Orange Book Blog

McAndrews, Held & Malloy and Volker Vossius to Co-Host Patent Law Symposia in Chicago and Munich

The law firms of McAndrews, Held & Malloy and Dr. Volker Vossius will be co-hosting two complimentary patent law symposia next month--one in Chicago and the other in Munich.  CLE credit will be available.

On May 3, 2011, the firms will sponsor a symposium in Munich, entitled "U.S. and European Patent Law Update for European Practitioners."  The symposium will be held at the Hotel Vier Jahreszeiten Kempinski, from 14:00 to 18:00, and will be followed by a cocktail reception.  The agenda includes:

• Inventions under the German Employee's Inventions Act - relevant aspects in light of the new law from October 2009, by Dr. Susanne Schollweck
• Update on U.S. patent damages law, by Thomas J. Wimbiscus
• Supplementary protection certificates - recent decisions and current topics, by Dr. Kathrin Körner
• Update on recent case law of the EPO, by Dr. Jörk Zwicker
• Biosimilars legislation in the U.S., by Troy A. Groetken
• EPC trends in pharma patenting, by Dr. Georg Schnappauf

On May 19, 2011, the firms will sponsor a symposium in Chicago, entitled "Global Practical IP Perspectives."  The symposium will be held at the offices of McAndrews, Held & Malloy, from 8:00 a.m. to 4:30 p.m., and will include a complimentary lunch and cocktail reception.  The agenda includes:

• Protecting trade secrets to better enforce enforce them in litigation and avoiding or defending trade secret lawsuits, by Greg Vogler
• Pharmaceutical life cycle management in Europe -- challenges and chances of a changing environment, by Dr. Kathrin Körner
• The current state of intellectual property in view of pending Supreme Court cases, by Robert A. Surrette and Eligio C. Pimentel
• Update on recent case law of the EPO, by Dr. Jörk Zwicker
• Patent licensing, by William M. Wesley
• Alternative dispute resolution: improving your odds, by Leland G. Hansen
• Status of U.S. patent reform 2011, by Dr. Nabeela Rasheed
• EPC trends in pharmaceutical patenting, by Dr. Georg Schnappauf
• Obligations of confidentiality and candor, by Wendy J. Muchman
• Reducing the cost of discovering electronically-stored information, by Gregory C. Schodde

To attend, please RSVP to [email protected] (for Munich) or [email protected] (for Chicago).

District Court Set to Decide Whether Ranbaxy Forfeited 180-Day Exclusivity on Generic Lipitor

Mylan Pharms. and Matrix Labs. v. FDA, No. 11-566 (D.D.C.)

Last month, Mylan filed suit against the FDA in the U.S. District Court for the District of Columbia, seeking a declaration that there is no applicable period of 180-day exclusivity for generic Lipitor (atorvastatin) that would block approval of Mylan's atorvastatin ANDA; and an injunction preventing FDA from withholding final approval of Mylan's ANDA on the basis of Ranbaxy's 180-day exclusivity.  Within days, Mylan filed a motion for preliminary injunction.  FDA and Ranbaxy (as Intervenor) then filed motions to dismiss Mylan's complaint.  Briefing on the motions was recently completed, and the briefs are available below.

The crux of Mylan's suit is that "FDA has arbitrarily, unreasonably, and unlawfully failed to decide whether the Agency will enforce the terms of its Application Integrity Policy ("AIP") against the atorvastatin ANDA application submitted by Ranbaxy."  According to the Complaint, "FDA found that Ranbaxy engaged in a pattern and practice of submitting to FDA drug applications containing false and unreliable data generated from Ranbaxy's Paonta Sahib, India manufacturing site, where, Ranbaxy markets its generic LIPITOR."  Mylan contends that "if FDA enforces the AIP against Ranbaxy's ANDA, then the plain language of the FDA Act and the AIP require FDA to deny Ranbaxy's ANDA, and terminate any period of 180-day marketing exclusivity originally provided to Ranbaxy."

According to Mylan, Ranbaxy cannot market generic Lipitor before November 2011 (due to a settlement with Pfizer), meaning that if Ranbaxy has 180-day exclusivity, other generic makers could not enter the market until May 2012.  But in the absence of Ranbaxy's 180-day exclusivity, Mylan could launch its generic Lipitor as early as June of this year.  Mylan further states that "upon market entry of generic LIPITOR, it is estimated that U.S. consumers, the government, and third party payors could save between $10.9 million and $18.6 million per day, which equates to between $3.97 billion and $6.8 billion in potential savings per year."

FDA, in its motion to dismiss, responds that Mylan lacks standing, because it has not (yet) been injured; Mylan's claims are not ripe, because its own ANDA is not ready for approval; FDA's enforcement discretion is not subject to judicial review; and Mylan fails to state a claim for unreasonable delay under the Administrate Procedure Act.

A hearing on the motions is scheduled for April 28th at 9:30 a.m.  The court should issue a decision shortly thereafter.

Filings:

• Mylan v. FDA Complaint
• Mylan Motion for Preliminary Injunction
• FDA Motion to Dismiss and Opposition to Motion for PI
• Ranbaxy Motion to Dismiss and Opposition to Motion for PI
• Mylan Reply i/s/o Motion for PI and Opposition to Motion to Dismiss
• FDA Reply i/s/o Motion to Dismiss
• Ranbaxy Reply i/s/o Motion to Dismiss
• Mylan Surreply in Opposition to Motion to Dismiss
  

Federal Circuit Authorizes Narrowing Reissue Patents That Only Add Dependent Claims

In re Tanaka, No. 2010-1262 (Fed. Cir. 2011)

    by Nabeela Rasheed

Once a patent issues it behooves the patentee to scrutinize the claims to ensure that it has claimed all that it had a right to claim.  Where the patentee discovers that without deceptive intent the patent claims more or less than it should have, the patentee can seek a reissue patent under 35 U.S.C. §251.  In In re Tanaka, decided today, the Federal Circuit held that the simple omission from a patent of a dependent claim is sufficient reason to allow the patentee to seek reissue.  While today’s decision concerned a patent directed at an alternator pulley for improving an automobile alternator’s efficiency, it applies equally to pharmaceutical patents.

In re Tanaka addressed an appeal from a decision of the Board of Patent Appeals and Interferences.  The Board had been asked to address the question of whether an examiner “erred in determining that the presentation of a narrower claim in a reissue application that still contains all of the original patent claims does not present the type of error correctible by reissue under 35 U.S.C. § 251.”  Procedurally, the Applicant initially had tried to broaden claim 1 with the reissue but during prosecution went back to the original scope of issued claim 1 while including in the reissue application a new claim dependent from original issued claim 1.  Thus, the only “error” the Applicant presented was the lack of presence of this dependent claim in the original issued patent.  The Board affirmed the Examiner’s decision by interpreting § 251 as not allowing a reissue where the sole correction in the reissue is the addition of a narrower dependent claim while retaining the original claims as issued.

At the Court of Appeals, the PTO took the position that omission of a dependent claim does not make the patent “partially inoperative” because the subject matter of the dependent claim is covered by the independent parent claim.  Moreover, the PTO argued that omitting the dependent claim is not a case of “claiming more or less than the patentee had a right to claim in the patent.”

The Federal Circuit disagreed, relying on Judge Rich’s opinion from In re Handel 312 F2d 943 (CCPA 1963), and concluded that “adding dependent claims as a hedge against possible invalidity of original claims is a proper reason for asking that a reissue be granted.” According to the majority opinion, hedging against the possible invalidity of the broader independent claims has been tacitly approved and is in accordance with the remedial purposes of the reissue statute.  Further, for the purposes of § 251 “inoperative” is construed as “inoperative adequately to protect the invention”  The Federal Circuit advises that contrary to the Board’s assertions, applying for a reissue that adds only narrower claims without amending any of the original claims is not the same as a “no defect” reissue.

Thus, the Federal Circuit holds that omission of a narrower claim from a patent can render a patent partly inoperative by failing to protect the disclosed invention to the full extent allowed by law.  This case thus allows the applicant a second bite at the apple to pick up any additional dependent claims he/she may have forgotten along the way during prosecution.  Because the addition of a dependent claim is a “narrowing” amendment it is not subject to the 2 year broadening statute of limitations of the reissue statute and thus a reissue adding an omitted dependent claim could be filed at any time during the lifetime of the patent.

Judge Dyk dissented – mostly reasoning that the precedent relied on by the majority did not address the issue of whether inclusion of a narrower claim is sufficient basis for a reissue.  Judge Dyk reasoned that some correction of an error affecting the original claims is required and in the present case the addition of the dependent claim had no impact on the applicants rights under the original patent.

The case was remanded to the PTO.

ACI "Paragraph IV Disputes" Conference, New York City, May 3-4

American Conference Institute will be holding its 5th annual "Paragraph IV Disputes" conference in New York City on May 3rd and 4th at the Marriott New York Downtown.  This is a great conference if you're looking to keep up with the latest developments in Paragraph IV litigation.

I will be speaking at the conference on May 3rd, on "Forfeiture of Exclusivity Dilemmas Relative to Paragraph IV Litigation."  The other talks include:

• Pre-Suit Due Diligence Strategies:  Anticipating Paragraph IV Challenges to Small Molecule and Small Protein Patents
• "Invalid or Will Not Be Infringed":  Re-Assessing the ANDA Applicant's Pre-Litigation Considerations and Obligations Under Paragraph IV vis-a-vis Microsoft v. i4i
• New Standards and Controversies in Obviousness-Type Double Patenting:  Repercussions for Paragraph IV Challenges
• Throwing Down the Gauntlet:  The Paragraph IV Notice Letter
• Let the Games Begin:  The Start of the Paragraph IV Law Suit--Pleadings and Considerations
• A View From the Bench on Paragraph IV Litigation (featuring Judges Garrett E. Brown, Joel A. Pisano, and Tonianne Bongiovanni, all from the District of New Jersey)
• Mastering Regulatory Maneuvers essential to PIV Litigation
• FTC Keynote:  Pay for Delay Settlements (by Markus H. Meier, Assistant Director at the Federal Trade Commission)
• Damages and Injunctions:  Exploring the Consequences and Conundrums of Launching At Risk
• Alleging and Defending Against Inequitable Conduct in a Paragraph IV Case:  Legal and Ethical Considerations
• Discovery Strategies and Other Pre-trial Tactics for Brand Names and Generics

In addition, ACI is offering a pre-conferencce workshop, "Hatch-Waxman and BPCIA 101," on May 2nd; and a post-conference workshop, "The Master Class on Settling Paragraph IV Disputes," on May 5th.

For more information or to register, please visit the conference website.  Use discount code OBB to save $400 on registration fees.  I hope to see you there!

I've Moved!

Dear Readers,

I am happy to report that I recently joined McAndrews Held & Malloy, a large IP law firm in Chicago.  The left sidebar of the blog is updated with my new contact information.

I will soon resume regular posting on Orange Book Blog, and I anticipate that some of my new colleagues will contribute posts as well.

Thank you for continuing to read Orange Book Blog!

Aaron Barkoff