Patent law in Europe: What pharmaceutical companies need to know
Addressing for the first time the issue of whether bioequivalence data and in vitro testing can show that an abbreviated new drug application (ANDA) product with different immediate and delayed release portions infringed on a...more
Hosted by C5 Group, the 17th Annual Forum on Pharma & Biotech Patent Litigation in Europe returns for another exciting year with curated programming that will provide up-to-the-minute information and strategic insights on...more
Cell therapy products in the U.S. are estimated to be worth approximately $4.5 billion currently and expected to grow to over $30 billion in the next ten years. As market value increases litigation is bound to heat up....more
The U.S. Supreme Court recently struck down broad patent claims covering a “genus” of antibodies, reaffirming in a 9-0 decision that a patent must “enable” the full scope of its claims (Amgen Inc. v. Sanofi). Amgen, Inc.,...more
Some chemical innovators have found the recent Supreme Court decision in Amgen v. Sanofi to suggest that chemical inventions will be subject to new and draconian disclosure standards going forward. A few have even suggested...more
The Supreme Court’s recent decision in Amgen v. Sanofi puts a spotlight on enablement of functionally defined claims. Future developments may shed light on a number of remaining questions for patent applicants. Here are five...more
United States courts have recently tightened the written description requirements for antibody claims. The scope of issued claims is now often limited to antibodies with specific sequences of the CDR and the heavy chain and...more
Case Name: Azurity Pharms., Inc. v. Alkem Labs., Ltd., No. 20-cv-1094, 2022 WL 605746 (D. Del. Jan. 31, 2022) (Goldberg, J.) Drug Product and Patent(s)-in-Suit: Firvanq® (vancomycin HCl); U.S. Patents Nos. 10,493,028 (“the...more
The PTAB Strategies and Insights newsletter provides timely updates and insights into how best to handle proceedings at the USPTO. It is designed to increase return on investment for all stakeholders looking at the entire...more
Case Name: Almirall, LLC v. Torrent Pharms., Ltd., Civ. No. 20-1373-LPS (D. Del. July 13, 2021) (Stark, J.) - Drug Product and Patent(s)-in-Suit: Aczone® Gel, 7.5% (Dapsone); U.S. Patent No. 9,517,219 (“the ’219 patent”)...more
Doctrine of equivalents (DOE) can be applied as a mechanism to hold a party liable for patent infringement even if the product or process does not literally infringe a patent claim, if the difference is “insubstantial”....more
There is an undercurrent in patent law these days that litigation favors the defendant. Rather than contending infringement of a few claims of one patent, plaintiffs are now advised to assert multiple claims across several...more
Duexis® (ibuprofen / famotidine) - Case Name: Horizon Medicines LLC v. Alkem Labs. Ltd., No. 18-1014-RGA, 2020 WL 7022591 (D. Del. Nov. 30, 2020) (Andrews, J.) ...more
After reflecting upon the events of the past twelve months, Patent Docs presents its 14th annual list of top patent stories. For 2020, we identified eight stories that were covered on Patent Docs last year that we believe...more
2020 has been referred to as an unprecedented year for the world in so many ways—the pandemic, the California and Washington fires, the racial justice protests and calls to action—but that didn’t stop the Federal Circuit from...more
After more than two decades of being the red-headed stepchild of patent infringement before the Federal Circuit, infringement under the doctrine of equivalents has made a dramatic comeback in the past few years, the Court...more
The Federal Circuit affirmed the U.S. District Court for District of Delaware's judgment of noninfringement agreeing the case could be dismissed at the pleadings stage because the disclosure-dedication doctrine barred...more
The Federal Circuit during 2019 and 2020 has issued a spate of decisions on the proper application of the Doctrine of Equivalents (see, e.g., UCB, Inc. v. Watson Laboratories Inc. and Galderma Laboratories, L.P. v. Amneal...more
EAGLE PHARMACEUTICALS INC. V. SLAYBACK PHARMA LLC. Before O’Malley, Reyna, and Chen. Appeal from the United States District Court for the District of Delaware. Summary: The disclosure-dedication doctrine precludes...more
On May 8, 2020, the Court of Appeals for the Federal Circuit affirmed the District of Delaware’s application of the disclosure-dedication doctrine in granting a motion for judgment on the pleadings in Eagle Pharmaceuticals...more
Infringement under the doctrine of equivalents (as a basis of a successful cause of action having renewed vigor before the Federal Circuit recently (see, e.g., "Galderma Laboratories, L.P. v. Amneal Pharmaceuticals LLC") is...more
The Federal Circuit continued its recent willingness to affirm findings of infringement under the doctrine of equivalents (see, e.g., "Eli Lilly & Co. v. Hospira, Inc. (Fed. Cir. 2019)"), in Galderma Laboratories, L.P. v....more
In Illumina, Inc. v. Ariosa Diagnositcs, Inc., (Fed. Cir. Slip Op. 2019-1419, March 17, 2020) the Federal Circuit held that process claims that exploit the discovered size differences between fetal and maternal DNA in serum...more
Recently, the Federal Circuit has taken up issues relating to infringement under the doctrine of equivalents (DOE) and a related doctrine, prosecution history estoppel (PHE), that limits the scope of equivalents that can be...more
Perfect Your Patent Prosecution Strategies and Master the Patent Application Process in the U.S and Around the World. ACI’s 18th Global Summit on Life Sciences Patents virtual conference this August will provide practical...more