Civil society groups have formally petitioned India's Department for Promotion of Industry and Internal Trade to reject secondary patent claims that cover salt forms, formulations, and dosing regimens for lenacapavir. They argue these filings lack inventive steps and unfairly extend the original 20-year exclusivity term to 28 years. Currently, six generic manufacturers, including Dr. Reddy's, hold voluntary licensing pacts to supply 120 low- and lower-middle-income countries at an estimated $40 per patient annually. However, all other pharmaceutical companies remain completely barred from producing or marketing generic versions.
Key points
Opponents argue the extensive patent strategy is an evergreening attempt designed to stre…: Opponents argue the extensive patent strategy is an evergreening attempt designed to stretch monopoly control until 2042 instead of the standard 20-year term.
Voluntary licensing terms allow selected generic manufacturers to distribute the essentia…: Voluntary licensing terms allow selected generic manufacturers to distribute the essential HIV therapy at roughly $40 per person annually.
Unlicensed generic manufacturers remain prohibited from producing the twice-yearly inject…: Unlicensed generic manufacturers remain prohibited from producing the twice-yearly injection, restricting broader market competition and alternative supply channels.
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An unusually high 18 patent applications filed in India for lenacapavir
NEW DELHI: An unusually high 18 patent applications filed in India for lenacapavir, a breakthrough HIV therapy, have raised concerns that these could prolong market exclusivity, delay affordable generics, keep prices high and restrict patient access. Contesting the move, patient groups and civil society have filed opposition with the regulatory authorities, arguing the applications lack novelty and inventive steps.Lenacapavir, a long-acting injectable, administered twice yearly for both HIV prevention and treatment, a medicine designated as essential by WHO.Last year, US FDA approved Gilead Sciences' lenacapavir as the first and only twice-yearly injectable pre-exposure prophylaxis to reduce sexually acquired HIV. Gilead has filed at least 18 patent pleas till date in India, covering different aspects of it, including the base compound, salt forms, formulations, dosing regimens, compositions, and methods of use."The pattern of filings reflects a systematic strategy to create layered patent protection around a single medicine, with the effect of deterring generic entry and prolonged monopoly control beyond the standard 20-year patent term.
Medical professionals across the country are facing heightened challenges as an extremely potent veterinary tranquilizer infiltrates the unregulated drug market. The newly detailed protocols aim to standardize acute care responses for patients experiencing severe physiological distress, helping clinicians distinguish the compound from other life-threatening medical emergencies. Without proper pharmacological interventions, untreated individuals risk rapid cardiovascular deterioration that can overwhelm emergency d…
The newlyweds directed attendees of their July 3 nuptials to forego traditional gift-giving in favor of supporting charitable organizations. Their wedding registry initiative builds upon an extensive joint philanthropic campaign that disbursed tens of millions of dollars nationwide ahead of the ceremony. This approach has already channeled unexpected contributions directly to grassroots nonprofits, including local animal welfare groups.
Public health teams have successfully discharged all 62 individuals who crossed paths with an infected traveler, finding zero secondary infections even after 13 displayed non-specific symptoms. The initial index case was evacuated back to Switzerland, where she achieved a full recovery. Despite clearing these contacts, officials remain on high alert because the rare Bundibugyo strain driving regional infections currently lacks any approved vaccines or targeted medical treatments.