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Momenta

Goodwin

Johnson & Johnson Announces Acquisition of Momenta For $6.5 Billion

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Johnson and Johnson announced that it has entered into an agreement to acquire Momenta Pharmaceuticals, Inc. for $6.5 billion. The acquisition gives J&J’s Janssen unit full global rights to Momenta’s nipocalimab (M281), an...more

Robins Kaplan LLP

Financial Daily Dose 8.20.2020 | Top Story: Apple Becomes First U.S. Company to Hit $2 Trillion Valuation Mark

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Apple tipped the $2 trillion mark this week, the first U.S. company to reach that valuation milestone, doing so just 2 years after it first hit $1 trillion. That it’s done so in the middle of a pandemic only punctuates how...more

Goodwin

EYLEA (Aflibercept) Biosimilar Development Updates

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Regeneron’s EYLEA (aflibercept) was approved by the U.S. FDA on November 18, 2011, and is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal...more

McDermott Will & Emery

Mootness on Appeal from PTAB

The US Court of Appeals for the Federal Circuit dismissed an appeal of an inter partes review (IPR), finding that the challenger lacked appellate standing because it had terminated its attempts to develop the infringing...more

Foley & Lardner LLP

Court Dismisses Biosimilar Petitioner's IPR Appeal For Lack of Standing

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In Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., the Federal Circuit dismissed Momenta’s appeal from an adverse IPR decision for lack of standing after Momenta suspended its potentially infringing biosimilar...more

Foley & Lardner LLP

Termination Of Product Development Precludes Standing To Appeal PTAB IPR Decision Upholding Patent

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In Momenta Pharmaceuticals, Inc. v. Bristol-Meyers Squibb Co., the Federal Circuit issued another decision analyzing the contours of a petitioner’s Article III standing to appeal PTAB decisions upholding a patent. In contrast...more

WilmerHale

Federal Circuit Holds Petitioner Lacks Standing to Appeal Inter Partes Review Decision

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On February 7, 2019, in Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Company, the Federal Circuit dismissed an appeal brought by a petitioner in an inter partes review (IPR) for lack of standing and mootness because...more

McDonnell Boehnen Hulbert & Berghoff LLP

Momenta Pharmaceuticals, Inc. v, Bristol-Myers Squibb Co. (Fed. Cir. 2019)

The Federal Circuit has on several occasions taken the opportunity to address (and in doing so, flesh out) the requirements for Article III standing to appeal an adverse determination in a post-grant review proceeding...more

Troutman Pepper

Sometimes the Patent Office Has the Last and Only Word

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The Federal Circuit just issued a decision that confirms its stance on Article III standing for appeals from inter partes reviews (IPRs), making it tougher for unsuccessful IPR petitioners to obtain judicial review of U.S....more

Goodwin

Federal Circuit Dismisses Momenta’s Appeal of Adverse Final Written Decision in Abatacept IPR

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This morning, the Federal Circuit issued a precedential opinion dismissing Momenta’s appeal from the PTAB’s final written decision upholding the patentability of Bristol-Myers Squibb’s abatacept patents against Momenta’s IPR...more

Goodwin

Biosimilar-Related Patent Litigation Updates

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Here are some recent developments in U.S. legal proceedings relating to biosimilars: On December 10, 2018, in the Southern District of Florida, Apotex filed a motion to dismiss the patent infringement complaint that Amgen...more

Goodwin

Biosimilar Legal Decisions to Keep an Eye out for in 2019

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Here are our picks of some legal developments to keep an eye out for in the new year: 1. Etanercept biosimilar trial decision – This past September, in the Immunex v. Sandoz BPCIA patent litigation concerning Sandoz’s...more

Goodwin

Global Biosimilar Development Updates

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Over the past month, several drug developers announced updates regarding their biosimilar programs. Below are some highlights, in addition to the many biosimilar developments on which we have already reported...more

Goodwin

AbbVie Grants Momenta Global Patent Licenses for Biosimilar of HUMIRA (Adalimumab)

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Today, AbbVie and Momenta announced that they have entered into an agreement under which AbbVie has granted Momenta a global, royalty-bearing non-exclusive license to AbbVie’s intellectual property relating to Humira®...more

Goodwin

Momenta Contends ORENCIA IPR Appeal Is Not Moot

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On October 23, 2018, we previously reported that the Federal Circuit ordered Momenta to show cause as to why Momenta’s appeal of a PTAB decision upholding the patentability of BMS’s U.S. Patent No. 8,476,239, relating to...more

Goodwin

Federal Circuit Orders Momenta to Show Cause in ORENCIA IPR Appeal

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As we have previously reported, Momenta appealed a PTAB decision upholding the patentability of BMS’s U.S. Patent No. 8,476,239, relating to BMS’s ORENCIA® (abatacept) product. On October 1, 2018, Momenta informed the Court...more

Goodwin

BMS and Momenta File Additional Letters Regarding Standing in Orencia IPR Appeal

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As we reported here, Momenta is appealing a PTAB decision upholding the patentability of BMS’s U.S. Patent No. 8,476,239 (“the ’239 patent”), which relate to BMS’s Orencia® (abatacept) product. Momenta has not yet filed an...more

Goodwin

Momenta and Mylan Collaborating to Develop Biosimilar of Eylea® (aflibercept)

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Yesterday, Momenta Pharmaceuticals and Mylan announced a development strategy for M710, a proposed biosimilar of Regeneron’s Eylea® (aflibercept), including their plan to initiate a pivotal clinical trial in the first half of...more

Goodwin

BMS Challenges Momenta’s Standing In Federal Circuit Appeal of PTAB Decision

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On December 5, 2017, the Federal Circuit heard oral argument in Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Company, 17-1694. Momenta is appealing a PTAB decision upholding the validity of BMS’s U.S. Patent No....more

Goodwin

Momenta’s Orencia (abatacept) biosimilar candidate M834 does not meet primary endpoints in Phase I study

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Yesterday, Momenta and Mylan reported that initial results obtained from their proposed abatacept biosimilar M834 did not meet primary pharmacokinetic endpoints in a Phase I study comparing the pharmacokinetics, safety and...more

McDonnell Boehnen Hulbert & Berghoff LLP

Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. (D. Mass. 2017)

District Court Finds Claims Directed to Method for Analyzing Enoxaparin Sample to Be Patent Eligible - Last month, in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., District Judge Nathaniel M. Gorton of...more

Goodwin

Q2 Earnings Round-Up

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Below are some highlights from second quarter earnings reports recently released by biologics and biosimilar companies. ..Coherus reported that it has cash and cash equivalents of $118.3 million as of June 30, 2017 and...more

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