Orange Book Blog

At the intersection of Patent and FDA Law

Recent Posts

  • First-Ever Judicial Interpretation of Biosimilar Patent Litigation Statute Results in Dismissal of DJ Action

    Sandoz v. Amgen and Hoffman-La Roche, No. 13-204 (N.D. Cal.)

        by Aaron F. Barkoff

    In what appears to be the first court decision interpreting the patent litigation provisions of the BPCIA (the "Biosimilar Act"), the U.S. District Court for the Northern District of California granted Amgen's motion to dismiss Sandoz's declaratory judgment complaint concerning patents protecting Enbrel (etanercept).  In its order dismissing the case, the court stated that "neither a reference product sponsor, such as Amgen, nor [a biosimilar] applicant, such as Sandoz, may file a lawsuit unless and until they have engaged in a series of statutorily-mandated exchanges of information."

    Sandoz filed its complaint in June, alleging that it is conducting clinical trials on a "biologic drug containing etanercept" and that it "intends to file an FDA application for licensure of its etanercept product as biosimilar to Enbrel" upon completion of the clinical trials.  Sandoz sought a declaration that its biosimilar product does not infringe either U.S. Patent No. 8,063,182 or 8,163,522 and that the two patents are invalid and unenforceable.

    Amgen responded by filing a motion to dismiss for lack of subject matter jurisdiction, arguing that the complaint was premature for two reasons: (1) a district court lacks statutory authority to consider a patent dispute involving a biosimilar product until after such time as an application for FDA approval of the biosimilar product has been filed, and (2) as a factual matter, a cognizable case or controversy does not presently exist.

    Sandoz argued in its opposition brief that the Biosimilar Act "provides [declaratory judgment] actions can be filed by either party upon the biosimilar manufacturer's notice of commercial marketing, which Sandoz has given here."  But the court disagreed:

    First, as set forth in the section on which Sandoz relies, a "notice of commercial marketing" is required to be given by the applicant to the reference product sponsor "not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k)."  Here, Sandoz cannot, as a matter of law, have provided a "notice of commercial marketing" because, as discussed above, its etanercept product is not "licensed under subsection (k)."  Second, even after an applicant provides a "notice of commercial marketing," it cannot bring an action for declaratory relief until, at a minimum, it has complied with its obligations under § 262(l)(2)(A).

    In addition, the court determined that Sandoz failed to establish a "case or controversy" as required by Article III of the Constitution.  Here, the court found that Amgen never threatened to sue Sandoz and that Sandoz did not submit "evidence demonstrating [Amgen], by some means other than an express threat to sue, subjected Sandoz to an 'immediate' threat of injury."  Further, citing two Federal Circuit cases in support, the court found that "Sandoz's allegation that it intends in the future to file an application with the FDA is insufficient to create a case or controversy."

    Ever since the Biosimilar Act was passed in 2010, litigators have studied the patent litigation provisions of the Act and debated which strategies to pursue.  The court's interpretation of the Act in this case is significant–particularly since it is the first.  If other district courts interpret the Act in the same way, certain litigation strategies will be off the table.

  • PTAB Finds Counterclaims Alleging Infringement Within § 315(b) and Declines to Institute Inter Partes Review of Cardiovascular Diagnostic Device Patent

    St. Jude Medical, Cardiology Division, Inc. v. Volcano Corp., IPR2013-00258 (PTAB)

        by Robert F. Kappers and Herbert D. Hart III

    On
    October 16, 2013, the Patent Trial and Appeal Board issued a decision denying the petition for inter
    partes     review filed by St. Jude Medical targeting Volcano Corp.'s U.S. Patent No. 7,134,994 ("the '994 patent").  The
    '994 patent relates to a multifunctional invasive cardiovascular diagnostic
    measurement device.

    The
    Board denied St. Jude's petition because it was filed more than one year after
    Volcano served a counterclaim asserting a claim of
    infringement in a prior district court suit between the parties (St. Jude Medical, Cardiology Division, Inc.,
    et al. v. Volcano Corp.    , 1:10-cv-00631 (D. Del.)).

    Specifically,
    the Board found that Volcano's counterclaim alleging infringement of the '994 patent is a "complaint alleging infringement
    of the patent" within the meaning of the one-year statutory time bar of 35
    U.S.C. § 315(b).  In adopting a broad interpretation
    of § 315(b), the Board relied on legislative history indicating Congress'
    intent to provide a quick and cost effective alternative to litigation:

    Nothing
    in the legislative history indicates that Congress intended to apply the §
    315(b) time limit to some, rather than all, accused infringers.  Construing "complaint" in § 315(b)
    restrictively, to exclude counterclaims that present allegations of
    infringement, would have just that effect. 
    It would leave a patent open to serial attack, even after years of
    patent infringement litigation, in the event that the accused infringer is
    accused of infringement only via a counterclaim.

    This
    decision comes as further development of the Board’s previous interpretation of
    § 315(b) in Accord Healthcare v. Eli
    Lilly and Co.    , IPR2013-00356    , where the Board found
    that the filing of a second complaint in the second of two prior lawsuits did
    not reset the time for filing a petition.

    St.
    Jude's petition can be found here, and Volcano's
    patent owner response can be found here.

  • PTAB Declines to Institute Inter Partes Review of Alimta (Pemetrexed) Patent

    Accord Healthcare v. Eli Lilly and Co., IPR2013-00356 (PTAB)

        by Herbert D. Hart III

    On October 1, 2013, the Patent Trial and Appeal Board issued
    a decision denying the petition for inter partes review filed by Accord
    Healthcare targeting Eli Lilly's U.S. Patent No. 7,772,209.  The '209 patent is listed in the Orange Book for Alimta (pemetrexed disodium).

    The Board denied Accord's
    petition because it was filed more than one year after the filing date of the complaint in
    the first of two ANDA lawsuits between the parties (Lilly v.
    Accord    , 1:12-cv-00086-TWP-DKL (S.D. Ind.)
    ("the '086 action"), filed January 20, 2012 and served January 23, 2012).  Accord had argued that its petition was
    timely because it was filed within one year of the filing of the complaint in
    the second of the two lawsuits (Lilly v. Accord, 1:13-cv-00335-TWP-DKL (S.D. Ind.) ("the '335 action"),
    filed February 28, 2013 and served March 7, 2013).  The first lawsuit concerns Accord's 100 mg/vial and 500 mg/vial pemetrexed products and the second concerns its 1000 mg/vial product.

    Specifically, the Board found that the filing of the second
    complaint did not reset the time for filing a petition for inter partes
    review:

    We reject Accord's implicit argument
    that the one-year period set forth in § 315(b) should not be measured from the
    date of service of the complaint in the '086 action.  The plain language of the
    statute does not indicate or suggest that the filing of a later lawsuit renders
    the service of a complaint in an earlier lawsuit a nullity.

    Accord's petition can be found here, and Lilly's
    patent owner response can be found here.

    Of the eleven petitions for inter partes review so far filed
    by generic drug companies, six (including Accord's) were filed against patents
    already in litigation, and five were filed by just two petitioners.  Three
    trials have been instituted, while no institution decision has been issued in
    response to the remaining seven petitions.  There have as yet been no final
    decisions in any inter partes review trials.

  • ACI “Paragraph IV Disputes Master Symposium,” Chicago, October 3-4

    American Conference Institute will be holding its first-ever "Paragraph IV Disputes Master Symposium" next week, October 3-4, in Chicago.  McAndrews, Held & Malloy Partner Scott McBride will be speaking at the conference on claim construction strategies.  The rest of the agenda is as follows:

    • Identifying patents which may be ripe for challenges of invalidity and noninfringement: offensive and defensive strategies for brand and generic companies
    • Use of IPR and other PTO proceedings in a paragraph IV challenge: strategies for brand names and generics in navigating new proceedings in alternate and parallel forums which may change the rules of the Hatch-Waxman endgame
    • The start of the paragraph IV litigation countdown: the paragraph IV certification and notice letter
    • Obviousness in review: formulating assertions and defenses in view of new substantive and procedural developments in the federal courts and PTO
    • Advanced strategies for drafting and perfecting pleadings and effectively using dispositive motions in paragraph IV disputes
    • Of customs and courts: the importance of mastering the requirements of local patent rules in paragraph IV disputes
    • A view from the bench (featuring Judge Davis of the E.D. Tex.; Judge Holderman of the N.D. Ill.; and judges Brown, Pisano, and Bongiovanni of the D.N.J.)
    • The end of Roche v. Bolar? Understanding how new 271(e)(1) controversies may alter the course of brand name and generic strategies in paragraph IV litigation relative to safe harbor research exceptions
    • Mastering regulatory maneuvers in paragraph IV disputes: seeking relief from the FDA in the course of Hatch-Waxman litigation
    • New exclusivity challenges for brand names and generics
    • Pay-for-delay and settlement drafting update
    • Continuing claim construction conundrums impacting Markman strategies
    • Evolving theories of inducement and divided infringement in paragraph IV litigation concerning method of treatment patents
    • Protonix–case study of an at-risk launch: pros and cons of launching at risk and survey of new developments in seeking injunctive relief and damages
    • Inequitable conduct: ethical considerations for paragraph IV matters before the PTO and district court

    In addition, ACI is offering two pre-conference workshops on October 2: "Hatch-Waxman and BPCIA Master Class–Perfecting Your IP and Regulatory IQ of Small and Large Molecules"; and "Post-Grant Review and Inter Partes Review Boot Camp: Essential Considerations for Brand Names and Generics Regarding the Use of These PTO Procedures in Paragraph IV Scenarios."

    Orange Book Blog readers receive discounted registration with code OBB 200.  For more information or to register, please visit the conference website.

  • Invalidity Due to Public Use in ANDA Cases

    Pronova Biopharma Norge v. Teva Pharms., No. 2012-1498 (Fed. Cir.)

        by Aaron F. Barkoff

    It is not unusual for a defendant in an ANDA case to assert invalidity due to prior public use, but it is rare that such a defense succeeds.  In a unanimous decision last week, the Federal Circuit held the asserted claims of Pronova's U.S. Patent No. 5,656,667 invalid as anticipated by prior public use, reversing a District of Delaware trial decision in the process.

    Pronova's '667 patent protects Lovaza capsules, a drug product derived from fish oil and indicated to reduce triglyceride levels.  The asserted claims of the '667 patent were directed to pharmaceutical compositions comprising specific concentrations of different omega fatty acids.

    The parties agreed that more than one year before the priority date of the '667 patent, Pronova's predecessor shipped two vials of a composition that met all of the limitations of the asserted claims to a third-party researcher, Dr. Skrinska.  Evidence at trial showed that Skrinska "tested the two samples to confirm (and did confirm) their content."  There was no evidence, however, that Skrinska used the samples to reduce triglyceride levels in a person.

    The primary issue on appeal was whether Pronova's shipment of the samples and Skrinka's testing amounted to an invalidating public use.  Pronova argued that to be invalidating under § 102(b), an invention must be used by someone other than the inventor for its intended purpose—here, to reduce triglyceride levels.  The ANDA filers, on the other hand, contended that an invalidating public use need not be the intended use of the invention, as long as the invention is fully disclosed without restriction.

    The Federal Circuit explained the test for "public use" in Invitrogen v. Biocrest:

    The proper test for the public use prong of the § 102(b) statutory bar is whether the purported use: (1) was accessible to the public; or (2) was commercially exploited.  Commercial exploitation is a clear indication of public use, but it likely requires more than, for example, a secret offer for sale.  Thus, the test for the public use prong includes the consideration of evidence relevant to experimentation, as well as, inter alia, the nature of the activity that occurred in public; public access to the use; confidentiality obligations imposed on members of the public who observed the use; and commercial exploitation.

    The Federal Circuit held that the "use" in Pronova met this test, stating:

    Because we find that [Pronova] sent samples of the invention claimed in the '667 patent Skrinska . . . without restriction and Skrinska thereafter tested the samples, we hold that [Pronova] put its invention to an invalidating public use.

    The court contrasted this case to Dey v. Sunovion, another recent case in which an ANDA filer asserted prior public use as an invalidity defense.  There, the purported public use was a clinical trial of the claimed pharmaceutical composition.  But there, as the court explained:

    Because only the clinical trial administrator, not the subjects taking the medication, was made aware of the invention's claimed formulation and stability characteristics, and the administrator had signed a pledge of confidentiality, we held that "a finder of fact could conclude that the study was conducted with a reasonable expectation of confidentiality as to the nature of the formulations being tested, [such that] summary judgment on the public use issue was inappropriate."  A fact finder could so conclude even though the subjects did not likewise sign a confidentiality pledge because "they were given incomplete descriptions of the treatment formulation."

    Finally, the court addressed Pronova's argument that only the "intended use" of a pharmaceutical can qualify as a "public use":

    We are not persuaded by Pronova's argument that "use" of a pharmaceutical formulation cannot occur until it is used to treat the condition it is intended to counteract, or at least physically ingested.  Certainly, where . . . unsophisticated users are provided a compound with no detail regarding its formulation—as in Dey—there will be no public use.  Where, as here, however, a compound is provided without restriction to one highly skilled in the art, that compound's formulation is disclosed in detail, and the formulation is subject to confirmatory testing, no other activity is needed to render that use an invalidating one.  Once the formulation was disclosed in full to Skrinska, without any restriction on its use, it had been released into the "public domain" for purposes of 102(b).

  • 41st IPO Annual Meeting, Boston, September 15-17

    The Intellectual Property Owners Association will hold its 41st Annual Meeting on September 15-17 in Boston.  The keynote speakers include David Goulden, President and COO, EMC Corporation, and Hon. Kathleen O'Malley, Circuit Judge, U.S. Court of Appeals for the Federal Circuit.

    In addition, McAndrews, Held & Malloy Shareholder Herbert D. Hart III will be a featured speaker.  Because of his significant experience litigating before the Patent Trial and Appeal Board (PTAB), Hart was invited to organize and participate in the session titled, "Back To The Future: Trial Practice of the PTAB."

    Specifically, Hart will address current practice, decisions, and strategies in both litigating and managing PTAB trials, which are highly specialized, fast-paced, and unforgiving for those inexperienced in PTAB trial practice.  Hart will also provide trial practice tips directly applicable to today's post-grant trial proceedings.  Other long-time PTAB practitioners featured on the panel include:

    • Bruce Stoner, Greenblum & Bernstein, P.L.C. (Former Chief Administrative Patent Judge, Board of Patent Appeals and Interferences)
    • Oliver Ashe, Ashe, P.C.
    • Mark A. Charles, The Procter & Gamble Company
    • Danny Huntington, Rothwell, Figg, Ernst & Manbeck, P.C.

    For more information or to register for the IPO Annual Meeting, please click here.

  • Momentum Events “International Congress on Paragraph IV Litigation,” New York, September 23-24

    Momentum Event Group will be holding its inaugural "International Congress on Paragraph IV Litigation" September 23-24 in New York City.  The conference will feature a panel discussion with Judge Plager of the Federal Circuit and Judges Salas and Schneider from the District of New Jersey.

    Here is the complete agenda:

    • Paragraph IV Caselaw Year in Review: An Examination of Recent Circuit and District Court Decisions and Trends in Paragraph IV Disputes
    • FTC Keynote Address: The Use of Reverse Payment Settlements to "Pay for Delay"
    • Regulatory Trends: Addressing Recent Trends in Citizens Petitions and Dissecting the Impact on Paragraph IV Litigation Strategies for Both Patentees and ANDA Filers
    • In-House Roundtable: Corporate Views on the Costs, Benefits, and Strategies Behind Paragraph IV Litigation
    • View from the Bench: Judicial Perspectives on Paragraph IV Litigation
    • International Litigation Case Study: How to Manage, Oversee, and Coordinate Multi-Jurisdictional IP Litigation and Overcome Global Settlement Obstacles
    • Focus on Biosimilars: Comparing and Contrasting the Divergent Litigation Pathways of Small- vs. Large-Molecule Products
    • Impact of the AIA on Litigation Strategies for Branded and Generic Pharmaceutical Companies
    • Label "Carve-Outs" and Listing Strategies: Practical Tips for Minimizing Downstream Exposure to Paragraph IV Challenges and Drafting Codes to Limit Carve-Out Opportunities
    • Claim Construction and the Markman Hearing: Practical Tips for Ensuring the Best Interpretation of Key Patent Claims and Obtaining the Results You Want from the Markman Hearing
    • Effective Motion Practice in Paragraph IV Disputes: When and How to Successfully Pursue and Respond to Motions for Summary Judgment and Preliminary Injunctions
    • Special Litigation Considerations for Paragraph IV Disputes Involving Multiple ANDA Filers
    • 180-Day Exclusivity and Forfeiture: A Dissection of Key Filing Benchmarks and Timing Considerations for Counsel on Both Sides
    • "At Risk" Launches: Assessing the Pros and Cons of Launching During Litigation and Considering the Downstream Impact an "At Risk" Launch Can Have on Your Settlement Strategy
    • Paragraph IV Appeals: A Litigators Guide to Effectively Preserving Issues for Appeal and Keeping Your Case Alive Post-District Court
    • Litigation Strategies for Negotiating a Paragraph IV Settlement that Will Withstand Government Scrutiny

    In addition, attendees can choose from two pre-conference workshops, which each begin at 8:30 am on September 23rd: "Preparing for and Anticipating a Paragraph IV Challenge: Assessing the Business Risks and Legal Costs of a PIV Challenge" and "Paragraph IV Mock Trial: Inside a Real-Time Examination of a Company Witness, Inventor, and Scientist."

    You can receive a 15% discount off registration fees by using promo code SP15OK.  For more information or to register, please visit the conference website.

  • ACI “Legal and Regulatory Summit on Generic Drugs,” New York City, July 17-18

    ACI will be holding its first "Legal and Regulatory Summit on Generic Drugs" in New York City on July 17-18.  The conference co-chairs are Shashank Upadhye, formerly of Apotex, and Kurt Karst of FDA Law Blog.

    Here's the agenda:

    • The Politics and Policy of the Generic Drug Industry: Understanding the Role of the 113th Congress in Shaping the Future of Generic Pharma
    • The Game Changer: Analyzing the Legal and Business Impact of the Generic Drug User Fee Amendments
    • Breaking Developments in Hatch-Waxman Litigation: Paragraph IV Disputes and Beyond
    • Examining Branded-Generic Alliances that Maximize the Potential of Biosimilars and Minimize Investment Risks
    • Reverse Payments Update: Key Strategies to Bring to the Settlement Table
    • The Evolution of Authorized Generics Agreements Including New Controversies Under Health Care Reform
    • A View from the Bench: The Judges Speak on Major Developments in Case Law Impacting the Pharmaceutical Industry
    • Developing Strategies for Bypassing Roadblocks to REMS-Controlled Drugs Access
    • How Generic Companies Are Defending Against Evolving Theories of Products Liability Law Following Pliva v. Mensing
    • Protecting Your Company From Price Erosion Through Improved Pricing Reimbursement Strategies Tailored to the Generics Industry
    • Insights from the Office of Generic Drugs
    • Eyes on the 180-Day Prize: Identifying Current and Future Trends to Successfully Position Your Generic Pipeline Strategy

    In addition, ACI is offering two pre-conference workshops: "Industry Roundtable: Addressing the Day to Day Legal, Regulatory, and Business Challenges of Generic Manufacturers" and "Business Development Master Class: In-House Counsel Perspectives on Selecting and Evaluating Outside Counsel."

    Orange Book Blog readers receive $200 off registration fees with discount code OBB 200.  For more information or to register, please visit the conference website.

  • Federal Circuit Holds That Good-Faith Belief of Invalidity Can Be Evidence of No Inducement

    Commil USA, LLC v. Cisco Sys., Inc., No. 2012-1042 (Fed. Cir.)

        by Sandra A. Frantzen

    The law
    regarding what proofs are necessary to establish inducement of infringement
    and what defenses are available to those accused of inducement has been hotly
    debated.  In Commil v. Cisco, decided on Tuesday, a unanimous Federal Circuit panel reaffirmed the rule that proof
    of specific intent to induce infringement (and not just knowledge of the acts
    that constitute infringement) is necessary to establish inducement of
    infringement.  Moreover, in a case of
    first impression, a majority of the panel held that the fact finder should
    consider whether an accused inducer had a good-faith belief of invalidity in
    determining whether the accused inducer had the requisite intent.  This ruling will likely affect how inducement
    claims are presented and defended in a wide variety of cases, including
    Hatch-Waxman cases involving method-of-use patents.

    In Commil, the
    patentee accused Cisco of inducing infringement of its patent, which claimed an
    improved method of handoffs of mobile devices between base stations in a
    network area.  After two jury trials (a
    new trial was granted on a few issues due to prejudicial statements made by Cisco's trial
    counsel at the first trial), the juries ultimately found that Cisco induced
    infringement and the patent was not invalid. 
    On appeal, Cisco objected to a jury instruction that instructed the jury
    that it could find inducement if "Cisco actually intended to cause the acts
    that constitute direct infringement and that Cisco knew or should have known
    that its actions would induce actual infringement."  Cisco also objected to the district court's
    in limine ruling that precluded Cisco from presenting evidence during the
    second trial of its good-faith belief of invalidity to rebut the patentee's
    inducement allegations.  In an opinion by
    Judge Prost (with separate opinions authored by Judges O'Malley and Newman),
    the Federal Circuit held in favor of Cisco on both issues.

    First, the panel
    unanimously held that the "knew or should have known" language in the district
    court's jury instruction (which was a verbatim recitation of the inducement
    standard in Federal Circuit precedent) did not accurately recite the law of
    inducement in view of the Supreme Court's 2011 ruling in Global-Tech:

    A finding of
    inducement requires both knowledge of the existence of the patent and
    "knowledge that the induced acts constitute patent infringement."  Global Tech, 131 S. Ct. at 2068; see also DSU
    Med. Corp.    , 471 F.3d at 1306 (explaining that an "alleged infringer must be
    shown . . . to have knowingly induced infringement," not merely knowingly induced
    the acts that constitute direct infringement" (citation omitted)).  . . .  The jury
    was . . . instructed that Cisco must have actively and knowingly aided and abetted
    direct infringement.  The jury, however,
    was not instructed that in order to be liable for induced infringement, Cisco
    must have had knowledge that the induced acts constitute patent
    infringement. 

    The Federal Circuit thus
    held that it was "clear that the jury instruction in this case was erroneous as
    a matter of law."  The court vacated the
    induced infringement verdict and remanded for a new trial.

    Next, a majority
    of the panel (Judges Prost and O'Malley) found that the district court erred in
    preventing Cisco from presenting evidence on its good-faith belief of
    invalidity to rebut the patentee's inducement allegations.  Citing several cases as authority, the
    majority demonstrated how existing Federal Circuit precedent already recognized
    that an accused inducer may rely on its good-faith belief of non-infringement
    as evidence that it lacked the requisite level of intent needed for indirect infringement.  But the majority noted that the issue of
    whether a good-faith belief of invalidity may serve as evidence of lack of
    intent had not yet been decided by the Court. 
    The majority could "see no principled distinction between a good-faith
    belief of invalidity and a good faith belief of non-infringement for the
    purpose of whether a defendant possessed the specific intent to induce
    infringement of a patent."  Thus, the
    majority held "that evidence of an accused inducer's good-faith belief of
    invalidity may negate the requisite intent for induced infringement" and such
    evidence should be considered in determining whether the accused inducer knew
    that the induced acts constitute infringement.

    In a dissent that
    the majority characterized as "little more than construc[ing] a straw man and
    set[ting] him ablaze," Judge Newman contended that the majority's view of the
    law was contrary to principles of tort liability.  Judge Newman wrote that "[a] mistake of law,
    even if made in good faith, does not absolve a tortfeasor" and thus "a
    'good-faith belief' in invalidity does not avoid liability for infringement
    when the patent is valid."

    While we will continue to watch how the Federal Circuit resolves the issue of indirect infringement in Hatch-Waxman cases, a few
    things remain clear.  Litigants should
    continue to consider what evidence is needed to establish (or refute) that an
    accused indirect infringer is, in fact, an infringer and patent prosecutors
    should avoid writing claims that require lawsuits against indirect infringers
    (where possible).

  • ACI “Advanced Summit on Global Patenting Strategy & Practice,” New York City, July 15-16

    American Conference Institute will be holding its first "Global Patenting Strategy & Practice" conference July 15-16 in New York.  McAndrews, Held & Malloy Partner Scott McBride will be speaking on strategies for protecting trade secrets in multiple jurisdictions.

    The rest of the agenda includes the following presentations:

    • Understanding the Importance of Developing a Global Strategy for Your Patent Portfolio
    • An Alignment of Interests: Determining the Impact of Patent Harmonization Efforts on IP Protection
    • Devising Effective Strategies for Working with Inventors in Foreign Jurisdictions
    • A Review of Guidelines for Patentability and Novelty in Different Patent Offices
    • Comparing Claim Drafting and Construction Standards in important Jurisdictions
    • Exploring Obviousness and Inventive Step Concepts Around the World
    • Analyzing Written Description and Specification Requirements Across Different Patent Regimes
    • Comparing and Contrasting Opposition Proceedings in the US and EU
    • Navigating the "Ins" and "Outs" of Opposition Practice Across the World
    • Managing Unique Challenges and Investigating Emerging Trends in Foreign Patent Litigation
    • Using the International Trade Commission (ITC) as a Venue for Global Patent Conflicts
    • Addressing the Challenges Presented by Compulsory Licensing Provisions Abroad

    In addition, two post-conference workshops will be held on July 17:  "Mastering the Foreign Patent Law and Regulatory Requirements for Life Sciences Companies in a Global Context" and "Negotiating the Obstacles and Challenges Associated with Patenting a Product in Multiple Jurisdictions."

    Orange Book Blog readers receive discounted registration by using code OBB 200.  For more information or to register, please visit the conference website.