Patent Docs

IPO Webinar on New PTAB Rules and Recent Decisions

September 5, 2015

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "A Kinder, Gentler PTAB? Proposed New Trial Rules & Important Recent Decisions" on September 9, 2015 from 2:00 to 3:00 pm (ET). Hon. Michael Tierney, Lead Administrative Patent Judge, Patent Trial and Appeal Board, U.S. Patent & Trademark Office; Steven Baughman of Ropes & Gray LLP; and Lissi Mojica of Dentons US LLP will discuss what the proposed PTAB rules changes are likely to mean in practice, focusing on: 1) the patent owner’s new ability to offer evidence in its preliminary response, and 2) the lowering of the hurdle to amend claims through clarification of the relevant prior art, as explained in the recent inter partes review opinion ImageMaster 3D. The panel will also discuss the pros & cons of a proposed pilot program under which a single APJ would decide whether to institute an IPR trial, with two additional APJs being assigned to conduct the IPR trial, if instituted.

The registration fee for the webinar is $130 (government and academic rates are available upon request). Those interested in registering for the webinar can do so here.
Webcast on International Post Grant Practice

September 5, 2015

Practising Law Institute (PLI) will be offering a one-hour webcast entitled "Where to Challenge Patents? International Post Grant Practice — Strategic Considerations Before the USPTO, EPO, SIPO and JPO" on September 9, 2015 from 1:00 to 2:00 pm (Eastern). Dr. Jeffery P. Langer, Christophe Besnard, Shigeki Takeuchi, and Cliff Yang of Osha Liang LLP will:

• Provide an overview of post grant proceedings before the USPTO, EPO, SIPO, and JPO;
• Highlight strategic considerations and relevant emerging issues when seeking review before these offices; and
• Discuss the strengths and weaknesses of the procedures before the offices and how to use these to your client’s advantage.

The registration fee for this webcast is $299. Those interested in registering for the webcast, can do so here.
ACI FDA Boot Camp

September 5, 2015

American Conference Institute (ACI) will be holding the next session of its FDA Boot Camp conference on September 30 to October 1, 2015 in Boston, MA. ACI faculty will help attendees:

• Master the basics of the application and approval processes for drugs, biologics, and devices;
• Comprehend the structure of the FDA and the roles of the three major agency centers: CDER, CBER, and CDHR;
• Develop a practical working knowledge of clinical trials for drugs and biologics and the clearance process for devices;
• Learn how devices are classified, monitored, and regulated;
• Appreciate the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products;
• Recognize the pivotal role of labeling in the drug and biologics approval process;
• See the importance of cGMPs to the post-approval regulatory process; and
• Navigate the protocols of adverse events monitoring, signal detection, product withdrawals, and recalls.

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

• Brief Overview of FDA Practice
• The Nature of the Approval Process
• Understanding the Clinical Trial Process for Drugs and Biologics
• Drugs and Biologics: Labeling
• Patent and IP Overview for Drugs and Biologics: Understanding The Connection Between FDA Regulation and IP and Related Mechanisms Under Hatch-Waxman and BPCIA
• Part 1 — Patents, Trademarks and Other IP Protections and Mechanisms
• Part 2 — Hatch-Waxman and BPCIA Overview
• Using FDA's Citizen Petition Process and Litigation to Achieve Market Success
• cGMPs: Drugs and Biologics (Current Good Manufacturing Practices)
• The Drug Supply Chain Security Act — Summarizing the Act and Its Effect on FDA Practice
• Medical Devices: Classifications, the Essentials of the Premarket Review Process, and Post-Market Requirements and Concerns
• Adverse Events Monitoring, Pharmacovigilance and Risk Management, and Recalls

A pre-conference workshop on the "Fundamentals of FDA Regulatory Law" and "Resolving Ethical Challenges Encountered During the Drug Approval Process" will be offered on September 29, 2015 from 1:00 to 5:00 pm. Two post-conference master classes will be offered on October 1, 2015. The first master class is entitled "Hatch-Waxman and BPCIA: Overview of Biosimilars and Life Cycle Planning for Drugs and Biologics," and the second master class is entitled "Post-Approval Marketing Guidance and Preemption Protocols."

An agenda for the conference can be found here, and additional information regarding the workshop and master classes 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.

The registration fee is $2,195 (conference alone), $2,795 (conference and workshop or conference or one master class), or $3,095 (conference, workshop, and one master class). 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.
ACI Paragraph IV Disputes Conference

September 5, 2015

American Conference Institute (ACI) will be holding its 3rd Annual Paragraph IV Disputes master symposium from September 30 to October 1, 2014 in Chicago, IL. ACI faculty will provide insights into:

• Paragraph IV Due Diligence Strategies Analyses
• Pending Patent Reform Legislation and Its Potential Impact on Hatch-Waxman Litigation
• Personal and General Jurisdiction Challenges Under Daimler and Mylan
• IPR, CBM, and PGR Utilization in ANDA Litigation
• FRCP 16 and 26 Discovery Dilemmas Relative to Scheduling Orders, Protective Orders and ESIs in ANDA Litigation
• Myriad 101 Rejections and Nautilus 112 Indefiniteness Findings
• Barraclude and New Obviousness Considerations
• The Merits of Bringing A Declaratory Judgment Action in a Paragraph IV Case
• Settlement Strategies Post-Actavis
• At-Risk Launches and Damages
• Markman strategies post–Teva v. Sandoz
• Willfulness and recklessness considerations in relation to ANDA filing

The conference will offer presentations on the following topics:

• Paragraph IV Due Diligence Analysis: Economic Impact of Pharmaceutical Patent Wins and Losses at District Courts and PTAB
• Patents, Politics, Trolls and System Abuse: An Update on How Proposed Patent Reform Legislation May Impact the Patent End Game
• Establishing Personal and General Jurisdiction in A Paragraph IV Case in the Aftermath of Daimler and Mylan
• RCP 16 and 26: Brand and Generic Viewpoints on Scheduling Orders, Protective Orders and ESIs in a Hatch-Waxman Setting
• Obviousness of the Unexpected: Understanding How a Compound Patent Defeat in Baraclude May Raise New Questions for Prior Art
• PTO Proceedings Update: The Continuing Use of IPR, PGR and CBM Review in the Hatch-Waxman Arena
• A Hatch-Waxman Practitioner's Guide to The Patent Trial and Appeals Board: The PTAB Live
• A View From the Bench: The Judges Speak
• Myriad and Nautilus: Exploring New Paragraph IV Invalidity Challenges Under 101 and 112
• Re-Evaluating Claim Construction and Markman Strategies in Wake of Teva v. Sandoz
• Evaluating the Merits of Bringing A Declaratory Judgment Action in a Paragraph IV Case: Duplication or Necessity?
• 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, two post-conference workshops will be offered on October 2, 2014. The first, entitled "PTO Practice Master Class: Anatomy of a PTO PTAB Patent Trial in the Hatch-Waxman Arena" will be offered from 8:30 am to 12:30 pm, and the second, entitled "Biosimilars Boot Camp for the Paragraph IV Litigator," will be offered from 1:00 to 4:30 pm.

The agenda for the Paragraph IV Disputes master symposium can be found here. More information regarding the workshops 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.

The registration fee for the conference is $2,295 (conference alone), $2,895 (conference and one workshop), or $3,495 (conference and both workshops). 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.
USPTO Patent Quality Chat Webinar Series

September 5, 2015

The U.S. Patent and Trademark Office will be offering the next webinar in its Patent Quality Chat webinar series on September 8, 2015 from 12:00 to 1:00 pm (EDT). The latest webinar, which will be hosted by Deputy Commissioner for International Patent Cooperation Mark Powell and Director of International Programs Maria Holtmann, will address the topic of Improving Global Patent Prosecution. Mr. Powell and Ms. Holtmann will discuss how to improve global patent prosecution and highlight a new program the USPTO is exploring with other IP offices – a global preliminary search.

Additional information regarding the Patent Quality Chat webinar series can be found on the USPTO's Patent Quality Chat webpage.
Amicus Briefs in Support of Sequenom’s Petition for Rehearing En Banc: 23 Law Professors

September 3, 2015

By Donald Zuhn —

Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted claims of U.S. Patent No. 6,258,540 (see "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)"). On August 13, Sequenom filed a petition for rehearing en banc, arguing that the panel's decision in June was inconsistent with the Supreme Court's decisions in Diamond v. Diehr, 450 U.S. 175 (1981), Mayo v. Prometheus Laboratories, 132 S. Ct. 1289 (2012), and Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013), and that the panel's decision poses a threat to patent protection in multiple fields of invention. Last week, twelve amicus curiae briefs were filed in support of Sequenom's petition for rehearing en banc. Over the next few weeks, Patent Docs will examine these amicus briefs. Today, we review the brief filed by twenty-three law professors*, which was submitted by Patent Docs author Kevin Noonan.

The brief begins by noting that while the amici — twenty-three law professors who teach and write on patent law and policy — "may differ amongst themselves on other aspects of modern patent law and policy, they are united in their professional opinion that this court should grant rehearing en banc because the panel decision's application of § 101 undermines the function of the patent system to promote and to legally secure twenty-first-century innovation." The brief then proceeds to "offer two further insights as to how the panel decision undermines the essential function of the patent system in promoting new innovation." In particular, amici argue that the Ariosa panel decision undermines "exactly the type of twenty-first-century innovation the patent system is designed to promote," and that the panel decision "would call into question nineteenth-century patented innovation the Supreme Court deemed valid."

With respect to the brief's first insight, the amici contend that the Ariosa panel decision "contravenes the Bilski Court's injunction that § 101 tests should not impede the progress of future innovation," noting that "[a]s the Bilski Court recognized, the patent system exists to promote new inventions on the frontier of human technological knowledge like genetic testing methods, which by necessity require massive R&D expenditures that can only be recouped via the protections offered by property rights in this innovation." According to the amici, "[t]he panel decision contravenes this insight by the Supreme Court because it threatens to preclude many genetic and other diagnostic tests from the ambit of patent protection," and "disincentivizes making the massive R&D investments required to create this new innovation in the twenty-first century."

Turning to the professors' second insight, the brief cites Mayo Collaborative Services v. Prometheus Laboratories, Inc., where "the Supreme Court recognized that 'too broad an interpretation of this exclusionary principle [regarding laws of nature, natural phenomena and abstract ideas] could eviscerate patent law,'" since "'all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.'" The amici argue that "not only does the panel decision threaten an entire field of twenty-first-century inventive activity, it would also cast serious doubt about classic nineteenth-century patented innovation either validly issued under the patent laws or sustained by the Supreme Court," and present three examples in support of their argument.

The first, U.S. Reissue Patent No. 117, issued June 13, 1848, was involved in O'Reilly v. Morse, 56 U.S. 62 (1853). Although the Supreme Court affirmed the validity of the first seven claims in that case, the brief contends that "the Ariosa panel's application of the Mayo test, if applied to Claim 1 of Morse's patent in the same way the panel applied it to Sequenom's patent, leads to the conclusion that Morse's Claim 1 is arguably unpatentable subject matter," which amici argue "directly contradicts the Supreme Court's analysis and decision in Morse that Claim 1 is valid."

The second, U.S. Patent No. 174,465, issued Mar. 7, 1876, was involved in Dolbear v. American Bell Telephone Co., 126 U.S. 1 (1888). The brief contends that "applying the Ariosa panel's analysis to Claim 5 in Bell's patent leads to the same conclusion reached for Claim 1 of Morse's patent," adding that "contrary to the Supreme Court's own analysis and decision in 1888, the Ariosa panel's analysis leads to the logical conclusion that Bell's famous Claim 5 is unpatentable subject matter."

For the third and final example, the brief goes all the way back to the first patent ever issued: U.S. Patent No. X00001 (at left), granted July 31, 1790 to Samuel Hopkins. Arguing that this patent, which is directed to a method of making potash (mined and manufactured salts that contain potassium in water-soluble form), would be invalid under the panel's application of the Mayo two-step test, amici state that "[t]his is significant because Hopkins' patent was signed by Thomas Jefferson as Secretary of State and as a member of the committee created under the 1790 Patent Act who reviewed Hopkins' application," adding that "Jefferson was both a drafter of some of the early patent laws and has long been known for his views that patents should be severely restricted in their issuance to inventors." Amici argue that "when a contemporary court reaches a decision that calls into question a patent validly issued under the 1790 Patent Act and signed by Jefferson himself, it is cause to question whether this court has applied the law correctly." The brief concludes by declaring that the panel decision "casts doubt on classic patented innovation validly issued or upheld by the Supreme Court, which "suggests that the Ariosa panel has misapplied § 101 jurisprudence and that the error is significant enough to warrant en banc consideration."

• The twenty-three law professors comprising the amici curiae on the brief are: Dan L. Burk (University of California, Irvine School of Law), Bernard Chao (University of Denver Sturm College of Law), Ralph D. Clifford (University of Massachusetts School of Law), Christopher A. Cotropia (University of Richmond School of Law), Gregory Dolin (University of Baltimore School of Law), Richard A. Epstein (New York University School of Law), Christopher Frerking (University of New Hampshire School of Law), Yaniv Heled (Georgia State University College of Law), Timothy Holbrook (Emory University School of Law), Christopher M. Holman (UMKC School of Law), Gus Hurwitz (Nebraska College of Law), Mark D. Janis (Indiana University Bloomington Maurer School of Law), Adam Mossoff (George Mason University School of Law), Sean M. O’Connor (University of Washington School of Law), Kristen Osenga (University of Richmond School of Law), Lee Petherbridge (Loyola Law School), Michael Risch (Villanova University School of Law), Mark F. Schultz (Southern Illinois University School of Law), Sean B. Seymore (Vanderbilt University Law School), Ted Sichelman (University of San Diego School of Law), Brenda M. Simon (Thomas Jefferson School of Law), Shine Tu (West Virginia University College of Law), and Saurabh Vishnubhakat (Texas A&M University School of Law).
Federal Circuit Lifts Injunction Against Sandoz

September 2, 2015

By Kevin E. Noonan —

Sandoz successfully (at least for now) has overcome conventional wisdom, the plain language of the Biologics Price Competition and Innovation Act (BPCIA) (or, at least those provisions regarding patent litigation) and Amgen in obtaining approval for its figastrim biosimilar product, Zarxio™ in Amgen v. Sandoz. The only thing standing between this biosimilar biologic drug and the marketplace was an injunction imposed by the Federal Circuit during the pendency of the parties' cross appeals from the District Court's decision, favoring Sandoz with regard to the patent litigation provisions and Amgen with regard to the timing of the 180-day marketing notice provisions of the Act.

That injunction was lifted today (technically, it expired and the Court refused to extend it), in an opinion by Judges Lourie and Chen (Judge Newman disagreed). These types of orders rarely contain any reasoning and this one is no different, merely announcing the outcome. The Court could have maintained the injunction, at least until the entire Court decided whether to reconsider the merits panel's decision en banc (both parties have filed petitions request en banc reconsideration). The decision not to do so is consistent with the panel decision and this Court's (and courts generally) looking beyond the law to what they perceive to be Congress's (or their own) policy goals and aspirations. Here, getting biosimilar Neupogen^® to market is undoubtedly believed to be the fastest way to get the drug to patients at a lower price, and that is likely to be true. But Sandoz's motivations are not entirely altruistic: their decision to launch (if they make that decision) will likely be due to the presence of other biosimilar applicants who have filed filgastrim biosimilar applications. Such a launch also will be at risk, in view of the ongoing litigation with Amgen, posing the question for Sandoz of whether to risk treble damages if Amgen's asserted patents are determined to be not invalid and infringed or risk competition from other biosimilars applicants. In other times, this situation might lead to a settlement with Amgen to permit Sandoz to reap the benefits of the combination of its early approval and its creative lawyering. However, any such agreement would likely run afoul of the Federal Trade Commission, in view of its "victory" before the Supreme Court in FTC v. Actavis. This confluence of factors cannot be what Congress intended in passing the BPCIA; perhaps its Members could set aside the partisanship that has produced legislative gridlock and correct those provisions of the law that have caused the current situation and its attendant confusion about what Congress intended in passing the Act.
Eli Lilly and Company v. Teva Parenteral Medicines, Inc. (S.D. Ind. 2015)

September 1, 2015

District Court Finds Lilly Patent Infringed Based on Inducement of Infringement by Single Actor

By Donald Zuhn —

Last week, in Eli Lilly and Company v. Teva Parenteral Medicines, Inc., Judge Tanya Walton Pratt of the U.S. District Court for the Southern District of Indiana determined that Eli Lilly and Company had shown by a preponderance of the evidence that U.S. Patent No. 7,772,209, owned by Lilly, would be infringed by the ANDA products for which Defendants Teva Parenteral Medicines, Inc.; Teva Pharmaceuticals USA, Inc.; APP Pharmaceuticals, LLC; Barr Laboratories, Inc.; and Pliva Hrvatska D.O.O. sought approval to market (opinion). The District Court indicated that its finding of infringement was "based upon inducement of infringement by a single actor, the physician administering pemetrexed disodium in accordance with the claimed methods" of the '209 patent.

Claims 1 and 12 of the '209 patent recite:

1. A method for administering pemetrexed disodium to a patient in need thereof comprising administering an effective amount of folic acid and an effective amount of a methylmalonic acid lowering agent followed by administering an effective amount of pemetrexed disodium, wherein the methylmalonic acid lowering agent is selected from the group consisting of vitamin B12, hydroxycobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-cobalamin perchlorate, azidocobalamin, cobalamin, cyanocobalamin, or chlorocobalamin.

12. An improved method for administering pemetrexed disodium to a patient in need of chemotherapeutic treatment, wherein the improvement comprises: a) administration of between about 350 μg and about 1000 μg of folic acid prior to the first administration of pemetrexed disodium; b) administration of about 500 μg to about 1500 μg of vitamin B12, prior to the first administration of pemetrexed disodium; and c) administration of pemetrexed disodium.

Claims 9, 10, 12, 15, 18, 19, and 21 of the '209 patent were asserted by Lilly with respect to Defendants' ANDA products. Claims 9 and 10 depend indirectly from claim 1 and claims 15, 18, 19, and 21 depend indirectly or directly from claim 12.

The District Court noted that the '209 patent covers the method of administering a chemotherapy drug, pemetrexed disodium, with vitamins, which Lilly markets under the trade name ALIMTA®. The Court also noted that Defendants' product labeling for their proposed generic versions of ALIMTA® instructs physicians to follow exactly the claimed regimen, since Defendants' ANDA products will be required to be distributed with identical labeling as that for ALITMA®. Experts for both Lilly and the Defendants agreed that following the labels, physicians would administer vitamin B12 by injection and administer pemetrexed disodium by infusion, but that patients, at the instruction of the physician, would obtain and take the folic acid. Thus, the issue at trial was whether the steps of the claimed methods could be attributed to a single actor, the physician, thus supporting a finding that Defendants would induce infringement of the asserted claims.

In a separate trial on validity, the Defendants had failed to show by clear and convincing evidence that the asserted claims were invalid. Although the Defendants had appealed that ruling to the Federal Circuit, both parties jointly moved to remand the appeal in order to litigate the issue of infringement in light of the Supreme Court's decision in Limelight Networks, Inc. v. Akamai Techs., Inc., in which the Supreme Court reversed the Federal Circuit's decision, and remanded the case to the Federal Circuit. In an en banc per curiam opinion, the Federal Circuit set forth the law of divided infringement under 35 U.S.C. § 271(a). The District Court noted that "for purposes of this case, the Court must apply this most current articulation of the law of divided infringement as stated by the Federal Circuit in its most recent ruling."

In finding for Lilly, the District Court observed that "[a]lthough the instant case involves the administration of a medical treatment, the factual circumstances are sufficiently analogous to those in Akamai to support a finding of direct infringement by physicians under § 271(a), and thus inducement of infringement by Defendants under § 271(b), under the legal standard recently set forth by the Federal Circuit." The Court was not persuaded by the Defendants' argument that the actions of the patient in taking folic acid prior to pemetrexed treatment cannot be attributed to the physician because the physician does not physically place the folic acid into the patients' mouth, and because patients are instructed to obtain folic acid, either by prescription or over the counter, and take it on their own. According to the Court, whether patients actually take the folic acid was irrelevant to the issue of infringement, and "the only relevant question is whether the actions of the patient in taking folic acid as instructed may be attributable to the physician as a single actor." With respect to this question, the Court pointed out that "[t]he physician, based upon the patented method, directs the manner and timing of the patient’s ingestion of folic acid — 400 to 1000 μg of folic acid for at least five days out of the seven days prior to and during pemetrexed administration — and the patient is required to do so to receive the full benefit of the treatment." The Court therefore concluded that:

Lilly has shown, by a preponderance of the evidence that, in accordance with Defendants' proposed labeling, the physician directs or controls the patient's administration of folic acid such that the performance of all the claimed steps, including the administration of folic acid, can be attributed to a single person, i.e. the physician. The evidence showed that physicians specify both the "manner and timing" in detail, including prescribing an exact dose of folic acid and directing that it be ingested daily.
Inline Plastics Corp. v. EasyPak, LLC (Fed. Cir. 2015)

August 31, 2015

Claim Terms Not Limited to Specific Embodiment

By Joseph Herndon —

In Inline Plastics Corp. v. EasyPak, LLC, the Federal Circuit offered some bits of wisdom for patent application specification drafting, while applying well-known case law to conclude that claims are not limited to a specific embodiment when the specification includes a broader disclosure.

Inline Plastics Corporation sued EasyPak, LLC for infringement of U.S. Patent No. 7,118,003 (the '003 patent) and No. 7,073,680 (the '680 patent), directed to tamper-resistant plastic food containers. Following the District Court's claim construction, Inline moved for entry of final judgment of non-infringement of its own '003 patent, on the premise that the claims as construed are not infringed. Presumably, Inline did so in order to obtain a final judgment necessary for appeal.

The '003 patent covers plastic food containers with a tamper-evident and tamper-resistant feature. The containers have a hinged plastic bridge between the top and bottom portions of the container, and the bridge has a frangible section that must be severed in order to open the container. Thus, tampering or opening of the container is readily evident. Figure 1 of the '003 patent shows an embodiment of the tamper-resistant container, and is reproduced below:

Claims 1 and 2 are representative:

1. A tamper-resistant/evident container comprising:
    a) a plastic, transparent cover portion including an outwardly extending peripheral flange;
    b) a base portion including an upper peripheral edge forming at least in part an upwardly projecting bead extending substantially about the perimeter of the base portion and configured to render the outwardly extending flange of the cover portion relatively inaccessible when the container is closed; and
    c) a tamper evident bridge connecting the cover portion to the base portion.

2. A tamper-resistant/evident container as recited in claim 1, wherein the tamper evident bridge includes a hinge joining the outwardly extending flange of the cover portion with the base portion, the hinge including a frangible section, which upon severing, provides a projection that extends out beyond the upwardly projecting bead of the upper peripheral edge of the base portion, for facilitating removal of the cover portion from the base portion to open the container.

The District Court construed "frangible section" to mean "a removable tear strip, delimited by at least two severable score lines." This was a problem for Inline because while EasyPak's accused containers embody all of the elements of claims 1 and 2, the EasyPak frangible section has a single score line along which the cover is severed from the base. Thus, using the District Court's claim construction, EasyPak could not infringe.

The District Court acknowledged that it limited the claims to the embodiment shown in Figure 1, and recognized that claims 1 and 2 did not contain a limitation to two severable score lines, but reasoned that the prosecution history supported this limitation.

Claim Term "frangible section"

The '003 specification describes the invention's features as "intended to prevent and deter opening container 10 without first removing frangible strip 18 from hinge 16." The specification does use language such as "preferably" to describe the embodiment (e.g., "Preferably, frangible strip 18 is limited at least in part by a pair of parallel score lines 42a, 42b or areas that have been weakened or stressed during the forming process"). But, the specification also states that a single score line or perforation is an alternative embodiment.

Despite this explicit disclosure of an alternative single score line, the District Court limited "frangible section" to require at least two score lines. The District Court referred to the frequency with which the specification described the frangible section as having two score lines that form a severable strip as support for doing so, and used a passing reference to the prosecution history as a secondary basis.

The Federal Circuit noted that the preferred embodiment is not described as having certain unique characteristics of patentable distinction from other disclosed embodiments. Nor are traditional aspects of restrictive claim construction present (e.g., no disavowal or damaging statements present in the specification), and thus, Inline is entitled to claim scope commensurate with the invention that is described in the specification.

The Federal Circuit also analyzed the prosecution history, and found no support for any estoppel or disclaimer of claim scope. The Federal Circuit found that during prosecution, Inline distinguished its invention from cited art on the basis that "[n]owhere in [cited art] is there any disclosure, teaching or suggestion to modify the container therein to provide a tamper evident bridge that connects a cover portion to a base portion." The distinction between the cited art and the '003 device has no relation to the number of score lines on a tear strip, but rather to differences in the structure and opening mechanism as a whole.

EasyPak attacked Inline over phases of the prosecution asserting that a declaration submitted for long-felt need limited the claims to having two score lines, and that other declarations submitted for commercial success had the same limiting effect. The Federal Circuit found no such statements in the declarations, and also noted that the patent examiner placed no emphasis on the number of severable lines whatsoever in making the determination of allowable subject matter.

The Federal Circuit noted that there simply is no discussion in the specification or the prosecution history of any patentability reliance on the number of score lines by which the frangible section is severed.

The doctrine of claim differentiation also supported Inline, in that Claim 4 depends from claim 2 and is specific to the embodiment of two parallel score lines.

Thus, the Federal Circuit found that the District Court erred in limiting the claims to a specific embodiment.

Claim Term "tamper evident bridge"

Construction of this claim term was also found to be in error since it similarly relied on the "two score lines". The Federal Circuit reconstructed it to be "at least one".

It is curious to note the District Court's strict conclusion and reliance on a "preferred embodiment" that ignored the patent application's explicit recitation of alternatives so as to issue a limiting claim construction. An odd reference to a "frequency with which the specification described the frangible section as having two score lines that form a severable strip," is not enough for this conclusion. Generally, this will always be the case, in which the invention is overwhelmingly described in terms of a "preferred embodiment", and thus, will have a high frequency of description of that manner. Other alternatives of the invention are usually described with less frequency in the specification, or even mentioned only one time per alternative. Making sure that each alternative is recited the same number of times would result in redundant descriptions and lengthy patent applications, and just does not make sense to do.

In any event, it is long-standing case law that for broad patent disclosures, i.e., those that include description of many embodiments, absent any disavowal of claim scope or specific language in the specification limiting to one/preferred embodiment, claim terms should not be so limited. And, here, the Federal Circuit followed such law.

Inline Plastics Corp. v. EasyPak, LLC (Fed. Cir. 2015)
Panel: Circuit Judges Newman, Clevenger, and Dyk
Opinion by Circuit Judge Newman
Court Report

August 30, 2015

By Sherri Oslick —

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

Bristol-Myers Squibb Co. et al. v. Merck & Co., Inc. et al.
1:15-cv-00572; filed July 7, 2015 in the District Court of Delaware

• Plaintiffs: Bristol-Myers Squibb Co.; E. R. Squibb & Sons, L.L.C.; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo
• Defendants: Merck & Co., Inc.; Merck Sharp & Dohme Corp.

Infringement of U.S. Patent No. 9,073,994 ("Immunopotentiative Composition," issued July 7, 2015) based on Merck's manufacture and sale of its Keytruda® product (pembrolizumab, an anti-PD-1 antibody, used to treat metastatic melanoma). View the complaint here.

Prinston Pharmaceutical, Inc. v. Noven Therapeutics, LLC
2:15-cv-05308; filed July 2, 2015 in the District Court of New Jersey

Declaratory judgment of non-infringement and invalidity of U.S. Patent No. 8,946,251 (("Method of Treating Thermoregulatory Dysfunction with Paroxetine," issued February 3, 2015) in conjunction with Prinston's filing of an ANDA to manufacture a generic version of Noven's Brisdelle® (paroxetine mesylate, used for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause). View the complaint here.

Otsuka Pharmaceutical Co., Ltd. v. Macleods Pharmaceuticals Ltd. et al.
1:15-cv-05109; filed July 2, 2015 in the District Court of New Jersey

• Plaintiff: Otsuka Pharmaceutical Co., Ltd.
• Defendants: Macleods Pharmaceuticals Ltd.; Macleods Pharma USA, Inc.

Infringement of U.S. Patent Nos. 8,017,615 ("Low Hygroscopic Aripiprazole Drug Substance and Process for the Preparation Thereof," issued September 13, 2011), 8,580,796 (same title, issued November 12, 2013), 8,642,760 (same title, issued February 4, 2014), and 8,759,350 ("Carbostyril Derivatives and Serotonin Reuptake Inhibitors for Treatment of Mood Disorders," issued June 24, 2014) following a Paragraph IV certification as part of Macleods' filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (aripiprazole, used to treat bipolar disorder and schizophrenia). View the complaint here.

Gilead Sciences, Inc. et al. v. Sigmapharm Laboratories, LLC
1:15-cv-04898; filed June 30, 2015 in the District Court of New Jersey

• Plaintiffs: Gilead Sciences, Inc.; Royalty Pharma Collection Trust
• Defendant: Sigmapharm Laboratories, LLC

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 SigmaPharm'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.

Horizon Pharma Ireland Ltd. et al. v. Taro Pharmaceuticals USA, Inc. et al.
1:15-cv-05021; filed June 30, 2015 in the District Court of New Jersey

• Plaintiffs: Horizon Pharma Ireland Ltd.; HZNP Ltd.; Horizon Pharma USA, Inc.
• Defendants: Taro Pharmaceuticals USA, Inc.; Taro Pharmaceutical Industries, Ltd.

Horizon Pharma Ireland Ltd. et al. v. IGI Laboratories, Inc.
1:15-cv-05022; filed June 30, 2015 in the District Court of New Jersey

• Plaintiffs: Horizon Pharma Ireland Ltd.; HZNP Ltd.; Horizon Pharma USA, Inc.
• Defendant: IGI Laboratories, Inc.

Horizon Pharma Ireland Ltd. et al. v. Amneal Pharmaceuticals LLC
1:15-cv-05024; filed June 30, 2015 in the District Court of New Jersey

• Plaintiffs: Horizon Pharma Ireland Ltd.; HZNP Ltd.; Horizon Pharma USA, Inc.
• Defendant: Amneal Pharmaceuticals LLC

Horizon Pharma Ireland Ltd. et al. v. Actavis Laboratories UT, Inc. et al.
1:15-cv-05025; filed June 30, 2015 in the District Court of New Jersey

• Plaintiffs: Horizon Pharma Ireland Ltd.; HZNP Ltd.; Horizon Pharma USA, Inc.
• Defendants: Actavis Laboratories UT, Inc.; Actavis, Inc.; Allergan PLC

Horizon Pharma Ireland Ltd. et al. v. Lupin Ltd. et al.
1:15-cv-05027; filed June 30, 2015 in the District Court of New Jersey

• Plaintiffs: Horizon Pharma Ireland Ltd.; HZNP Ltd.; Horizon Pharma USA, Inc.
• Defendants: Lupin Ltd.; Lupin Pharmaceuticals Inc.

The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 9,066,913 ("Diclofenac Topical Formulation," issued June 30, 2015) in conjunction with defendants' filing of an ANDA to manufacture a generic version of Horizon's Pennsaid® (diclofenac sodium topical solution, used for the treatment of signs and symptoms of osteoarthritis of the knee(s)). View the Taro complaint here.

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