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Venable LLP

The State of Biosimilars in 2023

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It has been 13 years since the Biologics Price Competition and Innovation Act (BPCIA) was enacted and biosimilars had a pathway to enter the U.S. market. While there have been challenges over this time, the U.S. biosimilar...more

Fish & Richardson

Biosimilars 2022 Year in Review

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2022 heralded the next chapter for biosimilars in the United States, including U.S. Food and Drug Administration approval of biosimilars in new therapeutic areas, additional interchangeable designations, and litigation...more

Fish & Richardson

Biosimilars 2021 Year in Review

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2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more

Goodwin

Year in Review: Top Five Legal Developments of 2019 Impacting Biosimilars

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As we close out another calendar year, we look back at the top legal developments of 2019 that could influence the market for biologics and biosimilars. These five major court decisions will likely impact the legal strategy...more

Hogan Lovells

Emerging issues in the connected cars and autonomous vehicles market are influencing standard-essential patents and IP...

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In this hoganlovells.com interview, Hogan Lovells partner Celine Jimenez Crowson addresses the relationship between standard-essential patents (SEPs) and the connectivity technologies used in connected and autonomous vehicles...more

BakerHostetler

Patent Invalidity Offense: When Is District Court Action the Better Option Over IPR, PGR or CBM?

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It’s Monday morning after the Thanksgiving holiday. Easing back into the workweek with the lingering effects of turkey, stuffing and a miraculous Ohio State victory still sapping my brain, I open the court docket report....more

Knobbe Martens

Federal Circuit Review | October 2016

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Withdrawal of Claims During Prosecution Can Trigger Prosecution History Estoppel In UCB, Inc. v. Yeda Research and Development Co., Ltd., Appeal No. 2015-1957, the Federal Circuit held that prosecution estoppel can apply even...more

Weintraub Tobin

Can You Appeal the PTAB’s Decision to Institute Review of Patent Claims on Grounds Not Raised in an IPR, PGR, or CBM Petition?

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The America Invents Act provided several procedures for challenging the validity of patent claims, including inter partes review (“IPR”), post-grant review (“PGR”) and covered business method patent challenges (“CBM”). An...more

WilmerHale

Design Patent Post-Grant: Is Anticipation Easier to Prove Than Obviousness?

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Since the advent of AIA post grant practice four years ago, only 26 inter partes review petitions have been filed for design patents.1 The Patent Trial and Appeal Board issued 23 institution decisions, instituted 10 of those...more

Skadden, Arps, Slate, Meagher & Flom LLP

"After Period of High Invalidation Rates, New US Patent Challenge Procedures May Slow Down to Moderate Pace"

When the U.S. Patent and Trademark Office's (USPTO) Patent Trial and Appeal Board (PTAB) began hearing post-issuance patent challenge proceedings under the America Invents Act in September 2012, the PTAB became one of the...more

Womble Bond Dickinson

USPTO to Implement Significant Rule Changes for AIA Trial Proceedings Impacting Both Petitioners and Patent Owners

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The United States Patent and Trademark Office (USPTO) has released the final set of the latest round of changes to the rules governing inter partes review, post grant review, and other AIA trial proceedings before the Patent...more

Fish & Richardson

Practical Post-Grant Tip: Waiver of Service

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When considering an inter partes review in conjunction with a pending patent infringement suit, defendants must time the filing of their petition to beat the one-year-from-service bar imposed by 35 U.S.C. § 315(b). ...more

Troutman Pepper

Patent Trial and Appeal Board Adds Two More Cases to its List of Precedential and Informative Decisions

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Earlier this month, the Patent Trial and Appeal Board (PTAB) added two decisions to its list of “precedential” opinions for the USPTO’s new proceedings for challenging patents under the America Invents Act. The list (which...more

Troutman Pepper

No Second Bite Of The Apple for Square, Inc. – PTAB Applies Estoppel Provision Of 35 U.S.C. §325(e)(1) TO CBM Review

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In the case of Square, Inc. v. Unwired Planet, LLC (CMB2015-00148), the PTAB held that the grounds raised by Square, Inc. (Petitioner) to challenge the validity of claims 1-4 of Unwired Planet’s U.S. Patent No. 7,711,100...more

Saul Ewing Arnstein & Lehr LLP

PTAB Designates Two America Invents Act Review Decisions as Precedential

Recently, the Patent Trial and Appeal Board (PTAB) designated two America Invents Act (AIA) review decisions as precedential: LG Electronics, Inc. v. Mondis Technology, Ltd. and Westlake Services, LLC v. Credit Acceptance...more

Troutman Pepper

Federal Circuit Affirms Invalidity Of A Merck Patent Based On Substantial Evidence Standard

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In a recent case, the Court of Appeals for the Federal Circuit affirmed the PTAB’s decision that certain claims of Merck’s U.S. Patent No. 6,011,040, which were challenged by Gnosis, were invalid as anticipated or obvious....more

Foley & Lardner LLP

Federal Circuit Upholds Broadest Reasonable Interpretation in Inter Partes Review

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A divided Federal Circuit denied the petition for rehearing en banc that would have required the court to revisit its decision in In re Cuozzo Speed Technologies, LLC (Fed Cir 2015), that upheld the USPTO’s use of the...more

King & Spalding

Patent Pending: The Outlook for Patent Legislation in the 114th Congress

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The field of patent law is in a state of flux. Just four years after the America Invents Act (“AIA”) went into effect, Congress is taking up the issue once again, this time seeking to pass legislation to curb abusive patent...more

Robins Kaplan LLP

Is The Deck Stacked Against Patent Owners In The PTAB?

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Two years after the creation of the America Invents Act post-grant proceedings, many patent owners are facing an uphill battle when attempting to defend their intellectual property before the Patent Trial and Appeal Board...more

McAfee & Taft

New procedures available for invalidating patents before the USPTO

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Business executives have long struggled with whether to defend a patent infringement suit in court, try to settle the dispute for less than the cost/risk of defending it, or seek to deal with the problem patent by requesting...more

Troutman Pepper

USPTO Responds To Criticism By Promising PTAB Rule Changes That Should Benefit Patent Owners

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Newly appointed USPTO Director Michelle Lee has responded to public criticism of the post-grant patent review mechanisms provided by the America Invents Act (AIA) by announcing in her blog last week that the government will...more

K&L Gates LLP

Federal Circuit Affirms Dismissal of Sandoz’s BPCIA-Related Declaratory Judgment Action Regarding Enbrel® Patents, but Declines to...

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The biologics industry has been eagerly awaiting the Federal Circuit’s ruling on Sandoz Inc.’s (“Sandoz”) appeal from the United States District Court for the Northern District of California’s dismissal of its declaratory...more

Knobbe Martens

Federal Circuit Affirms Dismissal in Sandoz v. Amgen under Traditional Jurisdictional Grounds and Declines First Opportunity to...

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In the first Federal Circuit case involving the Biologics Price Competition and Innovation Act (“BPCIA” or “Biosimilars Act”), the Court of Appeals for the Federal Circuit affirmed Judge Maxine E. Chesney’s (N.D. Cal.)...more

Knobbe Martens

IP Strategies for Software Tech Companies

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In This Presentation: - Key IP Concerns for Software Tech Companies - New Post-Grant Proceedings for Challenging Patents - Impact of Alice on Software Patents and the Importance of Building a Strong Patent...more

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