Zydus moves Delhi HC against order restraining sale of its cancer drug
on Thursday moved the division bench of the
Delhi High Court
against its single judge's earlier order that temporarily restrained the Ahmedabad-based drug maker from manufacturing, selling
biosimilar
of US pharma giant E.R. Squibb's patent
Nivolumab
, a therapeutic antibody used in the treatment of cancer.
The Division Bench while refusing to stay the single judge's interim order sought response from the US pharma company, which had alleged
patent infringement
of its blockbuster anticancer drug Opdyta (nivolumab) branded as Opdivo in other countries. In India, Nivolumab is being imported and marketed as Opdyta.
Explore courses from Top Institutes in
Please select course:
Select a Course Category
PGDM
Technology
Digital Marketing
Data Science
Others
Management
Cybersecurity
Healthcare
Data Science
Product Management
Public Policy
MBA
others
Design Thinking
Finance
Leadership
Project Management
CXO
MCA
Data Analytics
Artificial Intelligence
Operations Management
healthcare
Degree
Skills you'll gain:
Financial Analysis & Decision Making
Quantitative & Analytical Skills
Organizational Management & Leadership
Innovation & Entrepreneurship
Duration:
24 Months
IMI Delhi
Post Graduate Diploma in Management (Online)
Starts on
Sep 1, 2024
Get Details
While Squibb alleged that Zydus was conducting clinical trials for nivolumab and had plans to launch it during is valid patent period, the Indian company denied the allegations, saying its product ZRC-3276 does not infringe upon the existing patents, was following the regulatory provisions and had applied for a marketing approval with the central drug regulatory agency.
by Taboola
by Taboola
Sponsored Links
Sponsored Links
Promoted Links
Promoted Links
You May Like
Simoes Filho: Unsold Furniture Liquidation 2024 (Prices May Surprise You)
Unsold Furniture | Search Ads
Learn More
Undo
Zydus argued that its product, ZRC-3276, is bio-similar to Squibb Nivolumab, but bio-similarity by itself does not substantiate infringement as it is based upon product-to-product comparison, whereas, infringement required claim to product mapping.
The generic drug maker claimed that process steps were already known from the prior art and even several techniques for the preparation of human anti-PD1 antibodies were well-known on the priority date of the suit patent.
Live Events
The post-grant opposition that was filed by its subsidiary Zydus Healthcare led to the recommendation for revocation of the suit patent by the Opposition Board, and the said recommendation clearly showed that such a method was commonly employed to produce antibodies, the Ahmedabad-based drug manufacturer claimed.
On July 18, Justice Mini Pushkarna had noted that E.R. Squibb shall suffer irreparable loss in case an interim relief was not granted. Therefore, the single judge had restrained Zydus from selling a biosimilar of Nivolumab till the main suit was decided.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Hindustan Times
6 minutes ago
- Hindustan Times
Turbhe paint factory found misusing govt-subsidised fertiliser
MUMBAI: In a statewide crackdown on the misuse of government-subsidised fertilisers, a large-scale irregularity from a Turbhe-based paint manufacturing company was recently unearthed by the quality control department. The fertilisers, exclusively meant for farmers, were allegedly used by the company after the department found their Benzene Soluble material containing neem oil, a marker of agricultural-grade need-coated urea. Turbhe paint factory found misusing govt-subsidised fertiliser The matter came to light on June 6 after a team from the quality control department carried out a surprise inspection at the company's industrial units in Dombivli and Turbhe, suspecting diversion of subsidised agricultural urea for commercial manufacturing. Around 4,690 bags of urea, each weighing 50kg and labelled 'Technical Grade Urea for Industrial Use Only', were found. To verify its contents, samples were sent to the fertiliser Control Laboratory in Nashik. 'The lab results clearly prove the urea in question was not technical grade as claimed, but subsidised neem-coated fertiliser meant exclusively for farmers. This is a serious breach of law and public trust,' stated Balaji Manchakrao Shinde, district quality control inspector, in his official complaint with the Turbhe police. After the lab results were sent to the department on June 30, the authorities issued a show cause notice on July 3 and placed a sales ban on the remaining 171.271 metric tons of urea, valued at ₹91.47 lakh, that were found on-site. The company's initial documentation was submitted on July 7 and was deemed incomplete. Additional documents submitted on July 11 reportedly failed to justify the procurement and use of stock. 'When we requested documents such as purchase bills, delivery challans, and usage logs, the company representatives reportedly failed to produce them,' said the investigating officer. 'The accused have colluded to misuse government-subsidised fertiliser for personal gain and committed fraud against the government,' Shinde further stated in his complaint. An FIR was registered on July 28 against 14 accused from the company for conspiracy, misuse of government resources, intentional deception for financial gain and other relevant sections of the Essential Commodities Act, 1955, Bharatiya Nyaya Sanhita 2023, and the Fertiliser Movement and Handling Control Order, 1973. The Turbhe police said the matter is currently under investigation.
&w=3840&q=100)
Business Standard
6 minutes ago
- Business Standard
Columbia Sportswear sues Columbia Univ over confusingly similar merchandise
For decades, T-shirts, sweatshirts and other clothing under the Columbia Sportswear brand and clothing emblazoned with the Columbia University name coexisted more or less peacefully without confusion. But now, the Portland-based outdoor retailer has sued the New York-based university over alleged trademark infringement and a breach of contract, among other charges. It claims that the university's merchandise looks too similar to what's being sold at more than 800 retail locations, including more than 150 of its branded stores, as well as its website and third-party marketplaces. In a lawsuit filed July 23 in the US District Court for the District of Oregon, Columbia Sportswear, whose roots date back to 1938, alleges that the university intentionally violated an agreement the parties signed on June 13, 2023. That agreement dictated how the university could use the word Columbia on its own apparel. As part of the pact, the university could feature Columbia on its merchandise provided that the name included a recognisable school insignia or its mascot, the word university, the name of the academic department or the founding year of the university 1754 or a combination. But Columbia Sportswear alleges the university breached the agreement a little more than a year later, with the company noticing several garments without any of the school logos being sold at the Columbia University online store. Many of the garments feature a bright blue colour that is confusingly similar to the blue colour that has long been associated with Columbia Sportswear, the suit alleged. The lawsuit offered photos of some of the Columbia University items that say only Columbia. The likelihood of deception, confusion, and mistake engendered by the university's misappropriation and misuse of the Columbia name is causing irreparable harm to the brand and goodwill symbolised by Columbia Sportswear's registered mark Columbia and the reputation for quality it embodies, the lawsuit alleged. The lawsuit comes at a time when Columbia University has been threatened with the potential loss of billions of dollars in government support. Last week, Columbia University reached a deal with the Trump administration to pay more than $220 million to the federal government to restore federal research money that was cancelled in the name of combating antisemitism on campus. Under the agreement, the Ivy League school will pay a $200 million settlement over three years, the university said. Columbia Sportswear aims to stop all sales of clothing that violate the agreement, recall any products already sold and donate any remaining merchandise to charity. Columbia Sportswear is also seeking three times the amount of actual damages determined by a jury. Neither Columbia Sportswear or Columbia University couldn't be immediately reached for comment. (Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
Time of India
15 minutes ago
- Time of India
US defense bill proposes examination of Apple display supplier
A measure added into a massive U.S. defense spending bill in recent weeks will, if passed, ask the Pentagon to determine whether one of Apple's display suppliers should be listed as a Chinese military company . Being on the list does not block companies from doing business in the U.S. but will in coming years block them from being part of the U.S. military's supply chain. Explore courses from Top Institutes in Please select course: Select a Course Category Technology Data Analytics healthcare Artificial Intelligence Digital Marketing Product Management CXO Data Science Project Management Finance Leadership MCA Design Thinking Others Degree Public Policy Management Healthcare Cybersecurity PGDM MBA others Data Science Operations Management Skills you'll gain: Duration: 12 Weeks MIT xPRO CERT-MIT XPRO Building AI Prod India Starts on undefined Get Details The bill, known as the National Defense Authorization Act , was approved in July by key committees in both houses of the U.S. Congress. The final bill, considered a "must-pass" because it funds the U.S. military, is expected to become law later in the year. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like The Most Beautiful Twins in The World! Undo When the bill was approved by the U.S. House of Representatives Armed Services Committee, a newly added amendment for the first time asked the U.S. Defense Department to consider whether BOE Technology Group Co, listed on Apple's official suppliers list, should be added to a list of firms that allegedly aid China's military. BOE and Apple did not respond to requests for comment. Live Events Craig Singleton, a China expert at the Foundation for Defense of Democracies, a Washington think-tank, said Beijing had offered billions of dollars in subsidies, tax breaks and loans to help firms such as BOE dominate global panel production. "This creates a single-source vulnerability that could be easily exploited to disrupt or degrade U.S. military operations, not to mention undermine commercial supply chains, during a conflict or period of heightened bilateral tension with Beijing," Singleton added. A study published last month by New York-based NERA Economic Consulting and commissioned by BOE's U.S. subsidiary found that the display industry, which includes major Korean players such as Samsung Electronics and LG Electronics, remains highly competitive, with no single player capable of significantly affecting global prices. "There is no credible risk of a supply chain disruption by mainland China display manufacturers," the report said.
