Miniature Ingestible Capsule
Overview
Miniature Ingestible Capsule is the name used by an inventor for a wireless capsule endoscope for gastrointestinal viewing [1] and is being sold as EndoCapsule by Olympus Corporation [2] and PillCam by Given Imaging Ltd [3].The professional societies in America have abbreviated the name to Capsule Endoscopy.Miniature Ingestible Capsule is the name used by many other inventors for other uses for humans as well as animals.Miniature Ingestible Capsule name goes back to 70's for its use in many movies.While Ingestible Capsule name has been in use for much longer time,Europeans came up with Wireless Capsule Endoscopy name for specific use and American professionals abbreviated it only in last 7 years.The professional US Gastroenterolgy societies opted for Capsule Endoscopy in their literature from original name of Ingestible Capsule.The original name implies its use for Endoscopy,Colonoscopy and other diagnostic tests like ph,temperature etc.. Wikipedia users search for this subject based on their personal familiarity around the world. James Bond and other Movie buffs search for this as Ingestible Capsule.This is also clear when someone does patent search in the US and rest of world.There are many patents for Ingestible Capsule for different usage.Wikipedia search engine is used by different users and therefore it is important that all the names be respected and kept rather the recent name chosen by professional groups for specific application.The Miniature Ingestible Capsule can be safely ingested into human/animal Gastrointestinal tracts and the camera using CCD or CMOS technology with long battery life takes picture and transmits them to an outside device for viewing. Battery life is key as the Capsule takes longer than 8 hours to reach Colon. Newer versions of Wireless Endoscopy Capsule have the longer life for viewing the Colon for Polyps or other problems. Patent application#20060195015 has been submitted for 140 claims for Therapeutic/surgical functions by Wireless Capsule [4]. However, a Wireless Colon Capsule by itself, offers a great opportunity to screen millions who are not getting Cancer Screening today. This Colon Cancer Capsule is expected to receive approval in late 2007.[5] SEC 6K filing on March 05,2007.
History:
This Miniature Ingestible Capsule was conceived by Tarun Mullick in 1985 and developed in late 1980's with the help of gastroenterologist, Dr. Sudhir Dutta. Because of the patenting regulations, both of them waited until after patent filing to tell others as their original patent application had 157 claims for much broader use. Mullick was interested in the thought of painless screening after witnessing several GI procedures in 1985 in Dr.Blaine Cobb's Guthrie clinic site in Corning(city), New York,NY.MICROGIZZMOS LLC,Geneva,IL has the rights to these patents and Dr.Tarun Mullick is the CEO of MICROGIZZMOS LLC.[6].
Recent Developments:
This Miniature Ingestible Capsule or Wireless Capsule Endoscopy, when approved by US FDA for colon screening in 2007, would unleash a huge demand as a painless, low-cost option.Another use for studying food myths was demonstrated by Dr.Oz on Oprah show on Sept.17,2007 using PillCam.[7]Added
Three companies are competing in this market -- Olympus Corporation [8] , Given Imaging Ltd and RF System Lab. with its Sayaka Capsule Camera.[9] RF System claims to have better quality at a much lower price. Sony Corp. has shown interest in working with RF System.
PATENT Litigation:
Olympus Corporation and Given Imaging Ltd. are battling in the Eastern District Court of Pennsylvania for their right to produce this Miniature Ingestible Capsule or Wireless Endoscopy Capsule [10] [11] . US District Judge James Knoll Gardner has announced his decision for Jury trial.(see the website referenced below for Case2:06-cv-02132 ,Document#38 for details thru Pacer). This suggests big legal spending(30 to 40 million$) for this billion dollars opportunity worldwide unless they settle out of court which is unlikely.These legal estimates were provided by Given Imaging Inc.on Aug.2,2007.We doubled these estimates to include similar spending by Olympus Corp.Given Imaging Inc. stated their litigation expenses are likely to be 4 million$ in 2007.
Patent Reexaminations:
Olympus Corp. requested reexamination of Iddan's patent# 5604531 owned by Given Imaging Inc. in Dec. 2003 and US Patent office rejected Claims 1,2,3 and 11 that are basic to the other claims--in 2006. [12] .In Israel,once the basic claims are rejected-the rest of patent is considered ineffective according to an attorney who writes in Israel.The US litigation should prove whether Iddan's patent is effective after 4 main claims rejection by US patent office.US District Judge of Eastern Court of Pennsylvania in Allentown,Pennsylvania has ordered a jury trial starting on Nov.3,2008 and Given Imaging reported that they have spent 1.5 million$ in the first half,2007 on legal expenses and they expect to spend 4 million$ in 2007 on the litigation expenses and it is estimated that legal costs by both companies are likely to be between 8 and 10 million$ in 2007 and 16 to 20 million$ in 2007 and 2008.Several documents have already been submitted to support their arguments that both Given Imaging and Olympus Corp. have patents in this area.Microgizzmos has not filed a lawsuit yet,but their company holds the rights to patent#7039453 which was issued on the principle criteria of "First to Invent".First to Invent criteria is more relevant and important than first to file criteria in the US Patent laws.Moreover,in the last 7 years,the US Courts have imposed multimillion dollars penalty on willful infringement of small inventors patents as evident in NTP vs.Research in Motion (RIM)case.The US Supreme Court sided against E bay when they appealed against 30 million$ penalty but advised the lower court to reconsider shutting down EBay.Penalties in this case are likely to top 50 million $ based on penalty on RIM.So this patent battle is likely to go on for 4 years for this major new Capsule Endoscopy invention.
Products Sales Growth:
The sales in 2006 were over 100 million$ for both companies for PillCam and EndoCapsule,the names under which Miniature Ingestible Capsule or Capsule Endoscopy is being sold by Given Imaging Ltd. and Olympus Corp.Given Imaging announced that it will be launching Colon Pill in the second half of 2007.They expect 20 to 25% growth in sales.These estimates were provided in SEC Filings 6-K,March 05,2007 by Given Imaging Inc.referenced below.We added 5 million$ to this total as Olympus Corp. sales outside USA.[13] SEC filings. The Wall Street Journal has called it as one of the biggest medical technology inventions to find a painless way to screen the GI/Digestive System.This was given this distinction in 2005.
References
- [14]
- [15]
- [16]
- [17]
- [18] Please Click Product and then Click photo of Capsule to read about SAYAKA introduced in Dec.2005
- [19]
- [20] ,then access PACER--log in and enter 2:06cv02132 and read Document 38 Filed on 03/02/2007 4 pages in the US District court for Eastern District of Pennsylvania--Jury Trial order by Judge James Knoll Gardner.
- [21] SEC Filings 6-K ,March 05,2007.
- [22] NTP Inc. writeup in Wikipedia