Biopharma Lawsuit Tracker 2023: Pfizer Settles Trade Secrets Case

Pictured: A wooden gavel on a table with a book in the background/iStock, nathaphat

Between the hotly debated Inflation Reduction Act, tightening Federal Trade Commission regulation and ongoing patent battles, biopharma legal news is abundant. Follow along as we keep you up to date on who’s headed to court and why, and let BioSpace be your news source for industry lawsuits through 2023.

July 20:

Pfizer initiated a lawsuit against a biotech company founded by its former employees in 2022, accusing them of misappropriating trade secrets and breaching contracts. Now, both companies have reached a settlement. On Wednesday, attorneys representing Pfizer and Regor Therapeutics submitted a two-page document to the U.S. District Court for the District of Connecticut, stating that an agreement had been reached. Pending court approval, both Pfizer and Regor Therapeutics will drop their claims against each other and be responsible for their respective costs and legal fees. However, the specific details of the settlement were not made public.

The legal dispute began on February 2, 2022, when Pfizer filed the initial complaint against Regor, alleging various instances of trade secret misappropriation, contract breaches, unfair and deceptive trade practices, and more. Notably, just two months prior to Pfizer’s lawsuit, Regor, which was founded by former Pfizer employees Xiayang Qiu and Min Zhong, secured a discovery and development deal with Eli Lilly for metabolic indications. Regor secured a deal that provided them with an upfront payment of $50 million and the potential to earn up to $1.5 billion in milestone payments.

July 19:

In the midst of a nationwide halt on Johnson & Johnson’s talc litigation, one exceptional case that managed to proceed has reached a trial verdict favoring the plaintiff.

Anthony Hernandez Valadez, the plaintiff, brought forward his case last year after being diagnosed with a rare form of mesothelioma, which he attributed to his prolonged use of J&J’s baby powder during his childhood.

According to reports from various news outlets, a California jury ruled in favor of the plaintiff, awarding him $18.8 million in damages to cover his medical expenses and suffering. However, the jury chose not to impose punitive damages on J&J.

July 14:

In a lawsuit filed in Massachusetts federal court, Roche and two of its subsidiaries took legal action against biotech company Biogen. The allegations stated that Biogen’s proposed similar version of Roche’s highly successful rheumatoid arthritis medication, Actemra, would violate multiple patents owned by the plaintiffs, according to multiple outlets.

Roche, along with Genentech and Chugai, presented their case to the court, asserting that Biogen’s proposed biosimilar drug, BIIB800, would infringe upon patents specifically related to the production and utilization of their biologic medication.

Roche claimed Biogen had not adequately disclosed the manufacturing process of its copycat drug, BIIB800. Roche also raised concerns about Biogen allegedly infringing on intellectual property related to the treatment methods for rheumatoid arthritis, the condition for which Actemra initially obtained approval in 2010. Furthermore, Roche argues that Biogen’s method of inhibiting the IL-6 receptor with BIIB800 constitutes a violation of Roche’s patent.

Originally approved by the FDA in 2010 as a treatment for rheumatoid arthritis, Actemra has gained additional approvals for various purposes, including the treatment of hospitalized COVID-19 patients.

July 13:

The U.S. Chamber of Commerce requested a judge to intervene and halt the implementation of the IRA law by the federal government with a letter of support from an executive at AbbVie.

The Chamber filed a motion for a preliminary injunction in a federal district court in Dayton, Ohio. This motion seeks an order to prevent the Centers for Medicare and Medicaid Services (CMS) from implementing the relevant sections of the IRA, which would enable Medicare to begin drug price negotiations in 2026.

Though several groups have contested the IRA in court (Merck, Bristol Myers Squibb and industry lobbying group PhRMA), this is the only preliminary injunction request submitted thus far.

July 13:

In response to a patent infringement lawsuit brought by Arbutus Biopharma and Genevant, Pfizer and BioNTech have denied the allegations that their COVID-19 vaccine violates patents held by Arbutus and licensed to Genevant.

Pfizer and BioNTech submitted their response to the lawsuit, which was filed in April, in the U.S. District Court for the District of New Jersey. Arbutus and Genevant, in which Arbutus and Roivant Sciences have partial ownership, claimed that the COVID vaccine infringes upon five Arbutus patents related to the composition, manufacturing, delivery and utilization of nucleic acid-lipid particles.

Pfizer and BioNTech denied the accusations.

July 12:

Merck requested a federal court to render a decision on its suit against the IRA without the need for a trial. The company filed a document urging the U.S. District Court for the District of Columbia to grant a summary judgment in its lawsuit against the government. Merck’s legal action argues that the IRA infringes upon the First and Fifth Amendments by compelling companies to provide drug discounts without any discretion.

Merck, along with BMS, PhRMA and the U.S. Chamber of Commerce, have filed suits challenging the legislation in court. Merck filed its original suit five weeks ago.

July 12:

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

In an attempt to seek compensation for alleged patent infringement, Moderna filed fresh lawsuits at the High Court in Dublin and the Brussels Commercial Court in Belgium, as per a report from Juve Patent, a European intellectual property outlet.

The case filed by Moderna in the Irish court pertains to the alleged infringement of Spikevax patents by Pfizer-BioNTech. The hearing for this case is scheduled for early 2024, as stated in the publication. Juve Patent highlights that there is less information available regarding the current status of Moderna’s lawsuit in Belgium.

July 12:

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

Illumina’s fine surpasses the previous record for the largest merger regulation penalty imposed by the commission, which amounted to $125 million or 1% of annual turnover, levied on telecommunications firm Altice in 2018.

July 11:

Novartis announced it plans to appeal a ruling by the U.S. District Court in Delaware that invalidated a patent that protects the Swiss pharma’s best-selling medicine, the heart drug Entresto. This ruling can allow generic versions of Entresto to enter the market, although currently, none are approved in the U.S.

The invalidated patent, which covers combinations of the two active pharmaceutical ingredients in Entresto, is set to expire in 2025. Novartis stated that any generic drugmaker who launches a copy of Entresto while their appeal is pending would be doing so at the risk of litigation. Despite the district court’s verdict, Novartis maintains its sales forecast for the year and its mid-term outlook.

July 7:

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

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

July 3:

Gilead and Teva Pharmaceuticals won a lengthy four-year legal battle, where they were accused of striking an illicit agreement that caused the prices of HIV drugs to soar. A California jury unanimously concluded the companies did not participate in any anti-competitive conspiracy to obstruct the introduction of generic versions of Truvada—an HIV pre-exposure prophylaxis (PrEP) medication—and other drugs.

Consumers and various direct purchasers, including the Blue Cross Blue Shield Association, initiated the lawsuit in 2019. They alleged that Gilead maintained a monopoly in the HIV drug market by unlawfully extending patent protection for their drugs, thus impeding the entry of generic competitors.

June 30:

• Following a lawsuit filed by the FTC in May aiming to block a multi-billion-dollar merger between Amgen and Horizon, the companies have filed a countersuit against the FTC, claiming the original suit is unconstitutional, Law360 reported on June 30. “The FTC’s case is wholly novel and impossibly speculative,” the companies wrote, according to Endpoints News.

June 29:

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

• Liquidia intends to defend itself against a potential new patent related to United Therapeutics’ treprostinil for treating 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 stated in its SEC filing that United Therapeutics had received a notice of allowance for its patent application, which broadly covers the treatment of PH-ILD using an inhaled form of treprostinil. This notice indicates that the U.S. Patent and Trademark Office has determined that United Therapeutics is entitled to the patent.

June 23:

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

June 21:

• PhRMA, Merck and Bristol-Myers Squibb have jointly filed a lawsuit against the federal government concerning the price-setting provisions outlined in the IRA. The lobbying group and the two pharmaceutical companies have come together in their legal action, claiming that the legislation violates the U.S. Constitution.
• Novo Nordisk initiated lawsuits against medical spas, wellness and weight loss clinics and pharmacies. The lawsuits allege that these establishments have been advertising and selling products containing semaglutide, the active ingredient found in Novo Nordisk’s diabetes medications Ozempic and Rybelsus, as well as the weight loss injection Wegovy.

June 20:

• Sanofi announced that an arbitration tribunal from the International Chamber of Commerce had dismissed a claim made by Boehringer Ingelheim. The claim was related to legal responsibilities associated with the ranitidine-based 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, developed in partnership with Pfizer and authorized for emergency use in 158 countries.

June 19:

• Bristol Myers Squibb (BMS) filed a lawsuit against the Biden administration. The lawsuit contends that an upcoming Medicare drug negotiation program via the IRA infringes upon the First and Fifth Amendments of the U.S. Constitution.

June 15:

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

June 12:

• The U.S. Chamber of Commerce has 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 in the IRA.

June 9:

• Pharmacies and drug manufacturers 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 resolve lawsuits accusing them of fueling the opioid epidemic.

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

June 8:

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

June 7:

• Promosome filed individual lawsuits against Moderna and Pfizer. The lawsuits allege that both companies infringed upon patent protections associated with mRNA technology. In the filings presented to the Southern District Court of California, Promosome asserted that its affiliated scientists made a breakthrough in 2009. They reportedly discovered a method for enhancing protein expression by making minor modifications to mRNA. This is the latest in a growing number of patent suits over the COVID mRNA vaccines.

June 6:

• Merck initiated a lawsuit against the Biden administration in the U.S. District Court for the District of Columbia. The lawsuit challenges the IRA’s constitutionality, encompassing provisions related to drug price negotiation.

Lisa Munger is a senior editor at BioSpace. You can reach her at lisa.munger@biospace.com. Follow her on LinkedIn.