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  • Amgen Receives No Help from the FDA — A Biosimilar Update

    By Andrew Williams —

    FDANear the end of last month, the U.S. Food and Drug Administration ("FDA") denied a citizen petition filed by Amgen in which it requested that action be taken to ensure that biosimilar applicants comply with the disclosure and exchange provisions described in the Biologics Price Competition and Innovation Act ("BPCIA").  Amgen had filed its petition on October 29, 2014, after Sandoz refused to disclose a copy of its biosimilar application related to Amgen's NEUPOGEN® (filgrastrim) biologic drug product.  More precisely, Sandoz had alleged that the disclosure provision of the BPCIA was not mandatory.  Instead, as noted in the petition, Sandoz had independently offered to provide Amgen with the information, but with conditions and restrictions not found in the statute.  Amgen requested in the petition that the FDA require all new biosimilar applicants to certify that they would comply with the disclosure provisions (in a manner similar to how an ANDA filer must provide a certification in the Hatch-Waxman context).  However, the FDA denied this request because the provisions of the BPCIA do not in fact impose such a certification requirement, which stands in opposition to the explicit certification requirement for ANDA filers as found in the Hatch-Waxman statute.

    AmgenOf course, this comes on the heels of the Northern District of California's denial of Amgen's motion for a preliminary injunction and partial judgement on the pleadings in the Amgen v. Sandoz case.  As previously reported here, the Court in that case sided with Sandoz in determining that the disclosure provisions were not mandatory.  In large part, the Court based its decision on the fact that, even though the BPCIA states that the biosimilar applicant "shall provide to the reference product sponsor a copy of the application," and other information related to the manufacturing process, the statute also provides the "penalty" for not so disclosing.  Essentially, Sandoz was just opting for the penalty — being subject to "an action under section 2201 of Title 28, for a declaration of infringement, validity, or enforceability of any patent that claims the biological product or a use of the biological product."  42 U.S.C. § 262(l)(9)(C).  The obvious problem, however, is that a product sponsor will likely not be aware of which patents it can assert in the absence of such a disclosure.

    In its citizen petition to the FDA, Amgen again alleged that the disclosure provisions and patent exchanges dictated by the BPCIA — the so-called biosimilar "patent dance" — were mandatory, not optional or discretionary.  Amgen pointed to the text and the history of the statute for the support.  In fact, without the initial disclosure by the biosimilar applicant, the "patent dance" cannot even begin.  "All of these provisions quickly become nullities if biosimilar applicants are free to simply ignore the requirements of § 351(l)(2)(A)," Amgen asserted.  This can become an even more serious issue when considering "interchangeable" biosimilar products.  Such products earn a period of exclusivity tied in part to any potential litigation.  As such, it would behoove a biosimilar applicant to delay, or even eliminate, any litigation by not disclosing its application or manufacturing information.  Indeed, if a biosimilar applicant were not required to disclose that it had, in fact, filed an application, it could maintain the fact that it had filed an application secret.  This could not have been what Congress intended, Amgen contended.

    Momenta Pharmaceuticals also submitted a paper to the FDA in response to Amgen's citizen petition on November 25, 2014.  This paper echoed Momenta's comments that it submitted to the FDA in May 2012, expressing concern that the "patent dance" provisions of the BPCIA would be converted to an FDA regulated regime.  Instead, Momenta alleged that granting Amgen's petition would be contrary to the intent of Congress.  Specifically, Momenta asserted that Congress intended:

    • to separate the FDA from the patent resolution process;
    • to allow applicants to choose to engage in the patent exchange process at the time a 351(k) Application is filed when appropriate;
    • to provide reference biologic sponsors with procedural patent exchange protections should applicants elect to seek patent resolution early; and
    • to allow for specific remedies should applicants elect not to seek patent resolution prior to commercial launch.

    In the end, the FDA sided with Momenta and denied Amgen's petition.  "Neither section 351(k) nor section 351(l) requires the FDA to impose certification requirements as part of the biosimilar review process."  This is, again, in contrast to the Hatch-Waxman statute, which requires ANDA filers to certify regarding each patent listed in the FDA's Orange Book.  "Viewed against the explicit requirements under the FD&C Act, the Petition's contention that FDA 'should' require a certification for biosimilar applications implicitly acknowledges that imposing such a requirement is a matter of regulatory discretion and not compelled under the PHS Act."  With regard to that discretion, the FDA noted that the issue about whether the disclosure provisions were mandatory was being resolved in the Federal courts.  Nevertheless, the FDA did provide Amgen with a glimmer of hope, if not for now than for the future:  "In light of the ongoing litigation regarding interpretation of section 351(l) of the PHS Act, at this time, the Agency denies the request to exercise its discretion to require biosimilar applications to include a certification to FDA that the applicant will timely comply with section 351(l)(2)(A) of the PHS Act" (emphasis added).  Of course, this likely provides little solace to Amgen, because if it does receive a favorable ruling on appeal in the Amgen v. Sandoz case, such FDA action will not be necessary.

  • InSite Vision Inc. v. Sandoz, Inc. (Fed. Cir. 2015)

    By Kevin E. Noonan —

    InSite VisionThe Federal Circuit showed once again the importance of a district court's factual findings (and the deference the appellate court gives those findings, particularly when supported by expert testimony), in InSite Vision Inc. v. Sandoz, Inc.  In last week's decision in this case the Court affirmed a finding of non-obviousness of four Orange Book-listed patents challenged by generic drugmaker Sandoz in ANDA litigation under 35 U.S.C. § 271(e)(2).

    The case involved a topical formulation of the antibacterial drug azithromycin formulated for ocular administration for the treatment of bacterial infections in the eye and sold by Insite as Azasite®.  The four patents-in-suit were U.S. Patents Nos. 6,861,411 (the "'411 patent"); 6,239,113 (the "'113 patent"); 6,569,443 (the "'443 patent"); and 7,056,893 (the "'893 patent"); the first patent was owned by Pfizer and licensed to InSite and the rest were owned solely by InSite.  Representative claims at issue are as follows:

    Claim 1 of the '411 patent:

    1.  A method of treating an ocular infection, comprising topically administering to an eye of an animal in need of such treatment an ocular infection-treating amount of azithromycin.

    Claim 1 of the '113 patent:

    1.  A process for treating an eye, which comprises: topically applying an aqueous polymeric suspension of an azalide antibiotic, wherein said suspension comprises water, 0.01% to 1.0% of an azalide antibiotic, and 0.1 to 10% of a polymeric suspending agent.

    Claim 16 of the '443 patent:

    16.  A topical ophthalmic composition comprising an aqueous polymeric suspension comprising water, 0.01% to 1.0% of an azalide antibiotic and 0.1 to 10% of a polymeric suspending agent, wherein said topical ophthalmic composition has an osmotic pressure of from 10 to 400 mOsM and wherein said composition does not contain constituents that are physiologically or ophthalmically harmful to the eye.

    Claim 1 of the '893 patent:

    1.  A composition comprising water, a polymeric suspending agent and an azalide antibiotic, wherein said composition has a pH of about 6.0 to 6.6.

    Sandoz #1After claim construction Sandoz conceded infringement but challenged the asserted claims on obviousness grounds.  The District Court found that Sandoz had failed to show by clear and convincing evidence that the claims of the Orange Book-listed patents were invalid for obviousness, and Sandoz appealed.

    The Federal Circuit affirmed, in an opinion by Opinion by Judge Linn, joined by Chief Judge Prost and Judge Newman.  The panel first addressed the District Court's non-obviousness determination regarding the '411 patent, specifically with regard to the question of how the obviousness issue was framed.  InSite argued that the District Court had properly considered whether it would have been obvious to the skilled worker to produce a topical azithromycin formulation for ophthalmic uses, while Sandoz contended that the proper question was whether it would have been obvious to use azithromycin topically to treat conjunctivitis.  These considerations impacted Sandoz' burden of proof: framed narrowly, which Sandoz contended was proper, they would not have the burden of showing "the obviousness of topical treatments of all manner of eye infections and not merely conjunctivitis with azithromycin."  The District Court agreed with InSite that there was "no reason to limit the question to conjunctivitis and to azithromycin," based on the need in the art for such formulations for treating things other than conjunctivitis, including corneal infections.

    The Federal Circuit noted in its opinion that this question of "framing" the obviousness issue was one of fact, and thus that on appeal Sandoz had the burden of showing clear error in the District Court's decision not to narrow the scope of the obviousness question to treatment of conjunctivitis with azithromycin.  On that basis, the panel found no clear error, at least in part because the Court opined that nothing stopped Sandoz from presenting evidence that it would have been obvious to use the claimed formulations to treat conjunctivitis (which, the panel apparently believed, could have resulted in Sandoz prevailing).  The Federal Circuit panel held that the District Court "did not clearly err" on this record.  Citing In re Kahn, the Court noted that motivation sufficient to establish obviousness is not limited to the 'specific problem solved by the invention," 441 F.3d 977, 988 (Fed. Cir. 2006), and that "[d]efining the problem in terms of its solution reveals improper hindsight in the selection of the prior art relevant to obviousness," citing Monarch Knitting Mach. Corp. v. Sulzer Morat GmbH, 139 F.3d 877, 881 (Fed. Cir. 1998).  Sandoz' argument, that the District Court should have defined the "problem" addressed more narrowly, could itself be reversible error, according to the Court, because "an overly narrow 'statement of the problem [can] represent[] a form of prohibited reliance on hindsight, [because] [o]ften the inventive contribution lies in defining the problem in a new revelatory way,'" citing  Mintz v. Dietz& Watson, Inc., 679 F.3d 1372, 1377 (Fed. Cir. 2012).

    The panel recognized that Sandoz' primary authority, Alcon Research, Ltd. v. Apotex Inc., 687 F.3d 1362, 1368 (Fed. Cir. 2012), stands for the proposition that "if the prior art would motivate a person of skill in the art to make the claimed invention, even if that was not based on 'the same motivation that the patentee had,' the patent would have been obvious" (emphasis in opinion).  However, the opinion noted that this is a question of fact, and that the District Court did not err in deciding that the problem in the art addressed by the claimed invention was broader than preparing topical azithromycin formulations for treating conjunctivitis.  Specifically, the District Court found, and the panel approved, that azithromycin was known in the art to be a "poor choice" for topical administration to the eye, based on its intrinsic chemical properties ("the unique balance of log P, molecular weight, solubility, and charge").  The panel also noted that the District Court relied upon and credited the testimony of InSite's expert regarding the understanding in the art that the ability to penetrate the cornea and not just the conjunctiva was important to avoid spread of a conjunctival infection into the cornea.

    The panel summarized its conclusions regarding Sandoz' argument on whether the District Court properly "framed" the obviousness issue by stating:

    [T]he district court's framing of the question did not prevent Sandoz from attempting to invalidate the asserted claims, which were not limited to the cure of conjunctivitis, by proving that it would have been obvious to use azithromycin in a topical treatment to cure that one infection.  The problem for Sandoz, as we will next address, is that its proofs simply failed to carry the day in satisfying its clear and convincing burden.

    Turning to the merits, the panel characterized Sandoz' argument to be that the claimed formulation was an obvious variant of a prior art formulations for topical administration of erythromycin and oral administration of azithromycin sold as Zithromax®.  Based on the testimony of its expert, Sandoz contended that substituting azithromycin for erythromycin in topical formulations for treating conjunctivitis would have been obvious, due to the similarities between the two antibacterial drugs.  Another Sandoz expert testified that making a topical formulation of azithromycin would have been obvious because it was known in the art that "topical treatments [were] more effective than oral treatments." Sandoz also relied upon purported public suggestions for using azithromycin in topical formulations for treating conjunctivitis.

    The panel was not persuaded by Sandoz' arguments, based on its judgment that "[t]he district court thoroughly and properly considered all of the evidence presented and the various arguments raised by the parties in ruling the asserted claims to be not invalid."  This evidence included the existence of preferred alternative ophthalmic treatments, particularly ones using fluoroquinolones, which the Court determined were known in the art to be a better choice than azithromycin, due to their known antibacterial properties and better penetration of ocular tissues like the conjunctiva and cornea.  These properties were in contrast to azithromycin, which the skilled worker would have had reason to anticipate would not be as able to penetrate such ocular tissues (due to, inter alia, its higher molecular weight).  The panel also found no error in the District Court crediting InSite's expert over Sandoz' expert's testimony, and in discounting the relevance of prior art formulations in view of differences of opinion by the experts (including evidence that Sandoz' expert had his own patent for topical ophthalmic treatments that included "24 potential antibiotics, including erythromycin but did not list azithromycin").

    The panel also affirmed the District Court's non-obviousness determination for the remaining formulation patents (the '113 patent, '443 patent, and '893 patent) owned by InSite.  Here, the Court based its opinion on the District Court's finding that the skilled worker would not have been motivated to use "water-based polymeric solutions" known in the prior art when formulating azithromycin because the drug was "considered insoluble and unstable in water."  The District Court also found that the skilled worker would have used a colloidal system, rather than the claimed gelling polymer, in view of the teachings in the prior art.  The panel rejected Sandoz' contention that a prior InSite patent, U.S. Patent No. 5,192,535, taught erythromycin formulations having the same gelling polymer recited in InSite's claims, and that this teaching would have made it obvious to substitute azithromycin for erythromycin to arrive at the claimed formulation.  The Federal Circuit agreed with InSite and the District Court that the '535 patent taught "a laundry list of active ingredients" and that that patent did not exemplify formulations of such gelling polymers with erythromycin (again, based on expert testimony).  In reaching this conclusion the panel distinguished the teachings of Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989), asserted by Sandoz in support of its obviousness arguments, on the basis that in Merck the prior art "expressly taught the combination of compounds claimed in the [later] patent," which was not the case here.  And it was also significant that not only did the '535 patent not expressly teach the combination of erythromycin with a gelling polymer but that the skilled worker would have to modify the patent's teachings to arrive at the invention claimed in the patents in suit.

    Finally, the opinion said there was no clear error in the District Court's finding that there were "meaningful" secondary considerations of non-obviousness (although in view of the remainder of the opinion it is clear that the Federal Circuit did not need to rely on these factors).

    In sum, the opinion shows that the Federal Circuit will defer to district court factual determinations in questions involving ultimate questions of law, such as non-obviousness and that an apparently important factor in deciding to defer is a district court's reliance on expert testimony to resolve factual disagreements between the parties.  While this behavior is consistent with how courts traditionally parse review by appellate courts, compliance with these traditional standards reintroduces some uncertainty into the application of patent law doctrines that, while inevitable because the facts of each case are necessarily different, is a far cry from the consistency in outcome that the Court spent its first quarter century trying to erect.  Whether this was a prudent or even practical course is moot:  more than a decade of Supreme Court disapproval has clearly influenced the Federal Circuit to adopt the presumptions and practices of its Sister Circuits in such matters.

    InSite Vision Inc. v. Sandoz, Inc. (Fed. Cir. 2015)
    Panel: Chief Judge Prost and Circuit Judges Newman and Linn
    Opinion by Circuit Judge Linn

  • USPTO Announces Patents for Humanity Winners

    By Donald Zuhn —

    PatentsforhumanityforourwebsiteOn Monday, the U.S. Patent and Trademark Office announced the latest winners of the Patents for Humanity program.  The Patents for Humanity program, which was launched by the Office in February 2012, is a competition recognizing patent owners and licensees who address global challenges in health and standards of living.  Entrants are divided into five categories:  medicine, nutrition, sanitation, household energy, and living standards.  Winners receive accelerated processing of select matters at the USPTO (i.e., a patent application, ex parte reexamination, or an ex parte appeal to the Patent Trial and Appeal Board) in addition to recognition for their work.  The latest winners are as follows:

    • Sanofi for its work in manufacturing artemisinin, an important antimalarial drug derived from the sweet wormwood plant in Asia and Africa, thereby supplying large quantities of artemisinin anti-malarial compounds on a no-profit-no-loss basis for use in developing countries.

    • Novartis for its discovery of a class of compounds called indolcarboxamides that are active against drug-sensitive and multidrug-resistant strains of tuberculosis, and providing its entire tuberculosis R&D program, including these compounds, to the TB Alliance, a non-profit product development partnership that seeks to find new and improved tuberculosis treatment regimens.

    • American Standard for partnering with BRAC, UNICEF, Save the Children, and other NGOs to distribute its “SaTo” (Safe Toilet) Technology, which was created for people worldwide who do not have access to safe, basic sanitation, throughout the developing world.

    • SunPower Corp. for outfitting standard shipping containers with solar panels on top and equipment inside to power hundreds of safe, rechargeable lanterns, and donating the containers and supplies to partner organization for distribution in impoverished communities.

    • Nutriset for developing nutritional products made from peanuts and other ingredients that help malnourished children quickly and safely regain weight and digestive function, delivering its Plumpy’Nut branded products throughout the world with partners like UNICEF and USAID, and assembling entrepreneurs in participating countries to manufacture the Plumpy' range of products for local needs.

    • The Golden Rice Project for inventing the Golden Rice technology (genetically enhanced rice that provides a source of vitamin A for people subsisting mainly on rice) and donating the technology to the resource poor in developing countries.  Local Golden Rice varieties are currently being developed by public sector institutions in Bangladesh, China, India, Indonesia, Philippines, and Vietnam.

    • Global Research Innovation & Technology (GRIT), founded by engineering graduates of the Massachusetts Institute of Technology (MIT), for creating a wheelchair technology to increase mobility for the disabled around the world.  The GRIT three-wheel Leveraged Freedom Chair, built from standard bicycle parts, uses a push-lever drivetrain to help people move over broken pavement, dirt roads, fields, hills, rocky terrain and more.  The chair has been distributed in partnership with the World Bank, Red Cross, and others in India, Brazil, Guatemala, Guinea, Kenya, Haiti, Easter Island, Nepal, and Tanzania.

    Additional information regarding the latest winners of the Patents for Humanity program can be found here.

  • Court Report

            By Sherri Oslick —

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

    Supernus Pharmaceuticals, Inc. v. Actavis Inc. et al.
    1:15-cv-02499; filed April 7, 2015 in the District Court of New Jersey

    • Plaintiff:  Supernus Pharmaceuticals, Inc.
    • Defendants:  Actavis Inc.; Actavis Laboratories FL, Inc.; Activis Pharma, Inc.; Watson Laboratories, Inc.; Anda, Inc.

    Infringement of U.S. Patent No. 8,821,930 ("Modified Release Preparations Containing Oxcarbazepine and Derivatives Thereof," issued September 2, 2014) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Supernus' Oxtellar XR® (oxcarbazepine extended-release tablets, used for adjunctive therapy in the treatment of partial seizures in adults and in children 6 to 17 years of age).  View the complaint here.

    Merial Inc et al. v. Ceva Sante Animale SA et al.
    3:15-cv-00039; filed April 6, 2015 in the Middle District of Georgia

    • Plaintiffs:  Merial Inc; Merial SAS
    • Defendants:  Ceva Sante Animale SA; Horizon Valley Generics Inc; Trurx LLC

    Infringement of U.S. Patent No. 6,096,329 ("Insecticidal Combination to Control Mammal Fleas, in Particular Fleas on Cats and Dogs," issued August 1, 2000), licensed to Merial in the animal health field, based on Ceva's manufacture and sale of its PetAction Plus and PetLock Plus flea and tick products .  View the complaint here.

    Sanofi-Aventis U.S. LLC et al. v. Accord Healthcare, Inc.
    3:15-cv-02520; filed April 6, 2015 in the District Court of New Jersey

    • Plaintiffs:  Sanofi-Aventis U.S. LLC; Aventis Pharma S.A.; Sanofi
    • Defendant:  Accord Healthcare, Inc.

    Sanofi-Aventis U.S. LLC et al. v. BPI Labs, LLC et al.
    3:15-cv-02521; filed April 6, 2015 in the District Court of New Jersey

    • Plaintiffs:  Sanofi-Aventis U.S. LLC; Aventis Pharma S.A.; Sanofi
    • Defendants:  BPI Labs, LLC; Belcher Pharmaceuticals, LLC

    Sanofi-Aventis U.S. LLC et al. v. Dr. Reddy's Laboratories, Inc. et al.
    3:15-cv-02522; filed April 6, 2015 in the District Court of New Jersey

    • Plaintiffs:  Sanofi-Aventis U.S. LLC; Aventis Pharma S.A.; Sanofi
    • Defendants:  Dr. Reddy's Laboratories, Inc.; Dr. Reddy's Laboratories, Ltd.

    Sanofi-Aventis U.S. LLC et al. v. Glenmark Generics Inc. et al.
    3:15-cv-02523; filed April 6, 2015 in the District Court of New Jersey

    • Plaintiffs:  Sanofi-Aventis U.S. LLC; Aventis Pharma S.A.; Sanofi
    • Defendants:  Glenmark Generics Inc.; Glenmark Pharmaceuticals Ltd.

    The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 8,927,592 ("Antitumoral Use Of Cabazitaxel," issued January 6, 2015) following a Paragraph IV certification as part of defendants' filing of an ANDA and/or an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture a generic version of Sanofi's Jevtana® (cabazitaxel injection, used in combination with prednisone for the treatment of patients with hormonerefractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen).  View the Accord complaint here.


    Purdue Pharma L.P. et al. v. Acura Pharmaceuticals Inc. et al.
    1:15-cv-00292; filed April 3, 2015 in the District Court of Delaware

    • Plaintiffs:  PF Laboratories Inc.; Purdue Pharma LP; Purdue Pharmaceuticals LP
    • Defendants:  Acura Pharmaceuticals Inc.; Egalet Corp.; Egalet US Inc.

    Declaratory judgment of infringement of U.S. Patent No. 8,389,007 ("Pharmaceutical Composition Containing Gelling Agent," issued March 5, 2013) based on Acura's anticipated marketing and sale of Oxaydo® (formerly Oxecta®, oxycodone hydrochloride, used for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate).  View the complaint here.

    Gilead Sciences, Inc. et al. v. Watson Laboratories, Inc. et al.
    2:15-cv-02350; filed April 3, 2015 in the District Court of New Jersey

    • Plaintiffs:  Gilead Sciences, Inc.; Royalty Pharma Collection Trust
    • Defendants:  Watson Laboratories, Inc.; Actavis, Inc.; Actavis PLC

    Infringement of U.S. Patent No. RE42,462 ("Carboxylic Acid Derivatives, Their Preparation and Use," issued June 14, 2011) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Gilead's Letairis® (ambrisentan, used to treat pulmonary arterial hypertension).  View the complaint here.


    Elan Pharma International Ltd. v. Actavis Laboratories UT Inc. et al.
    1:15-cv-00291; filed April 2, 2015 in the District Court of Delaware

    • Plaintiff:  Elan Pharma International Ltd.
    • Defendants:  Actavis Laboratories UT Inc.; Actavis Inc.; Actavis plc

    Infringement of U.S. Patent No. 6,899,890 ("Bioadhesive Drug Delivery System," issued May 31, 2005) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Elan's Clindesse®(clindamycin phosphate vaginal cream, used to treat bacterial vaginosis).  View the complaint here.


    Merck Sharp & Dohme Corp. v. Apotex Inc. et al.
    3:15-cv-02384; filed April 2, 2015 in the District Court of New Jersey

    • Plaintiff:  Merck Sharp & Dohme Corp.
    • Defendants:  Apotex Inc.; Apotex Corp.

    Infringement of U.S. Patent No. 6,127,353 ("Mometasone Furoate Monohydrate, Process for Making Same and Pharmaceutical Compositions," issued October 3, 2000) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Merck's Nasonex® (mometasone furoate monohydrate metered nasal spray, used to treat diseases of the upper airways, including allergic and nonallergic rhinitis).  View the complaint here.

  • Conference & CLE Calendar

    CalendarApril 15-17, 2015 – 2015 Spring Intellectual Property Counsels Committee (IPCC) Conference (Biotechnology Industry Organization) – St. Louis, MO

    April 16, 2015 – "Patent Subject Matter Eligibility: Navigating the New USPTO Guidance — Analyzing Subject Matter and Avoiding Rejection Under the USPTO's Detailed Framework" (Strafford) – 1:00 to 2:30 pm (EDT)

    April 21, 2015 – U.S. Biosimilars (American Conference Institute) – Munich, Germany

    April 21, 2015 – CincyBIO conference (CincyIP) – Cincinnati, OH

    April 23, 2015 – "Key Trade Secret Developments in 2015" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    April 24, 2015 – Ethics in the Practice of Intellectual Property Law (The John Marshall Law School Center for Intellectual Property, Information & Privacy Law) – Chicago, IL

    April 27-29, 2015 – M&A and Strategic Alliances in the Life Sciences Industries*** (American Conference Institute) – New York, NY

    April 27-28, 2015 – Paragraph IV Disputes conference*** (American Conference Institute) – New York, NY

    April 30, 2015 – "Interim Guidance on Patent Subject Matter Eligibility" (American Bar Association) – 1:00 to 2:30 pm (ET)

    May 12, 2015 – "Patent Prosecution: Leveraging Declarations to Strengthen Patents Against Post-Grant Proceedings" (Strafford) – 1:00 to 2:30 pm (EDT)

    May 12, 2015 – 31st Annual Joint Patent Practice Seminar (Connecticut, New Jersey, New York, and Philadelphia Intellectual Property Law Associations) – New York, NY

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

  • CincyBio 2015

    CincyBioCincyIP will be holding its annual CincyBIO conference on April 21, 2015 at the Horseshoe Casino in Cincinnati, OH.  The conference will consist of the following sessions:

    • Draft and Prosecute Biotech Patent Applications That Can Withstand IPR and PGR Challenges
    • The Patentability of Natural Products: A European Perspective
    • Protecting Natural Products in the Wake of Evolving Eligibility Standards
    • Strategies for Patenting at the Intersection of Biotech, Informatics & Healthcare IT
    • The Future of Biotechnology Innovation, and How it can be Protected and Monetized

    Additional information about the conference, including an agenda and list of speakers can be found here.

    There registration fee for the conference is $125 (CincyIP member), $150 (non-member with CLE), $100 (non-member without CLE), or $25 (students).  Those interested in registering can do so here.

  • ACI Paragraph IV Disputes Conference

    New York #2American Conference Institute (ACI) will be holding its 9th Annual Paragraph IV Disputes conference on April 27-28, 2015 in New York, NY.  ACI faculty will provide insights into:

    • Teva v. Sandoz and the Impact of a New Claim Construction Standard of Review
    • Personal and General Jurisdiction Challenges Under Daimler and Mylan
    • Myriad 101 Rejections and Nautilus 112 Indefiniteness Findings
    • Barraclude and New Obviousness Considerations
    • IPR, CBM, and PGR Utilization in ANDA Litigation
    • Reissue Applications as a Cure for Invalidity Findings
    • Akamai's Effect on Method of Treatment Claims and Carve-Outs
    • Settlement Strategies Post-Actavis
    • At-Risk Launches and Damages

    CoverThe conference will offer presentations on the following topics:

    • The Role of Legal Analytics in the Paragraph IV Disputes Landscape: Playing Moneyball for Successful ANDA Litigation Strategy
    • Questions of Personal and General Jurisdiction in A Paragraph IV Case: Exploring Daimler's Applicability in a Hatch Waxman Scenario
    • Exploring Possible New Grounds Paragraph IV Invalidity Challenges: How 101 Rejections Under Myriad and Findings of 112 Indefiniteness Under Nautilus May Alter Paragraph IV Litigation
    • Defeating the Undefeatable: New Obvious Considerations for Paragraph IV Compound Patent Challenges in Light of Baraclude
    • PTO Proceedings Retrospect: Exploring the Growing Use of IPR, PGR and CBM Review in Hatch-Waxman Litigation
    • Exploring the Utilization of Reissue Applications to Cure Invalidity Findings at the PTAB and District Courts
    • The Patent Trial and Appeals Board Live: A Conversation with Administrative Patent Judges on PTAB Practices and Protocols for Hatch-Waxman Practitioners
    • A View From the Bench: The Federal Judges Speak
    • Teva v. Sandoz — Claim Construction Redoux: De Novo vs. Deferentia
    • Limelight v. Akamai: Assessing Its Impact on Method of Treatment Patents and Section viii Label Carve Outs
    • FTC Keynote: Reverse Payment Settlements and Other Antitrust Concerns Impacting Paragraph IV Litigation in the Wake of Actavis
    • Developing Practical Strategies for Settling A Paragraph IV Case Post-Actavis: A Litigator's Perspective
    • FDA Update: Survey of Agency Activity Impacting Paragraph IV Litigation
    • Assessing the True Measure of Damages in At Risk Launch Scenario
    • The Ethics of Paragraph IV Practice: New Developments Impacting Professional Responsibility in the Hatch-Waxman Arena

    In addition, a pre-conference workshop, entitled "Anatomy of a PTO PTAB Patent Trial in the Hatch-Waxman Arena" will be offered from 8:30 am to 12:30 pm on April 29, 2015.

    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 InstituteThe registration fee for the conference is $2,295 (conference alone) or $2,895 (conference and workshop).  Those interested in registering for the conference can do so here, by e-mailing CustomerService@AmericanConference.com, 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.

  • Webinar on Interim Guidance on Patent Subject Matter Eligibility

    ABAThe American Bar Association (ABA) Section of Intellectual Property Law and Young Lawyers Division will be offering a live webinar entitled "Interim Guidance on Patent Subject Matter Eligibility" on April 30, 2015 from 1:00 to 2:30 pm (ET).  Leslie McDonell (moderator) of Finnegan, Henderson, Farabow, Garrett & Dunner, Dr. Amelia Feulner Baur of McNeill Baur PLLC; Ali Salimi, Legal Advisor, Office of Patent Legal Administration, U.S. Patent and Trademark Office will:

    • Explore the impact of the new guidance on patent examination;
    • Examine the quality of issued patent claims; and
    • Provide practitioners with "best practices" insights on how to avoid potential pitfalls associated with subject matter eligibility.

    The registration fee for the webcast is $150 for members and $195 for the general public.  Those interested in registering for the webinar, can do so here.

  • Webinar on Leveraging Declarations to Strengthen Patents

    Strafford #1Strafford will be offering a webinar/teleconference entitled "Patent Prosecution: Leveraging Declarations to Strengthen Patents Against Post-Grant Proceedings" on May 12, 2015 from 1:00 to 2:30 pm (EDT).  Thomas L. Irving, Deborah M. Herzfeld, and Jonathan R.K. Stroud of Finnegan Henderson Farabow Garrett & Dunner will provide guidance to patent counsel for preparing and submitting declarations during prosecution of U.S. patent applications to support the desired claim interpretation, non-obviousness and § 112 positions.  The webinar will review the following questions:

    • How can practitioners prepare and submit declarations during prosecution to strengthen the application against the threat and/or efficacy of a third-party’s post-grant challenges?
    • What can patent owners do to try and obtain the desired claim construction in both litigation and post-grant proceedings?
    • How can practitioners introduce strong grounds for patentability under §§ 102, 103 and 112 in the specification and prosecution history so that IPRs and PGRs are either denied or otherwise ineffective against the challenged instituted claims?

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those registering by April 17, 2015 will receive a $50 discount.  Those interested in registering for the webinar, can do so here.

  • 31st Annual Joint Patent Practice Seminar

    JPPCLE_31The Connecticut, New Jersey, New York, and Philadelphia Intellectual Property Law Associations will be holding their 31st Annual Joint Patent Practice Seminar on May 12, 2015 in New York, NY.  The seminar will consist of five panels:  USPTO Practice, Pharmaceuticals/Life Sciences, High Tech, Litigation, and Supreme Court with each panel addressing a series of cases and topics.  An agenda for each of the panels can be found here.

    A featured morning address will be given between 8:54 and 9:25 am by Drew Hirshfeld, Deputy Commissioner for Patent Examination Policy, U.S. Patent and Trademark Office.  In addition, the Hon. Jimmie V. Reyna, Circuit Judge, U.S. Court of Appeals for the Federal Circuit will provide a keynote address entitled "Looking Ahead: New Developments and Challenges for the CAFC."

    The registration fee for the conference is $450 (for those registering by April 30, 2015).  Those interested in registering for the conference can do so here.