Health-related Device Sector Patent Litigation Most Likely To Rise?

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Trenutačna izmjena od 07:48, 16. rujna 2013.

Can patent lawsuits inside the medical device sector be forecast? Recent studies recommend that certain attributes of patent applications themselves have a tendency to correlate using a larger likelihood that some patents will finish up in court. Innovation is at the heart from the health-related device business. As with several industries, in case you are not consistently operating to bring new goods and technology to the market, there's a very good opportunity you can not survive. Providers that happen to be profitable, and that continue to survive, invest millions of dollars in research and improvement each year to create new or superior merchandise. Organizations which might be profitable, and that continue to survive, invest millions of dollars in analysis and development each year to create new or far better products. Not just are these firms investing inside the improvement of new technology, they're also investing inside the protection of their innovations through the patent program. In reality, for fiscal year 2006 the United states of america Patent and Trademark Office (USPTO) reported a record of more than 440,000 patent applications filed, more than double the amount of applications filed ten years ago.

Needless to say, together with the record number of patent applications getting filed, along with the large number of patents issued every year, it would be logical to expect that the amount of patent connected lawsuits would also increase. Current statistics often substantiate this logic as much more and more patent owners are turning towards the courts to assist safeguard their important intellectual property assets. As an example, from 1995 to 2005, the amount of patent lawsuits filed inside the Usa elevated from approximately 1700 to more than 2700, a 58% enhance in just ten years.

Nevertheless, the probabilities of a lawsuit remain low on a probability basis. Though the amount of patent suits filed has substantially enhanced over the past ten years, it's exciting to note that current research estimate that on typical only roughly 1% of U.S. patents might be litigated. Nonetheless, these research also note many different traits that often predict regardless of whether a patent is most likely to become litigated. These traits contain: (1) the number of claims describing the invention; (2) the number and kinds of prior art citations; and (three) the "crowdedness" of the technological field. Each and every characteristic is described beneath, like how the characteristic relates towards the health-related device market.

Variety of Claims

A patent ought to involve at least one particular claim that describes with particularity what the applicant regards as his invention. The claims of a patent are typically analogized for the property description in a deed to true estate; each define the boundaries and extent of the home. Given that the claims set the boundaries of the invention, the applicant has an incentive to define the invention through many broad claims. Nevertheless, in some technological locations exactly where there's a vast volume of prior art, the applicant might have to define the invention through quite a few narrow claims to avoid the invalidating prior art.

So how does the number of claims appearing inside a patent correlate to the likelihood that the patent will someday be litigated? Empirical studies have located that litigated patents include a bigger quantity of claims as opposed to non-litigated patents. Actually, one study determined that litigated patents had almost 20 claims on average, in comparison with only 13 claims for non-litigated patents. Researchers cite a couple of motives that assistance clarify their findings: the perceived worth of your patent and the crowdedness of your field of technologies protected by the patent.

Patent claims are simply essentially the most important portion in the patent. Therefore, it should come as no surprise that claims are high priced to draft and prosecute. Paying extra revenue to get a larger variety of claims suggests that the patentee believes a patent with a lot more claims is probably to be a lot more beneficial. On the other hand, some researchers conclude that the cause litigated patents have much more claims than non-litigated patents is the fact that the patentee knew the patent will be useful, anticipated the prospect of litigation, and consequently drafted far more claims to assist the patent stand up in litigation.

The field of technology protected by the patent may well also explain why patents with a huge quantity of claims are a lot more most likely to be litigated. In a crowded technological field there will probably be extra competitors who're building related goods. Therefore, it appears to create sense that patents getting a big number of claims in these crowded fields are a lot more probably to conflict with competitors.

In an effort to get a general thought of how the amount of claims relate towards the healthcare device sector, 50 from the most recently issued patents for endoscopes were analyzed. The results show an typical of 17 claims per patent. This quantity falls somewhere inside the middle in the claim numbers for litigated and non-litigated patents cited above. It would appear extra most likely, as outlined by the empirical research, that these patents will have a higher chance of becoming litigated. Also to obtaining a greater chance of becoming litigated, these outcomes could indicate that the crowded medical device market values their patents and anticipates litigation, with all the finish outcome being patents having a larger number of claims.

Prior Art Citations

Under U.S. patent law, the inventor and each other particular person who's substantively involved in the preparation and prosecution of an application has a duty to disclose all facts recognized to be material towards the patentability from the invention. To discharge this duty, patent applicants ordinarily file what exactly is generally known as an data disclosure statement, typically referred to as an IDS. In the IDS, the applicant lists all of the U.S. patents, foreign patents, and non-patent literature that they are conscious of and that's relevant for the invention. Also, a USPTO patent examiner conducts a search of the prior art and may possibly cite prior art against the applicant that was not previously disclosed in an IDS.

When a patent is granted, the prior art citations produced of record in the course of prosecution prior to the USPTO are listed in the patent. Researchers have applied this citation information and facts to conclude that the number of prior art citations appearing within a patent is a fantastic predictor of irrespective of whether a patent is probably to be litigated. 1 study identified that litigated patents on typical cited 14.two U.S. patents, when non-litigated patents cited only eight.six U.S. patents. The study also showed that litigated patents are additional probably to be cited as prior art by other issued patents, and that litigated patents consist of a lot more self-citations, that's, citations to other patents owned by the same assignee.

How do patents from the healthcare device business examine? Again, working with the compact sample of endoscope patents noted above as a proxy for the healthcare device business, the average number of U.S. patents cited was approximately 37. This really is significantly greater than the study's finding of 14.two U.S. patents. Does this outcome imply that healthcare device patents are more likely to become litigated? Not necessarily. The study notes that two distinct categories of prior art citations (citations received and self-citations) are much more considerable predictors of litigation. Despite the fact that the study doesn't cite an typical for self-citations, it does find that litigated patents received an average of 12.two citations from other patents, in comparison to only 4.1 citations received on average for non-litigated patents. The typical variety of self-citations and citations received for the endoscope patents had been only 1.74 and 0.34, respectively. Nonetheless, because the study authors suggest, the large number of prior art citations located in this small sample set may possibly indicate that the applicant anticipated the prospect of litigation and took reasonable steps to create the patent as strong as you possibly can. Similarly, the large quantity of citations could be as a consequence of attempts to get about prior art in the crowded and ultra-competitive healthcare device field.

Crowded Fields

Both with the previously discussed characteristics of litigated patents have described the idea of crowded technological fields. It may be apparent, but the term "crowded field" refers to an location of technologies exactly where there are numerous competitors and several issued patents that define the technologies. Thus, for patents which are issued within a crowded field, there is by definition additional competitors and hence much more chance that the patent are going to be litigated.

Beneath the existing U.S. patent classification system, which incorporates more than 430 classes, there appear to be eight classes which are directly associated towards the healthcare device business. Within these eight classes, you'll find over 2300 subclasses in which a medical device patent may possibly be classified. The large variety of classes and subclasses seems to suggest that the healthcare device field, as a complete, would likely be thought of a crowded field. Moreover, most healthcare device companies are sophisticated and have a far better understanding of your value of their intellectual house. Considering the fact that innovation could be the lifeblood with the sector, it tends to make sense that the business protects far more of their inventions, which results in more medical device patents being issued. Therefore, more patents in the technological field bring about a larger likelihood of patent litigation inside that field.

A minimum of a single study indicates that patents on healthcare devices are significantly extra most likely to become litigated than the average of all patents. The study gives an explanation for why health-related device patents are extra likely to become litigated by noting that the healthcare device sector, as a whole, view patents as important assets.

Conclusion

Patent litigation is, in fact, on the rise. The empirical research carried out more than current years have identified a number of the qualities which can be strong predictors of regardless of whether a patent is probably to become litigated. A large quantity of claims and prior art citations may perhaps increase a patent's likelihood to end up before a court. A crowded technological field may perhaps also bring about a larger risk of patent litigation.

By virtue of becoming in such a crowded field, the healthcare device industry will most likely remain quite litigious. Certainly, this race to the courthouse is indicative of your value that the market as a entire places on its innovations, and hence its survival.

© 2007, Gallagher & Dawsey Co., LPA April 2007

DISCLAIMER

We hope you understand that we cannot possibly give accurate legal advice to all inventors inside a brief article on intellectual house issues. Accordingly, nothing inside the above is intended as specific legal advice to any individual. Such legal advice can only be given by a qualified practitioner after a careful review of all the individual facts. We urge you to consult us, or another licensed professional, ahead of you proceed.

David Dawsey is an experienced intellectual house attorney specializing in the prosecution and litigation of domestic and foreign patents, trademarks, and copyright. David is one in the few patent attorneys that is also a registered Professional Engineer. Also to his legal and engineering education, David has also earned an MBA degree. You may reach David via the firm website
Gallagher and Dawsey Co. LPA is a unique intellectual house law firm whose practice contains intellectual property counseling and services to businesses and individual inventors, as well as other law firms, regarding patent, trademark, copyright, and trade secret issues.

Our experienced patent attorneys and trademark attorneys provide various intellectual property legal services such as patent searches, patent applications, trademark searches, trademark applications, copyright applications, infringement advice/opinions, and infringement litigation.

The U.S. patent and trademark attorneys of Gallagher & Dawsey Co. LPA serve clients about the world from our Midwest offices. Our patent and trademark law firm has offices in Columbus, Dayton, and Cincinnati, Ohio.


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