Biopharma Lawsuit Tracker 2023: Moderna, Illumina, Novartis | Biospace

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Between the much-debated Inflation Reduction Act, tightening Federal Trade Commission regulation, and ongoing patent battles, legal news about biopharmaceuticals is abundant.

Here, we present our new, exclusive Biopharma Lawsuit Tracker. Follow along as we keep you updated on who’s headed to court and why, and leave Biospace be your news source for industry lawsuits through 2023.

July

July 12:

Moderna has initiated two new lawsuits against Pfizer and BioNTech in their ongoing patent dispute over the COVID-19 vaccine.

In a bid to seek compensation for alleged patent infringement, Moderna has filed new lawsuits in the Dublin High Court and the Brussels Commercial Court in Belgium, according to a report by Juve Patent, a European intellectual property outlet.

The case presented by Moderna to the Irish court concerns Pfizer-BioNTech’s alleged infringement of Spikevax patents. A hearing in this case is scheduled for early 2024, as noted in the publication. Juve Patent points out that there is less information available on the current status of Moderna’s lawsuit in Belgium.

July 12:

Illumina, a San Diego-based company, was hit with a $476 million fine by European Union regulators for a regulatory violation. Regulators said the company violated protocols by finalizing its acquisition of Grail, a developer of cancer tests, without obtaining prior approval. This fine, issued by the European Commission, represents 10% of Illumina’s turnover, which is the maximum allowed under EU merger laws.

Illumina’s fine surpasses the previous record for the largest merger regulatory fine imposed by the commission, which amounted to $125 million or 1 percent of annual revenue, imposed on telecommunications company Altice in 2018.

July 11:

Novartis has announced plans to appeal a US district court ruling in Delaware that invalidated a patent protecting the top-selling drug by Swiss drugmakers, the heart drug Entresto. This ruling may allow generic versions of Entresto to enter the market, although none are currently approved in the United States

The invalidated patent, which covers combinations of Entresto’s two active pharmaceutical ingredients, is set to expire in 2025. Novartis said any generic drug maker that launches a copy of Entresto while its appeal is pending would do so at risk of litigation. Despite the district court verdict, Novartis stands by its sales forecast for the year and its medium-term outlook.

July 7:

Novo Nordisk filed lawsuits in Florida federal court against TruLife Pharmacy, Brooksville Pharmaceuticals and WellHealth Inc. The pharmaceutical company accused these pharmacies of engaging in illegal practices by selling products that falsely claim to contain semaglutide, the active ingredient found in Novo Nordisk for weight loss and diabetes treatment.

Wegovy, an FDA-approved drug, is specifically designed for weight loss, while Ozempic and Rybelsus have received FDA approval for the treatment of type 2 diabetes.

July 3:

Gilead and Teva Pharmaceuticals have won a long four-year legal battle, in which they were accused of entering into an illicit deal that drove up the prices of HIV drugs. A California jury unanimously concluded that the companies did not participate in any anticompetitive conspiracy to obstruct the introduction of generic versions of Truvadaan HIV pre-exposure prophylaxis (PrEP) and other drugs.

Consumers and various direct buyers, including the Blue Cross Blue Shield Association, filed the lawsuit in 2019. They claimed Gilead maintained a monopoly in the HIV drug market by illegally extending patent protection for their drugs, thus preventing the entry of generic competitors.

June

June 30th:

• Following a lawsuit filed by the FTC in May aimed at blocking a multibillion-dollar merger between Amgen and Horizon, the companies have filed a countersuit against the FTC arguing the original lawsuit is unconstitutional, Law360 reported on 30 June. The FTC case is entirely new and incredibly speculative, the companies wrote, according to Endpoint news.

June 29:

• Alexion-Portola has been charged with inside trading by the Securities and Exchange Commission (SEC) against a pharmaceutical executive, doctors and individuals involved in an alleged scheme surrounding the deal, several outlets reported. According to the SEC, Joseph Dupont, a former vice chairman of Alexion and a member of the company’s acquisitions team, is accused of initiating the tip. The charges, filed in the US District Court for the Southern District of New York, allege that Dupont knowingly or recklessly shared confidential information about the acquisition with his close friends, who then passed it on to other associates.

• Liquidia intends to defend against a potential new patent on United Therapeutics’ treprostinil for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) in response to an SEC filing. The two companies have been locked in an ongoing legal dispute over the drug. Liquidia said in its SEC filing that United Therapeutics had received an indemnity notice for its patent application, which broadly covers the treatment of PH-ILD using an inhaled form of treprostinil. This notice indicates that the United States Patent and Trademark Office has determined that United Therapeutics is entitled to the patent.

June 23:

• The Amgen-Horizon deal saw increased scrutiny as six states joined the FTC in asking the District Court for the Northern District of Illinois to grant a preliminary injunction against the acquisition. This injunction would remain in effect while the FTC prepares an administrative complaint and until decisions regarding the complaint are made.

June 21st:

• PhRMA, Merck and Bristol-Myers Squibb have filed a joint lawsuit against the federal government regarding the price fixing provisions outlined in the IRA. The advocacy group and the two pharmaceutical companies have joined in their lawsuit, arguing that the legislation violates the US Constitution.
• Novo Nordisk has filed lawsuits against medical spas, wellness and weight loss clinics, and pharmacies. The lawsuits allege that these establishments advertised and sold products containing semaglutide, the active ingredient found in Novo Nordisk’s diabetes drugs Ozempic and Rybelsus, as well as Wegovy weight-loss injection.

June 20:

• Sanofi announced that an International Chamber of Commerce arbitral tribunal has rejected a request made by Boehringer Ingelheim. The complaint was related to legal liabilities associated with the ranitidine product Zantac.
• BioNTech, a German company specializing in mRNA-based vaccines, is facing its first lawsuit in Germany related to alleged side effects of its COVID-19 vaccine, which was co-developed with Pfizer and licensed for emergency use in 158 countries.

June 19:

• Bristol Myers Squibb (BMS) has filed a lawsuit against the Biden administration. The lawsuit alleges that an upcoming Medicare drug trading program through the IRA violates the First and Fifth Amendments to the United States Constitution.

June 15:

• AbbVie has filed a lawsuit alleging patent infringement by China’s BeiGene regarding their new blood cancer drug, Brukinsa (zanubrutinib). The lawsuit alleges that Brukinsa infringes AbbVies’ patent for Imbruvica (ibrutinib), a drug co-developed with Janssen and AbbVies Pharmacyclics. Imbruvica received FDA approval in 2014 as a therapy for chronic lymphocytic leukemia.

June 12th:

• The US Chamber of Commerce filed a lawsuit in federal court against the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS). The lawsuit challenges the constitutionality of the drug price negotiation program outlined by the IRA.

June 9:

• Pharmacies and drugmakers Allergan and Teva Pharmaceuticals, along with retail chains CVS, Walgreens and Walmart, have agreed to pay state and local governments an additional $18.75 billion to settle lawsuits accusing them of fueling the opioid epidemic.

• After a two-month trial, Walgreens agreed to pay $500 million in settlement to the state of New Mexico for failing to acknowledge the abuse of opioid prescriptions.

June 8:

• Eli Lilly and Takeda were hit with a class action suit accusing drug companies of racketeering, certified by a California federal judge. The allegations stem from the companies’ alleged failure to disclose the bladder cancer risk associated with their diabetes drug, Actos (pioglitazone), during its marketing.

7 June:

• Promosome has filed individual lawsuits against Moderna and Pfizer. The lawsuits allege that both companies have violated the patent protections associated with mRNA technology. In documents filed in the Southern District Court of California, Promosome said its affiliated scientists made a breakthrough in 2009. They reportedly discovered a method to enhance protein expression by making small changes to mRNA. This is the latest in a growing number of COVID mRNA vaccine lawsuits.

June 6:

• Merck filed a lawsuit against the Biden administration in the US District Court for the District of Columbia. The lawsuit challenges the constitutionality of the IRA, including provisions relating to the negotiation of drug prices.

Lisa Munger is senior editor of Biospace. You can contact her at [email protected]. Follow her on LinkedIn.