Topic
Pharmaceuticals
1,001 published works
India Corporate Law
Patchwork of Legal Classification: How Transdermal Patches reveal the fault lines in India’s Drug–Cosmetic Divide
By Biplab Lenin, Priyam Rajkumar, Pranjal Diler
Summary: This article explores the regulatory challenges surrounding acne and transdermal patches in India. An acne patch that promises to “reduce a blemish overnight” and a nicotine patch that delivers…
Spicy IP
SpicyIP Tidbit: CGPDTM Calls for Comments and Suggestions on New Draft Pharma and Biotech Patent Application Guidelines (2026)
In the time of this oncoming monsoon, it feels like its raining draft guidelines from the Controller General’s office! The office of the Controller General of Patents, Designs and Trademarks…
Patent Law Weblog
Exelixis, Inc. v. MSN Laboratories Private Ltd. (Fed. Cir. 2026)
By Kevin E. Noonan –Written description jurisprudence has been one of the areas of statutory explication of Section 112(a) (along with enablement) primarily under the purview of the Federal Circuit…
Big Molecule Watch
Eli Lilly to Acquire Merida Biosciences
By Emma Murray
On August 31, 2026, Eli Lilly and Merida Biosciences (“Merida’) announced that they have entered into a definitive agreement for Lilly to acquire Merida. Under the terms of the agreement,…
Big Molecule Watch
AbbVie Submits Regulatory Application to EMA for Subcutaneous SKYRIZI®
By Emma Murray
On August 27, 2026, AbbVie announced that it submitted an application to the European Medicines Agency (“EMA”) seeking approval for SKYRIZI® (risankizumab) for subcutaneous (“SC”) induction for the treatment of…
Big Molecule Watch
Takeda Files BPCIA Suit Against Alvotech for Vedolizumab Biosimilar
By Emma Murray
On September 1, 2026, Takeda Pharmaceuticals USA, Inc. and Takeda Pharmaceuticals International AG (collectively, “Takeda”) filed a BPCIA complaint in the U.S. District Court for the District of New Jersey…
The Securities Law Blog
SEC and FDA Announce MOU to Bolster Cooperation and Ensure Market Integrity
The Securities and Exchange Commission and the Food and Drug Administration today announced that they have entered into a Memorandum of Understanding (MOU) designed to assist the agencies in carrying out…
Spicy IP
Merely Citing Isn’t Applying: Looking at the DHC Order in Array Biopharma v. Deputy Controller
By SpicyIP
The Delhi High Court’s decision in Array Biopharma Inc. v. Deputy Controller of Patents highlights a basic but important point: patent objections must be tied to the claims and evidence,…
Spicy IP
Remembering Mr. P. H. Kurian (1959-2026)
Mr. P. H. Kurian (1959-2026) It is with great sorrow that we share that the Indian IP fraternity lost one of its most remarkable administrators, Mr. P. H. Kurian, yesterday…
Drug & Device Law
State of the States (Rankings, part 2)
Last week we reviewed our 2020-25 Best and Worst lists to see if any patterns emerged in terms of the federal circuits. Our tentative conclusions were that the Fifth Circuit…