EUROPE
BGI wins $333m in DNA patent suit with Illumina
llumina has been ordered to pay more than $333 million to Chinese sequencing company MGI—a subsidiary of BGI Group formally known as Complete Genomics—following a jury ruling that Illumina infringed two of its DNA-sequencing patents.
A jury verdict handed down on Friday, May 6, ruled that Illumina willfully infringed the two patents and disregarded a counterclaim challenging their validity.
The jury ruled with BGI on all counts, finding that Illumina infringed four claims of US patents 10,662,473 and 9,222,132, which are both titled “Methods and Compositions for Efficient Base Calling in Sequencing Reactions”.
BGI was found to have proven that it was entitled to a total of $333,801,990 in damages as a result of the infringement.
The jury also said that the three patents Illumina had accused BGI of infringing in a countersuit were invalid.
Commenting on the ruling, BGI said: “The protection of intellectual property is very important to life science and biotechnology companies around the world, and it is also a value that BGI has always adhered to.”
“The jury also said that the three patents Illumina had accused BGI of infringing in a countersuit were invalid.”
Complete Genomics sued Illumina in 2019, claiming that the American biotech company had infringed the ‘132 patent with its “two-channel” sequencing system, later adding the ‘473 patent to the proceedings.
This case is a part of a broader global dispute between BGI and Illumina. The two companies are litigating their respective genomics inventions across several jurisdictions.
In December, a California court awarded Illumina $8 million in damages, ruling that BGI and its subsidiaries had deliberately infringed a patent over a six-year period.
In January 2021, Illumina secured another victory at the English High Court, which ruled that four of Illumina’s EU patents were infringed by BGI’s StandardMPS and CoolMPS systems.
Illumina said that it intended to seek a permanent injunction to halt the supply or sale of the BGI systems in the UK until its European patents expire.
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CHINA
Roche asks court for halt of Novartis units’ generic launch
Roche’s subsidiary Genentech has asked a Delaware court to block two of Novartis’ units from selling a generic version of the blockbuster lung-disease drug Esbriet (pirfenidone).
In an emergency motion, filed Thursday, 31 March, Genentech and Intermune asked the US District Court for the District of Delaware to put in a place a temporary restraining order while District Judge Richard Andrews considered the duo’s request for an injunction pending Roche’s appeal to the US Court of Appeals for the Federal Circuit.
Genentech had sued Sandoz and several other drugmakers for patent infringement in 2019, after the drugmakers filed Abbreviate New Drug Applications.
Following a trial in November last year, on March 22, 2022, Andrews dismissed Roche’s lawsuit that claimed Sandoz’s and Lek Pharmaceuticals’ proposed generic versions of Esbriet would infringe six patents directed towards treatment methods involving pirfenidone.
“The court found that Sandoz’s label only encouraged non-infringing uses of the drug.”
While Genentech argued that the generic’s label would encourage doctors to prescribe it in a way that infringes the patents, the court found that Sandoz’s label only encouraged non-infringing uses of the drug.
“The infringing uses are presented as options, not recommendations,” said Andrews. “Sandoz’s label merely provides physicians with multiple dose modification options, some covered by the asserted patents and some not, and leaves it to the physician’s clinical judgment to determine how to modify the patient’s dosage.”
Genentech has now appealed against the decision to the Federal Circuit, and filed its notice of appeal at the Delaware court on Friday, April 1.
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UNITED STATES
Harvard and 10x say Vizgen infringes genomics patents
Harvard College and 10x Genomics have sued Vizgen, claiming that the Massachusetts-based biotech rival infringes five patents covering molecular analysis methods.
The complaint, filed with the US District Court for the District of Delaware on Tuesday, May 3, claims that Vizgen’s in-development genomic platform infringes patents covering “Compositions and Methods for Analyte Detection”.
The patents in suit are US patents 11,021,737, 11,293,051, 11,293,052, 11,293,054, and 11,299,767 and are exclusively licensed to 10x.
In 2020, 10x bought ReadCoor, a genome sequencing company founded by Harvard professor George Church, acquiring its IP related to “in situ” analysis, which involves analysing a large number of molecules directly in tissue samples.
10x is now developing its new “Xenium” platform, an in situ analysis technology designed to create “spatial maps of gene expression in the original tissue at true cellular and subcellular resolutions”.
The complaint says that the technology “allows researchers and clinicians to build a comprehensive map—a kind of Google Earth—of where each analyte is, so that function can be tied to location”.
“The complaint says that the technology ’allows researchers and clinicians to build a comprehensive map—a kind of Google Earth—of where each analyte is, so that function can be tied to location’.”
Nearly half a year since the acquisition of ReadCoor, Vizgen announced the launch of its “Merscope” genomics platform in March 2021, which 10x claims practises the asserted patents.
10X notified Vizgen with a letter detailing how its Merscope platform infringes the five patents “on or around” May 2, 2022.
The complaint requests that the court rule that the patents are infringed by Vizgen’s genomics platform, serve a permanent injunction enjoining Vizgen from infringing, and award a monetary compensation for damages resulting from the infringement.
In March, both 10x and Harvard sued another rival genomics company Nanostring Technologies, claiming that its “CosMx” imaging platform infringes two of its patents for gene-mapping technology.
The Nanostring lawsuit also claims that the company infringes technology developed in part by ReadCoor following its acquisition by 10x.
Image: Shutterstock.com / Zita
UNITED STATES
Illumina gets $8m plus injunction from DNA sequencing suit
DNA-sequencing company Illumina has convinced a California court to bar Chinese pharma firm BGI Genomics from selling technology that infringes its genome-sequencing patents.
In an order handed down by the US District Court of the Northern District of California, Judge William Orrick ruled that BGI was prohibited from infringing four of Illumina’s patents until the latest expiration date.
As a result, BGI will not be able to sell its CoolMPS sequencers in the US until the expiration of the Illumina patent.
Orrick also struck one claim from the fifth patent as invalid for obviousness and a failure to satisfy the written description or enablement requirements. He said that BGI also willfully infringed the invalid claim of the patent.
However, Illumina failed to convince the judge that BGI willfully infringed the patents and to therefore enhance the one-time $8 million damages award handed out by a jury, substantially less than the $25 million the firm sought.
The order said: “In sum, the jury’s damages award is supported by substantial evidence that doing R&D in China is not commercially reasonable.”
BGI also petitioned the court for a new trial due to Illumina’s continued use of “inflammatory language” insinuating that the company was “aligned with stereotypes of communism or Chinese companies and/or business practices”.
However, Orrick concluded that there was no basis for a new trial on these grounds and denied BGI’s motion.
“BGI also petitioned the court for a new trial due to Illumina’s continued use of ’inflammatory language’.”
Case history
Illumina first sued BGI Genomics in 2019, claiming that BGI’s CoolMPS and StandardMPS systems infringed its gene sequencing patents, and followed up with a motion for a preliminary injunction.
Orrick later granted the preliminary injunction and denied BGI’s motion for a summary judgment that one of the patents was invalid but granted another.
On September 9, 2021, Orrick granted Illumina’s motion for summary judgment that its StandardMPS and CoolMPS products directly infringe five patents.
Willful infringement was also found by the jury in a trial in November 2021. At the close of evidence, both parties moved for a judgment as a matter of law on all issues.
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UNITED STATES
Novartis’ Gilenya patent survives invalidity bid
Novartis has convinced a Delaware court that a patent for its flagship multiple sclerosis treatment Gilenya (fingolimod) is directed at patent-eligible matter, dismissing a challenge from Handa Pharmaceuticals that the patent is directed at natural phenomena and invalid.
Gilenya is the brand name of Novartis’ 0.5mg daily dose fingolimod treatment. The flagship drug is used to treat multiple sclerosis.
Judge Maryellen Noreika gave an oral order denying Handa’s motion for judgment attempting to invalidate the patent.
“The court does not view the claims to be directed to a patent-ineligible observation of a natural phenomenon. Rather, the claims appear to be directed to a method of treating multiple sclerosis in certain patients by administration of a specific amount of a specific compound (fingolimod),” Noreika ruled.
Handa still has the opportunity to “obtain additional evidence” to pursue patent ineligibility arguments at trial, she added.
Novartis launched several patent infringement proceedings against Handa in the US District Court for the District of Delaware, claiming that Handa’s planned fingolimod 0.5mg tablets infringe on existing Gilenya patents.
Handa filed a New Drug Application with the US Food and Drug Administration to develop its fingolimod drug, but the application was opposed by Novartis.
Novartis initially alleged that Handa infringed two patents, US patents 9,187,405 and 10,543,179.
“Handa still has the opportunity to ’obtain additional evidence’ to pursue patent ineligibility arguments at trial.”
Handa challenged the validity of the ‘179 patent in a motion for judgment submitted in June last year, arguing that the claims of the patent, and the related ‘405 patent, do not “shift the focus” away from natural phenomenon to a patent-eligible invention.
It argued that the invention “merely observed” adverse effects of treatment with fingolimod, which could lead to patients contracting “serious” varicella zoster virus (VZV) infections. Novartis’ patentable invention was to immunise individuals against VZV, “an entirely natural and well-known phenomenon that results from vaccination”, prior to the dose of fingolimod.
However, judge Noreika appeared to disagree with this assessment, stating that the patents seemed to be directed at patent-eligible subject matter.
Novartis recently prevailed in another challenge to its ‘405 patent from China’s HEC Pharm in proceedings before the US Court of Appeals for the Federal Circuit.
The precedential decision handed down in January saw the majority of the panel uphold the validity of the patent, which Novartis has been enforcing across several high-profile generic drug manufacturers including Apotex, Bionpharma, Emcure Pharmaceuticals, Heritage Pharmaceuticals, and Glenmark Pharmaceuticals.
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UNITED STATES
Moderna aims to offset COVID vaccine lawsuit to US govt
Moderna has rejected claims that its COVID-19 vaccine violates the patent rights of two biopharma companies, arguing that its contract with the US federal government has conferred immunity.
The biotech filed its countersuit at the US District Court for the District of Delaware on May 6, holding that the plaintiffs, Arbutus Biopharma and Genevant Sciences, should instead pursue the US government.
Back in February, the companies jointly sued Moderna over royalties from the sales of its COVID-19 vaccine, which allegedly uses their tech for a drug-delivery system without authorisation.
According to the complaint, Moderna’s breakthrough vaccine would not have been possible without the use of the technology Arbutus had already created and patented—a revolutionary lipid nanoparticle (LNP) delivery platform.
World War II statute
But Moderna insisted that it is shielded by a statute that was first enacted during World War II. According to Section 1498, when an allegedly infringing product is used or manufactured by or for the US, the only remedy for the alleged infringement is an action against the US in the US Court of Federal Claims.
“Moderna insisted that it is shielded by a statute that was first enacted during World War II.”
The statute was amended over a century ago specifically “to prevent patent infringement suits from interfering with the supply of war materials during World War I”, as “Congressional concern was that if contractors feared an infringement suit, they might decide not to manufacture desperately-needed products for the United States’ war effort.”
Moderna argued that the government and companies had been presented with a similar scenario during the height of the pandemic. “Short of war, it is difficult to conceive of a situation more within the heart of Section 1498 than the COVID-19 crisis, ‘one of the greatest public health challenges in modern history’.”
Moderna pointed out that the complaint against it contains no indication that the plaintiffs ever approached the government to seek compensation.
It further argued that the plaintiffs’ complaint completely ignores the terms of Moderna’s contract with the US government. “This was not by mistake—in prior disputes with plaintiffs, Moderna informed plaintiffs that sales to the US government are subject to Section 1498,” Moderna contended.
Image: Shutterstock.com / Mongkolchon Akesin
UNITED STATES
MSD targets Mankind’s diabetes generic in patent suit
Merck Sharp & Dohme (known as MSD outside the US) has filed a complaint against New Dehli-based Mankind Pharma, looking to halt the approval of a generic version of the type two diabetes treatment, Januvia (Sitagliptin).
The US pharma giant filed the lawsuit at the US District Court for the District of Delaware on April 4, claiming that Mankind’s submission of an Abbreviated New Drug Application (ANDA) to make and market the generic infringed one of its patents.
The patent-in-suit, US patent number 7,326,708, covers “Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor” and is expected to expire in April 2026.
Mankind Pharma worked with US company Lifestar Pharma to prepare and submit the ANDA to the US Food and Drug Administration (FDA).
MSD claims that Mankind and Lifestar cooperated with the goal of selling the ANDA product before the expiration of the ‘708 patent and that the generic includes sitagliptin phosphate as an active ingredient, which is covered by the patent.
“MSD claims that Mankind and Lifestar cooperated with the goal of selling the ANDA product before the expiration of the ‘708 patent.”
“Notwithstanding Mankind’s knowledge of the claims of the ’708 patent, Mankind has continued to assert its intent to manufacture, offer for sale, sell, distribute, and/or import Mankind’s ANDA product with its product labelling following FDA approval of Mankind’s ANDA prior to the expiration of the ’708 patent,” the complaint said.
MSD seeks a declaratory judgment ruling that Mankind and Lifestar infringed the ‘708 patent and a preliminary or permanent injunction preventing Mankind and its partners from selling the generic before the expiration of the patent.
In February, MSD teamed up with AstraZeneca to file a pair of lawsuits against MSN and Sandoz, claiming that their planned generic versions of leukaemia treatment Calquence (acalabrutinib) infringe six patents.
MSN and Sandoz specified that they wanted to create an acalabrutinib oral capsule at a 100mg dosage, the same dosage as AstraZeneca’s variant.
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