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At the intersection of Patent and FDA Law

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  • Cadence Prevails Over Exela in OFIRMEV® (Acetaminophen) ANDA Litigation

    Cadence Pharms., Inc. v. Exela Scis., LLC, No. 11-733-LPS (D. Del.)

        by Dunstan H. Barnes

    On November 22, 2013, the U.S. District Court for the District of Delaware issued a Final Judgment and Permanent Injunction barring Exela from manufacturing a generic version of OFIRMEV®, which is an injectable liquid acetaminophen composition.  Judge Leonard Stark held that all fourteen asserted claims from the two patents in suit were not invalid and would be infringed by Exela's generic product.  Judge Stark's reasoning was revealed in his November 14 Memorandum Opinion which was unsealed on November 22.

    Plaintiff Cadence Pharmaceuticals, Inc. ("Cadence") holds approved NDA No. 022450 for OFIRMEV®, which was approved by the U.S. Food and Drug Administration in November 2010.  Plaintiff SCR Pharmatop ("Pharmatop") is a French civil law partnership that owns U.S. Patent Nos. 6,028,222 ("the '222 patent") and 6,992,218 ("the '218 patent"), which are directed to, respectively, a formulation of, and a method for preparing, a liquid acetaminophen (or paracetamol) composition.  Paracetamol is the name used outside of the United States for acetaminophen.  Cadence is a Delaware corporation based in California that has an exclusive license to the '222 and '218 patents.

    In 2011, Cadence and Pharmatop sued Exela Pharma Sciences, LLC, Exela Pharmsci, Inc., and Exela Holdings, Inc. (collectively, "Exela") for patent infringement after Exela notified the plaintiffs that it had filed ANDA No. 203092 seeking regulatory approval for a generic version of OFIRMEV®. 

    Cadence and Pharmatop had also sued Perrigo Company, and its subsidiaries Paddock Laboratories, Inc. and Paddock Laboratories, LLC.  Each of these three parties were dismissed from the suit by a joint stipulation of the parties after the parties settled and entered into a license agreement.  Cadence announced in November 2012 that, under the license agreement, Perrigo has the exclusive right of first refusal to negotiate an agreement with Cadence to market an authorized generic version of OFIRMEV® in the United States if Cadence elects to launch an authorized generic version of the product.

    After construing the claims in August 2012, the Court conducted a seven-day bench trial in May and July of 2013.

    At trial, Cadence and Pharmatop successfully proved by a preponderance of the evidence that Exela's generic version of OFIRMEV® literally infringed all ten asserted claims of the '222 patent.  Despite Exela's arguments to the contrary, the plaintiffs successfully proved that in Exela's generic product, sodium ascorbate acted as a "buffering agent" and mannitol acted as a "free radical scavenger" (i.e., an antioxidant).  This meant that Exela's generic product met each of the asserted claim limitations.

    Although Cadence and Pharmatop failed to prove literal infringement of any of the four asserted claims of the '218 patent, the plaintiffs succeeded under the doctrine of equivalents.  The court found no literal infringement because independent claim 1 required the solution to have a dissolved oxygen content of greater than 2.0 ppm prior to the deoxygenation step.  Because the evidence at trial showed no substantial difference based on the time at which the oxygen content is reduced to below 2.0 ppm, the court held that Exela infringed under the doctrine of equivalents.

    To invalidate the '222 patent, Exela argued that three pieces of prior art—Greek Patent Application No. 870101510, Korean Patent No. 1993-011994, and U.S. Patent No. 5,270,050—rendered the '222 patent anticipated or obvious.  Excela's anticipation argument failed because Exela was unable to convince the court that the prior art disclosed a "stable" liquid formulation, as recited in claim 1, the only independent claim at issue in the '222 patent.  Exela's obviousness argument failed for the same reason and additionally because the court was persuaded that each of the following secondary considerations supported a finding of nonobviousness: (1) unexpected results, (2) satisfaction of an unmet need, (3) failure of others, (4) commercial success, (5) successful licensing, and (6) praise of others.

    Exela was similarly unable to win its argument that the '218 patent was invalid as obvious in view of the '222 patent combined with an article from the 1978 Journal of Pharmaceutical Studies.  Importantly, the 1978 article concerned the oxidative degradation of pyrogallol, which is highly sensitive to oxidation, rather than paracetamol, which is not.  The court was unconvinced by Exela's argument for two reasons.  First, the court found independent claim 1 was valid and nonobvious given the technical differences in degradation of paracetamol compared to the degradation of pyrogallol (hydrolysis instead of oxidation), as well as the technical difficulties of deoxygenation.  Second, Cadence and Pharmatop persuaded the court that all six secondary considerations listed above supported the nonobviousness of the '222 patent.

    Based on its findings, the court enjoined Exela from producing its generic version of OFIRMEV® until the '222 and '218 patents expire:  August 5, 2017 for the '222 patent and June 6, 2021 for the '218 patent.

  • PTAB Finds § 315(b) Barred Petition for Inter Partes Review Challenging Claims Amended in Reexamination

    BioDelivery Sciences Int'l, Inc. v. MonoSol RX, LLC, IPR2013-00315 (PTAB)

        by Robert F. Kappers

    On November 13, 2013, the Patent Trial and Appeal Board issued a decision denying the petition for inter partes review filed by BioDelivery Sciences targeting MonoSol Rx's U.S. Patent 7,425,292.  The '292 patent relates to thin films with non-self-aggregating uniform heterogeneity for use in drug delivery systems.

    BioDelivery filed its petition for inter partes review on June 12, 2013, more than one year after MonoSol served BioDelivery with a complaint asserting infringement of the '292 patent, but less than one year after an ex parte reexamination proceeding terminated upon issuance of a reexamination certificate that confirmed or amended each of the original claims.

    The Board denied BioDelivery's petition because it was untimely filed under 35 U.S.C. § 315(b).  Specifically, the Board found that § 315(b) barred BioDelivery's petition even though the petition challenged claims that were amended by a reexamination certificate issued after service of the complaint.  In adopting a broad interpretation of § 315(b), the Board emphasized that reexamination does not result in a new patent:

    A reexamination certificate merely "incorporates in the patent any proposed amended or new claim determined to be patentable."  35 U.S.C. § 307(a).  The reexamination certificate itself states: "The patent is hereby amended as indicated below."  The identical reference in § 315(b), to the "date on which the petitioner . . . is served with a complaint alleging infringement of the patent" indicates that the timeliness analysis is to be made with reference to "the patent."

    This decision comes as further development of the PTAB's broad interpretation of § 315(b).  See, e.g., Accord Healthcare v. Eli Lilly and Co., IPR2013-00356 (a second complaint in the second of two prior lawsuits did not reset the time for filing a petition); St. Jude Medical, Cardiology Division, Inc. v. Volcano Corp., IPR2013-00258 (counterclaim is a "complaint alleging infringement of the patent" within the meaning of § 315(b).)

  • Motion to Amend Pleadings to Assert Inequitable Conduct Denied in Rapamycin Case

    Pfizer Inc. v. Sandoz Inc., No. 12-654-GMS-MPT (D. Del.)

        by Malaika D. Tyson

    Undue delay that resulted in prejudice to Pfizer coupled with failure to demonstrate good cause are some of the reasons why on November 4, 2013, Magistrate Judge Mary Pat Thynge issued a report and recommendation denying Sandoz’s motion to amend its answers, defenses and counterclaims to add an inequitable conduct defense.

    On May 24, 2012, Pfizer filed suit against Sandoz for infringement of U.S. Patent No. 8,026,276 directed to parenteral formulations of rapamycin.  In Sandoz's expert reports, which were served August 20, 2013, Sandoz first raised the theory of inequitable conduct.  On September 20, 2013, Sandoz moved to amend its pleadings to add claims of inequitable conduct.  The deadline to amend the pleadings was March 22, 2013.

    When deciding whether to grant leave to amend pleadings under Rule 15(a), the court considers four elements: 1) undue delay by the movant; 2) unfair prejudice to the nonmovant; 3) improper purpose; and 4) futility.  As for the good cause requirement of Rule 16(b), the movant must demonstrate "that the amendment could not have been reasonably sought in a timely manner despite diligence."

    While undue delay alone is "not sufficient to justify a denial of leave to amend," it weighs in favor of denial.  Here, the court focused on the actions of Sandoz, concluding that because Sandoz had the required documents in its possession within a few weeks of the deadline to amend the pleadings, its delay was undue.  The court was not convinced by Sandoz’s explanation for the delay–the volume of the record and concurrent litigation–concluding that Sandoz did not establish good cause under Rule 16(b) because it could not "satisfactorily explain its substantial delay."

    The court then concluded that Pfizer would be subject to unfair prejudice if the leave to amend was granted.  Even though the inequitable conduct allegations were based on documents within Pfizer's control, the court concluded that Pfizer had "a significantly compressed time frame" for a response compared to the "fourteen months" Sandoz had to develop its inequitable conduct defense.

    The court also concluded that Sandoz's amendment would be futile (improper purpose was not challenged by Pfizer and therefore not addressed by the court).  Inequitable conduct is based in fraud and under Rule 9(b) the elements of fraudulent claims must be plead with particularity.  Sandoz argued that Pfizer’s Rule 131 and Rule 132 declaration were "unmistakably false and the falsehood is both material and evidence of specific intent."  But the court concluded that Sandoz failed to "create a reasonable inference of specific intent to deceive the PTO" because "other than alleging that the inventor filed two false affidavits, [Sandoz] does no more than argue that information and belief is sufficient to reasonably infer intent. Thus, there is an insufficient factual basis to draw an inference of specific intent to deceive."

    Finally the court held that "[e]ven if the proposed amendment is not futile, the failure to demonstrate good cause and inadequately explained delay for filing the motion resulting in prejudice warrant denying the motion."

    On November 12, 2013, the parties jointly submitted a letter to the court stating that they had agreed to settle the case.

  • 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.