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On January 26, 2022, in what appears to be a case of first impression, U.S. District Court Judge John Z. Lee of the United States District Court for the Northern District of Illinois denied a biosimilar applicant defendant’s motion to dismiss patent infringement claims brought in the second phase of the parties’ Biosimilar Price Competition and Innovation Act (“BPCIA”) litigation. In so doing, Judge Lee held that the reference product sponsor (“RPS”) plaintiff is not limited to only declaratory judgment actions in the second phase of litigation under the BPCIA.
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A Business Deal Could Kill Your Right to Challenge a Patent’s Validity

February 22, 2022 | Blog | By William Meunier, Peter Cuomo, Marguerite McConihe, Sean Casey

Last week, the Federal Circuit issued a decision holding that parties can contractually bargain away their rights to file petitions for Inter Partes Review (“IPR”) at the Patent Trial and Appeals Board (“the Board”). This precedential case is the first to hold that a forum selection clause can forfeit the right to challenge a patent’s validity by IPR. The takeaway from this case is that when entering into any type of patent related agreement, be careful to ensure that your right to file IPR petitions is not stripped away, particularly by way of a forum selection clause which is “prima facie valid and should be enforced” in the words of the Federal Circuit.
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D. Del. Says ANDA Specification Trumps All Else in Infringement Analysis

February 17, 2022 | Blog | By Peter Cuomo, Adam Samansky, Joe Rutkowski, Tianyi Tan

On February 8, 2022, U.S. District Court Judge Maryellen Noreika of the United States District Court for the District of Delaware granted the plaintiff’s motion to exclude defendant’s expert testimony for being “based on an erroneous legal theory” in a suit alleging defendants’ proposed generic Abbreviated New Drug Application (“ANDA”) product would infringe Exela’s patents under the Hatch-Waxman Act. Judge Noreika’s decision in this case reinforces the Federal Circuit’s holding in Sunovion and serves as a reminder that ANDA product infringement is primarily assessed by comparing the asserted claims with the ANDA specification, rather than other ANDA submission materials further describing the ANDA product.
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Fintiv in Decline?

February 17, 2022 | Blog | By William Meunier, Brad M Scheller, Serge Subach

Going forward, parties litigating before the PTAB should consider the Fintiv factors comprehensively rather than zeroing-in on the procedural schedule in their parallel litigation. As the data suggests, an aggressive and fast-moving schedule alone may no longer result in a discretionary institution denial.
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Keep Out: Uniloc Gets Second Chance to Seal Licensing Documents

February 16, 2022 | Blog | By Daniel Weinger, Robert Sweeney

The Federal Circuit decision in Uniloc USA, Inc. et al. v. Apple, Inc., where a 2-1 panel ruled that the district court had abused its discretion by refusing to seal certain patent-licensing documents provided by plaintiffs, Uniloc USA, Inc. and Uniloc Luxembourg, S.A., demonstrates the Federal Circuit’s recognition of the importance of keeping certain patent licensing and other trade secret materials confidential.
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We previously discussed which portions of an artificial intelligence/machine-learning (“AI/ML”) platform can be patented.  Under what circumstances, however, is it best to keep at least a portion of the platform a trade secret? And what are some best practices for protecting trade secrets? In this post, we explore important considerations and essential business practices to keep in mind when working to protect the value of trade secrets specific to AI/ML platforms, as well as the pros and cons of trade secret versus patent protection.
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The U.S. Patent and Trademark Office (USPTO) recently launched an online First Office Action Estimator, which provides an estimate when a patent application will receive a first Office action. Having an idea of when a patent application will be first subject to examination can help applicants make a variety of strategic decisions to manage costs and/or proceed faster to allowance. This article explores these decisions.
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On January 18, 2022, U.S. District Judge R. Gary Klausner of the Central District of California sided with the majority of divided district courts, dismissing claims of willful and induced infringement that based the defendants’ required knowledge of the asserted patents on its receipt of the original complaint for patent infringement. Ravgen Inc. v. Quest Diagnostics Inc., No. 21-cv-09011 (C.D. Cal. Jan. 18, 2022) ECF 146 - Order dismiss willful infringement
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Prior Daubert Orders and Discovery Lessons Out of N.D. Cal.

February 4, 2022 | Blog | By Peter Snell, Robert Sweeney

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The Federal Circuit recently provided strategic guidance for defending software claims against Alice challenges that claims recite ineligible patent subject matter under 35 U.S.C. § 101. In Mentone Solutions LLC v. Digi International Inc., defendants alleged that representative claim 5 of U.S. Patent No. 6,952,413, directed towards allocating data channels using shifted uplink status flags in cellular mobile stations, claimed only an abstract idea. The District Court agreed and dismissed. On appeal, the Federal Circuit reversed, holding that claim 5 is not directed to an abstract idea because the claim improved the functionality of a computer.
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Domestic Industry Alive and Well at ITC; Important New Opinion Continues Trend

February 1, 2022 | Blog | By Jonathan Engler, Marguerite McConihe, Michael Renaud

The U.S. International Trade Commission (the “ITC”), in an important new opinion, recently extended a series of final determinations that complainants had satisfied the “economic prong” of Section 337’s domestic injury requirement.  This decision reinforces the Commission’s critical role in defending U.S. intellectual property rights and bodes well for patent owners.  In Certain Percussive Massage Devices, Inv. No. 337-TA-1206, the Commission found that complainant Hyperice Inc. proved it had “significant” domestic industry investments in labor, notwithstanding that all of the domestic industry devices were manufactured overseas.  Indeed, thus far in 2022, the Commission has found the economic prong of the domestic industry requirement satisfied in all four public final determinations.  In 2021 and 2022 combined, the Commission found the economic prong of the domestic industry requirement satisfied in 80% of all patent-based investigations that resolved on the merits, demonstrating that Complainants with well-organized, substantiated domestic industry cases continue to meet with success at the ITC.
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Last year, the U.S. District Court for the Southern District of New York addressed an issue of first impression concerning what constitutes “misappropriation” under the Defend Trade Secrets Act (DTSA) in a decision potentially relevant to cases involving allegations of trade secret misappropriation under the DTSA against a former employee. This case is worthy of note for any trade secret practitioner and is an important reminder that when pleading alleged trade secret misappropriation, it is not only important to describe the trade secret with sufficient particularity, but also to sufficiently describe the alleged misappropriation so as to illustrate the alleged acquisition of the trade secret by improper means or disclosure of the trade secret without consent.
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USPTO’s New Deferred Subject Matter Eligibility Response Pilot Program

January 21, 2022 | Blog | By Brad M Scheller, Meena Seralathan

Recently, the U.S. Patent and Trademark Office (“USPTO”) published a notice informing the public that it will be implementing a pilot program (called the Deferred Subject Matter Eligibility Response Pilot Program, or the “DSMER Pilot Program”) to determine the value of allowing applicants to defer responding to 35 USC § 101 rejections (commonly known as “101 rejections” or “Alice rejections”). The Program is only available for certain applications, and certain procedures are required for participation; however, the Program has the potential to encourage more efficient patent prosecution. Below we answer some questions patent applicants are likely to have about the Program.
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Earlier this month, in Novartis Pharms. Corp., Inc. v. Accord Healthcare, Inc., et al., No. 2021-1070, the Federal Circuit issued a helpful decision concerning the not-often-discussed written description requirement. The panel specifically addressed whether sufficient written description can exist for claim limitations that are not explicitly or directly disclosed in the specification (including negative claim limitations). This new ruling provides patent owners with a useful guide for successfully navigating similar written description challenges in patent infringement cases. For example, Patent Owners seeking to combat written description requirement challenges should proffer expert witnesses who can clearly articulate how they understand the patent description in relation to the claims and what portions of that description support the same.
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Entire Market Value Rule Strikes Again in WDTX

January 19, 2022 | Blog | By Brad M Scheller, Marguerite McConihe, Robert Sweeney

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Patent Owner Tips for Surviving an Instituted IPR: From Depositions to Sur-Replies

January 14, 2022 | Blog | By William Meunier, Michael Renaud, Brad M Scheller

As a Patent Owner in an instituted Inter Partes Review (IPR), there are dozens of considerations to bear in mind – from strategically approaching depositions and maximizing expert testimony, to drafting the final say in your sur-reply. We provide a summary of key takeaways from throughout the series and invite you to access all of our tips for more detail on Surviving an Instituted IPR.
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Year in Review: The Most Popular IP Posts of 2021

January 5, 2022 | Blog | By Christina Sperry

As 2022 begins and intellectual property (IP) strategies are being developed for the new year, it is a good time to reflect on what IP issues were prominent in 2021.  According to many readers, hot topics included efficient and expeditious U.S. patent prosecution, new copyright and trademark laws, and standard essential patents (SEPs). Below are 5 of the most read IP Posts on Mintz.com from last year.
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Unauthorized use of a trademark on the Internet occurs often and in many forms, usually involving the profiting, whether intentionally or unintentionally, from the goodwill associated with a trademark belonging to someone else. Such use, however, does not always rise to the level of trademark infringement. Unauthorized use of a trademark is only infringing if the particular use causes likely confusion among consumers. The most common type of confusion is confusion over source, which occurs at the time of purchase, but confusion can also arise as to affiliation, connection, or sponsorship, and confusion does not necessarily need to occur at the time of purchase.
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China’s New Intellectual Property Mediation Rules

January 4, 2022 | Blog | By Matthew Hurley, Oliver Ennis, Tianyi Tan

In what appears to be an effort to standardize and professionalize its mediation practices and procedures, China recently enacted new rules governing the mediation of intellectual property disputes. Issued by the Mediation Center of the China Council for the Promotion of International Trade, a national foreign trade body, the new rules create a framework that can guide IP dispute mediation nationwide. It appears that China is hoping that these steps will make it a more popular mediation forum among foreign parties.
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Is an unused registered trademark preventing you from clearing or registering your mark? Or was the blocking registration filed for goods or services that were not in use when the registrant declared that they were? The Trademark Modernization Act’s (“TMA”) new procedures for cancelling unused registrations, or registrations with goods and services that were not in use at the time of declaration, are now effective. 
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