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Take the case of Humira, the AbbVie AbbVie arthritis drug that reached $20 billion in annual sales. Humira’s core composition of matter patent expired in 2016, and “biosimilar” generic ...
They can also alter the process by which a drug is made — so-called “process patents.” Each tweak gets a new patent, which the manufacturer then adds to its official compendium of drug patents.
An analysis of patent applications for 10 top-selling prescription drugs found that nearly three-quarters of them were filed after FDA approval, a cross-sectional study of U.S. patent thickets found.
The court concluded that Regs. Sec. 1.263(a)-4 did not require capitalization of the litigation expenses. “The legal expenses incurred — which originate from the branded drug companies’ patent ...
BioNxt Solutions (TSE:BNXT) has released an update.BioNxt Solutions Inc. has embarked on the nationalization process for its patents related to the sublingual delivery of anticancer drugs, aiming ...
In addition to making drugs expensive, and providing incentives to misrepresent the safety and effectiveness of drugs, patent monopolies can also slow the development process itself.
Amgen identified 26 antibodies that bind to the protein PCSK9 — which inhibits the extraction of cholesterol from the bloodstream — in its patent by amino-acid sequence, but Lamken noted that ...
We will discuss recent guidance from the U.S. Patent and Trademark Office (USPTO) and dive into questions that the field is just beginning to consider as the number of AI-assisted patent ...
Further grounds for "good cause shown" are if there is a "material change" in the biological product (or process with respect to the biological product) by the biosimilar applicant or if the ...
In Mylan, Inc., 76 F.4th 230 (3d Cir. 2023), the Third Circuit affirmed the Tax Court’s opinion that patent infringement litigation expenses resulting from abbreviated new drug application (ANDA) ...
For example, instead of a pill, they make a capsule. Or instead of a dose every six hours, they create a longer-acting, once-a-day version. They can also alter the process by which a drug is made — so ...
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