Focus: 2014 global medical device patent war

Focus: 2014 global medical device patent war

Release date: 2014-10-30

In the pharmaceutical industry, patents mean market exclusivity. But in the medical device industry, having proprietary technology often means jumping into the trenches. In the equipment industry, top companies sued each other for patent infringement, hoping to set obstacles in the competition and give the other party a fatal blow. Sometimes, such battles do not require many legal procedures and can easily win. But in most cases, in order to obtain a judgment that is beneficial to them, equipment companies often need to be in a protracted court debate.

This year is no exception. Medical device giants such as Johnson & Johnson, Medtronic and Boston Scientific have patent cases, some of which have been backlogged for several years. For example, Johnson & Johnson's Ethicon is evading patent infringement attacks from Irish giant Covidien, trying to maintain its market position in ultrasound surgery products. Fortunately, Johnson & Johnson achieved a temporary victory in a patent infringement lawsuit against Stryker's DePuy for hip implant technology.

However, the battles of other companies are still in progress and they are struggling to defend their products. The battle between Medtronic and Edwards Lifesciences was one of the most noteworthy battles of the year, and the two companies had different patents for transcatheter aortic valve replacement products (TAVI). The tug-of-war finally reached a global settlement, Medtronic will give the other party a $750 million one-off, and agreed to give Edward Life Science a certain percentage of sales based on Core Valve's sales.

The US Congress has also contributed to this year's patent case, which has dealt with the company's patents for products and services based on these patents only for licensing fees. In July of this year, the US House of Representatives Chamber of Commerce, Manufacturing and Trade voted to approve legislation granting the Federal Trade Commission the right to impose fines on such fraud to reduce insignificant patent litigation.

Johnson & Johnson

In the past year, Johnson & Johnson has had a loss in the patent war: it lost in the subsidiary's Ethicon surgical product lawsuit, but successfully resisted patent infringement cases of hip implants and coronary stent devices.

In June of this year, Irish medical device giant Ke Hui filed a lawsuit in the District Court of Connecticut, USA, accusing Johnson & Johnson's Ethicon Endo-Surgery's latest ultrasound surgical product, Harmonic ACE+7, infringing the company's three patents. Ke Hui also asked the court to prevent Ethicon from continuing to produce and sell Harmonic ACE+7 equipment and to compensate for patent infringement. In October, a US District Court issued a verdict in support of Ke Hui and gave a preliminary ban on Johnson & Johnson Ethicon's Harmonic ACE+7.

But Johnson & Johnson also has a victory. In August 2014, Stryker agreed to withdraw a patent infringement lawsuit against Johnson & Johnson's subsidiary DePuy regarding hip implant products. Johnson & Johnson was sued by Stryker along with Smith & Nephew, Wright Medical Group and Zimmer, claiming they infringed the latter's "acetabular cup and bearing and acetabular cup components" Proprietary technology. The other three companies, Xerox, Reiter Medical and Zimmer, also asked the US District Court to reject the case.

Of course, Johnson & Johnson's patent saliva war is far more than that. In August of this year, Medinol asked the US District Court to overturn a previous decision. The lawsuit is about a patent for a coronary stent that is no longer sold by Cordis of Johnson & Johnson. Medinol's original lawsuit was dismissed by the court earlier this year because the company filed suit more than eight years later. However, Medinol claims that in May of this year, the US Supreme Court's decision on the copyright of Petrella and Metro-Goldwyn-Mayer broke the time limit.

2. Medtronic

The tree is big, and the recent patent battle of Medtronic is undoubtedly the best proof. One of the biggest lawsuits the giant faced this year was its patent litigation against TAVI products by its old rival Edward Life Sciences.

In April of this year, a local court in Wilmington, DE, ruled that Medtronic's CoreValve infringed on the patents of Edwards Life Sciences' Sapien product and supported the latter's sales ban. This judgment is consistent with the previous two similar cases. In 2010, a court ruled that Medtronic's CoreValve infringed on Edwards Life Sciences patents and would need to pay the latter $74 million. Earlier this year, another US District Court asked Medtronic to pay $394 million to Edwards Life Sciences. These decisions have helped Edward Science gain more share in the $3 billion TAVI market.

Medtronic fought back and filed an urgent appeal with a Circuit Court of Appeal to prevent the CoreValve ban from taking effect. Medtronic cited some lower court judgments that the company's CoreValve products are safer and better treated than Edward's competitors. Medtronic also pointed out that Edward's similar products cannot be used in patients with an annulus greater than 25 mm, so if the company's CoreValve is banned, such patients will have no product available.

In May, the battle turned sharply. Medtronic and Edwards Life Sciences agreed to reach a global settlement agreement, withdraw all pending litigation, and agreed not to prosecute each other for eight years. Medtronic will pay Edwards $750 million in a lump sum and will pay sales to Edwards based on CoreValve sales until April 2022. After the announcement, Edwards Life Science's share price jumped 10%, and the settlement fee greatly improved the company's later earnings.

Despite this, Medtronic is still struggling to defend its TAVI products. In March of this year, the European Patent Office determined that the Spencer patent of Edward Sapien XT product was invalidated and the patent was revoked, allowing Medtronic to sell CoreValve products in Germany. In September, Medtronic announced that a two-year clinical study of CoreValve products was good, with data showing that only 4.4% of patients had moderate to severe paravalvular leaks after implantation of the device.

Medtronic has also won in patent battles for other products, including years of cardiac resynchronization therapy equipment (CRT). In January, the US Supreme Court unanimously decided to overturn a decision of the lower court, saying that Medtronic did not need to prove that its products did not infringe two related patents of Mirowski Family Ventures.

Medtronic has obtained a patent license from Mirowski, but the company said that the company's new CRT products did not infringe Mirowski's patents, so there is no need to pay an authorization fee. The Supreme Court unanimously decided to support Medtronic with a 9-0 vote, saying that Medtronic did not need to prove that it did not infringe the patent, although there was a licensing agreement between the patent holder and the product manufacturer. In October, the Supreme Court rejected Mirowski's appeal against the above patent.

3. Boston Science

Medtronic is not the only company that pulls back and forth in patent cases. In January of this year, the Boston company failed in a patent battle with Vascular Solutions, and a US federal appeals court reiterated the sales ban on the company Guidezilla.

The case goes back to 2013, when Vascular claimed that a former employee of the company, Sam Rasmussen, senior product manager, also held the same position at Boston Science to help promote the Guidezilla catheter. In July of that year, Vascular filed a patent infringement appeal and demanded that Boston Scientific be banned from selling the product in the US and Europe.

Boston Scientific requested that the judgment not be executed temporarily, pending its appeal to the US Federal Circuit. The court rejected the request to temporarily refrain from executing the sales ban, but accepted the request to temporarily refrain from patent infringement.

In September 2014, Boston Science received more bad news. The Montgomery County Circuit Court of Maryland ruled that Boston Science infringed Mirowski's pacemaker patent and demanded that the company pay $309 million in licensing fees and other fees.

The case stems from an earlier case: Mirowski accused Boston Science and its Guidant of a secret agreement with St. Jude Medical, asking Boston Scientific to pay $570 million in licensing fees and damages. . Boston Science and Mirowski have filed a lawsuit against St. Jude for infringing their patents and received $313 million in damages. However, it was discovered that Boston Science had made a false certificate, so the compensation was also squandered.

The court finally overturned the original verdict and demanded that Boston Scientific compensated $377 million and claimed that one of the patents was invalid, prompting the company to refuse to pay Mirowski an authorization fee. In September 2013, Boston Science filed an appeal with the federal court, but in 2014 the court sent the case back to the Maryland District Court for further investigation. Obviously, Boston Science does not agree with the court's recent judgment, hoping to make a comeback in subsequent trial proceedings or appeals.

4. Baxter

Some patent wars are hard and protracted, such as Baxter's recent legal dispute with Fresenius Medical Care. In May of this year, the US Supreme Court rejected the appeal filed by Baxter, which sued the German company Fresenius for infringing its patent on kidney dialysis equipment in 2003. In 2012, Baxter won the victory, when the court ruled that Fresenius compensated him for $24 million. But a year later, the US Patent and Trademark Office revoked Baxter's patent and prompted the federal court to withdraw the verdict.

Baxter decided to appeal and asked the US Supreme Court to decide whether to comply with the Patent and Trademark Office during the patent dispute. Some instrument giants, such as Medtronic, encouraged the Supreme Court to accept the case. But in the end, it was proved that Baxter was in vain, and the US Federal Circuit continued to maintain the original judgment.

5. Philips

For Philips, this year is another busy year. This year the company completed its restructuring and added a new product line. But in October, the company was still plagued by patent infringement cases and lost in the battle with Masimo, which required compensation of $466 million.

After a two-week trial, a jury in Wilmington, Delaware, determined that Philips' fingertip pulse oximeter violated Masimo's two patents. Philips believes these patents are invalid because they are not properly documented, and the technology is obvious. However, the jury of eight people did not agree and asked Philips to pay compensation. Philips is quite dissatisfied with this decision and said it will file an appeal.

This case dates back to 2009. At the time, Masimo sued Philips' branch in Andover, MA, alleging that the latter's imported oximeter infringed the company's two US patents and claimed compensation of $650 million. Philips countered, claiming that Masimo's products infringed on one of its patents and demanded that the other party pay $169 million in damages.

6. Diagnostic companies: Illumina, Ariosa and Sequenom

In the increasingly competitive prenatal diagnosis market, maintaining the position of the leader is a skill. A recent market research report predicts that the industry is expected to grow to $3.6 billion by 2019, and the demand for prenatal diagnosis will triple in the next six years. As a result, heavyweight companies in the diagnostic industry, such as Illumina, Sequenom, and Ariosa, struggled to defend their cake.

In April of this year, Illumina sued Ariosa Diagnostics for infringing its patent for non-invasive prenatal testing technology. Illumina's subsidiary, Verinata Health, filed a lawsuit in the US District Court for Northern California, indicting Ariosa's Harmony prenatal testing for a pre-infringement of one of its patents. Harmony's digital analysis of specific regions of DNA allows for more effective screening of Down's syndrome and other embryonic developmental abnormalities. Illumina's similar prenatal testing products are based on the same method to detect chromosomal aberrations.

This is not the first time the two companies have played against each other. Illumina had previously sued Ariosa for infringing on two patents in the Northern California District Court, and the court ruled that Illumina was supported.

But this year Illumina did not win all the battles. In April, the US Patent and Trademark Office ruled that it supported Sequenom's four patents on DNA sequencing. Both Sequenom and Illumina use this technology for prenatal diagnosis and screening for chromosomal abnormalities such as Down's syndrome. But Sequenom said the patents were from the Chinese University of Hong Kong and it has been licensed to replace Illumina/Verinata Health's technology. Sequenom plans to use the ruling of the Patent Office to support its ongoing patent infringement lawsuit.

Source: Bio-Exploration

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