• Managing Intellectual Property 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.

  • By Kevin Noonan

    Feinstein on Senate Floor 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.

  • By James DeGiulio

    Abbott and Elan End TriCor Suit with Ranbaxy

    Abbott Laboratories #1 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.

    Ranbaxy 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 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.

    Teva #2 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

    Medimmune #1 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).

    PDL BioPharma 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.

  • By Kevin E. Noonan

    Leahy, Patrick 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.

    Senate Seal 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.

  • By James DeGiulio

    European Parliament 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.

    European Union (EU) Flag 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.

  • By Donald Zuhn

    USPTO and IMPI Establish Patent Prosecution Highway (PPH) Pilot Program

    Mexican Patent Office - Instituto Mexicano de la Propiedad Industrial On Friday, the U.S. Patent and Trademark Office announced that it was establishing a new Patent Prosecution Highway (PPH) pilot program with the Mexican Institute of Industrial Property (IMPI).  As with other PPH programs, the new PPH pilot will permit an applicant having an application whose claims have been allowed in the IMPI to fast track the examination of an application in the USPTO, or vice versa, such that the latter application is examined out of turn.  In particular, an applicant receiving a ruling from the USPTO (or the IMPI) that at least one claim in an application is patentable may request that the IMPI (or USPTO) fast track the examination of corresponding claims in the corresponding application in that office.

    The USPTO-IMPI PPH pilot program will begin on March 1, 2011, and is set to expire on February 29, 2012 (although the pilot program may be extended for up to one year or terminated earlier depending on volume of activity and other factors).  Requirements for participation in the new PPH pilot program at the USPTO can be found here, and details regarding the new PPH program with the IMPI can be found here.

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


    USPTO and IP Australia Extend PPH Pilot Program

    IP Australia #2 Earlier this month, the USPTO and announced that it would be extending its PPH pilot program with IP Australia.  The two offices agreed to extend the program to April 13, 2012.  The USPTO-IP Australia PPH was originally established on April 14, 2008 (see "Patent Prosecution Highway Extended to IP Australia"), and had been previously extended once before on April 10, 2009 (see "USPTO Extends Patent Prosecution Highway Pilot Program with IP Australia").


    USPTO Provides Additional Information about PCT-PPH Programs with IP Australia and NBPR

    Last month, the USPTO and IP Australia (IPAU) announced that the two offices had agreed to enter into a new PPH pilot agreement utilizing Patent Cooperation Treaty results (PCT-PPH) (see "USPTO News Briefs").  Under the PCT-PPH framework, which began on January 24, 2011, faster examination is available for an application receiving positive PCT international search reports with written opinions or international preliminary examination reports.  The new PCT-PPH program is scheduled to continue until April 13, 2012.  On February 15, the USPTO published additional information regarding the PCT-PPH between the two offices in a notice in the Official Gazette.

    NBPR (Finland) Seal The USPTO also published additional information regarding its expanded PCT-PPH program with the National Board of Patents and Registration of Finland (NBPR) in a February 15 notice in the Official Gazette.  The expanded PCT-PPH program with the NBPR was also announced last month (see "USPTO News Briefs").


    USPTO and CIPO Agree to Full Implementation of PPH

    CIPO Earlier this month, the USPTO published a notice in the Official Gazette announcing that the Office had reached an agreement with the Canadian Intellectual Property Office (CIPO) to fully implement the PPH program between the two offices on a permanent basis beginning on January 29, 2011.  The USPTO and CIPO initiated a PPH pilot program on January 28, 2008 (see "USPTO Announces Two Additional Partners in the Patent Prosecution Highway Pilot Program"), and had extended the pilot once before (see "Patent Prosecution Highway Pilot with CIPO Is Extended").

    In the OG notice, the USPTO indicated that the PPH program with CIPO was being fully implemented because "[t]he results of the pilot program showed that (1) applicants have been able to expeditiously obtain a patent in the Office of second filing (OSF) at an early stage, by utilizing the petition to make special procedures currently available in the OSF, based on claims that have been allowed in the Office of first filing (OFF); (2) the OSF has been able to reduce duplication of search efforts by exploiting the search and examination results of the OFF to a maximum extent practicable; and (3) the OSF has been able to reduce the examination workload since the scope of the claims in the OSF application has been clarified through the OFF’s examination prosecution."  Additional information regarding the USPTO-CIPO PPH can be found in the OG notice.

  • By Juan Serrano —

    COFEPRIS The Federal Commission for Protection Against Sanitary Risks (COFEPRIS) is the Mexican equivalent of the U.S. Food and Drug Administration (FDA).  For the past three years this Commission was headed by Miguel Angel Toscano, who had previously held a position at the Ministry of Economy.  Mr. Toscano's exit from COFEPRIS has been announced by several news outlets, and his replacement is Mikel Arriola, an attorney who was previously working as the head of tax legislation at the "Secretaria de Hacienda" (the Ministry of Treasury).

    The appointment of a commissioner lacking technical background is noteworthy, especially considering the process of approval of biologic drugs.  For starters, this change will  probably cause a further delay in the issuance of specific regulations, as the project announced last year is still under review.  The latest development regarding the regulations is an analysis performed by the Federal Antitrust Commission (COFECO) recommending the removal of two items in the regulation, specifically:

    • The prohibition of substitution of innovator drugs for biocomparable ones, unless the physician specifically allows it in the corresponding prescription.

    The main arguments by the COFECO for the removal of this provision, are that it will limit consumer access, and that substitution has been allowed in other jurisdictions such as the U.S.

    • The requirement included in the regulations stating that when a drug (either an innovator or a biocomparable) will be manufactured in Mexico, clinical trials will have to be performed within the country.

    This requirement is considered by COFECO  as an unnecessary market barrier, and that a better option would be to establish minimum standards in order to approve drugs based on clinical trials performed abroad.  The report by COFECO (in Spanish) can be found here.

    Juan Serrano is an attorney with Olivares & Cia in Mexico City and frequent contributor to Patent Docs.  He can be contacted at jls@olivares.com.mx.

  • By Sherri Oslick

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

    Medicines Company v. Mylan Inc. et al.
    1:11-cv-01285; filed February 23, 2010 in the Northern District of Illinois

    • Plaintiff:  The Medicines Company
    • Defendants:  Mylan Inc.; Mylan Pharmaceuticals Inc.; Bioniche Pharma USA, LLC

    Infringement of U.S. Patent Nos. 7,582,727 ("Pharmaceutical Formulations of Bivalirudin and Process of Making the Same," issued September 1, 2009) and 7,598,343 (same title, issued October 6, 2009) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of The Medicines Company's Angiomax® (bivalirudin, used as an anticoagulant in patients with unstable angina undergoing percutaneous translurninal coronary angioplasty).  View the complaint here.


    Regeneron Pharmaceuticals, Inc. v. Genentech, Inc.

    7:11-cv-01156; filed February 18, 2011 in the Southern District of New York

    Declaratory judgment of non-infringement and/or invalidity of U.S. Patent Nos. 5,952,199 ("Chimeric Receptors as Inhibitors of Vascular Endothelial Growth Factor Activity, and Processes for Their Production," issued September 14, 1999), 6,100,071 ("Receptors as Novel Inhibitors of Vascular Endothelial Growth Factor Activity and Processes for Their Production," issued August 8, 2000), 6,383,486 ("Inhibitors of Vascular Endothelial Growth Factor Activity, Their Uses and Processes for Their Production," issued May 7, 2002), 6,897,294 (same title, issued May 24, 2005), and 7,771,721 ("Methods for Using Chimeric Vascular Endothelial Growth Factor Receptor Proteins," issued August 10, 2010) based on Regeneron's newly filed Biological License Application for its VEGF Trap for treating wet age-related macular degeneration.  View the complaint here.

  • Calendar

    March 2, 2011 – Biotechnology/Chemical/Pharmaceutical (BCP) Customer Partnership Meeting (U.S. Patent and Trademark Office) – 10:00 am – 4:15 pm (Eastern)

    March 2, 2011 – "KSR and the Ripple Effect: Examining the Broad and Increasing Impact of KSR on Patent Litigation and Practice" (American Intellectual Property Law Association) – 12:30 – 2:00 pm (Eastern)

    March 4, 2011 – Sixth Annual Symposium, "The Economics of Intellectual Property and Technology" (Northwestern Journal of Technology & Intellectual Property) – Chicago, IL

    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

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

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

  • New York #2 American Conference Institute (ACI) will be holding its next Paragraph IV Disputes conference on May 3-4, 2011 in New York, NY.  The conference will allow attendees to:

    • Decipher the proposed revision to the standard of invalidity under Microsoft v. i4i;
    • Assess the evolving state of the law on double patenting type obviousness;
    • Analyze the significance of the Supreme Court's grant of certiorari in Global Tech v. SEB to Paragraph IV related inducement of infringement actions;
    • Explore new damages quantification criteria in view of Plavix, Protonix, and Prilosec; and
    • Comprehend the legal and ethical considerations surrounding a possible shift in the standard of inequitable conduct.

    Brochure In particular, ACI's faculty will offer presentations on the following topics:

    • Pre-suit due diligence strategies: Anticipating of the 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-à-vis Microsoft v. i4i;
    • New standards and controversies in double patenting type obviousness: 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;
    • Forfeiture of exclusivity dilemmas relative to Paragraph IV litigation;
    • A view from the Bench on Paragraph IV litigation;
    • Mastering regulatory maneuvers essential to PIV litigation;
    • Comprehending the new found significance of inducement actions in Paragraph IV litigation;
    • FTC keynote: Pay for delay settlements;
    • 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; and
    • Discovery strategies and other pre-trial maneuvering tactics for brand names and generics.

    Two additional workshops will be offered before and after the conference.  A pre-conference workshop, entitled "Hatch-Waxman and BPCIA 101 — A Primer on IP Basics and Regulatory Fundamentals," will be offered from 10:00 am to 5:00 pm on May 2, 2011.  During this workshop, ACI's faculty will offer presentations on the following topics:

    • The FDA approval process for drugs and biologics: A guide for life sciences patent lawyers;
    • IP overview for drugs and biologics:  Hatch-Waxman, BPCIA, trade dress, and more;
    • Patent and non-patent exclusivity;
    • Bioequivalence and the "same active ingredient" vis-à-vis patentability; and
    • Exploring Patent Term Adjustment and Patent Term Extensions and understanding their applicability to drugs and biologics.

    In addition, a post-conference workshop, entitled "The Master Class on Settling Paragraph IV Disputes: Drafting and negotiating strategies for brand-names and generics — A hands-on, practical approach," will be offered from 9:00 am to 12:30 pm on May 5, 2011.  In this workshop, ACI faculty will explore the best practices for reaching and finalizing settlements that the parties and the FTC can live with.

    The agenda for the Paragraph IV Disputes conference can be found here.  A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

    ACI - American Conference Institute The registration fee for the conference is $2,395 (conference alone), $3,290 (conference and pre-conference workshop), $2,995 (conference and post-conference workshop), $3,795 (conference and both workshops), $1,395 (pre-conference workshop alone), or $795 (post conference workshop alone).  Those registering by March 4, 2011 will receive a $400 discount (except for the workshops alone) and those registering by April 8, 2011 will receive a $200 discount (except for the workshops alone).  Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

    Patent Docs is a media partner of the Paragraph IV Disputes conference.