Supreme Court Justice Neil Gorsuch’s ruling that Amgen’s PCSK9 inhibitor patents don’t satisfy enough “enablement” requirements to cover its “broad” patent protection claims.

Cardiology Pharmaceuticals

SCOTUS Rules Against Amgen in PCSK9 Patent Dispute

The U.S. Supreme Court ruled against Amgen in its PCSK9 inhibitor patent dispute with Sanofi and Regeneron that was intended to revive patents for Amgen’s cholesterol-lowering drug, Repatha. 

The unanimous ruling brings closure to a decade-long battle between PCSK9 leader Amgen and its rivals Sanofi and Regeneron Pharmaceuticals (Sanofi‘s U.S. distributor), which will remain free to market their Praluent PCSK9 in the U.S. 

The Supreme Court upheld a 2021 federal appeals court decision that invalidated two Amgen patents, finding that they didn’t satisfy “enablement” requirements. In other words, the patents were too broad and weren’t detailed enough to allow a skilled scientist to recreate the invention. 

Amgen’s Supreme Court case argued that the lower courts set an inappropriately high bar for “enablement,” its patents didn’t have to detail every possible claim, and the patents actually are enabled because “scientists can make and use every functional antibody” if they follow Amgen’s “roadmap” or “conservative substitution.”

• However, the Supreme Court disagreed, stating that “the more one claims, the more one must enable” and that Amgen “failed to enable all that it has claimed.”
  
• Justice Neil Gorsuch’s statement added that Amgen sought to “monopolize . . .  every antibody that both binds to particular areas of the sweet spot of PCSK9 and blocks PCSK9 from binding to LDL receptors,” covering far more functional antibodies than the 26 involved in Repatha’s amino acid sequences.

Sanofi and Regeneron’s Praluent PCSK9 inhibitor has a similar mechanism as Repatha. Both use laboratory-produced antibodies to block the PCSK9 inhibitor protein, which limits liver cells’ ability to remove LDL-C from the blood. However, Praluent and Repatha use different chemical combinations.

• Amgen’s Repatha remains the market leader with $1.3B in global sales last year, far more than Praluent’s $530M globally ($130M in the U.S. via Regeneron), although neither of the PCSK9 inhibitors have achieved what some viewed as their potential.

Insiders suggest that the ruling could have a broad impact on the pharmaceutical industry, protecting against what some see as patent overreach, while encouraging innovation. 

• The ruling also has specific implications for pharma’s $160B antibody segment, with similarly long lists of antibody patent holders that are disappointed by this ruling (AbbVie, GSK, Biogen, Bristol Myers Squibb) and other pharma companies that are celebrating the court’s decision (Pfizer, Bayer, AstraZeneca, Genentech, J&J).

The Takeaway

Although this ruling doesn’t bring tangible changes to the PCSK9 inhibitor segment in the short term, the court’s narrower patent enablement definition could open the door for more antibody drugs targeting cardiovascular and other diseases.

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The Wire

• Edwards TAVR Benchmark Efficiency: Data presented at EuroPCR 2023 highlighted the efficiency benefits of Edwards Lifesciences’ Benchmark program, which is a set of “minimalist” TAVR care pathways focused on conscious sedation, recovery outside the ICU, and next-day discharge. Analysis of 2,405 patients who underwent TAVR with a balloon-expandable valve at 28 European sites found that patients treated via the Benchmark program experienced 25% shorter ICU stays and 33% faster median hospital stays, while maintaining similar 30-day clinical outcomes as patients treated before the implementation of the Benchmark pathway.

• USHV Acquires Memorial Katy Cardiology: Private equity-backed cardiology managed service organization US Heart & Vascular continued its practice M&A spree, acquiring Houston-area cardiology practice Memorial Katy Cardiology Associates (~15 physicians, ~7 locations). The acquisition is USHV’s fourth in the Houston area and its third overall in the last month (following Kansas’ Heartland Cardiology and Dallas’ HeartPlace), as it works towards its goal of creating a nationwide cardiology practice.

• Mobile CBT Lowers LDL-C: A randomized trial in JMIR showed that mobile phone-based cognitive behavioral therapy (CBT) reduced LDL cholesterol levels in patients with atherosclerotic cardiovascular disease. The study enrolled 300 patients, with the intervention group receiving CBT for ASCVD lifestyle interventions via the WeChat MiniApp. After six months, the intervention group had higher LDL-C up-to-standard rates (odds ratio 1.57) and increased self-efficacy and quality of life scores compared to the control group, even among participants who already had standard LDL-C levels.

• Cardio Diagnostics’ Epi+Gen CHD Platform: Cardio Diagnostics Holdings announced the launch of its Actionable Clinical Intelligence (ACI) platform, which provides clinicians with additional data from epigenetic and genetic laboratory developed tests (LDTs) for assessing coronary heart disease. The new ACI platform integrates LDT results with biomarkers and clinical information, offering personalized insights on patients’ CHD risk factors, biomarker contributions, and changes over time.

• SGLT2i’s Slow Start in the VA: SGLT2 inhibitors might be among the hottest meds in America, but a new JACC study suggests that they were underutilized in the Veterans Affairs Health System in 2020. Among 105k VA patients with type 2 diabetes, heart failure, and ASCVD who were seen by a primary care provider in 2020, just 14.6% received SGLT2 inhibitors. SGLT2i prescription rates varied by as much as 55% when comparing similar patients treated at different VA facilities.

• Asundexian’s AFib Fast Track: Bayer’s investigational oral Factor XIa inhibitor, asundexian, received FDA Fast Track Designation as a potential treatment to prevent stroke and systemic embolism in people with atrial fibrillation. This marks asundexian’s second Fast Track Designation, following a designation for stroke prevention after non-cardioembolic ischemic stroke. Bayer highlighted asundexian’s potential to reduce clot formation while maintaining the body’s ability to respond to bleeding, noting that many patients have concerns about bleeding and are not treated adequately with current anticoagulants.

• Abbott TriClip’s bRIGHT Data: Abbott announced late-breaking bRIGHT study data from EuroPCR supporting its TriClip transcatheter edge-to-edge repair (TEER) system’s safety and effectiveness after 30 days. Among 511 patients who underwent TriClip TEER procedures at 26 European sites, 77% experienced a reduction in tricuspid regurgitation grade to “moderate or less,” 79% achieved NYHA Functional Class I/II (vs. 20% at baseline), and 56% reported 15-point improvements to their KCCQ quality of life scores. Only 2.5% of the patients experienced major adverse events.

• Explaining Broken Heart Syndrome: A JACC study revealed new insights into the hemodynamic mechanisms of Takotsubo Syndrome (TTS, aka “broken heart syndrome”) that might contribute to novel TTS treatments. Researchers recorded LV pressure-volume loops from 24 TTS patients and 20 controls, finding that TTS might be caused by decreased phosphorylation of myofilament proteins, which could be a potential TTS therapeutic target.

• Sensydia’s Cardiac Performance Funding: Sensydia scored another $8M in funding (total raised $17.8M) to support the commercialization and development of its non-invasive cardiac performance system (CPS) platform. Sensydia’s CPS platform combines biosensors and AI to produce multiple hemodynamic measurements and support heart failure management, allowing cardiac performance assessments to be performed “anywhere” ranging from the OR to home care settings.

• Liability Premiums on the Rise: An AMA analysis found that 36.2% of physicians’ medical liability premiums increased between 2021 and 2022, marking the highest rate seen since 2005 and the fourth straight year of increases. Among the premiums that increased last year, the average hike was 8.1%, which the AMA says could cause physicians in states with difficult liability environments to relocate or even drop clinical services that raise their risk.

• Edwards’ Evoque TTVR System Safe & Effective: A new JACC study found that Edwards Lifesciences’ EVOQUE tricuspid valve replacement system (TTVR) is safe and effective for patients with severe or greater tricuspid regurgitation (TR) through two years. The retrospective analysis of 38 patients who underwent TTVR using EVOQUE showed that tricuspid annular plane systolic excursion was reduced to <17 mm among 53% of patients, TR was reduced to ≤1 in 97% of patients at the end of the procedure and 94% at follow-up, and survival rates at 1 and 2 years were 86% and 71%.

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