Pfizer has asked a Delaware court to drop an infringement lawsuit against Teva Pharmaceuticals over a proposed generic of its rheumatoid arthritis drug Xeljanz (tofacitinib).
Pfizer submitted the stipulation of dismissal to the US District Court for the District of Delaware on September 7, requesting that all claims and counterclaims be dismissed without prejudice, but to keep any protective orders entered by the court in place.
Teva had filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA), notifying Pfizer in October 2018 that it planned to manufacture a generic version of Xeljanz prior to the expiration of the key patent US 9,937,181.
The ‘181 patent was issued in April 2018, titled “Tofacitinib Oral Sustained Release Dosage Forms” and is set to expire in March 2034.
“The FDA’s ‘Orange Book’ features four additional patents related to the drug which are not at issue.”
The FDA’s “Orange Book” features four additional patents related to the drug which are not at issue. The trial for the case had been originally been proposed for January 3, 2022, according to a motion to amend the case schedule.
Xeljanz litigation
Alongside its litigation with Teva, Pfizer had sued Aurobindo for submitting an ANDA for a Xeljanz generic in January 2021, claiming it had infringed two other patents related to the drug US 6,965,027 and reissue patent RE41,783.
Pfizer launched similar litigation against Zydus Pharmaceuticals in February 2021, claiming that Zydus had infringed on the same two patents with its proposed Xeljanz generic.
Both cases are still pending before the Delaware court.
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Advanced Biologics (AB) has convinced the English High Court to expedite a patent infringement and validation suit it is embroiled in with German rival Med-El.
In a judgment handed down on August 31, the English patents court granted the expedition of the trial to February 2022.
AB has petitioned the courts to either invalidate Med-El’s European patent UK number 3,138,605B or to establish that AB’s cochlea implant device does not infringe.
Med-El has counterclaimed, claiming that the arrangement of four rotatable magnets in AB’s device infringed on its ‘605 patent.
AB wanted to expedite the UK proceedings to prevent a potential early injunction of its cochlea implant in parallel litigation in a German court, which AB argued could severely impact its business in the UK.
Initially, AB sought to expedite the trial for a deadline in December 2021, but this would have required a “very compressed timetable”, according to Mellor.
UK impact
Med-El’s infringement case against AB, being heard at the Mannheim Regional Court, sought a preliminary injunction barring AB from selling its implant device, the Hi-Res 3D, which has been available on the UK market since 2018.
In its argument that the case should be expedited, AB had to prove to the UK court that the German injunction would have an effect on the UK market.
Justice Mellor noted “many cases where the effect of a German injunction on the UK market is slight or even non-existent”. However, AB’s case was unique in that an injunction over its flagship product may raise concerns in the UK market of which AB holds a 20% market share of cochlea implants, the judgment claims.
Med-El argued that all of AB’s fears about the effect of a German injunction on the UK market were “exaggerated and/or not objectively justifiable”.
Mellor said: “Even if I assume that no audiologists in the UK would become aware of the German infringement action, I find it very difficult to understand how UK audiologists would not hear very quickly that the 3D device was off the market in the major German market.
“Expedition cases have been considered ‘many times’ in recent memory at the English High Court, according to Mellor.”
“Many would then speculate whether the same was going to happen in the UK. This would lead audiologists and patients to doubt whether it was advisable to have a 3D device implanted, and to discussions to that effect on the blogs.”
Expedited cases
Expanding on the UK court’s handling of expedited cases, Mellor referenced a judgment he made in Abbot Laboratories v Dexcom from August this year, a similar case in which the claimant sought to expedite a German trial by appealing to the English court.
Expedition was sought to avoid the problems caused by the “injunction gap”—a concept in the German legal system in which months can pass between the first instance injunction and the decision of the validity of the patent.
Expedition cases have been considered “many times” in recent memory at the English High Court, according to Mellor. Specifically, Mellor referenced Nicoventures Trading v Philip Morris as another recent example of expedition rulings at the court in order to avoid the injunction gap.
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The US District Court for the Northern District of California has denied an attempt by Chinese company BGI Genomics to invalidate an Illumina DNA sequencing patent in a summary judgment, leaving the dispute over infringement of another Illumina patent to be decided at trial.
The order on a motion for partial summary judgment ruled that BGI’s CoolMPS gene sequencing product does not infringe Illumina’s US patent 10,480,025, but also denied BGI’s motion that Illumina’s US patent 7,777,973 is invalid.
Separate from this motion, both parties sought additional claim construction regarding the ‘025 patent following the addition of a new infringement theory brought by Illumina.
But with the court ruling that the CoolMPS did not infringe the patent, the hearing, which was scheduled for September 3, has been vacated.
‘973 validity
BGI alleged that the ‘973 patent was invalid for failure to satisfy the enablement and written description requirements of the patent claims.
BGI posed a “simultaneous nucleotide addition” theory, arguing that the scope of the claims did not properly describe the situation where multiple nucleotide types are bought into contact with the target simultaneously.
In its counterargument, Illumina claimed that BGI failed to disclose this theory in its contentions required when arguing invalidity, meaning it should not be applied to invalidity proceedings.
While the court held that BGI did not waive its right to present the theory, it upheld that claims 1 and 13 of the ‘973 patent were valid.
“In its counterargument, Illumina claimed that BGI failed to disclose this theory in its contentions required when arguing invalidity.”
‘025 infringement
Illumina argued that BGI waived its non-infringement argument because it did not raise a question regarding claim construction early enough.
Specifically, BGI argued that “a base linked to a detectable label”, detailed in the ‘025 patent requires that a detectable label be linked “only” to the base.
In the order, District Judge Orrick wrote: “The specification clearly disavows the attachment of the label to the sugar and there is no factual dispute that the CoolMPS attaches labels to the sugar. As a result, there can be no literal infringement of the ’025 Patent.”
Case history
Illumina filed its complaint against BGI after it learned that the company would be selling its CoolMPS product in the US.
It alleged that BGI’s product infringed claim 13 of the ‘973 patent, claim 1 of the ‘025 patent and claim 3 of the ‘444 patent.
In November 2020, the court entered a claim construction order on disputed terms in the three patents and on June 16, 2021, BGI filed the motion for partial summary judgment, alleging the ‘973 patent is invalid for failure to satisfy the enablement and written description requirements and that CoolMPS does not infringe the ‘025 patent.
In February, BGI was given the go-ahead to appeal an English High Court ruling in an ongoing lawsuit launched by competitor Illumina regarding its DNA sequencing patents.
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In a victory for Bristol Myers Squibb (BMS) and Pfizer, the US Court of Appeals for the Federal Circuit has affirmed the validity of a pair of patents covering blood clot treatment, Eliquis (apixaban).
The Federal Circuit handed down its brief opinion on September 3, blocking any generic version of the blood-thinning treatment for another seven years.
BMS and Pfizer complained that the bioequivalent versions of Eliquis that generic makers Sigmapharm Laboratories, Sunshine Lake Pharma and Unichem Laboratories were planning to bring to market would infringe two patents.
In August 2020, the US District Court for the District of Delaware affirmed the patents and Sigmapharm appealed to the Federal Circuit a month later, contending that the patents were invalid.
The patents, US numbers 6,967,208 and 9,326,945, claim apixaban and certain compositions containing apixaban, respectively.
“The Federal Circuit praised the lower court’s ‘thorough and thoughtful’ ruling.”
BMS and Pfizer co-developed Eliquis, an anticoagulant used to prevent serious blood clots, and share profits and losses.
In its conclusion, the Federal Circuit praised the lower court’s “thorough and thoughtful” ruling, noting that it could “find no error, and certainly no clear error, in the district court’s findings of fact, including its expert witness credibility determinations”.
In 2019, the US FDA approved Micro Labs and Mylan Pharmaceuticals’ applications for the first generics of Eliquis. However, the two companies reached a settlement with BMS and Pfizer, preventing the launch of the generic until at least 2026.
According to a report by FiercePharma, Eliquis earned more than $9 billion for BMS and Pfizer last year, enough to rank it in the top five of the world’s bestselling medicines.
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