Health-related Device Sector Patent Litigation Probably To Rise?

Can patent lawsuits in the healthcare device sector be forecast? Recent research recommend that particular functions of patent applications themselves have a tendency to correlate using a higher likelihood that some patents will finish up in court. Innovation is in the heart with the medical device market. As with several industries, should you be not consistently operating to bring new products and technology for the market, there is certainly a great possibility you are going to not survive. Firms which are thriving, and that continue to survive, invest millions of dollars in study and development each year to create new or improved items. Companies that are productive, and that continue to survive, invest millions of dollars in analysis and improvement every year to make new or superior goods. Not only are these providers investing in the development of new technologies, they are also investing in the protection of their innovations by means of the patent system. In reality, for fiscal year 2006 the United states of america Patent and Trademark Workplace (USPTO) reported a record of greater than 440,000 patent applications filed, more than double the amount of applications filed ten years ago.

Needless to say, using the record quantity of patent applications becoming filed, and the big variety of patents issued annually, it would be logical to expect that the amount of patent connected lawsuits would also raise. Current statistics are likely to substantiate this logic as much more and more patent owners are turning for 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 United states improved from about 1700 to greater than 2700, a 58% improve in just ten years.

Nonetheless, the possibilities of a lawsuit stay low on a probability basis. Whilst the number of patent suits filed has substantially increased over the previous ten years, it is actually fascinating to note that recent research estimate that on typical only roughly 1% of U.S. patents will probably be litigated. On the other hand, these studies also note a number of characteristics that usually predict no matter if a patent is likely to become litigated. These qualities include things like: (1) the amount of claims describing the invention; (2) the quantity and sorts of prior art citations; and (three) the "crowdedness" of your technological field. Every characteristic is described beneath, which includes how the characteristic relates to the medical device industry.

Number of Claims

A patent have to involve at the very least one claim that describes with particularity what the applicant regards as his invention. The claims of a patent are generally analogized to the property description within a deed to actual estate; both define the boundaries and extent from the home. Due to the fact the claims set the boundaries in the invention, the applicant has an incentive to define the invention via several broad claims. Even so, in some technological areas exactly where there is certainly a vast volume of prior art, the applicant might have to define the invention via numerous narrow claims to avoid the invalidating prior art.

So how does the amount of claims appearing inside a patent correlate for 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. In actual fact, 1 study determined that litigated patents had nearly 20 claims on average, in comparison with only 13 claims for non-litigated patents. Researchers cite a couple of factors that assist explain their findings: the perceived worth on the patent and the crowdedness of the field of technologies protected by the patent.

Patent claims are quickly the most significant portion of your patent. As a result, it really should come as no surprise that claims are high priced to draft and prosecute. Paying additional income to get a larger variety of claims suggests that the patentee believes a patent with a lot more claims is likely to become additional valuable. Nevertheless, some researchers conclude that the cause litigated patents have a lot more claims than non-litigated patents is that the patentee knew the patent could be important, anticipated the prospect of litigation, and as a result drafted far more claims to assist the patent stand up in litigation.

The field of technology protected by the patent may also explain why patents having a big number of claims are more most likely to become litigated. In a crowded technological field there will likely be additional competitors that are creating comparable products. Consequently, it seems to create sense that patents obtaining a sizable quantity of claims in these crowded fields are additional likely to conflict with competitors.

As a way to get a basic concept of how the number of claims relate for the healthcare device business, 50 from the most not too long ago issued patents for endoscopes have been analyzed. The results show an average of 17 claims per patent. This quantity falls someplace inside the middle with the claim numbers for litigated and non-litigated patents cited above. It would appear more probably, based on the empirical studies, that these patents will have a larger likelihood of getting litigated. Moreover to possessing a larger opportunity of being litigated, these results may perhaps indicate that the crowded health-related device market values their patents and anticipates litigation, together with the end result getting patents having a larger quantity of claims.

Prior Art Citations

Below U.S. patent law, the inventor and just about every other particular person who is substantively involved within the preparation and prosecution of an application has a duty to disclose all information and facts identified to be material towards the patentability of the invention. To discharge this duty, patent applicants commonly file what's known as an information disclosure statement, generally known as an IDS. Within the IDS, the applicant lists all of the U.S. patents, foreign patents, and non-patent literature that they're aware of and which is relevant to the invention. Also, a USPTO patent examiner conducts a search with the prior art and may perhaps cite prior art against the applicant that was not previously disclosed in an IDS.

When a patent is granted, the prior art citations made of record during prosecution prior to the USPTO are listed in the patent. Researchers have made use of this citation info to conclude that the amount of prior art citations appearing inside a patent is actually a excellent predictor of no matter if a patent is most likely to become litigated. One study located that litigated patents on typical cited 14.2 U.S. patents, while non-litigated patents cited only 8.six U.S. patents. The study also showed that litigated patents are additional likely to become cited as prior art by other issued patents, and that litigated patents involve far more self-citations, that is definitely, citations to other patents owned by the identical assignee.

How do patents in the health-related device industry compare? Once more, employing the smaller sample of endoscope patents noted above as a proxy for the healthcare device business, the typical quantity of U.S. patents cited was roughly 37. This is significantly more than the study's discovering of 14.two U.S. patents. Does this result imply that healthcare device patents are much more likely to become litigated? Not necessarily. The study notes that two particular categories of prior art citations (citations received and self-citations) are more considerable predictors of litigation. Although the study will not cite an typical for self-citations, it does find that litigated patents received an typical of 12.two citations from other patents, when compared with only 4.1 citations received on average for non-litigated patents. The average number of self-citations and citations received for the endoscope patents have been only 1.74 and 0.34, respectively. Nonetheless, as the study authors recommend, the large quantity of prior art citations located within this small sample set may well indicate that the applicant anticipated the prospect of litigation and took reasonable methods to make the patent as robust as possible. Similarly, the substantial quantity of citations may well be as a consequence of attempts to get around prior art in the crowded and ultra-competitive health-related device field.

Crowded Fields

Each on the previously discussed characteristics of litigated patents have talked about the concept of crowded technological fields. It might be obvious, however the term "crowded field" refers to an location of technology where there are lots of competitors and numerous issued patents that define the technologies. As a result, for patents that happen to be issued in a crowded field, there is certainly by definition far more competitors and hence a lot more opportunity that the patent are going to be litigated.

Below the existing U.S. patent classification program, which includes more than 430 classes, there appear to become eight classes which can be straight related towards the medical device market. Within these eight classes, you will find over 2300 subclasses in which a healthcare device patent may well be classified. The massive number of classes and subclasses seems to recommend that the medical device field, as a entire, would likely be deemed a crowded field. Furthermore, most health-related device manufacturers are sophisticated and have a greater understanding with the worth of their intellectual property. Given that innovation is definitely the lifeblood in the market, it makes sense that the business protects a lot more of their inventions, which leads to additional health-related device patents being issued. Thus, a lot more patents within the technological field bring about a greater likelihood of patent litigation within that field.

At least 1 study indicates that patents on healthcare devices are drastically extra likely to be litigated than the average of all patents. The study gives an explanation for why healthcare device patents are far more probably to become litigated by noting that the healthcare device industry, as a complete, view patents as precious assets.

Conclusion

Patent litigation is, in actual fact, around the rise. The empirical studies performed more than current years have identified a few of the characteristics that are sturdy predictors of whether or not a patent is most likely to become litigated. A sizable number of claims and prior art citations could improve a patent's likelihood to finish up before a court. A crowded technological field may well also cause a larger risk of patent litigation.

By virtue of becoming in such a crowded field, the health-related device industry will probably stay quite litigious. Certainly, this race to the courthouse is indicative in the value that the sector as a whole 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 within 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, just before you proceed.

David Dawsey is an experienced intellectual home attorney specializing in the prosecution and litigation of domestic and foreign patents, trademarks, and copyright. David is 1 with the few patent attorneys that is definitely also a registered Professional Engineer. In addition to his legal and engineering education, David has also earned an MBA degree. You may well reach David via the firm website Gallagher and Dawsey Co. LPA is often a unique intellectual house law firm whose practice consists of 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 house 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 around the world from our Midwest offices. Our patent and trademark law firm has offices in Columbus, Dayton, and Cincinnati, Ohio.

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