Patent Docs

Reaction to Senate Passage of S. 23

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

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

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

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 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

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

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

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.

International Patent Forum 2011

Managing Intellectual Property will be holding the International Patent Forum 2011 on April 5-6, 2011 in London, UK.  Among the topics that will be covered at the forum are:

• National offices and international trends;
• Forum shopping in Europe;
• Licensing and tech transfer: making the most out of your patent;
• Cross border patent infringement strategies in Latin America -- An in-house perspective;
• Risk management and defense strategies;
• Latest issues in life sciences;
• How to protect your innovations in China;
• Obtaining patent protection for early-stage inventions;
• Comparing patent reform across jurisdictions; and
• Best practices in portfolio management.

The program schedule for the forum can be found here.  The registration fee for the forum is €1,195 (private practice rate), €595 (in-house counsel rate), or €395 (academic/research institute rate).  Those interested in registering can do so here, by e-mailing hotline@euromoneyplc.com, by calling +44 20 7779 8999, or by faxing a registration form to +44 20 7779 8279.

Senator Feinstein Opposes First-to-File Provisions of Patent Reform Bill (S. 23)

By Kevin Noonan --

On Wednesday afternoon, Senator Dianne Feinstein (D-CA) (at right) addressed the Senate, calling for passage of an amendment to strip the "first-inventor-to-file" provisions from the Senate patent reform bill (S. 23).  That amendment lost, 87-13 on Thursday, but her 5-minute speech raised important issues for the House of Representatives to consider when it takes up patent reform legislation (as well as issues that may be raised in any Constitutional challenge).  Senator Feinstein said the following:

I rise today to offer an amendment [SA 133] to strike the first to file provisions of this bill.  I am joined in this effort by my co-sponsors, Senator [James] Risch [R-ID], Majority Leader [Harry] Reid [D-NV], and Senators [Mike] Crapo [R-ID] and [Barbara] Boxer [D-CA].  I also ask unanimous consent that Senator [John] Ensign [R-NV] be added as a co-sponsor of the amendment.  I know that the bill has contained these provisions for some time now, and I acknowledge that I have voted for different versions of it that contained these provisions.  But I've heard more and more in the past two years from small . . . inventors, startup companies, small businesses, venture capitalists, and yes even large companies, from all around our country, but especially in my state of California, that this proposed transition, from our first to invent system to a first to file system would be severely harmful to innovation, and especially burdensome on small inventors, startups, and small businesses.  And I have become convinced that it's the wrong thing to do.

For the benefit of my colleagues, who have not been so embroiled in this rather technical issue, let me provide a little background.  For over a century, our country has awarded patents to the first inventor to come up with an idea, even if somebody else beat them to the Patent Office.  A "first to invent" system, and we have done very well under the first to invent system.  This bill would change that, so that the first person to file an application to a patent for a particular invention would be entitled to that patent, even if another person actually created the invention first.  And this is what's known as the "first to file" system.

Now the argument . . . that's made for transitioning is that the rest of the world follows first to file, and this will harmonize our system with theirs.  This is really supported by big companies, who have already made it, who have an international presence.  Therefore, I understand their support for first to file.  But under first to invent, we have been the world's leader in innovation, and the first to file countries have been playing catch-up with our technological advances.  So without all due respect, I wouldn't trade America's record of innovation for that of virtually any other country, or certainly any first to file country.  The genius of America is inventions in small garages and labs, and great ideas that come from inspiration and perspiration in such settings and then take off.  So many of America's leading companies -- Hewlett Packard, Apple, Google, even AT&T arising from Alexander Graham Bell's lab, for example -- started in such settings and grew spectacularly, creating jobs for millions of Americans and lifting up our economy and standard of living.

A coalition of affected small business groups, including the National Small Business Association and others, recently said and I quote, that "first to file disrupts the unique American startup ecosystem that has led to America's standing as the global innovation leader."  It's critical, I believe, that we continue to protect and nurture this culture of innovation.  And preserving the first to invent system that has helped foster it, is essential to do this.

Moreover, this bill would not actually harmonize our patent priority system with that of the rest of the world.  Many first to file countries allow more extensive use of prior art to defeat a patent application, and provide for greater prior user rights than this bill would provide.  And Europe does not provide even the limited one-year publication grace period that this bill does.

An important part of this debate are the changes the bill makes to the so-called "grace period" that inventors have under United States current law.  Presently, a person's right to their invention is also protected for one year from any of the following:  1) describing their invention in a printed publication; 2) making a public use of the invention; or 3) offering the invention for sale.  This is called "the grace period," and it's critical to small inventors.  108 startups and small businesses wrote last year and I quote, "U.S. patent law has long allowed inventors a one year grace period so that they can develop, vet and perfect their invention, begin commercialization, advance sales, seek investors and business partners, and obtain sufficient funds to prosecute the patent application."  During that grace period, many inventors learn about starting a technology-based business for the first time.  They must obtain investment capital.  They often have to learn from outside patent counsel (at considerable expense) about patenting and related deadlines and how to set up confidentiality agreements.  Many startups or small businesses are in a race against insolvency during this early stage.  The grace period protects them during this period, and loss of patent rights due to any activities, any information leaks or inadvertent unprotected disclosures prior to filing their patent applications.

S. 23 eliminates this grace period for offering an invention for sale or making a public use of it, leaving only a grace period from, quote, "disclosure" of the invention.  There are two problems with this.  First, disclosure is not defined in the bill.  This will generate litigation, while the courts flesh out that term's meaning.  While this plays out in the courts, there will be uncertainty about whether many inventions are patentable or not.  This uncertainty will in turn chill investment, as venture capitalists will be reluctant to invest until they are confident that the inventor will be able to patent on their own invention.  Secondly, because of this lack of definition, some patent lawyers interpret "disclosure" to mean a disclosure that is sufficiently detailed to enable a person of ordinary skill in the particular art to make the invented item.  In practical terms, this means a patent application or a printed publication.

Now this does provide some protection to universities, it's true; they often publish about their inventions.  However, it is scant protection for the small inventor.  They don't publish about their inventions, until they file a patent application.  As the 108 small businesses put it, and I quote, "no business willingly publishes complete, technical disclosures that will tip off all competitors to a company's technical direction.  Confidentiality is crucial to small companies."  The grace period from offering for sale or public use really is critical for their protection.  Eliminating it, will in the words of these small businesses, quote, "practically gut the American one-year grace period."  The National Small Business Association wrote recently, and I quote, "The American first to invent, grace period patent system has been a major mechanism for the dynamism of small business innovation.  It is clear that the weak or entirely absent grace periods used in the rest of the world's first to file patent systems, throttle small business innovation and job creation."

Our amendment would provide [sic, protect] America's world-leading system.  I'm also very concerned that first to file would proportionately disadvantage small companies and startups with limited resources.  I've become convinced that this change would impede innovation and economic growth in our country, particularly harming the small, early-stage businesses that generate job growth.  Obviously the process of innovation starts with the generation of ideas.  Small California companies and inventors have described to me, however, how most of these ideas ultimately do not pan out.  Either testing or development proves that they are not feasible technologically, or they prove not to be viable economically.  Unfortunately, first to file incentivizes inventors to race to the Patent Office, to protect as many of their ideas as soon as possible, so they're not beaten to the punch by a rival.  Thus, first to file will likely result in significant over-filing of these dead end inventions, unnecessarily burdening both the Patent and Trademark Office and inventors.

As Paul Michel, former Chief Judge of the Court of Appeals for the Federal Circuit, and Gregory Junamen, President of the International Federation of Professional and Technical Engineers put it in a recent letter to the [Judiciary] Committee, and I quote, "as Canada recently experienced, a shift to a first to file system can stimulate mass filing of premature applications as inventors rush to beat the effective day of the shift or later filings by competitors."  This presents a particular hardship for independent inventors, for startups and for small businesses, which do not have the resources, and volume, to employ in-house counsel, but must instead rely on more costly outside counsel to file their patents.  This added cost will drain resources away from the viable ideas that can build a patent portfolio, and a business.  At a time when the Patent and Trademark Office has a dramatic backlog of one million patents waiting to be examined and a pendency time of some three years, Congress should be careful to ensure that any legislative changes will not increase patent filings that are untruthful.

The counter argument is made that a small inventor could file a cheap, provisional patent application and that's sufficient protection.  However, patent lawyers who work with small clients have said that they advise their clients not to treat a provisional application any less seriously than a full patent application.  If there is part of an invention that's left out of the provisional application, that application will not be protected, and the parts that are included in the provisional application will also be vulnerable, under an attack that the inventor failed to disclose the best mode of the invention, by leaving out necessary information.

The argument is made that first to file will establish a simple, clear priority of competing patent applications.  Proponents of first to file argue that it will eliminate costly, burdensome proceedings to determine who actually was the first to invent, which are known as interference proceedings.  However, the reality is that this is not a significant problem under our current system.  There are only about 50 interference proceedings per year to resolve who made the invention first.  This is out of 480,000 patent applications that are submitted each year.  In other words, one hundredth of one percent of patent applications.

Another problem with the bill's first to file system is the difficulty of proving that someone copied your invention.  The bill's proponents assert that it protects against one person copying another person's invention by allowing the first inventor to prove that, and I quote, "such other patent was derived from the inventor of the invention."  Currently, you as a first inventor can prove that you were first by presenting evidence that's in your control:  your own records, contemporaneously documenting the development of your invention.  But to prove that somebody else's patent application came from you (under the bill, was "derived" from you), you would have to submit documents showing this copying.  Only if there was a direct relationship between the two parties will the first inventor have such documents.  If there was only an indirect relationship, or an intermediary (for example, the first inventor described his invention at an angel investor presentation or he didn't know the identities of many in attendance), the documents that show derivation (which means "copying") are not going to be in the first inventor's possession.  They would be in the second party's possession.  You would have to find out who they talked to, who they e-mailed with, to trace it back to your original disclosure.  But the bill doesn't provide for any discovery in these derivation proceedings.  So the first inventor can't prove their claim.

For these reasons, and many others, the first to invent system, which I believe has made our nation the leader in the world, which our amendment would preserve, is supported by numerous people and businesses around the country, including the National Small Business Association, the Coalition for Patent Fairness (that's a coalition of large, high-tech companies), the Institute of Electrical and Electronics Engineers, which has 395,000 members, the International Federation of Professional and Technical Engineers, AFL CIO, the University of California system, the University of Kentucky, Paul Michel, the former Chief Judge of the U.S. Court of Appeals for the Federal Circuit, which plays a critical role in hearing appeals in patent cases, and the U.S. Business and Industry Council, American Innovators for Patent Reform, the National Association of Patent Practitioners, Professional Inventors Alliance USA, Connect, a trade association for small technology and life science businesses, and many small inventors, as represented for instance by a letter signed by 108 startups and small businesses from across the country.

. . .

Mr. President, I don't often agree with the organization Gun Owners of America, an organization that believes that the National Rifle Association is too liberal.  But I do agree with them on this issue.  They are part of the coalition of 23 conservative organizations that wrote to the leaders about this, arguing and I quote, "our competitors should have to harmonize up to our superior intellectual property regime, rather than our having to weaken our patent system and harmonize down to their levels.  There are many other signatories, but I think this is really a battle between the small inventor, the beginning in the garage, the Apple computer who was nowhere, who through the first to invent system was able to create one of the greatest companies in the world.  America's great strength is the cutting edge of innovation and the first to invent system has served us well.  You know, if it isn't broke, don't change it and I don't really believe its broke.

Of course, the amendment was defeated.  But Senator Feinstein's remarks may contain a glimmer of how the first to file regime may be opposed when matters go to the House of Representatives.  Perhaps those members will be more receptive to the sentiment from the Gun Owners, that harmonization makes more sense if it improves, rather than weakens, the patent system.  Or at least there may be a sentiment to require that the other major patent offices provide a U.S. grace period before the first to file provisions comes into effect (which was a requirement in the last patent reform bill to pass the House three years ago).  Senator Feinstein's remarks can be viewed here.

Biotech/Pharma Docket

By James DeGiulio --

Abbott and Elan End TriCor Suit with Ranbaxy

After only a few months, Abbott Loaboratories and Elan Pharma International, along with Abbott subsidiary Fournier Laboratories, have dropped their patent suit against Ranbaxy Laboratories over the latter's generic version of the cholesterol drug TriCor.  The dispute between the companies began in June 2010, when Abbott, Fournier, and Elan brought two suits against Ranbaxy in the U.S. District Court for the District of New Jersey following Ranbaxy's ANDA filing in April for a generic fenofibrate drug (see "Court Report," June 13, 2010).  The plaintiffs accused Ranbaxy of infringing Fournier's U.S. Patent Nos. 6,277,405, 7,037,529, and 7,041,319, in one action, and Elan's and Fournier's 7,276,249 and 7,320,802 in the other action.  Abbott is the exclusive licensee of the patents, while Elan has developed a system for controlling how the drug is absorbed by the body.  The plaintiffs alleged that Ranbaxy acted without a reasonable basis or a good faith belief that it would not be liable for infringing the patents and asked for a preliminary injunction.  Ranbaxy filed counterclaims in August, asserting patent invalidity and noninfringement.

On February 17, Judge Garrett E. Brown Jr. signed off on the parties' joint stipulation of dismissal, dropping both the claims and counterclaims without prejudice and without admitting any liability.  Judge Brown's order can be found here.  On February 28, Elan subsequently dropped its claims against Ranbaxy, and the two sides also agreed to drop Ranbaxy's invalidity counterclaims.  The order for the latter dismissal can be found here.  The end of these suits could mean Ranbaxy can now enter the U.S. market.

Merck and Teva Settle Patent Dispute over Cancidas

Merck has dropped its patent suit against Teva over its planned marketing of a generic version of the anti-fungal drug Cancidas.  On November 25, 2009, Merck brought suit against Teva in the U.S. District Court for the District of New Jersey, alleging infringement of U.S. Patent Nos. 5,378,804, 5,514,650, and 5,952,300, which cover caspofungin acetate, the active ingredient in Cancidas (see "Court Report," December 7, 2009).  In May 2010, the District Court consolidated Merck's patent action against Teva with a similar lawsuit against Sandoz (see "Court Report," May 23, 2010).  Claim construction of the Merck patents at issue occurred in October through December 2010.

On February 23, Judge Stanley Chesler dismissed Merck's infringement action following its decision to settle the litigation.  Trial was set to begin in fall 2011.  All claims and counterclaims were dismissed, and each side will be responsible for its own costs and fees.  The rest of the settlement terms remain confidential.  Judge Chesler's order dismissing the case can be found here.

PDL BioPharma Settles Medimmune Synagis Litigation for $93M

After a key patent in PDL BioPharma's litigation with MedImmune was invalidated earlier this year, PDL has now settled the suit over the respiratory treatment Synagis and has agreed to pay MedImmune $92.5 million.  The relationship between the parties began in 1997, when PDL granted MedImmune a license to develop certain types of antibodies covered by five PDL patents.  In 1998, MedImmune received approval from the FDA to market the antibody drug Synagis, which is used to prevent lower respiratory tract disease in infants and children.  In December 2008, in a complaint filed in the U.S. District Court for the Northern District of California, MedImmune asked for a declaratory judgment that the five PDL patents covering the antibodies were invalid, and that it owed no payments to PDL under a patent license agreement reached by the companies (see "Court Report," December 21, 2008).  PDL argued that the patents were valid and that MedImmune's antibody treatments infringed those patents.  Leading up to the latest ruling in the case, only a single claim of one patent (U.S. Patent No. 6,180,370) remained at issue, which MedImmune claimed was invalid and which PDL claimed covered Synagis.  Recently, MedImmune moved for summary judgment of invalidity, and PDL moved for summary judgment with respect to MedImmune's restitution claim regarding the patent royalties paid.  In January, PDL was dealt a blow when a ruling came down invalidating the '370 patent at issue in the case (see "Biotech/Pharma Docket," January 20, 2011).

In the settlement, PDL agreed to pay $65 million immediately and pay another $27.5 million one year from now.  In return, MedImmune, a unit of AstraZeneca PLC, agreed to dismiss with prejudice its invalidity claims against PDL's patent.  The settlement resolves the last remaining claim of the long-standing patent dispute.  Details regarding the settlement can be found here.

Patent Reform Bill (S. 23) Debated and Amended on Senate Floor

By Kevin E. Noonan --

On Tuesday, for the second day in a row, Senator Patrick Leahy (D-VT) (at right) stood on the floor of the Senate and argued for his colleagues to pass S. 23, now named the "Invent America Act."  In Tuesday's action (which can be seen here:  Senate Session, Part I and Senate Session, Part 2), Senator Leahy introduced a Manager's Amendment (the reported provisions of which are summarized below).  In addition, Senator Mark Kirk (R-IL), joined by Senator Mark Pryor (D-AR), introduced an amendment (S.AMDT.123) to provide a fast lane for small businesses within the USPTO, while Senator DeMint (R-SC) introduced an amendment not germane to patent law.  Senator Leahy, while yielding to permit these amendments to be entered, insisted in each instance that the Manager's Amendment be the amendment under consideration by the Senate at all times.

The Manager's amendment is expected to have the following effects:

• Change the title of S. 23 to the "America Invents Act"

• Change the date of the repeal of statutory invention registrations, which are used only in first-to-invent, to conform to the date of the change to first-inventor-to-file.

• Strike all damages language remaining in the bill -- including the gatekeeper, sequencing, and recodification of current law as subsection (a) which was the "grand compromise" brokered in the last Congress by Senator Dianne Feinstein (D-CA), then-Senator Arlen Spector (R, then D-PA), and Senator Leahy.  The bill now makes no changes to 35 U.S.C. § 284; this turn of events is ironic, in view of the importance of changes to this section in motivating support and providing the genesis for patent reform.

• Regarding the post-grant review provisions, replace the subsection imposing a six-month deadline on filing after litigation is commenced with a provision requiring a court to consider a preliminary injunction without taking the existence of either a petition or post-grant review proceeding into account if the patent owner sues within 3 months of the issuance of patent.

• Limit the post-grant review provisions to only "first-inventor-to-file" patents -- i.e., "first-to-invent" patents will not be subject to post-grant review.  The rationale for this change is that first-to-invent patents raise discovery-intensive invention-date and secret-prior-art issues that would be difficult to address in an administrative proceeding.  This also facilitates PTO institution of the post-grant review regime.  In light of this change, the time for implementing post-grant review is moved back to one year after enactment, so that it becomes effective at the same time other provisions of the new law are implemented, which is what the PTO is said to prefer.

• Give the Director discretion to continue to use old inter partes reexam during the first four years after the new law is implemented.  The Director believes his reforms in the Office have greatly improved the existing inter partes procedure, and it may actually work more efficiently.  The existing inter partes procedure can also be used for post-grant review proceedings that are instituted only on the basis of patents and printed publications.

• Strike the codification of the In re TS Tech USA Corp. case regarding transfer-of-venue rule.  TS Tech already applies as a matter of case law in the Fifth Circuit.  (The Federal Circuit applies regional circuit law to procedural matters, and reads Fifth Circuit law as applying the transfer of venue rule.)  Complaints about venue generally focus on the Eastern District of Texas, so there is little need to apply TS Tech nationally or by Act of Congress.

• Add a new provision requiring the Director to charge reduced fees to small entities for use of accelerated examination.

• Add language making clear that the repeal of the Baldwin rule (which rule requires Federal Circuit judges to live within 50 miles of Washington, D.C.) shall not be construed to require the Administrative Office of the Courts to provide judges with office space or staff outside of D.C.

• Broaden the definition of "microentity," a status that entitles applicants to reduced fees (purportedly with PTO approval).

• In the tax patents section, add language:  (1) clarifying that the legislation does not bar patenting of tax software that is novel as software -- i.e., where the innovation is in the software, although this may not survive to final passage; and (2) establishing that making tax strategies unpatentable shall not be construed to imply that other business methods are patentable or valid.  This is intended to avoid the implication from Bilski v. Kappos (2010), where the Supreme Court interpreted Congress's 1999 enactment of a prior-user right that only applied against business-method patents as implying that business methods qualify as patentable subject matter under § 101, which was enacted in 1793.

• Add language to the part of the bill regarding the Surpreme Court's decision in Holmes Group v. Vornado Air Ciculation System allowing removal of patent cases from state to federal court to clarify that derivative jurisdiction is not required in such cases.  (Derivative jurisdiction is the doctrine that, even if a federal district court would have had original jurisdiction over an action, on removal, the district court can only have jurisdiction if the state court from which the action is removed properly had jurisdiction.)

• Include the Schumer-Kyl business-methods amendment, modified to accommodate industry concerns and PTO needs.  The Schumer amendment provides for a proceeding that is a relatively cheap alternative to civil litigation for challenging these patents, which will reduce the burden on the courts of dealing with invalid business-method patents.  The proceeding has been limited since mark up so that:  (1) only defendants or accused infringers may invoke the proceeding; (2) prior art is limited to existing § 102(a), which must be publicly available, or prior art of existing § 102(b) scope that falls outside the existing § 102(b) grace period (i.e., effectively, existing § 102(b) prior art but limited to existing § 102(a)'s publicly-available prior-art scope); (3) the proceeding may not be used to challenge a patent while it is eligible for a post-grant review challenge (i.e., a "first-inventor-to-file" patent during the first 9 months after its issue); (4) the proceeding is available only for four years; (5) district courts can decide whether to stay litigation based on the four-factor Broadcast Innovation v. Charter Communications test, and the Federal Circuit can review the decision to stay on interlocutory appeal to ensure consistent application of established precedent; (5) the definition of business-method patent, which tracks the language of Class 705, is limited to data processing relating to just a financial product or service (rather than also to an enterprise.

• Give the PTO greater flexibility in paying and compensating the travel of APJs.  A large number of APJs will need to be recruited, trained, and retained to adjudicate post-grant review and derivation actions.  This change's enhancements will be paid for out of existing funds.

• Include the Coburn amendment ending fee diversion.  Currently, PTO fees go into a Treasury account and are only available to the Office as provided in appropriations.  In the last two decades, about $800 million in PTO user fees has been diverted from PTO to other federal spending.  The Coburn amendment creates a revolving fund, giving PTO direct access to its fees without the need for enactment of an appropriations act.

In addition, in a separate amendment, the Office is authorized to set its own fees:

(1) IN GENERAL.--The Director shall have authority to set or adjust by rule any fee established, authorized, or charged under title 35, United States Code, and the Trademark Act of 1946 (15 U.S.C. 1051 et seq.), notwithstanding the fee amounts established, authorized, or charged thereunder, for all services performed by or materials furnished by, the Office, provided that patent and trademark fee amounts are in the aggregate set to recover the estimated cost to the Office for processing, activities, services, and materials relating to patents and trademarks, respectively, including proportionate shares of the administrative costs of the Office.

The amendment passed on a vote of 97-2.  Senators Jon Kyl (R-AZ) and Amy Klobucher (D-MN) spoke in favor of the bill and the Manager's Amendment, with neither exhibiting any particular understanding of the issues.  Debate continued today, with Senator Feinstein (D-CA) introducing an amendment to strip the bill of the first-inventor-to-file provisions (Patent Docs will have more on this debate in a subsequent post).  (When the Senate gets through with this bill, there may not be much left.)

In view of the amendments, the principal changes constituting "patent reform" will be the change to first-inventor-to-file and post-grant review, both of which have raised concerns from sole inventors and small businesses as having a disproportionately negative effect (see "More Reaction to Senate Patent Reform Legislation").  These complaints suggest that, as has happened before, interests who believe this bill will harm their capacity to innovate should make their views known to their Senators.

European Parliament Approves Enhanced Cooperation Procedure to Create Unified EP Patent System

By James DeGiulio --

In late December, after once again failing to get unanimous approval for a united EP patent system, twelve of the EU countries supporting the unified system requested relief from "enhanced cooperation," a rarely used provision of the Lisbon Treaty (see "Several EU Members Push for Unified Patent System").  This non-traditional legislative campaign proved successful, for on February 15, the  European Parliament approved the request to use "enhanced cooperation" to launch the reform of the European system, clearing perhaps the last major hurdle leading to a new unified single patent system in Europe.  The vote passed with the support of 471 members of the parliament.  Another 160 members opposed the bill, while 42 abstained.

Although there are still additional legislative steps required to ensure the reform, the February 15 approval paves the way for EU members to move forward with their proposal to create a unified EP patent system and court, despite holdouts from Italy and Spain.  Other opponents of the unified EP patent system, such as the Czech Republic and Cyprus, have now indicated that they plan to participate in the new reform.  Under the enhanced cooperation doctrine, Italy and Spain would still be able to join the efforts at any time.

The reform still requires additional legislative steps.  The request now moves to the European Council, which is expected to approve it at the March 9-10 session.  The process would then move to the European Commission.  The Commission will then submit two legislative proposals:  one establishing the single patent under the co-decision procedure, and the other a consultation procedure on the language regime, an issue that has repeatedly stalled negotiations.  In an effort to obviate this language issue, the EPO signed a deal with Google in November 2010 to translate European patents.  Regardless of the specifics of the final proposal, the EU has never been closer to establishing a new system that will abolish the differences between patent rights in the member states, with an aim to making the patent process more streamlined, creating a more level playing field for European businesses.