Federal judge rules for Medtronic, Abbott, Boston Scientific over J&J in DES lawsuit | Legal News

January 23, 2012 By MassDevice staff Leave a Comment

A trio of med-tech titans logged a win against Johnson & Johnson (NYSE:JNJ) in a long-running battle over drug-eluting coronary stent patents.

Judge Joel Pisano of the U.S. District Court for New Jersey last week dismissed J&J’s claims against Boston Scientific (NYSE:BSX), Abbott Laboratories (NYSE:ABT) and Medtronic (NYSE:MDT), finding that the patents in question hadn’t been adequately described and were thus invalid.

J&J’s Cypher stent, the first drug-eluting stent to hit the U.S. market, is coated in sirolimus (also called rapamycin and rapamune), the patents for which are held by Pfizer Inc.’s (NYSE:PFE) Wyeth subsidiary.

J&J and Wyeth claimed that Abbott’s Xience V DES and Medtronic’s Endeavor stent were using related drugs without permission. The drug coatings help prevent scarring in the blood vessels that can occur after angioplasty procedures, keeping the vessels from re-narrowing.

Boston Scientific got pulled into the lawsuit because its Promus stent is a private-label version of the Xience V, licensed from Abbott. The Xience V and Promus stents are coated in everolimus.

Medtronic’s Endeavor is coated in zotarolimus. Both everolimus and zotarolimus are made by modifying the sirolimus molecule at a single location.

J&J and Wyeth argued that the drug patent covers a family of analogs to sirolimus, while the trio of defendants argued that the patent only applied to the original configuration of the drug and not its variations.

Pisano ultimately invalidated Wyeth’s patents on the grounds that they didn’t meet description requirements, court documents show, closing another chapter in the ongoing battle between the stent warriors.

J&J plans to appeal the decision, Cordis spokeswoman Sandy Pound confirmed with MassDevice.

In January of last year, Judge Susan Robinson of the U.S. District Court for Delaware ruled in favor of Boston Scientific’s claim that J&J’s sirolimus patent doesn’t apply to everolimus.

Robinson also found that one of the patents wasn’t specific enough, in describing exactly which drug formulations it covered, to be valid, because the patent didn’t include a written description of at least 1 example of such a formulation, according to court documents.

Boston Scientific logged another win against J&J later that year, when a federal appeals court upheld Robinson’s ruling in June.

Cordis first joined forces with Wyeth in Sept. 2009, filing a lawsuit against Abbott and Boston Scientific the day after the pharma giant won its sirolimus patent.

Boston Scientific was quick to tout its win with a press release issued today.

"We are pleased with the Court’s finding that both of these Johnson & Johnson patents are invalid," Tim Pratt, executive VP, chief administrative officer and general counsel for Boston Scientific, said in a press release. "Boston Scientific will continue to vigorously defend against any claims of infringement."

Johnson & Johnson, Medtronic and Abbott did not immediately reply to requests for comment.

German dental products maker challenges Align’s European patents
German dental products maker Ortho Caps GmbH is challenging Align Technology’s European patents in response to Align’s patent infringement lawsuit.

Ortho sent a personal letter to Align CEO Thomas Prescott to inform him of its intent to challenge the patents, which are still in a period allocated for filing oppositions with the European Patent Office, according to Ortho’s press release.

Not to be ruffled, Align issued its own press release later the same day, expressing its intent to move forward with the lawsuit, which alleges that Ortho infringes on 5 patents pertaining to orthodontic aligners.

"We are not surprised by the allegations in the Ortho Caps’ press release," Align VP of legal affairs and general counsel Roger George said in prepared remarks. "When parties cannot defend against claims of patent infringement, they often resort to challenging the validity of the patents at issue. To date, Ortho Caps has not denied infringement of Align’s patents." Read more

Marine Polymer asks for en banc hearing in HemCon trial
Marine Polymer Technologies won a motion for an en banc hearing of its case against HemCon Medical Technologies for alleged infringement of silver-coated wound dressing patents.

The en banc hearing entails a full panel of 11 active Federal Circuit Judges as well as Senior Judge Gajarsa rehearing the case, according to a press release. The panel of judges decided not to request additional briefing or oral arguments, and will proceed based on briefs and arguments already submitted to the court.

In Sept. 2011 HemCon Inc. won its appeal of a U.S. District Court for New Hampshire decision that it infringed a Marine Polymer Technologies Inc. patent for silver-coated wound dressings.

The decision vacated a $29.4 million judgment against HemCon and a ruling that barred it from making the allegedly infringing products (the appeals court later stayed the verdict pending the outcome of HemCon’s appeal).

Sterigenics sues Ga. county to keep EtO plant open after emergency
Sterigenics has sued the government of a Georgia county to force a permanent reopening of the company’s Atlanta medtech sterilization plant. Officials of Cobb County, Ga. recently gave Sterigenics permission to reopen the plant for 21 days to sterilize personal protective equipment for healthcare workers treating COVID-19 patients. Sterigenics had told county officials it has… […]
Medline to reprocess N95 respirators to fight COVID-19 spread
Medline Industries has agreed to reprocess 100,000 N95 respirators and other face masks per day in its facilities beginning as early as this week. The process that Medline plans to use is close to receiving FDA emergency use approval (EUA) and will supplement the more than 38 million masks the company has distributed on average… […]
How FDA is changing medtech regulation under the coronavirus
The FDA’s Center for Devices & Radiological Health (CDRH) has issued a letter to the medtech industry that outlined the steps it is taking to address the impact of the COVID-19 pandemic. The administration has already expressed its openness to issuing emergency use authorization (EUA) for ventilator devices amid a shortage in the U.S. Last… […]
More dangerous than the virus? Converting manual resuscitators to ventilators
The shortage of respiratory ventilators in the face of the COVID-19 pandemic has led to numerous efforts aimed at turning hand-operated plastic pouches called bag-valve resuscitators into makeshift ventilators. The resuscitators, also called Ambu bags, are generally on-hand in large quantities. They are designed to be operated by hand, by trained technicians, to inflate patient… […]
Could respirator decontamination solve shortage problems?
The FDA has issued an emergency use authorization for the Battelle Critical Care Decontamination System, which can decontaminate tens of thousands of respirator masks per day so that health personnel can reuse them. The Columbus, Ohio-based nonprofit tech development company announced on March 28 that it began rapid manufacturing of its system to decontaminate N95 respirator masks and other… […]
Medline reopens Illinois medtech sterilization plant
Medline Industries resumed sterilization operations at its Waukegan, Ill., plant on Friday, following state certification of the company’s $10 million in emission-control upgrades, the company announced. The Waukegan plant reopening follows the decision this week by officials in Cobb County, Ga., to allow an Atlanta Sterigenics EtO plant to reopen for 21 days to sterilize… […]
DeviceTalks Weekly Podcast: Deconstructing medtech’s alphabet soup – DPA, MDR, FDA are all in the news
In this week’s DeviceTalks Weekly, we’ll examine how governmental effort, both foreign and domestic, are hitting the medtech industry. Our guests include Tracy Eberly, CEO of Fang Consulting, a regulatory advisory group. Eberly will update listeners on what pushing back the MDR deadline could mean for medtech companies and why some companies may be less than… […]
AdvaMed: Invoking Defense Production Act could hinder U.S. medtech imports
Forcing manufacturers to repurpose their production lines to make equipment to fight the coronavirus epidemic might actually hurt the U.S. supply of those items, the head of medtech trade group AdvaMed said today. AdvaMed officials have talked with U.S. secretary of Health and Human Services Alex Azar and FDA commissioner Dr. Stephen Hahn about medtech… […]
March 2020 Issue: Is software key to medical 3D printing innovation?
What’s the word on ethylene oxide? The coronavirus pandemic has pushed a lot of news out of people’s minds, but medtech has other big issues to deal with. For instance, 8 months have passed since the FDA issued a public challenge for alternatives to ethylene oxide (EtO) as a sterilant for medical devices. As I… […]
GE Healthcare quadruples ventilator production at Wisconsin plant
General Electric Healthcare (NYSE:GE) this week announced that it is doubling its production capacity for ventilators and expanding its Madison, Wisconsin, production line to 24-hour operation. In a report on GE’s website, the company shared that it has doubled its capacity of ventilator production with plans to double it again by the end of the second… […]
FDA issues FAQ on 3D-printed equipment against coronavirus
Intrepid 3D printing companies and individuals who want to print masks, gowns and other personal protective equipment (PPE) to fight the coronavirus pandemic might want to take a look at the FDA’s new frequently asked questions page on the topic. While it says it welcomes coronavirus-fighting efforts, the agency said that 3D-printed masks are unlikely… […]