Can patent lawsuits within the medical gadget trade be forecast? Current research counsel that sure options of patent purposes themselves are inclined to correlate with a better likelihood that some patents will find yourself in courtroom. Innovation is on the coronary heart of the medical gadget trade. As with many industries, in case you are not consistently working to deliver new merchandise and expertise to the market, there’s a good likelihood you’ll not survive. Corporations which can be profitable, and that proceed to outlive, make investments tens of millions of {dollars} in analysis and growth yearly to create new or higher merchandise. Corporations which can be profitable, and that proceed to outlive, make investments tens of millions of {dollars} in analysis and growth yearly to create new or higher merchandise. Not solely are these corporations investing within the growth of recent expertise, they’re additionally investing within the safety of their improvements by the patent system. In truth, for fiscal 12 months 2006 the US Patent and Trademark Workplace (USPTO) reported a document of greater than 440,000 patent purposes filed, greater than double the variety of purposes filed ten years in the past.
After all, with the document variety of patent purposes being filed, and the massive variety of patents issued every year, it will be logical to anticipate that the variety of patent associated lawsuits would additionally enhance. Current statistics are inclined to substantiate this logic as increasingly more patent house owners are turning to the courts to assist defend their invaluable mental property belongings. For instance, from 1995 to 2005, the variety of patent lawsuits filed in the US elevated from roughly 1700 to greater than 2700, a 58% enhance in simply 10 years.
Nonetheless, the possibilities of a lawsuit stay low on a chance foundation. Whereas the variety of patent fits filed has considerably elevated over the previous ten years, it’s attention-grabbing to notice that current research estimate that on common solely roughly 1% of U.S. patents might be litigated. Nonetheless, these research additionally notice quite a lot of traits that are inclined to predict whether or not a patent is more likely to be litigated. These traits embrace: (1) the variety of claims describing the invention; (2) the quantity and forms of prior artwork citations; and (3) the “crowdedness” of the technological area. Every attribute is described under, together with how the attribute pertains to the medical gadget trade.
Variety of Claims
A patent should embrace no less than one declare that describes with particularity what the applicant regards as his invention. The claims of a patent are sometimes analogized to the property description in a deed to actual property; each outline the boundaries and extent of the property. For the reason that claims set the boundaries of the invention, the applicant has an incentive to outline the invention by plenty of broad claims. Nonetheless, in some technological areas the place there’s a huge quantity of prior artwork, the applicant might should outline the invention by plenty of slim claims to keep away from the invalidating prior artwork.
So how does the variety of claims showing in a patent correlate to the chance that the patent will sometime be litigated? Empirical research have discovered that litigated patents embrace a bigger variety of claims versus non-litigated patents. In truth, one research decided that litigated patents had practically 20 claims on common, in comparison with solely 13 claims for non-litigated patents. Researchers cite a few causes that assist clarify their findings: the perceived worth of the patent and the crowdedness of the sector of expertise protected by the patent.
Patent claims are simply a very powerful a part of the patent. Subsequently, it ought to come as no shock that claims are costly to draft and prosecute. Paying extra money for a bigger variety of claims means that the patentee believes a patent with extra claims is more likely to be extra invaluable. Nonetheless, some researchers conclude that the explanation litigated patents have extra claims than non-litigated patents is that the patentee knew the patent can be invaluable, anticipated the prospect of litigation, and consequently drafted extra claims to assist the patent rise up in litigation.
The sector of expertise protected by the patent can also clarify why patents with a lot of claims usually tend to be litigated. In a crowded technological area there’ll probably be extra rivals who’re growing comparable merchandise. Subsequently, it appears to make sense that patents having a lot of claims in these crowded fields usually tend to battle with rivals.
To be able to get a normal concept of how the variety of claims relate to the medical gadget trade, 50 of essentially the most just lately issued patents for endoscopes have been analyzed. The outcomes present a median of 17 claims per patent. This quantity falls someplace in the course of the declare numbers for litigated and non-litigated patents cited above. It will appear extra probably, in keeping with the empirical research, that these patents may have a better likelihood of being litigated. Along with having a better likelihood of being litigated, these outcomes might point out that the crowded medical gadget trade values their patents and anticipates litigation, with the top consequence being patents having a bigger variety of claims.
Prior Artwork Citations
Beneath U.S. patent regulation, the inventor and each different one who is substantively concerned within the preparation and prosecution of an software has an obligation to reveal all info recognized to be materials to the patentability of the invention. To discharge this obligation, patent candidates usually file what is named an info disclosure assertion, generally known as an IDS. Within the IDS, the applicant lists all the U.S. patents, international patents, and non-patent literature that they’re conscious of and that’s related to the invention. Additionally, a USPTO patent examiner conducts a search of the prior artwork and should cite prior artwork towards the applicant that was not beforehand disclosed in an IDS.
When a patent is granted, the prior artwork citations fabricated from document throughout prosecution earlier than the USPTO are listed within the patent. Researchers have used this quotation info to conclude that the variety of prior artwork citations showing in a patent is an effective predictor of whether or not a patent is more likely to be litigated. One research discovered that litigated patents on common cited 14.2 U.S. patents, whereas non-litigated patents cited solely 8.6 U.S. patents. The research additionally confirmed that litigated patents usually tend to be cited as prior artwork by different issued patents, and that litigated patents embrace extra self-citations, that’s, citations to different patents owned by the identical assignee.
How do patents from the medical gadget trade examine? Once more, utilizing the small pattern of endoscope patents famous above as a proxy for the medical gadget trade, the common variety of U.S. patents cited was roughly 37. That is considerably greater than the research’s discovering of 14.2 U.S. patents. Does this consequence imply that medical gadget patents usually tend to be litigated? Not essentially. The research notes that two explicit classes of prior artwork citations (citations acquired and self-citations) are extra vital predictors of litigation. Though the research doesn’t cite a median for self-citations, it does discover that litigated patents acquired a median of 12.2 citations from different patents, in comparison with solely 4.1 citations acquired on common for non-litigated patents. The common variety of self-citations and citations acquired for the endoscope patents have been just one.74 and 0.34, respectively. However, because the research authors counsel, the massive variety of prior artwork citations discovered on this small pattern set might point out that the applicant anticipated the prospect of litigation and took affordable steps to make the patent as robust as attainable. Equally, the massive variety of citations could also be as a result of makes an attempt to get round prior artwork within the crowded and ultra-competitive medical gadget area litigation perth.
Crowded Fields
Each of the beforehand mentioned traits of litigated patents have talked about the concept of crowded technological fields. It could be apparent, however the time period “crowded area” refers to an space of expertise the place there are numerous rivals and lots of issued patents that outline the expertise. Thus, for patents which can be issued in a crowded area, there may be by definition extra competitors and therefore extra alternative that the patent might be litigated.
Beneath the present U.S. patent classification system, which incorporates over 430 courses, there look like eight courses which can be immediately associated to the medical gadget trade. Inside these eight courses, there are over 2300 subclasses during which a medical gadget patent could also be categorised. The big variety of courses and subclasses appears to counsel that the medical gadget area, as a complete, would probably be thought of a crowded area. Furthermore, most medical gadget producers are subtle and have a greater understanding of the worth of their mental property. Since innovation is the lifeblood of the trade, it is smart that the trade protects extra of their innovations, which ends up in extra medical gadget patents being issued. Thus, extra patents within the technological area deliver a few larger chance of patent litigation inside that area.
No less than one research signifies that patents on medical gadgets are considerably extra more likely to be litigated than the common of all patents. The research supplies a proof for why medical gadget patents usually tend to be litigated by noting that the medical gadget trade, as a complete, view patents as invaluable belongings.
Conclusion
Patent litigation is, the truth is, on the rise. The empirical research carried out over current years have recognized a few of the traits which can be robust predictors of whether or not a patent is more likely to be litigated. A lot of claims and prior artwork citations might enhance a patent’s chance to finish up earlier than a courtroom. A crowded technological area can also result in a better danger of patent litigation.
By advantage of being in such a crowded area, the medical gadget trade will probably stay very litigious. After all, this race to the courthouse is indicative of the worth that the trade as a complete locations on its improvements, and therefore its survival.
© 2007, Gallagher & Dawsey Co., LPA April 2007
DISCLAIMER
We hope you perceive that we can’t probably give correct authorized recommendation to all inventors in a quick article on mental property points. Accordingly, nothing within the above is meant as particular authorized recommendation to any particular person. Such authorized recommendation can solely be given by a certified practitioner after a cautious evaluation of all the person information. We urge you to seek the advice of us, or one other licensed skilled, earlier than you proceed.