatment.

On March 9, the plaintiffs filed a complaint in the U.S. District Court for the Western District of Pennsylvania. The plaintiffs in the case are six named Fabry disease patients, who are bringing suit individually and as a class action. Plaintiffs allege that despite the rationing plan, neither Mt. Sinai nor Genzyme has ever shown that a reduced dose of Fabrazyme is either safe or efficacious for treating Fabry disease. The complaint relies heavily on a November 2010 study by the EMA that determined that the lowered dose of Fabrazyme may have adverse effects, including accelerated the course of patient deterioration, and concluded by recommending no less than a full dose for Fabry patients in Europe.

The complaint alleges several counts, including negligence in maintaining manufacturing facilities, negligence per se, strict liability, loss of consortium, breach of warranty, and deceptive trade practices. Of particular note, the fifth count is an implied cause of action, described as a "Violation of Bayh-Dole Act proscription of non-use or unreasonable use of publicly funded inventions." This count alleges that Defendants instituted the drug ban for some citizens and rationing to other citizens despite a statutory duty under the Bayh-Dole Act to ensure that Fabrazyme was made available to U.S. citizens at the required dose. This source of this statutory duty is rooted in the Bayh-Dole Act's specific prohibition against a contractor's non-use and unreasonable use of publically funded invention under 35 U.S.C. § 200. As a result of this violation, Plaintiffs allege that Defendants caused special injuries unique to the class arising out of the non-use and unreasonable use of the invention, because the plaintiffs have Fabry disease and rely on access to the publicly funded invention.

C. Allen Black, Jr., who represents the Fabry patients in this case, said in a press release that "for the first time, the courts will be asked to determine whether patients who are guaranteed access to tax-payer funded inventions under the Bayh-Dole act may recover individual damages under the statute when a contractor misuses the invention or withholds it from the public. Even though Fabrazyme® is covered by a patent, taxpayer dollars paid for it under the Bayh-Dole act (35 U.S.C. § 200 et seq.). The Bayh-Dole Act specifically requires that the public be protected against a patentee's nonuse or unreasonable use of inventions paid for with tax dollars."

Fabry patients have requested compensation and punitive damages for lack of adequate treatment and Genzyme's failure to take adequate precautions including keeping a reserve inventory and providing second sources of manufacturing.
Obama Administration Supports S. 23

March 9, 2011

By Donald Zuhn —

On Tuesday, the Senate passed the America Invents Act (S. 23) by a 95-5 vote (see "Senate Passes S. 23"). While the provisions that made it into the bill were not entirely clear yesterday, a version of the legislation as passed was posted on the THOMAS website today. The bill moving to the House contains provisions on the following:

• First inventor to file (Sec. 2)
• Inventor's oath or declaration (Sec. 3)
• Virtual marking and advice of counsel (Sec. 4)
• Post-grant review proceedings (Sec. 5)
• Patent Trial and Appeal Board (Sec. 6)
• Preissuance submissions by third parties (Sec. 7)
• Venue (Sec. 8)
• Fee setting authority (Sec. 9)
• Supplemental examination (Sec. 10)
• Residency of Federal Circuit judges (Sec. 11)
• Micro entity defined (Sec. 12)
• Funding agreements (Sec. 13)
• Tax strategies deemed within the prior art (Sec. 14)
• Best mode requirement (Sec. 15)
• Technical amendments (Sec. 16)
• Clarification of jurisdiction (Sec. 17)
• Transitional program for covered business-method patents (Sec. 18)
• Travel expenses and payment of administrative judges (Sec. 19)
• Patent and Trademark Office funding (Sec. 20)
• Satellite offices (Sec. 21)
• Patent Ombudsman Program for small business concerns (Sec. 22)
• Priority examination for technologies important to American competitiveness (Sec. 23)
• Designation of Detroit satellite office (Sec. 24)

As we reported yesterday, a number of patent and industry organizations, including the American Intellectual Property Law Association (AIPLA), Innovation Alliance, Biotechnology Industry Organization (BIO), and Coalition for Patent Fairness, were quick to release statements regarding the Senate's passage of S. 23 (see "Reaction to Senate Passage of S. 23"). The Patent Office also issued a statement about the legislation, albeit prior to the Senate vote. In a short press release issued in anticipation of the Senate vote, USPTO Director David Kappos "urge[d] the Senate to pass this crucial legislation," which he said would "help to deliver a 21st century patent system that better equips the USPTO to move innovative ideas with sound patent protection to the marketplace." Not surprisingly, Director Kappos focused on provisions that would impact Office funding, citing an Federal Trade Commission (FTC) report recommending, in the Director's words, that "for our patent system to best serve America's innovators, it is essential that the USPTO have adequate funding to address the backlog of patent applications — one of the key reforms this legislation would make possible."

Last week, the Director wrote on his blog that the patent system was in "immediate need of attention," and that S. 23 would "update[] our patent system by offering greater certainty about patent rights, lower fees for independent inventors and micro-entities and faster alternatives to expensive litigation," as well as "enable[] a financially stable USPTO that promotes growth for innovators in all industries and of all sizes." In his post, the Director cited the Statement of Administration Policy on S. 23 from the Office of Management and Budget (OMB), which notes that "[t]he Administration supports Senate passage of S. 23," stating that:

As a whole, this bill represents a fair, balanced, and necessary effort to improve patent quality, enable greater work sharing between the United States Patent and Trademark Office (USPTO) and other countries, improve service to patent applicants and the public at the USPTO, and offer productive alternatives to costly and complex litigation.

The Administration's statement continues:

By moving the United States to a first-to-file system, the bill simplifies the process of acquiring rights. This essential provision will reduce legal costs, improve fairness, and support U.S. innovators seeking to market their products and services in a global marketplace. Further, by providing authority for the USPTO to establish and adjust its fees to reflect changes in costs, demand, and workload, the bill would enhance productivity — reducing delay in the patent application process — and ensure full cost recovery at no taxpayer expense.

With respect to the Senate bill's first inventor to file provision, the Director writes that:

By moving the United States to a First-Inventor-to-File (FITF) system, the bill establishes greater speed and certainty about property rights in the innovation marketplace, while also leveling the playing field for anyone seeking to participate in global commerce. While I recognize some have concerns about this switch, the reality is that the current First-to-Invent system is fraught with peril. Under the current system, a host of objections can be raised in litigation that undermine a patentee’s rights. Such litigation is expensive and time consuming.

The patent reform debate now moves to the House. Based on the Administration's comments concerning S. 23, if the House passes legilsation resembling the Senate bill, the six-year trek to enact some form of patent legislation could be at an end.
Reaction to Senate Passage of S. 23

March 8, 2011

By Donald Zuhn —

It took almost six years for Senate Judiciary Chairman Patrick Leahy (D-VT) to get a patent reform bill to the floor of the Senate for a vote. And after the Senate passed the most recent version of Senator Leahy's bill (S. 23) by a 95-5 vote earlier today (see "Senate Passes S. 23"), it took only minutes for patent and industry organizations to start rolling out press releases regarding the bill's passage.

The American Intellectual Property Law Association (AIPLA) was one of the first to issue a statement, saying that it "applaud[ed] the Senate passage of critical patent reform legislation (S. 23), marking a significant milestone in the effort to secure the U.S. position as the worldwide leader in innovation and the jobs it produces." The AIPLA commended the Senate, under the leadership of Chairman Leahy and Ranking Minority Member Charles Grassley (R-IA), for approving "a strong, bipartisan bill that includes the essential patent reform features, including the adoption of a first-inventor-to-file patent system, funding for the U.S. Patent and Trademark Office that will bring budget predictability to this critical agency, and the creation of an ever more effective post-grant review procedure." The AIPLA stated that it hopes the legislation, which now moves to the House of Representatives, "will continue to advance expeditiously to the enactment of the most important patent legislation in nearly 60 years." AIPLA Executive Director Q. Todd Dickinson called the passage of the bill a "historic step towards enactment of critical reforms to our patent system," and looked forward to "Congress finishing this work to enact the kind of patent reform the American innovation community needs and deserves."

In its statement, the Innovation Alliance "applaud[ed] the efforts of the Senate to date" and "recognize[d] that great strides have been made." However, the group noted that it "remain[s] neutral on S. 23 as passed." Among the group's "concerns" with the Senate bill were "the removal of the 'gatekeeper' compromise on damages achieved in the last Congress, as well as the creation of the new 'transitional post-grant review proceeding' for business method patents." The group did find some positives in the Senate bill that passed, including provisions for an expanded post-grant system and an end to fee diversion. With regard to the post-grant system, the Innovation Alliance stated that the bill "retains the important procedural safeguards that lessen the potential for abuse of the expanded post-grant system the Senate Judiciary Committee added to the bill last year." As for fee diversion, the Innovation Alliance said the adoption of this provision was "overdue," adding that "ending fee diversion is now a goal that unites virtually all stakeholders on all sides of the patent debate." According to the group's statement, the provision to end fee diversion would, more than any other provision of the bill, "promote the health of the innovation ecosystem in the United States." The group concluded by saying that it "will continue to be a constructive voice in the ongoing debate, which we hope will result in the enactment of a bill the Innovation Alliance can support." According to the Innovation Alliance website, the group "represents innovators, patent owners and stakeholders from a diverse range of industries that believe in the critical importance of maintaining a strong patent system that supports innovative enterprises of all sizes."

The Biotechnology Industry Organization (BIO) "hail[ed]" and "commend[ed] the Senate for its overwhelming passage" of S. 23, voicing its "appreciat[ion for] the dedication of Senate Judiciary Chairman Patrick Leahy (D-VT), Ranking Member Charles Grassley (R-IA) and the bill's other cosponsors for their tireless efforts to build bipartisan consensus on the legislation." BIO stated that "[o]nce enacted into law, it will strengthen and improve our nation's patent system, spurring innovation and job creation." (That assumes, of course, that the House finds favor with the Senate bill and that the President signs the bill into law.) BIO contended that "improvements made by the America Invents Act would benefit all sectors of the U.S. economy by enhancing patent quality and the efficiency, objectivity, predictability, and transparency of the patent system," and concluded by "encourage[ing] the House of Representatives to consider patent reform without delay."

The Coalition for Patent Fairness issued a statement on its website saying that while the Senate "improved S.23 by removing the damages, venue, and willfulness provisions before the final vote," the group "continue[s] to have concerns about the bill and could not support its passage at this time." As the patent reform debate moves to the House, the organization noted that it "stands ready to help reach a consensus on the most efficient way to lessen the growing burden of abusive and unjustified patent infringement claims." According to the Coalition's website, the group, which represents a broad range of companies and trade associations in the financial services, technology, energy, chemical, manufacturing and media industries, is "committed to the passage of patent legislation that will foster innovation and economic growth."
Senate Passes S. 23

March 8, 2011

By Kevin E. Noonan —

The Senate voted today in favor of S. 23, the "America Invents Act," aka the Patent Reform Act of 2011. The vote was 95-5, with Senators Barbara Boxer (D-CA), Maria Cantwell (D-WA), Mike Crapo (R-ID), John Ensign (R-NV), and James Risch (R-ID) voting against.

The version of the bill that passed the Senate is a far cry from the many earlier versions of the bill, from this and previous Congresses, and contains provisions that may affect the following aspects of patent law:

• First inventor to file (Sec. 2)
• Inventor's oath and declaration (Sec. 3)
• Defenses; evidentiary requirements (Sec. 4)
• Post-grant review (Sec. 5)
• Establishment of Patent Trial and Appeal Board (Sec. 6)
• Pre-issue third party submissions (Sec. 7)
• Venue (Sec. 8)
• PTO fee-setting authority (Sec. 9)
• Supplemental examination (Sec. 10)
• Residency of Federal Circuit Judges (Sec. 11)
• Creation of Micro-entities (Sec. 12)
• Changes in funding agreement percentages (Sec. 13)
• Tax strategies deemed to be in the prior art (Sec. 14)
• Best mode requirement (Sec. 15)
• Transitional program for Covered Business Method Patents (Sec. 18)

(We say "may affect" as the Library of Congress THOMAS website has not yet posted the text of the bill that the Senate passed today.)

The business method patents provisions, sponsored by Senator Schumer (D-NY), provide an administrative procedure for challenging business method patents:

SEC. 18. TRANSITIONAL PROGRAM FOR COVERED BUSINESS-METHOD PATENTS.

(a) References.–Except as otherwise expressly provided, wherever in this section language is expressed in terms of a section or chapter, the reference shall be considered to be made to that section or chapter in title 35, United States Code.

(b) Transitional Program.–

(1) ESTABLISHMENT.–Not later than 1 year after the date of enactment of this Act, the Director shall issue regulations establishing and implementing a transitional post-grant review proceeding for review of the validity of covered business-method patents. The transitional proceeding implemented pursuant to this subsection shall be regarded as, and shall employ the standards and procedures of, a post-grant review under chapter 32, subject to the following exceptions and qualifications:

(A) Section 321(c) and subsections (e)(2), (f), and (g) of section 325 shall not apply to a transitional proceeding.

(B) A person may not file a petition for a transitional proceeding with respect to a covered business-method patent unless the person or his real party in interest has been sued for infringement of the patent or has been charged with infringement under that patent.

(C) A petitioner in a transitional proceeding who challenges the validity of 1 or more claims in a covered business-method patent on a ground raised under section 102 or 103 as in effect on the day prior to the date of enactment of this Act may support such ground only on the basis of–

(i) prior art that is described by section 102(a) (as in effect on the day prior to the date of enactment of this Act); or

(ii) prior art that–

(I) discloses the invention more than 1 year prior to the date of the application for patent in the United States; and

(II) would be described by section 102(a) (as in effect on the day prior to the date of enactment of this Act) if the disclosure had been made by another before the invention thereof by the applicant for patent.

(D) The petitioner in a transitional proceeding, or his real party in interest, may not assert either in a civil action arising in whole or in part under section 1338 of title 28, United States Code, or in a proceeding before the International Trade Commission that a claim in a patent is invalid on any ground that the petitioner raised during a transitional proceeding that resulted in a final written decision.

(E) The Director may institute a transitional proceeding only for a patent that is a covered business-method patent.

(2) EFFECTIVE DATE.–The regulations issued pursuant to paragraph (1) shall take effect on the date that is 1 year after the date of enactment of this Act and shall apply to all covered business-method patents issued before, on, or after such date of enactment, except that the regulations shall not apply to a patent described in the first sentence of section 5(f)(2) of this Act during the period that a petition for post-grant review of that patent would satisfy the requirements of section 321(c).

(3) SUNSET.–

(A) IN GENERAL.–This subsection, and the regulations issued pursuant to this subsection, are repealed effective on the date that is 4 years after the date that the regulations issued pursuant to paragraph (1) take effect.

(B) APPLICABILITY.–Notwithstanding subparagraph (A), this subsection and the regulations implemented pursuant to this subsection shall continue to apply to any petition for a transitional proceeding that is filed prior to the date that this subsection is repealed pursuant to subparagraph (A).

(c) Request for Stay.–

(1) IN GENERAL.–If a party seeks a stay of a civil action alleging infringement of a patent under section 281 in relation to a transitional proceeding for that patent, the court shall decide whether to enter a stay based on–

(A) whether a stay, or the denial thereof, will simplify the issues in question and streamline the trial;

(B) whether discovery is complete and whether a trial date has been set;

(C) whether a stay, or the denial thereof, would unduly prejudice the nonmoving party or present a clear tactical advantage for the moving party; and

(D) whether a stay, or the denial thereof, will reduce the burden of litigation on the parties and on the court.

(2) REVIEW.–A party may take an immediate interlocutory appeal from a district court's decision under paragraph (1). The United States Court of Appeals for the Federal Circuit shall review the district court's decision to ensure consistent application of established precedent.

(d) Definition.–For purposes of this section, the term “covered business method patent'' means a patent that claims a method or corresponding apparatus for performing data processing operations utilized in the practice, administration, or management of a financial product or service, except that the term shall not include patents for technological inventions. Solely for the purpose of implementing the transitional proceeding authorized by this subsection, the Director shall prescribe regulations for determining whether a patent is for a technological invention.

(e) Rule of Construction.–Nothing in this section shall be construed as amending or interpreting categories of patent-eligible subject matter set forth under section 101.

Subsection (e) is reportedly intended to preclude courts from ascribing to Congress any intention to put its imprimatur on business method patents as patent-eligible subject matter (without deciding that such patents do not encompass patent-ineligible subject matter).

The House of Representatives must next consider patent reform, either by adopting (in whole or in part) S. 23 or by proposing its own version of patent reform. Readers are reminded that the bill passed by the House in September 2007 looked quite different from the bill the Senate passed today (see "Patent 'Reform' Bill Passes House of Representatives").
Supreme Court Refuses to Review Reverse Payments

March 7, 2011

By Kevin E. Noonan —

The Supreme Court today denied certiorari in Louisiana Wholesale Drug Co. v. Bayer AG (decided below as In re Ciprofloxacin Antitrust Litigation; see also "Second Circuit Denies En Banc Reconsideration in Cipro® Case"). According to the Court's website, neither Justice Sotomayor nor Justice Kagan participated in the decision.

The case arose from the Second Circuit's decision that a "reverse payment" agreement between Bayer and Barr Laboratories was not illegal under the antitrust laws. Bayer holds U.S. Patent No. 4,670,444 claiming generically certain antibiotic drugs, and specifically ciprofloxacin hydrochloride that Bayer sells as Cipro®. Barr filed an Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification that the '444 patent was invalid and unenforceable. Before trial, Bayer and Barr settled the litigation, entering into agreements providing that none of the defendants would challenge the validity or enforceability of the '444 patent, and that Barr would convert its Paragraph IV certification to a Paragraph III and not market its generic Cipro® until the '444 patent expired. Importantly, the agreements contained a provision that Bayer would sell Cipro® to Barr for resale or make quarterly payments ("reverse payments") until December 31, 2003. In return, Barr agreed not to sell a generic version of Cipro® until at least six months before the '444 patent expired. It is undisputed that Bayer had paid Barr a total of $398 million under this agreement. Similar agreements were also made between Bayer and other generic drug makers, including The Rugby Group and Watson Pharmaceuticals, Inc.

The Federal Circuit heard a portion of this case under a Walker Process antitrust claim, based on the willful assertion of an unenforceable patent, pursuant to Walker Process Equip., Inc. v. Food Mach. & Chem. Corp., 382 U.S. 172, 177 (1965), finding that the "reverse payment" agreement was not per se illegal under antitrust law. A coalition of patient groups, trade unions and pharmacies brought suit in the Eastern District of New York sounding solely in antitrust. The Court, bound by the Second Circuit's precedential Tamoxifen decision (In re Tamoxifen Citrate Antitrust Litigation, 466 F.3d 187, 208-12 (2d Cir. 2005)), that such reverse payments were not per se illegal, granted summary judgment to defendants. The original appellate panel, similarly bound by the Tamoxifen precedent, affirmed (see Patent Docs post), in a decision that urged the plaintiffs to petition for rehearing en banc. That petition was denied (see Patent Docs post), and the certiorari petition followed.

Several groups had filed amicus briefs recommending the certiorari petition be granted, including:

• The American Antitrust Institute (brief)

• States of California, Arizona, Arkansas, Delaware, Florida, Mawaii, Idaho, Illinois, Iowa, Maine, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Carolina, Oklahoma, Ohio, Oregon, South Carolina, Tennessee, Texas, Utah, Vermont, Washington, Wet Virginia and Wyoming (brief)

• 86 Intellectual Property Law, Antitrust Law, Economics, Business and Public Health Professors, written by Mark Lemley (brief)

• Consumer Federation of America, Prescription Access Litigation LLP, The National legislative Association of Prescription Drug Prices and U.S. PIRG (brief)

• AARP (brief)

• Public Patent Foundation (brief)

• National Association of Chain Drug Stores, Inc. (brief)

The basis of many of these arguments is that so-called "reverse payments" should be per se illegal under the Sherman Act, a position also espoused by Federal Trade Commission. (PubPat's brief, in keeping with a general theme, contains as a unique basis for opposing reverse payments the "extremely poor" quality of U.S. patents.) Indeed, the Commission is almost monomaniacal on the subject, going so far as to manipulate venue in an attempt to create a circuit appellate court split to "encourage" the Court to hear their arguments (see "FTC Continues Attempt to Block Reverse Payments"). The FTC issued a Report (see "FTC Disapproves of 'Pay-for-Delay' Drug Deals"), which provided data that there have been 53 reverse payment-containing agreements that had cost consumers "approximately $3.5 billion per year" (by FTC estimates, which may be flawed; see Patent Docs report).

This stance is in contrast to the decisions of several courts of appeal, not only that these arrangements are not per se illegal, but that they frequently do not amount to an antitrust violation under the rule of reason (see "Reverse Payments in Generic Drug Settlements" – Part I, Part II, Part III). Those decisions found that not only were these agreements not anticompetitive but, in many instances, resulted in generic versions of patented drugs being available to consumers earlier than they would have been if the patentee had prevailed at trial.

The Court's decision maintains the status quo tension between the exclusivity arising under patent law and its counter prohibitions on restraint of free competition under antitrust law. Until the Court decides to hear a "reverse payment case," it can be expected that both the practice and the uncertainty about its legality will continue.
Court Report

March 6, 2011

By Sherri Oslick —

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

Schering Corp. et al.v. Kappos
1:11-cv-00457; filed March 1, 2011 in the District Court of the District of Columbia

• Plaintiffs: Schering Corp.; Merck & Co., Inc.
• Defendant: David Kappos

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 7,304,078 ("Thrombin Receptor Antagonists," issued December 4, 2007). View the complaint here.

Cellectis S.A. v. Precision Biosciences Inc.
1:11-cv-00173; filed March 1, 2011 in the District Court of Delaware

Infringement of U.S. Patent No. 7,897,372 ("I-CreI Meganuclease Variants With Modified Specificity, Method of Preparation and Uses Thereof," issued March 1, 2011) based on Precision's use of its Directed Nuclease Editor technology. View the complaint here.

Precision BioSciences, Inc. v. Cellectis S.A.
5:11-cv-00091; filed March 1, 2011 in the Eastern District of North Carolina

Declaratory judgment of non-infringement and invalidity of U.S. Patent No. 7,897,372 ("I-CreI Meganuclease Variants With Modified Specificity, Method of Preparation and Uses Thereof," issued March 1, 2011) based on Precision's use of its Directed Nuclease Editor technology. View the complaint here.

Cephalon Inc. et al.v. Mylan Pharmaceuticals Inc. et al.
1:11-cv-00164; filed February 24, 2011 in the District Court of Delaware

• Plaintiffs: Cephalon Inc.; CIMA Labs Inc.
• Defendants: Mylan Pharmaceuticals Inc.; Mylan Inc.

Infringement of U.S. Patent Nos. 6,200,604 ("Sublingual Buccal Effervescent," issued March 13, 2001) and 6,974,590 (same title, issued December 13, 2005) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Cephalon's Fentora® (fentanyl citrate buccal tablets, used to treat breakthrough pain in adult patients with cancer). View the complaint here.

Takeda Pharmaceutical Co., LTD et al.v. Handa Pharmaceuticals, LLC
5:11-cv-00840; filed February 23, 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: Handa Pharmaceuticals, LLC

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 Handa'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.
Conference & CLE Calendar

March 6, 2011

March 16-17, 2011 – FDA Boot Camp*** (American Conference Institute) – New York, NY

March 18, 2011 – Intellectual Property Panel Symposium (George Washington University Law School) – San Francisco, CA

April 5-6, 2011 – International Patent Forum 2011 (Managing Intellectual Property) – London, UK

April 6-9, 2011 – 26th Annual Intellectual Property Law Conference (American Bar Association Section of Intellectual Property Law) – Arlington, VA

April 15, 2011 – 2nd Annual John Marshall Law School Review of Intellectual Property Law Symposium – Chicago, IL

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

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

***Patent Docs is a media partner of this conference or CLE
2nd Annual JMLS RIPL Symposium

March 4, 2011

The John Marshall Law School Review of Intellectual Property Law will be holding its 2nd Annual Symposium from 9 am to 5 pm on April 15, 2011 at the John Marshall Law School in Chicago, IL. The symposium will offer presentations on the following topics:

• Biosimilars
• Biosecurity
• Inequitable conduct
• TRIPS and TM rights
• Keynote speaker: Dr. Ananda Chakrabarty
• 1,000 genomes project
• Gene patents and DNA in the courts
• Medical diagnostic and biomarker-based patents
• Intersection of international patent protection and public health epidemics

Those interested in registering for the symposium online can do so here (scroll to event and click on "Register Online"); the registration fee is $25 (JMLS student rate) or $75 (general registration).
27th Annual Joint Patent Practice Seminar

March 4, 2011

The Connecticut, New Jersey, New York, and Philadelphia Intellectual Property Law Associations will be holding their 27th Annual Joint Patent Practice Seminar on April 27, 2011 in New York, NY. The seminar will consist of five panels: USPTO Practice, Pharmaceuticals/Life Sciences, Licensing/Foreign Practice, Ethics, and Litigation with each panel addressing a series of cases and topics. In particular, the panels will focus on the following cases and topics:

Panel I — USPTO Practice (9:30 to 10:30 am)

• Hyatt v. Kappos (Fed. Cir. 2010) (en banc)
• Bringing the fight to the patentee: Ex parte and inter partes reexamination
• Encyclopedia Britannica v. Alpine Electronics of America Inc. (Fed. Cir. 2010)
• 2010 KSR guidelines update (September 1, 2010): Updated PTO guidelines on obviousness determinations in a post-KSR world
• Q&A — 15minutes

Panel II — Pharmaceuticals/Life Sciences (10:45 to 11:35 am)

• King Pharmaceuticals Inc. v. Eon Labs Inc. (Fed. Cir. 2010)
• Prometheus Labs Inc. v. Mayo Collaborative Services and Classen Immunotherapies, Inc. v. Biogen
• Association for Molecular Pathology v. USPTO ("Myriad")
• Daiichi Sankyo Co. v. Matrix Laboratories Ltd. (Fed. Cir. 2010)
• Q&A — 10minutes

Panel III — Licensing/Foreign Practice (11:35 am to 12:35 pm)

• Global Tech v. SEB
• Stanford v. Roche
• Alfred E. Mann Foundation for Scientific Research v. Cochlear Corp.
• Costco v. Omega (2010)
• Abraxis Bioscience, Inc. v. Navinta LLC (Fed. Cir. 2010) and Spine Solutions v. Medtronic (Fed. Cir. 2010)
• Q&A — 10minutes

Panel IV — Ethics (1:50 to 3:15 pm)

• TheraSense Inc. v. Becton, Dickinson & Co.
• TIVO v. EchoStar
• Princo Corp. v. International Trade Commission (Fed. Cir. 2010)
• Ring Plus Inc. v. Cingular Wireless Corp. (Fed. Cir. 2010)
• Media Queue v. Netflix
• Lockwood v. Sheppard Mullin
• Ethical Considerations under the Federal Rules of Civil Procedure as Amended as of December 2010
• Q&A–15minutes

Panel V — Litigation (3:30 to 5:00 pm)

• False patent marking cases
• Wyers v. Masterlock (Fed. Cir. 2010)
• Hewlett-Packard Co. v. Acceleron LLC (Fed. Cir. 2009)
• Fujitsu Ltd. v. Netgear Inc. (Fed. Cir. 2010)
• Microsoft v. i4i
• Goeddel v. Sugano (Fed. Cir. 2010)
• Transocean Offshore Deepwater Drilling Inc. v. Maersk Contractors USA Inc. (Fed. Cir. 2010)
• Uniloc USA v. Microsoft
• Q&A –-10minutes

A featured morning address will be given between 8:45 – 9:35 am by Director David Kappos of the U.S. Patent and Trademark office. The lunch keynote speaker will by Circuit Judge Arthur J. Gajarsa of the U.S. Court of Appeals for the Federal Circuit.

A preliminary program preview for the seminar can be found here.

The seminar will be held at the Hilton New York, 1335 Avenue of the Americas. The registration fee for the conference is $440 (for those registering by April 14, 2011) or $470 (for those registering after April 14, 2011). Those interested in registering for the conference can do so by submitting a reservation form that can be obtained here.
26th Annual Intellectual Property Law Conference

March 4, 2011

The American Bar Association (ABA) Section of Intellectual Property Law will be holding the 26th Annual Intellectual Property Law Conference on April 6-9, 2011 in Arlington, VA. Among the topics that will be covered at the conference are

• Reform inside & outside the USPTO;
• Contrasting USPTO and Judiciary treatment of patent Issues: How the differing standards impact your practice;
• Litigating damages: Does the hypothetical negotiation work?
• The advent of biosimilars and its potential effect on patent litigation;
• Hot topics in international IP law and practice;
• Enhanced damages, willfulness and the adverse inference post-Seagate: How much has really changed?
• Contested Patent Office proceedings: Why they should not be overlooked as part of your IP strategy;
• Recent developments in patent term adjustments and extensions;
• Intellectual property as a corporate asset and managing outside counsel;
• Therasense, Inc. v. Becton, Dickinson & Co. — Discussion of en banc review; and
• Hot topics in patent litigation.

On April 7, the luncheon speaker will be Chief Judge Randall R. Radar of the U.S. Court of Appeals for the Federal Circuit. In addition, an evening reception will be held at the U.S. Court of Appeals for the Federal Circuit. On April 8, the luncheon speaker will be Robert Stoll, Commissioner for Patents, U.S. Patent and Trademark Office.

The program schedule for the conference can be found here. The registration fee is $295 (law students), $345 (corporate counsel and government, public interest, and academic rate), $695 (ABA-IPL section members and members of co-sponsoring section), $765 (ABA members), or $845 (non-ABA members). Those registering before March 22, 2011 will receive a $50 discount. Detailed registration information (and a registration form) can be found here.

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