• I Love Sugar
  

  I LOVE SUGAR is much more than a candy store. The high-end retailer takes the candy we all love and delivers a magical experience. State of the art design, including custom fixtures and attention to details, is what the experiential retailer believes makes shoppers often refer to I LOVE SUGAR as "the Apple store of candy". In a trade dress and trademark infringement case brought by their competitor, It’Sugar claimed that I LOVE SUGAR infringed their trademark and the overall look and feel of It’Sugar retail stores.

News

• Tarter Krinsky & Drogin Defeats Motion for Preliminary Injunction in Trade Dress Lawsuit Brought by It’Sugar
  

  Tarter Krinsky & Drogin successfully defended I love Sugar, a locally owned high-end candy retailer based in Myrtle Beach, South Carolina in a trade dress infringement case brought by their competitor It’Sugar.

• Firm Represents Hackermeter in Acquisition
  

  Tarter Krinsky & Drogin represented Hackermeter, a coding challenge website, in the negotiation and closing of an acquisition with Pinterest. The start-up was launched at Y Combinator’s Demo Day in August and matched developers with companies through code challenges.

Events

• Philip Braginsky and Jing Xia to Speak on Emerging Trends and Opportunities for Pharmaceutical Development at CPhI China
  

  On June 21, Intellectual Property co-chair Philip Braginsky and partner Jing Xia will speak at CPhI China, the leading pharmaceutical ingredients show in China and the wider Asia-Pacific region

• Amy Goldsmith, Philip Braginsky and Aasheesh Shravah to Present Lawline Webinar on Software Patentability
  

  Amy Goldsmith, Philip Braginsky and Aasheesh Shravah will present the Lawline Webinar “To Be or Not To Be: That is the Abstract Question, Naturally.”

• 3D Printing: The Newest Dimension in IP Protection
  

  Amy Goldsmith and Philip Braginsky, Co-Chairs of the Intellectual Property Practice, presented the Lawline webinar “3D Printing: The Newest Dimension in IP Protection.”

• Patent Design Strategy and the new Hague Agreement for Designs
  

  Amy Goldsmith and Philip Braginsky, Co-Chairs of the Intellectual Property Practice, presented the Lawline webinar “Patent Design Strategy and the new Hague Agreement for Designs.”

• Setting up Shop: Key Legal Issues for the Retail Industry
  

  Tarter Krinsky & Drogin partnered with Università Bocconi to host a full-day program as part of its In-Company Training Program. The presentation, titled “Setting up Shop: Key Legal Issues for the Retail Industry” focused on the  key legal challenges for retail clients entering the U.S. market. 

• Philip Braginsky Co-Authored Article on Building Effective Intellectual Property Strategies Into Pharma M&A
  

  On March 22, 2021, Partner and Co-Chair of Biologics Practice and China Practice Philip Braginsky co-authored the article, " Building Effective Intellectual Property Strategies Into Pharma M&A," featured in Patentography. 

• Philip Braginsky Co-Authored Article on the Impact of Quantum Computing and Artificial Intelligence in Drug Discovery
  

  On December 14, 2020, Intellectual Property Co-Chair Philip Braginsky and Barry Marenberg co-authored the article, "Quantum Computing and Artificial Intelligence in Drug Discovery," featured in Patentography. The article delves into the implications of utilizing quantum computing and artificial intelligence to discover new drugs. The authors explain that drug development is a long process that comes with high risks and high costs. Therefore, incorporating advanced technology has the potential to transform the pharmaceutical industry and the production of drugs.

• COVID-19 and Considerations for March-In Rights and Compulsory Licenses
  

  The COVID-19 pandemic has had an enormous and likely long-term impact on research into infectious diseases, ushering in a flurry of investigation into possible treatments and vaccines. The pandemic is also influencing how those in the wider healthcare system will bring relevant diagnostics and therapies to the market and ultimately to those in need.
  Many of the future underlying innovations in diagnostics, treatments, vaccines, and other related healthcare services for COVID-19 will come from a university, research institution or other recipient of federal research funding. The desperate healthcare, social and political needs for these innovations may dramatically influence how future research and medical innovations enter the market and ultimately reach patients in need. As such, COVID-19 could substantially affect how both the United States and the world deal with similar crises in the future.

• Prioritized Examination for Certain COVID-19 Related Patent Applications
  

  On May 8, 2020, the United States Patent and Trademark Office (USPTO) announced a new program for expediting certain COVID-19 related patent applications. Under the COVID-19 Prioritized Examination Pilot Program, the USPTO will grant requests for prioritized examination to small or micro entity status applicants without requiring payment of the typical prioritized examination fees. Also under this program, the USPTO will endeavor to reach final disposition of applications within six months if applicants are responsive.

• FDA Issues Guidance Related to CARES Act Amendments for Medical Device Manufacturers
  

  The U.S. Food and Drug Administration (FDA) recently published a new guidance (the Guidance) related to medical device shortages or potential shortages during the COVID-19 pandemic The Guidance is meant to implement Section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351 et seq.), which was added under Section 3121 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).

• Managing Patent Portfolio Costs
  

  Prosecuting and maintaining a patent portfolio costs many organizations millions of dollars. These costs should be continuously managed and controlled. However, many organizations allow these tasks to slip when times are good. Under the current circumstances, it is worth revisiting some ideas that go beyond the basics of implementing and practicing a good patent management system.

• USPTO Further Extends Certain Patent and Trademark Deadlines to June 1, 2020; U.S. Copyright Office Extends Deadlines to July 10, 2020
  

  In a follow up to our alert issued on April 2, 2020, in accordance with The Coronavirus Aid, Relief and Economic Security Act (CARES Act), on April 28, 2020, United States Patent and Trademark Office (USPTO) Director Andrei Iancu issued public notices regarding the further extension of certain patent and trademark deadlines to June 1, 2020.  

• USPTO Extends Certain Patent and Trademark Deadlines
  

  On March 31, 2020, in accordance with The Coronavirus Aid, Relief and Economic Security Act (CARES Act), United States Patent and Trademark Office (USPTO) Director Andrei Iancu issued a public notice regarding the extension of certain patent and trademark deadlines. 

• Effects of COVID-19 on Various Patent and Trademark Offices Worldwide
  

  The COVID-19 pandemic has had an impact on patent and trademark offices and operations globally. Below is a summary of changes seen over the past few weeks.

• Biosimilar and Generic Drug Companies Benefit from Patent Related Amendments to the USMCA
  

  It is very likely the U.S. President will soon sign the newly amended United States-Mexico-Canada Agreement (USMCA), which is intended to replace NAFTA. Mexico has already ratified the amended USMCA and Canada is expected to ratify soon. This trade agreement has important implications for intellectual property rights and the recent amendments will especially have an impact on the biopharma industries.

• At Least 249 ANDAs Are in Jeopardy: Are You Delinquent in Your Annual Reports?
  

  The U.S. Food and Drug Administration (FDA) announced plans to withdraw the approval of 249 Abbreviated New Drug Applications (ANDAs), since their manufacturers have failed to submit annual reports. This should serve as a wakeup call to all delinquent ANDA holders.

• Philip Braginsky Authors MD+DI Article on Patent Considerations for Connected Medical Devices
  

  Intellectual Property Group co-chair Philip Braginsky authored an article featured in Medical Device and Diagnostic Industry (MD+DI) titled, “Patent Considerations for Connected Medical Devices.” In the article, Phil discusses why developing new solutions, the Internet of Things (IoT) and Blockchain must be important components of a medtech company’s strategic planning.

• Food and Drug Administration Enhances Paragraph IV Certifications List
  

  The Food and Drug Administration (FDA) recently enhanced its Paragraph IV (PIV) Certifications List with additional data fields. The PIV Certification List regularly publishes information regarding the 180-day exclusivity provided under 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

  Historically, the information has included the name of the drug product, dosage form, strengths, RLD/NDA numbers and the date of first filing. The new data fields added by FDA will further help generic drug companies plan product development more strategically and are intended to increase approvals of more generic drugs.

• Natural Ingredients May Be Patentable – No Heavy Lifting Required
  

  In an important decision for the personal care and ingredients industries, the U.S. Court of Appeals for the Federal Circuit recently vacated a district court decision that held patent claims invalid as being directed to non-patent eligible subject matter in Natural Alternatives Int'l v. Creative Compounds, LLC (Case No. 18-295).

• IP in the Boardroom Part III: Executive Oversight
  

  As an addition to our ongoing series designed to help board members properly discharge their fiduciary duties in relation to company intellectual property, our next topic is the board’s obligations relating to executive qualification and officer oversight. It has become well established that in the United States, intellectual property and other forms of intangible assets make up a greater portion, than was the case a few years ago, of a business enterprise’s balance sheet. We do not anticipate this trend ending any time soon and as such, the need for intellectual property proficiency must be a priority for all governing bodies.

• FDA’s Safety and Performance Based Pathway Guidance Expands Abbreviated 510(k) for Certain Device Types
  

  There are three types of Premarket Notification 510(k)s that may be submitted to the U.S. Food & Drug Administration (FDA): Under the recently finalized Safety and Performance Based Pathway guidance, FDA has expanded the Abbreviated 510(k) route for certain well understood device types. The FDA expects to begin implementation of this pathway as soon as the device types and performance criteria are identified. Once implemented, a medical device manufacturer will be able to use performance criteria instead of direct comparisons to show substantial equivalence for qualifying devices.

• A New Tool for 351(k) Applicants
  

  This past December, the U.S. Food and Drug Administration (FDA) issued a biosimilar industry guidance on a variety of topics. Mostly overlooked was a Q&A regarding safety protections in a 351(k) application. The FDA Commissioner thought the matter was important enough to single out in his comments released the same day, calling it a "critical issue."

• Our Top 10 Legal Alerts from 2018
  

  As we start a new year, we would like to share with you some of our most popular legal alerts from 2018. Our top-read alerts range from construction, corporate and securities, labor and employment, tax and intellectual property, reflecting the broad array of our full-service practice. We hope that our alerts have been valuable to you and your colleagues, and demonstrate our commitment to providing helpful information to you.

• Key Takeaways from the Sixth Annual Best Practices in IP Conference
  

  The Sixth Annual Best Practices in IP Conference in Tel Aviv, which covered global best practices for issues affecting companies' IP, was another great success. Attendees benefited from top-notch educational opportunities and introductions to innovative companies.

• IP in the Boardroom: When Does the Board Receive Warning?
  

  Intellectual property can present operational risks - knowledge and protocols can help.

• IP in the Boardroom: As Company IP Value Increases, So Do Related Risks
  

  Although one might occasionally come across an article touching on intellectual property (IP) concerns in the corporate boardroom, not enough has been said on this topic. This is the first in a series of articles that are designed to help board members satisfy their duties of care regarding the various risks that IP often carries.

• Patenting and the New FDA Guidance on 3-D Printing of Medical Devices
  

  The U.S. Food and Drug Administration (FDA) recently finalized its publication on additive manufacturing (commonly referred to as 3-D printing) for medical devices.
  According to FDA Commissioner Scott Gottlieb, the guidance is meant to "help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submissions and making sure our regulatory approach is properly tailored to the unique opportunities and challenges posed by this promising new technology."

• FDA Includes Patent Submission Date Updates in Orange Book
  

  The U.S. Food and Drug Administration (FDA) recently updated the Orange Book to include patent submission dates. A patent submission date is the date the FDA receives patent information from the NDA holder. For each patent that claims a drug substance (active ingredient), drug product (formulation and composition), or method of use, the FDA requires all NDA applicants to submit the detailed patent information provided for under on 21CFR314.53. Now, the dates of these submissions are being recorded and published by the FDA.

• 2017 European Patent Office Updates
  

  The European Patent Office recently revised its Examination Guidelines. These Guidelines are primarily directed to the patent examiners and formalities officers of the EPO, but they are also helpful to anyone practicing before the EPO. This year the update contains a few important changes.

• New FDA Guidance on Determining Whether to Submit an ANDA or a 505(b)(2) Application
  

  The U.S. Food and Drug Administration (FDA) recently published a draft guidance summarizing the differences between abbreviated new drug applications (ANDA) and 505(b)(2) applications. Both sections were added to the FD&C Act to provide new routes for obtaining approvals for drug applications. The guidance focuses on ANDA submissions under Section 505(j) of the FD&C Act, petitioned ANDAs under Section 505(j)(2)(C), and NDAs pursuant to Section 505(b)(2) and discusses the regulatory and scientific considerations for determining whether to file an ANDA or 505(b)(2) application.

• License Agreement Restrictions Can Provide a Real Advantage to Patent Holders
  

  Generally, a patent owner's rights are exhausted after an authorized sale; the patent owner cannot sue a downstream customer who purchased an authorized patented product from a third party reseller. So how can a patent owner control the resale of a patented product?

• Quantity - Not Quality - Counts for Patent Infringement: More Than One Component of an Invention Must be Supplied for Patent Infringement
  

  The U.S. Supreme Court recently held in a recent decision in Life Technologies Corp v. Promega Corp. that the "supply of a single component of a multicomponent invention for manufacture abroad does not give rise to § 271(f)(1) liability."

• Federal Circuit Rules Software Patent for a User Interface is Patentable Subject Matter
  

  In the recent decision Trading Technologies International, Inc., v. CQG, Inc. et al., the Federal Circuit affirmed a district court's ruling that a software patent on a graphical user interface was patentable subject matter, and not directed to an abstract idea under Alice.

• Implications of the FDA's Recent Guidance on the Biologics Price Competition and Innovation Act
  

  In December 2016, the FDA published an industry guidance related to the Biologics Price Competition and Innovation Act. This guidance offers suggestions to sponsors on the design and use of clinical pharmacology studies to support a claim of biosimilarity to a reference product.

• Protecting Against Big Pharma's Tactics for Delaying Market Entry of Generics
  

  Branded companies make millions of dollars each day that a generic version of a drug is held from the market.

• Brexit and IP Rights
  

  On June 23rd, the UK voted to leave the European Union (Brexit).

• Legal Alert: A New System For International Design Protection
  

  Design patents continue to grow in importance for many industries. If your company designs tangible products or packages, there is a new, efficient way to seek international protection for design features.

• Legal Alert: .SUCKS is Here: Can Your Brand Be Protected?
  

  With the goal of fostering public commentary, the new domain name .SUCKS was approved by ICANN. Despite objections from some in the IP community, the sunrise period for .SUCKS is now open; it runs until May 29th.

• Legal Alert: Alice Corp. v. CLS Bank's Effect on Business Method Patents
  

  The patent landscape has changed regarding business method patents.
  In the summer of 2014, the Supreme Court issued a decision in Alice Corp. v. CLS Bank which invalidated certain business method patents related to finance. The basis for the invalidation was that the patents covered an abstract idea not eligible for patent protection.

• Beware of the Boilerplate Series: "Defend, Indemnify and Hold Harmless"
  

  Many agreements include an indemnification clause typically using language like this: “Party A will defend, indemnify and hold harmless all claims, losses and damages against Party B related to its use of the Technology.”

• Beware of the Boilerplate Series: Defining Confidential Information
  

  In Non-Disclosure Agreements, there is often boilerplate language that includes trade secrets in the definition of “Confidential Information.” This seemingly innocuous language can lead to problems for the owner of the trade secrets.

• Beware of the Boilerplate Series: Limitation of Liability
  

  Be wary of giving up your rights for "lost profits." In most jurisdictions, there are two types of "lost profits": (1) those arising from general damages (recovery of money that a party agreed to pay under a contract); and (2) those arising from consequential damages (recovery of money lost based on other business arrangements). The first is generally easier to prove, but often a party in breach can be reasonably expected to pay the second.

• Beware the Boilerplate Series: Always Define the Meaning of "Intellectual Property"
  

  Clearly define the grant provisions of all of your IP contracts. If you want to transfer or receive "intellectual property" or "technology," ensure that these terms are well defined and unambiguous. Definitions matter! By making the contract terms clear, you can potentially reduce (or eliminate entirely) future litigation costs.