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FDA Will Now Provide More Data on 180-Day Exclusivity in the Orange Book

FDA Will Now Provide More Data on 180-Day Exclusivity in the Orange Book

In a recent alert, the FDA announced that effective June 18, 2019, the Agency will publish additional data in the Orange Book Paragraph IV Certifications list. To enhance the already published data, the Orange Book will now include (1) the number of potential first applicants; (2) the 180-day decision date; (3) the date of the “first applicant” approval; (4) the date of first commercial marketing by any first applicant; and (5) the expiration date of the last qualifying patent. According to the FDA, the updated data listing comports with the Agency’s commitment under the Drug Competition Action Plan where the FDA “committed to enhancing efficiency of the development and approval of ANDAs, with the ultimate goal of more approvals.” Historically, the Orange Book Paragraph IV Certifications list has contained relevant information related to 180-day eligibility for generic drug products. Until recently, the listings included the name of the drug product, dosage form, dosage strength(s), the reference listed drug, the New Drug Application Number and the date upon which the first substantially complete application containing a Paragraph IV certification was submitted to the Agency. The new data will provide greater clarity to Hatch-Waxman litigants in a variety of ways. More specifically,...

Supreme Court Expands the Scope of Damages to Include Foreign Sales

Supreme Court Expands the Scope of Damages to Include Foreign Sales

The Supreme Court in WesternGeco LLC v. ION Geophysical Corp. opened a new door to recover for patent damages in its holding that a patent owner can recover damages for patent infringement under 35 U.S.C. §271(f)(2) and §284 of lost foreign profits. The Patent Act outlines several ways an alleged infringer may be liable for patent infringement, including §271(f) which “expands the definition of infringement to include supplying from the United States a patented invention’s components.” 35 U.S.C. §284 authorizes “damages adequate to compensate for the infringement, but in no event less than a reasonable royalty for the use made of the invention by the infringer.” In this case, WesternGeco developed technology for surveying the ocean floor for oil and gas companies. ION Geophysical Corp. sold a competing system where the components were manufactured in the United States and shipped abroad. The Southern District of Texas found that ION Geophysical Corporation infringed WesternGeco’s patents, and that WesternGeco lost specific contracts due to ION’s infringement. The district court awarded $93.4 million in lost profits and $12.5 million in royalties. On appeal, the Court of Appeals for the Federal Circuit reversed the award of lost-profit damages following its precedent in Power Integrations, Inc....

Supreme Court Upholds the Constitutionality of Inter Partes Review

Supreme Court Upholds the Constitutionality of Inter Partes Review

The Supreme Court in Oil States Energy Services v. Greene’s Energy Group upheld the constitutionality of inter partes reviews, holding that inter partes review does not violate Article III or the Seventh Amendment of the Constitution. The Supreme Court held that inter partes review involves public rights and is simply a reconsideration of the grant of a public franchise. Therefore, allowing the Patent and Trademark Office (PTO) to reconsider the grant of a public right does not violate Article III. The Supreme Court concluded that the grant of a patent has long been recognized as a public right, and the Seventh Amendment is not violated because a jury is not necessary since the PTO can properly conduct inter partes review. The Supreme Court qualified that its holding was narrow. The Supreme Court’s constitutionality determination applied to inter partes review only. The Court did not rule on the retroactive application of inter partes review to a patent granted before AIA post-grant proceedings were in place, nor to any due process challenges. Oil States Energy Services and Greene’s Energy are oilfield services company. After Oil States sued Greene’s Energy for infringing a patent related to hydraulic fracturing, Greene’s Energy challenged the patent’s validity...

Wendy Stein Promoted to Director in Intellectual Property Department

Wendy Stein Promoted to Director in Intellectual Property Department

Gibbons P.C. is pleased to announce that Wendy R. Stein has been named a Director in the Intellectual Property Department in the firm’s New York office, effective January 2, 2018. “We are extremely proud of Wendy and we look forward to working with her in her new role,” said Patrick C. Dunican Jr., Chairman and Managing Director of Gibbons. At Gibbons, Ms. Stein focuses her practice on intellectual property disputes, primarily in the patent and trademark areas. She has extensive experience litigating a broad variety of patent infringement and other matters in the pharmaceutical and life sciences arenas, including matters related to a variety of medications, and SABAs used to treat asthma and/or COPD. Ms. Stein also has substantial experience litigating patent infringement disputes in the non-pharma area, including matters related to GPS devices, gaming, hand-held devices, and packaging. In addition, Ms. Stein has litigated trademark ownership and infringement/counterfeiting disputes involving perfume, apparel, electronics, real estate, and gaming. Ms. Stein has appeared before federal and state courts throughout the United States including New York, New Jersey, Delaware, California, Florida, Texas, District of Columbia, Illinois, and Nebraska, and before the Court of Appeals for the D.C. and Federal Circuits, recently obtaining...

Gibbons Ranked Best Law Firm and Best Lobbying Firm in Inaugural NJBIZ Reader Rankings

Gibbons Ranked Best Law Firm and Best Lobbying Firm in Inaugural NJBIZ Reader Rankings

Gibbons P.C. has been selected as the best law firm and the best lobbying firm in New Jersey in the inaugural NJBIZ Reader Ranking Awards. The Reader Rankings were compiled through an online survey seeking the best of the best in a wide range of categories and subcategories. According to NJBIZ, “The publication of the 2017 Reader Rankings by NJBIZ is our way of recognizing the regard our readers have for the businesses in their communities. What makes the companies listed here distinct is the devotion they inspire among our region’s business leaders.” Gibbons has been recognized by numerous organizations and publications for the firm’s work on behalf of clients, including being named among the New Jersey Law Journal’s Litigation Departments of the Year, earning the top overall honors in 2014, as well as recognition for the practice areas of class actions (2017), products liability (2016), and commercial litigation (2013). The Gibbons Government Affairs Department has ranked as the #1 lawyer-lobbying firm in New Jersey for nine consecutive years, according to the New Jersey Election Law Enforcement Commission In addition, the firm and Gibbons attorneys are also consistently recognized in annual client-review publications such as the Chambers USA Guide to...

Do You Like What You’re Reading? Rate Our Blog: The ABA Journal’s “Web 100” Award

Do You Like What You’re Reading? Rate Our Blog: The ABA Journal’s “Web 100” Award

Thank you for visiting the Gibbons IP Law Alert blog! Content on our site, authored by members of the Gibbons Intellectual Property Department, analyzes and discusses ongoing legal and business news related to various aspects of intellectual property law. How are we doing? To review our blog and nominate the Gibbons IP Law Alert for this year’s ABA Journal’s “Web 100” award, please visit abajournal.com/blawgs/web100 and share why you are a “fan” of our site (Please note: the voting process closes on Sunday, July 30). Thank you in advance for your support.

Intellectual Asset Management Again Ranks Gibbons Among World’s Leading Patent Professionals

Intellectual Asset Management Again Ranks Gibbons Among World’s Leading Patent Professionals

Intellectual Asset Management (IAM) has again included Gibbons P.C. in its 2017 edition of IAM Patent 1000: The World’s Leading Patent Professionals. David E. De Lorenzi, Chair of the Gibbons Intellectual Property Department, and Department Counsel George W. Johnston and George M. Gould were also recognized individually among IAM’s leading patent practitioners. This is the seventh straight year that IAM has recognized the firm. To compile the IAM Patent 1000, the IAM team conducts extensive research over the course of five months with thousands of private practice attorneys based in dozens of countries, as well as the users of their services, in order to identify the practitioners and practices that are considered to excel at providing patent-related legal services. Among other accolades, IAM recognized that “intellectual property is a central pillar at general practice Gibbons” while also recognizing that the firm’s IP experience “across the board means that patents are prosecuted with aplomb, technology transfers are swiftly sewn up and high-stakes cases are favourably resolved.” Moreover, clients surveyed by IAM remarked that when working with the Gibbons Intellectual Property Department, the client’s “long-term business interests are always kept front and centre.” David E. De Lorenzi was again selected by IAM...

Privilege Claims and the Common Interest Doctrine

Privilege Claims and the Common Interest Doctrine

In a recent decision, in the District of Massachusetts, Magistrate Judge M. Page Kelley addressed the validity of privilege claims regarding third party communications under the common interest doctrine. In this case, plaintiffs Crane Security Technologies, Inc. and Visual Physics, LLC, a wholly-owned subsidiary of Crane Technologies, Inc. (collectively, “Crane”) alleged that defendant Rolling Optics, AB (“RO”) infringed the Crane patents that “relate generally to optical systems that project synthetic images that ‘move’ and that include image icons formed as voids or recesses” therefore, “useful as [an] anti-counterfeiting feature[] on currency.” Crane is the exclusive licensee to the patents-in-suit from third party, Nanoventions (“NV”). The relationship between the parties began in 2002 when Crane entered into a confidentiality agreement with NV because Crane was interested in using NV’s optical system as a security device on currency. Over the course of the next several years, Crane and NV entered into numerous additional agreements, culminating in Crane’s “purchase[] [of] the intellectual property from NV in 2008.” During discovery, RO challenged approximately 600 entries on Crane’s privilege log regarding certain communications between Crane and third parties pertaining to the Crane’s transactions with NV, including: (1) communications between Crane and NV dated before the...

Safe Harbor 2.0: Still a Work in Process 0

Safe Harbor 2.0: Still a Work in Process

Last month, judges from the European Court of Justice, the European Union’s top court, issued a judgment striking down a 15-year old agreement, known as the Safe Harbor framework, which allowed American and European businesses to freely move personal data between the two regions. This ruling impacts nearly 4,000 businesses that currently rely on Safe Harbor framework to transfer data between the U.S. and Europe and requires all businesses to revaluate their compliance with Europeans standards.

Target/Visa Settlement: A Potential Guide Post in Data Breach Litigation 0

Target/Visa Settlement: A Potential Guide Post in Data Breach Litigation

While the winter holidays are a time for spending and good cheer, the 2013 holiday season was one that continues to be costly for Target. On December 19, 2013, Target publicly announced that computer hackers had stolen data, including credit card payment information, from millions of Target shoppers. In January 2014, Gibbons P.C., in light of the Target data breach, discussed the ramifications of delay in notifying consumers, whether the delay was intentional or as a result of compliance with law enforcement requests. Banks and credit unions, which had issued credit cards affected by the breach, were forced to reimburse Target customers in some cases and reissue millions of cards, brought a class action lawsuit against Target.