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Life Sciences
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August 14, 2024
Grassley Asks HHS For Clarity On Cannabis Position
Sen. Chuck Grassley has asked federal health officials to clarify their position on marijuana, arguing that a recent U.S. Department of Health and Human Services report is at odds with its recommendation to loosen restrictions on the drug.
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August 14, 2024
Novartis' $45B Biz Can Survive If Generic Debuts, Judge Says
A D.C. federal judge told Novartis to stop acting like it would be destroyed financially by having a generic version of its best-selling drug Entresto enter the market, saying the drugmaker will be fine if it loses $3 billion in U.S. sales out of its $45 billion global revenue.
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August 14, 2024
AstraZeneca Freed From $107.5M Verdict In Pfizer Patent Case
A federal judge on Wednesday overturned a Delaware jury verdict that AstraZeneca owes $107.5 million for infringing two cancer drug patents owned by a Pfizer unit, concluding that both patents are invalid for failing to provide sufficient information about the invention.
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August 14, 2024
HHS Calls For More Research, Planning To Combat Heat Risks
Citing a sharp increase in deaths from extreme heat, the Biden administration unveiled a national strategy Wednesday that calls for better communicating the health risks of hot weather to the public and taking other steps to protect people from life-threatening heat waves.
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August 14, 2024
Samsung Biotech Unit Hit With Patent Suit Over Bone Drugs
The pharmaceutical giant Amgen Inc. is fighting a bid by a South Korean rival to sell biosimilar versions of its highly popular bone drugs Prolia and Xgeva, telling a New Jersey federal court that the proposed medications will infringe 34 patents.
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August 14, 2024
Calbiotech Beats Ex-Worker's 401(k) Retaliation Suit
A former Calbiotech Inc. employee must return a $12,500 payment he received after being terminated, a California federal judge ruled, finding he breached his severance agreement by filing a lawsuit claiming he was let go for asking about the life sciences company's 401(k) plan documents.
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August 14, 2024
Suit Claims Giant Uses Banned, Toxic Oil In Orange Soda
A proposed class of soda drinkers is suing The Giant Co. LLC in Pennsylvania federal court, alleging that it makes and sells orange soda made with a kind of vegetable oil that federal regulators banned for its negative effects on the thyroid gland.
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August 14, 2024
Zantac Judge Won't Step Aside Over Wife's Reed Smith Role
A Pennsylvania state judge overseeing the Zantac mass tort litigation against GlaxoSmithKline denied a motion to recuse himself Wednesday after expressing skepticism about the plaintiffs' contention that he could be unconsciously partial because his wife works for a firm defending the drugmaker in other jurisdictions.
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August 13, 2024
SEC Drops Insider Trading Suit Against Ex-Mylan Exec
The U.S. Securities and Exchange Commission on Tuesday dismissed a Pennsylvania federal suit accusing the former chief information officer of Mylan NV of insider trading due to what his attorneys describe as compelling evidence showing his innocence, seven months after the Department of Justice dropped a parallel criminal case.
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August 13, 2024
Entresto Release Delayed As Novartis Goes To Fed. Circ.
A Delaware federal judge said Monday that Novartis is unlikely to prove that it's entitled to an injunction that would block MSN Pharmaceuticals from launching a generic version of its top-selling drug Entresto, but stayed the generic release briefly so Novartis could appeal to the Federal Circuit.
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August 13, 2024
Mother Can't Revive Suit Against GE For Child's Brain Damage
A Pennsylvania appeals panel won't reinstate a mother's suit against General Electric Co. and subsidiary Datex-Ohmeda Inc. alleging that a faulty anesthesia machine caused her child permanent brain damage, finding the trial court rightly found that the state doesn't have jurisdiction over the claims.
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August 13, 2024
Spinal Implant Patents Verdict Must Stand, Pa. Judge Says
A Pennsylvania federal judge declined to order a new trial Tuesday in a patent infringement suit brought against medical device maker Globus Medical Inc., ruling that the jury verdict in the company's favor had sufficient evidentiary support and that the jurors did not seem confused by the law at issue.
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August 13, 2024
NY, NJ And Conn. Score $4.5M Penalty Over Enzo Data Breach
Molecular diagnostics company Enzo Biochem Inc. has agreed to pay a $4.5 million penalty after an investigation found that the company failed to implement recommended security protocols ahead of a data breach that affected millions of patients, New York's attorney general announced Tuesday.
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August 13, 2024
Janssen Wants New FCA Trial As Relators Seek $1.85B Win
Janssen has urged a New Jersey federal judge to toss a jury's $150 million False Claims Act verdict that found the pharmaceutical company illegally profited from the off-label marketing of popular HIV medications, while whistleblowers have asked the court for a whopping $1.85 billion judgment consisting of trebled damages and statutory penalties.
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August 13, 2024
Fed. Circ. Restores J&J, Allergan's Viberzi IP After Del. Loss
The Federal Circuit fully revived claims of patents covering Allergan's bowel treatment drug Viberzi on Tuesday, overruling a Delaware federal judge who said the claims don't meet obviousness-type double patenting or written description requirements.
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August 13, 2024
Former Sprinter Eyes Plea Deal In 2020 Olympics Doping Case
A onetime world-class sprinter from the Atlanta area is in talks to resolve charges that he illegally provided banned performance-enhancement drugs while training other athletes ahead of the 2020 Tokyo Olympic Games, a Manhattan federal judge heard Tuesday.
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August 13, 2024
DC Circ. Backs EPA's Ethylene Oxide Cancer Risk Value
The D.C. Circuit on Tuesday upheld federal environmental regulators' assessment of the cancer risk from exposure to certain chemical manufacturers' ethylene oxide emissions, rejecting a challenge from a chemical company and two chemical associations that argued the risk assessment was arbitrary and capricious.
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August 13, 2024
FTC Makes 2nd Request In Review Of Medical Device Co. Deal
Medical device company Surmodics Inc. disclosed Monday that federal regulators are taking a closer look at its agreement to be acquired by private equity giant GTCR in a $627 million deal.
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August 13, 2024
'Clever' Scheme Is Concealing Talc Litigation Funding, J&J Says
The Beasley Allen Law Firm needs to disclose alleged litigation funding fueling its litigation over Johnson & Johnson's talcum powder even if that funding was not given directly to the firm since the disclosure rules apply to "parties" and not "law firms," J&J has told a New Jersey federal court.
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August 13, 2024
Ex-McCarter & English Client Wants To Undo Malpractice Loss
A New Jersey pharmaceutical business is urging a New Jersey state court to reconsider its decision to throw out the company's malpractice case against McCarter & English LLP, saying the firm "brazenly" misstated part of the timeline of the case's lengthy history.
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August 13, 2024
Conn. Trial Attys Back McCarter's Bid For Punitive Award
The Connecticut Trial Lawyers Association has asked the state Supreme Court for permission to file a friend-of-court brief supporting McCarter & English LLP's bid for a punitive payout after winning multimillion-dollar judgments in a contract dispute with a former client.
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August 13, 2024
3 Firms Drive $3.8B Carlyle-Baxter Kidney Care Deal
Kirkland & Ellis LLP-led private equity firm Carlyle on Tuesday agreed to acquire the kidney care unit of Baxter International Inc., represented by Sullivan & Cromwell LLP and Baker McKenzie, for $3.8 billion, Baxter said in a statement Tuesday.
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August 12, 2024
Accused Accounting Prof Is No Tax Expert, NJ Jury Told
New Jersey federal jurors were urged Monday to keep one word at the front of their minds as they listen to the government present its case against an accounting professor accused of failing to report $3.3 million in income from a pharmacy he co-owned with his wife: willful.
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August 12, 2024
States Want Teva Generic Price Fixing Case Tried 1st
A coalition of state attorneys general suing a slew of generic drugmakers are asking for a Connecticut federal court to proceed with one of the two cases before the other, saying the outcome in that case will have a "significant impact" on settlement talks with other pharmaceutical company plaintiffs.
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August 12, 2024
Glass Tempering Co. Loses Early Exit Bid In NC Patent Fight
A glass processing equipment distributor can't ditch a Finnish competitor's patent infringement suit, a North Carolina federal judge has ruled, finding its rival has sufficiently alleged "exclusionary rights" to the patents for glass tempering.
Expert Analysis
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A Primer On EU's Updated Human Substance Regulations
The European Union's updated standards regarding quality and safety of substances of human origin meant for human application carry significant implications for companies that work with cells and tissues, and U.S. companies active in the EU market should pay particular attention to the import and export rules, say Geneviève Michaux and Georgios Symeonidis at King & Spalding.
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Series
Teaching Scuba Diving Makes Me A Better Lawyer
As a master scuba instructor, I’ve learned how to prepare for the unexpected, overcome fears and practice patience, and each of these skills – among the many others I’ve developed – has profoundly enhanced my work as a lawyer, says Ron Raether at Troutman Pepper.
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The Road Ahead For Regulation Of Digital Twins In Healthcare
Digital replicas of cells, organs and people — known as digital twins — can facilitate clinical trials for new drugs by reducing the number of patients required, but data limitations can create logistical hurdles and regulatory efforts addressing digital twins are still in early stages, say consultants at Keystone Strategy.
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Lawyers Can Take Action To Honor The Voting Rights Act
As the Voting Rights Act reaches its 59th anniversary Tuesday, it must urgently be reinforced against recent efforts to dismantle voter protections, and lawyers can pitch in immediately by volunteering and taking on pro bono work to directly help safeguard the right to vote, says Anna Chu at We The Action.
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3rd Circ. Ruling Shows Benefits Of IP Licenses In Bankruptcy
The Third Circuit’s recent ruling in Mallinckrodt’s Chapter 11 filing, which held that Mallinckrodt could sever its obligations to pay Sanofi royalties on sales of an autoimmune disease drug, highlights the advantages of structuring transactions as nonexclusive licenses for developers of intellectual property, say Gregory Hesse and Kaleb Bailey at Hunton.
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Opinion
Unclear Intellectual Property Laws Are Stifling US Innovation
U.S. intellectual property law’s lack of predictability means far less job-creating investments for companies that need patent protection to compete, and Congress must step in with legislation like the Patent Eligibility Restoration Act to help address the problem, says Michael Gulliford at Soryn IP Capital Management.
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The Fed. Circ. In June: More Liability For Generic-Drug Makers
The Federal Circuit’s June ruling in Amarin v. Hikma will likely result in more allegations of induced infringement by generic drugs postapproval, with more of those cases proceeding to at least the summary judgment stage instead of being cut off at the outset, say Jeremiah Helm and Sean Murray at Knobbe Martens.
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Opinion
Expert Witness Standards Must Consider Peer Review Crisis
For nearly two decades, the so-called replication crisis has upended how the scientific community views the reliability of peer-reviewed studies, and it’s time for courts to reevaluate whether peer review is a trustworthy proxy for expert witness reliability, say Jeffrey Gross and Robert LaCroix at Reid Collins.
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Analyzing Advance Notice Bylaws On 'Clear' Or 'Cloudy' Days
In Kellner v. AIM ImmunoTech, the Delaware Supreme Court recently clarified the framework for judicial review of advance notice bylaws adopted, amended or enforced on "clear" or "cloudy" days, underscoring the responsibility of boards to ensure that their scope does not overreach or prevent the possibility of a contested election, say attorneys at Venable.
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How To Grow Marketing, Biz Dev Teams In A Tight Market
Faced with fierce competition and rising operating costs, firms are feeling the pressure to build a well-oiled marketing and business development team that supports strategic priorities, but they’ll need to be flexible and creative given a tight talent market, says Ben Curle at Ambition.
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Patent Lessons From 5 Federal Circuit Reversals In June
A look at June cases where the Federal Circuit reversed or vacated decisions by the Patent Trial and Appeal Board or a federal district court highlights a potential path for branded drugmakers to sue generic-drug makers for off-label uses, potential downsides of violating a pretrial order offering testimony, and more, say Denise De Mory and Li Guo at Bunsow De Mory.
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Unpacking HHS' Opinion On Cell Therapy Refund Programs
A recent advisory opinion from the U.S. Department of Health and Human Services, determining that a biopharma company's refund program for its cell therapy will not be penalized, indicates an encouraging willingness to engage, but the regulator's assumptions about the program's limited term warrant a closer look, says Mary Kohler at Kohler Health.
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Series
Rock Climbing Makes Me A Better Lawyer
Rock climbing requires problem-solving, focus, risk management and resilience, skills that are also invaluable assets in my role as a finance lawyer, says Mei Zhang at Haynes and Boone.
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Think Like A Lawyer: Dance The Legal Standard Two-Step
From rookie brief writers to Chief Justice John Roberts, lawyers should master the legal standard two-step — framing the governing standard at the outset, and clarifying why they meet that standard — which has benefits for both the drafter and reader, says Luke Andrews at Poole Huffman.
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Alice Step 2 Trends Show Courts' Extrinsic Evidence Reliance
A look at recent trends in how district courts are applying Step 2 of the Alice framework shows that courts have increasingly relied on extrinsic evidence to help determine whether a claimed invention is "well-understood, routine, and conventional," says Jonathan Tuminaro at Sterne Kessler.