FDA Law Blog

JANUARY 4, 2022

On January 1, 2022, the recently revised version of the PhRMA Code on Interactions with Health Care Professionals went into effect. Several states, including Connecticut, California, District of Columbia , Massachusetts , and Nevada, have adopted or incorporated the Code in their statutes or regulations. Other jurisdictions like D.C.

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Manufacturing Statute Litigation Litigating 98

Patently O

SEPTEMBER 26, 2022

It is time to pick-up our consideration of Supreme Court patent cases for the 2022-2023 term. A quick recap: Despite dozens of interesting and important cases, the Supreme Court denied all petitions for writ of certiorari for the 2021-2022 term. 2022) (written description). by Dennis Crouch. American Axle (cert denied).

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Court Laws Manufacturing Statute 125

Conflict of Laws

MARCH 10, 2022

The Council on General Affairs and Policy of the HCCH met online from 28 February to 4 March 2022, with over 450 participants. Several important developments relating to Membership and HCCH Conventions occurred during the meeting: El Salvador deposited its instrument of acceptance of the Statute, becoming the 91 st Member of the HCCH.

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Depositions Drafting Litigation Litigating 40

FDA Law Blog

JANUARY 4, 2022

On January 1, 2022, the recently revised version of the PhRMA Code on Interactions with Health Care Professionals went into effect. Several states, including Connecticut, California, District of Columbia , Massachusetts , and Nevada, have adopted or incorporated the Code in their statutes or regulations. Other jurisdictions like D.C.

Manufacturing 75

Manufacturing Statute Litigation Litigating 75

FDA Law Blog

APRIL 21, 2024

Post-AIA, and a later change to the law to account for controlled substance FDA application approvals, the PTE statute at 35 U.S.C. § But that’s the controversy here: Did FDA approve LYTGOBI NDA 214801 on September 30, 2022 when the Agency issued its initial approval letter , or on October 5, 2022 when FDA issued a corrected approval letter

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Statute Litigation Litigating Laws 59

The IP Law Blog

APRIL 27, 2023

Although a patent can be challenged in federal district court, an IPR is an expedited and less costly procedure than federal court litigation. Thus, an IPR is a useful method for a defendant in a patent litigation lawsuit to invalidate the patent in issue. An IPR is like a mini-trial, as the Board must make a decision within one year.

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Litigation Litigating Statute Court 98

FDA Law Blog

JANUARY 11, 2024

In other words, FDA needed to determine whether the initial biosimilar litigation—pre-interchangeable supplemental approval—counts towards the FIE expiration date calculation. Notably, the purpose of the statute seemed to govern much of FDA’s interpretation.

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Litigation Litigating Statute Manufacturing 59

Patently O

FEBRUARY 22, 2022

The problem with that statement was that the statute appears to directly limit estoppel to challenged patent claims. Errata opinion (Feb 22, 2022). Going forward there will be a next step in litigating the scope of 315(2) estoppel — will they estoppel will apply to claims that are patentably indistinct from those challenged?

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Litigation Litigating Statute Technology 93

JURIST

APRIL 22, 2022

On January 12, 2022, the US Supreme Court heard oral arguments in the case. The court explained that there are many “non jurisdictional rules” that “promote the orderly progress of litigation but do not bear on a court’s power.” The statute does not say that as to the 30-day deadline.

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Court Rules Court Statute Law Firm 104

Patently O

DECEMBER 5, 2022

2022) ( MonolithicEnBancPetition ). In September 2022, that petition was denied with a 2-1 decision. Dennis Crouch, Remote Work and Patent Venue , Patently-O (Sept 30, 2022). Proper venue is rarely a big deal these days in Federal Litigation. by Dennis Crouch. In re Monolithic Power Systems, Inc. 21-cv-00655.

Statute 80

Statute Construction Litigation Litigating 80

Day on Torts

APRIL 15, 2022

M2020-01509-COA-R3-CV, 2022 WL 1040371 (Tenn. April 7, 2022, plaintiff filed suit against twelve defendants after she placed her child for adoption at birth but subsequently changed her mind. Plaintiff argued that the statute did not apply to Ms. Plaintiff argued that the statute was not applicable here, as Ms.

Statute 59

Statute Attorney Cause of Action Court 59

Patently O

MAY 11, 2023

Gugliuzza , Professor of Law, Temple University Beasley School of Law The judicial disability proceedings instituted against Federal Circuit Judge Pauline Newman have now spilled into litigation. From June 2021 through the end of 2022, Judge Newman wrote 23 of those separate opinions. Those numbers tell a complicated story.

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Litigation Litigating Statute Court 120

Conflict of Laws

DECEMBER 6, 2023

It is unsurprising then that Princess sought to defend the proceedings at a preliminary stage through litigation over where to litigate. The decision is significant not just for the litigants. In September 2022, by majority, the Full Court of the Federal Court allowed the Princess appeal.

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Contract Laws Court Statute 69

Patently O

JULY 19, 2022

In this ongoing litigation IPR litigation, Arthrex has filed another petition for rehearing — arguing that it still has not received the promised “Director Review” sufficient to cure the appointments clause problem apparent in the prior PTAB decision cancelling its patent claims. Arthrex Petition 2022.

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Litigation Litigating Statute Court 56

FDA Law Blog

MARCH 24, 2024

They argue that the 340B statute had never intended to give contract pharmacies such an outsized role in the program, in part because their proliferation stretched HRSA’s enforcement capacity and resulted in widespread noncompliance. Two 340B covered entities joined the litigation as intervenors arguing to uphold the law. & Mfrs.

Manufacturing 59

Manufacturing Contract Laws Statute 59

At the Lectern

MAY 1, 2024

California Commerce Club : Does California’s test for determining whether a party has waived its right to compel arbitration by engaging in litigation remain valid after the United States Supreme Court decision in Morgan v. 2022) _ U.S. _ [142 S.Ct. The court granted review in August 2022. Sundance, Inc. In re Kenneth D. :

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Calendaring Court Entertainment Statute 45

Day on Torts

NOVEMBER 15, 2022

When a litigant has filed a motion to dismiss pursuant to the Tennessee Public Participation Act (TPPA), that motion should be analyzed under the provisions of the TPPA rather than under the traditional Tennessee Rule of Civil Procedure 12 analysis. E2021-01513-COA-R3-CV, 2022 WL 16559447 (Tenn. In Reiss v. internal citation omitted).

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Prima Facie Case Tort Statute Construction 59

Constitutional Law Reporter

JUNE 3, 2022

S. _ (2022), the U.S. Then—nearly eight months after Morgan filed the lawsuit— Sundance moved to stay the litigation and compel arbitration under the FAA. In response, Morgan argued that Sundance had waived its right to arbitrate by litigating for so long. In Morgan v. Sundance, Inc. ,

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Court Contract Litigation Litigating 52

Day on Torts

OCTOBER 31, 2022

E2021-00812-COA-R3-CV, 2022 WL 14199150 (Tenn. 25, 2022), plaintiff filed multiple tort claims against multiple defendants, including libel claims against certain defendants based on their social media statements related to the death of a dog who died while in the care of plaintiff’s dog training business. In Laferney v. Livesay , No.

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Tort Statute Attorney Court 59

SCOTUSBlog

APRIL 25, 2022

Share The Supreme Court on Monday added two new cases to the merits docket for the 2022-23 term. Court of Appeals for the 11th Circuit has adopted a different rule, in which the statute of limitations only begins to run when all state-court litigation denying the request for DNA testing, including any appeals, has finished.

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Court Litigation Litigating Statute 82

Patently O

SEPTEMBER 12, 2022

2022), overruling Shaw Industries Group, Inc. But, the statute as written creates a slightly different test — asking what “reasonably could have raised during that inter partes review.” The statute charges the USPTO Director the role of instituting the IPR, although that duty had been delegated tot he PTAB.

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Statute Court Litigation Litigating 89

Patently O

MARCH 7, 2022

” In re Waste Management Data Breach Litigation , 21CV6147 (DLC), 2022 WL 561734, at *6 (S.D.N.Y. 24, 2022) [ WasteManagementDismissal ]. 4-weeks after discovering the breach, Waste Management disclosed the breach to individuals as well as to the California Attorney General (required by statute).

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Contract Statute Litigation Litigating 116

Conflict of Laws

APRIL 22, 2023

In my view, nothing in the academic world compares to taking the “international litigation” class with her. Although she took emerita status in September 2022, she continues as the Co-Director of the NYU Center on Transnational Litigation, Arbitration, and Commercial Law. 2022; 5th ed., 433 (2022) (with Aaron D.

Litigation 52

Litigation Litigating Laws Statute 52

Intelligize Blog

FEBRUARY 15, 2024

According to the unanimous ruling in favor of a former UBS employee, the Sarbanes-Oxley Act of 2022 guarantees whistleblowers protections from retaliation by their employers and doesn’t require them to prove their employers intended to retaliate against them. Meanwhile, a new program spearheaded by the U.S.

Government 62

Government Statute Attorney Litigation 62

Conflict of Laws

OCTOBER 25, 2023

An Ontology of the In-Between [18th Ernst Rabel Lecture, 2022] [OPEN ACCESS], 433–464, DOI: 10.1628/rabelsz-2023-0063 The conflict of laws can serve heuristically to underscore two established but radically opposing models of modernist legal ordering: multilateralism and statutism.

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Diligence Litigation Litigating Legal 57

SCOTUSBlog

APRIL 2, 2022

To create the compact, each state passed statutes and, as New York’s bill of complaint indicates is a constitutional requirement for interstate compacts, Congress consented as well. However, in 2018, New Jersey passed a statute to withdraw from the compact, and on Dec. However, the U.S.

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Government Statute Cause of Action Litigation 91

Patently O

OCTOBER 5, 2022

Courts to obtain discovery in order to facilitate foreign litigation; with the pending global litigation between Eli Lilly and Novartis serving as our key example. The standard today is that prior to trial the litigating parties will share “mutual knowledge of all relevant facts.” ” Hickman v.

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Litigation Litigating Statute Court 60

Patently O

OCTOBER 18, 2023

2022-1212 (Fed. Stark reversed the TTAB’s cancellation order, finding the statute only permits cancellation for fraudulent acts taken while obtaining the registration , not for establishing incontestability. Lets look at the statute. by Dennis Crouch In the trademark case of Great Concepts, LLC v. Chutter, Inc. ,

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Statute Attorney Sports Court 62

Patently O

FEBRUARY 21, 2022

Supreme Court 2022). To be clear Samsung and LG have previously litigated in Texas, they have lawyers in the state and lawyers willing to go to the state. The inconvenience of litigation is almost a total farce here. The statute provides two different ways for finding proper venue. by Dennis Crouch.

Litigation 89

Litigation Litigating Technology Lawyer 89

Conflict of Laws

OCTOBER 28, 2022

The burden that this decision places on the professional counterparty – the risk of foreign litigation even if the matter was purely domestic at the time the contract was concluded – seems reasonable, as choice of forum agreements (Art. 3 Lugano II) remain possible as a means of protection.

Contract 52

Contract Laws Government Court 52

Patently O

FEBRUARY 17, 2022

In Feb 2022, the Court of Appeals for the Federal Circuit released two separate opinions discussing the estoppel provisions of 35 U.S.C. § 4th —, 2022 WL 333669 (Fed. 4th —, 2022 WL 414252 (Fed. 4th —, 2022 WL 414252 (Fed. Lets dig into the statute first, and then the decisions. by Dennis Crouch.

Statute 56

Statute Litigation Litigating Court 56

ClimateChange-ClimateLaw

APRIL 12, 2023

21 of the ITLOS Statute. As a result, although the UNCLOS is silent on ITLOS’ advisory jurisdiction, ad hoc treaties related to UNCLOS’ purposes can confer advisory competence to the ITLOS under Article 21 Statute of the ITLOS. 21 of the ITLOS Statute and Art. 191 UNCLOS. 2 (2) COSIS Agreement). Two obstacles may lie ahead.

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Statute Laws Court Legal 109

Patently O

SEPTEMBER 21, 2022

In its 2022 Caltech decision, the Federal Circuit overturned its prior Shaw precedent and found that the estoppel broadly applies to all claims challenged in an IPR and all grounds “which reasonably could have been asserted” against the petitioned claims. 2022) (“Caltech”). 2022) (“Caltech”).

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Statute Construction Court Litigation 56

Patently O

AUGUST 31, 2023

6:22-cv-01207-ADA, 2022 WL 3747666 (W.D. Still, the company regularly argues that it would be too unfair and inconvenient to litigate patent cases in states such as Texas. Like Google, the defendants are typically corporations with national reach who can – and do – litigate anywhere. Google LLC , No.

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Work From Home Litigation Litigating Statute 57

Patently O

OCTOBER 7, 2022

Vidal (Supreme Court 2022). D746,078 (Patent being litigated). In particular, Zahner intents to raise the same question that Arthrex will likely raise, although this time in the reexamination context: Question : Does the Reexamination Statute permit a challenge to priority claims? by Dennis Crouch. Zahner Design Group v.

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Statute Litigation Litigating Court 76

Diane Drain

MAY 15, 2021

On January 1, 2022, HB2617 will become the law of Arizona. There are three parts to the bill and its amendments: The bill increases a homeowner’s homestead exemption from $150,000 to $250,000 effective January 2022. After January 1, 2022 all past valid judgments are now going to attach to your homestead.

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Laws Litigation Litigating Court 197

Conflict of Laws

AUGUST 14, 2023

It examines the jurisdiction of the Singapore courts (including the Singapore International Commercial Court) in cross-border litigation, the effect of foreign judgments in Singapore, choice of law methodologies and their particular application to contractual and non-contractual obligations and inter vivos property transactions.

Laws 52

Laws Statute Litigation Litigating 52