API and IP Newsletter
Contents
- Recent ANDA approvals
- General information
- Catalyst settles with Teva, staving off Firdapse generic until 2035
- A Decade of FTC v. Actavis:
- Intellectual Property
- 10x Vs NanoString
Recent ANDA approvals
We follow ANDA approvals. Of the 88 ANDAs approved in December 2024, 14 were tentative approvals. The companies listed below received the most approvals in December.
General information
Catalyst settles with Teva, staving off Firdapse generic until 2035
Under the agreement, Teva is barred from marketing its Firdapse copycat (Amifampridine Phosphate ) in the U.S. until Feb. 25, 2035, at the earliest, Catalyst said Wednesday. Teva’s generic version of the med, amifampridine, has not yet been approved by the FDA.
News here
A Decade of FTC v. Actavis:
Although the reverse payment framework is older, are the courts wiser in applying it? In Actavis, the Court held that certain types of so-called reverse payments—patent litigation settlement payments from brand pharmaceutical manufacturers to generic companies challenging the brand’s patent—might "sometimes" violate the antitrust laws.
News here
Intellectual Property
10x Vs NanoString
10x Genomics, Inc. and Prognosys Biosciences, Inc. (10x) filed a lawsuit against NanoString Technologies, Inc. for patent infringement. After a five-day trial, the jury concluded that NanoString wilfully, both directly and indirectly, infringed on 10x's asserted patents.
The jury awarded 10x 33 million USD, including over twenty-five million dollars in lost profits and more than six million dollars in lost royalties.
This Delaware court decision followed a jury verdict in November 2023, which found that NanoString's GeoMx products wilfully infringed seven patents exclusively licensed to 10x Genomics by Prognosys.
The jury heard testimony from Mark Chee, the sole inventor of the patents and co-founder of Illumina, along with Brad Gray, CEO of NanoString, and Joe Beechem, NanoString's CSO. After reviewing all the evidence, the jury concluded that NanoString had infringed all seven patents, deemed each patent valid, determined that NanoString willfully infringed upon those patents, and acknowledged that monetary damages were owed to 10x for the infringement of all seven patents.
The asserted patents in Case include (1) US10,472,669; (2) US 10,961,566; (3) US 10,983,113; (4) US 10,996,219; (5) US 11,001,878; (6) US 11,008,607 and (7) US 11,293,917. The seven patents were issued to Prognosys.
10x is a leader in single-cell and spatial biology. These fields of study use technologies to examine cells and tissues in detail. Companies like 10x and NanoString use the Digital Spatial Profiler and associated instruments and reagents for RNA and protein detection.
Single-cell biology is a specialised field that combines multiple disciplines to study cells individually. It uses technologies to provide insights into their function, dynamics, and heterogeneity within tissues. These technologies include single-cell RNA sequencing (scRNA-seq), single-cell proteomics, and “single-cell” epigenomics.
Spatial biology employs technologies to explore the organization of cells within tissues. One method is spatial transcriptomics, which links gene expression to specific locations in a tissue section.
More details about the technology can be found here. https://www.10xgenomics.com/spatial-transcriptomics
After briefly learning about the technologies, let us examine what occurred in this case.
After the unfavourable jury verdict, NanoString filed a motion in court for judgment as a matter of law concerning invalidity, infringement, and damages or for a new trial.
10x, on the other hand, has moved the Court for entry of a permanent injunction, enhancement of damages, attorneys' fees, supplemental damages, and pre-judgment and post-judgment interest.
The matter was heard before The United States District Court For The District of Delaware.
1. In the Delaware court, NanoString sought judgment as a matter of law (JMOL) or a new trial, arguing that the evidence presented was insufficient for a jury to determine infringement reasonably. In US civil cases, a JMOL is a motion a party can file during a trial to request the court rule in their favour based on the evidence provided.
2. NanoString contended that no reasonable jury could determine that the use of GeoMx products directly infringed the determined sequence or a comparable limitation in the claims of the '219, '669, '566, '113, '878, and '607 patents. The Court disagreed.
3. To demonstrate irreparable harm, a patentee must prove that they will endure irreparable harm without an injunction and that a sufficiently strong causal connection ties the alleged harm to the claimed infringement.
4. The Court found that 10x has demonstrated irreparable injury. The record indicates that NanoString's infringement has inflicted past harm on 10x.
5. The GeoMx® Digital Spatial Profiler provides a context in spatial transcriptomics and assists researchers in quickly obtaining spatial genomics data. Experts from both sides concurred that NanoString and 10x are competitors, with 10x's Visium products competing against GeoMx products.
6. NanoString's GeoMx products infringe on 10x's patents, as demonstrated by the jury's finding of infringement and its award of a reasonable royalty on GeoMx sales. Additionally, the evidence indicates that 10x suffered losses in sales and profits due to NanoString's infringing product sales.
7. A 10x expert, Dr. Quackenbush testified about NanoString's infringing GeoMx products. After reviewing NanoString's records, Dr. Quackenbush stated that GeoMX's products and workflow violated all 10x's patents.
8. Dr. Quackenbush identified each patent limitation in the GeoMx step-by-step workflow. Notably, he explained that step seven in the '219 Patent, using the determined sequence to determine the presence of the target biological molecule at the region of interest in the tissue sample, appears in GeoMx's workflow.
9. To succeed on a renewed motion for JMOL after a jury trial, a party must demonstrate that the jury's findings, whether presumed or explicit, lack substantial support from evidence, or if they do, that those findings cannot legally uphold the legal conclusions implied by the jury's verdict.
10. In affirming the jury's finding that NanoString wilfully infringed, the Court relied on evidence indicating that NanoString knew or was wilfully blind to the fact that its actions would infringe 10x's rights.
11. Thus, 10x secured a permanent injunction in the U.S. District Court for the District of Delaware against the GeoMx products sold by Bruker Corporation, which acquired this product line from NanoString Technologies.
The injunction, which the Court stated it would enter in January 2025, is expected to prohibit Bruker from making, using, selling, or offering to sell its infringing product in the United States.
Decision here
