Showing all posts written by Brian Flynn
· Medical Device: medical and dental instruments, implants, diagnostic
equipment, and communication and data systems
· Mechanical: automotive technology, sporting goods, kitchen
appliances, beverage containers, and toys
· Electronics: digital camera technology, mobile devices, GPS devices,
and sensor technology
Brian received his law degree from the University of Illinois College of Law, where he served as the Secretary for the Intellectual Property Legal Society and as an Articles Editor for the Journal of Law, Technology & Policy. Prior to his legal education, he received a Bachelor's Degree in Bioengineering from the University of Illinois. Click here to read full bio
Johnson & Johnson recently announced an agreement to acquire Abbott Medical Optics for $4.325 billion. Abbot Medical Optics, a subsidiary of Abbot Laboratories, reported $1.1 billion in sales in 2015. According to the press release, the acquisition will cover products in areas including cataract surgery, laser refractive surgery, and consumer eye health. Johnson & Johnson Vision Care, Inc. currently produces ACUVUE® brand contact lenses.
Ashley McEvoy, Company Group Chairman responsible for Johnson & Johnson Vision Care stated:
With the acquisition of Abbott Medical Optics’ strong and differentiated surgical ophthalmic portfolio, coupled with our world-leading ACUVUE® contact lens business, we will become a more broad-based leader in vision care. Importantly, with this acquisition we will enter cataract surgery – one of the most commonly performed surgeries and the number one cause of preventable blindness.
This acquisition comes shortly after Abbot Laboratories announced the acquisition of St. Jude Medical, Inc., diversifying Abbot Laboratories’ cardiovascular portfolio. Commenting on the sale of Abbot Medical Optics, Miles D. White, Chairman and Chief Executive Officer of Abbot Laboratories, said:
We’ve been actively and strategically shaping our portfolio, which has recently focused on developing leadership positions in cardiovascular devices and expanding diagnostics.
The acquisition is expected to be completed in the first quarter of 2017.
The Food and Drug Administration published a Final Rule in the Federal Register revising labeling regulations for medical devices and certain biological products to allow for the use of symbols without adjacent explanatory text if certain requirements are met. This rule is intended to better conform U.S. labeling requirements for symbols with regulatory requirements in European and other foreign markets.
The final rule allows symbols established in a standard developed by a standards development organization to be used in medical device labeling without adjacent explanatory text if (1) the standard is recognized by the FDA and the symbol is used in accordance with certain specifications for use set forth in the Food and Drug Modernization Act of 1997 or (2) the device manufacturer otherwise determines the symbol is likely to be read and understood by an ordinary individual under customary conditions of purchase and use in compliance with certain misbranding stipulations under the Federal Food, Drug, and Cosmetic Act and the manufacturer uses the symbols according to specifications for use set forth in the standards development organization’s developed standard.
Examples of international consensus standard symbols can be found in “Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use,” an FDA Guidance Document issued on November 30, 2004, that recognized 25 symbols from two international consensus standards for IVD devices for professional use. Symbols from that Guidance Document are reproduced below:
This final rule is estimated to lead to cost savings between about $7.9 million and $25.5 million for medical device manufacturers and will go into effect on September 13, 2016.
The Food and Drug Administration published a Proposed Rule in the Federal Register establishing a docket and requesting information and comments on third party entities that “refurbish, recondition, rebuild, remarket, remanufacture, service, and repair medical devices.” This request comes after stakeholders expressed quality and safety concerns for medical devices subject to those activities. Particularly, stakeholders expressed concerns about the use of unqualified personnel in performing the relevant activities and inadequate documentation of work performed. The FDA found that these activities could lead to public health issues including “ineffective recalls, disabled safety features, and improper or unexpected device operation.” In addition to comments regarding “service, maintenance, refurbishment, and alteration of medical devices by third party entities”, the FDA is also seeking comments on the challenges faced by third-party entities in “maintaining and restoring medical devices to their original or current specifications.” The comment period for the Proposed Rule ends on May 3, 2016.
Medtronic, a medical device manufacturer based in Dublin, Ireland, recently announced FDA approval and U.S. commercial launch of its MyCareLink Smart Monitor, the first app-based remote monitoring system for implantable pacemakers.
According to Medtronic, the MyCareLink Smart Monitor includes a handheld portable device reader paired with a MyCareLink Smart mobile app on a smartphone or tablet. The portable device reader receives pacemaker data (when placed in close proximity to the implanted device), and communicates with the mobile app on a smartphone. The data can then be transmitted to the patient’s physician or clinic (e.g., through cellular or Wi-Fi service). The MyCareLink Smart Monitor also allows patients to create personal profiles on the MyCareLink Connect Website and receive reminders, confirmations, and notifications about their data transmissions. HIT Consultant reports that the MyCareLink Smart Monitor will allow for faster treatment, reduced time in clinical care facilities, and potential improvements in survival rates.
“As a leader in remote cardiac monitoring, Medtronic is committed to providing cardiac patients with the latest technology to improve their health and make their lives easier, while helping to reduce the costs of healthcare. The MyCareLink Smart Monitor is just the first of many innovative solutions we are developing that leverage smart technology to increase patient engagement.”
The Patent Trial and Appeal Board (“PTAB”) denied a petition by C.R. Bard, Inc. requesting inter partes review of claims 1 and 2 of U.S. Patent No. 8,488,786, entitled “Catheter Tray, Packaging System, Instruction Insert, and Associated Methods,” with a listed assignee of Medline Industries, Inc. Figure 14 of the ‘786 patent is reproduced below.
The PTAB construed the claim term “reveal” to mean “[t]o make visible or to make (something that was hidden) able to be seen,” and found under this construction that “Petitioner has not explained adequately” how the prior art accounts for the step of “unfolding one or more layers of wrap to reveal an additional layer of wrap and the catheter assembly,” as recited in independent method claim 1. Consequently, the PTAB found that “we are not persuaded that Petitioner has established a reasonable likelihood of prevailing in its challenges…” A copy of the PTAB decision is available here.
C.R. Bard and Medline Industries are also involved in litigation regarding the ‘786 patent in the U.S. District Court for the Northern District of Illinois in Medline Industries, Inc. v. C.R. Bard, Inc., Case No. 1:14-cv-03618, filed on May 16, 2014, the Complaint of which is available here.
The parties have also been involved in three other petitions for inter partes review involving related U.S. Patent Nos. 8,631,935 (IPR trial instituted for Claim 21 only) and 8,678,190 (IPR proceedings terminated).
By Brian Flynn
On May 19, 2015, Molex Incorporated announced that Molex Ireland Holdings B.V. has acquired ProTek Medical Ltd. According to the press release, ProTek Medical, based in Sligo, Ireland, specializes in cleanroom injection molding and cleanroom device manufacturing and assembly. According to news sources, Molex, headquartered in Lisle, IL, is a subsidiary of Koch Industries Inc., having been acquired for $7.2 billion in September 2013. According to its website, Molex manufactures electronics interconnectors including medical connector products and medical cable assemblies. This acquisition follows Molex’s recent acquisition of Soligie, Inc., a corporation that provides printed electronic solutions for a range of products including medical goods, on May 5, 2015. The press release states that moving forward, ProTek Medical will operate as a subsidiary of Molex Ireland Holdings B.V.
Tim Ruff, Senior Vice President of Business Development and Corporate Strategy for Molex stated:
“This strategic acquisition broadens the scope of our integrated medical solution offerings and significantly strengthens our medical device design, manufacturing, and test capabilities.”
On April 2, 2015, the United States Department of Justice announced that Medtronic, a medical device manufacturer based in Ireland, reached a settlement agreement with the United States government for $4.41 million over allegations that Medtronic had violated the Trade Agreements Act of 1979. The Trade Agreements Act requires that products sold to the U.S. government originate in the United States or in a country that has signed an international trade agreement with the United States.
According to the press release, the government alleged that Medtronic made false statements regarding the origin of medical devices sold to the United States that had originated in China and Malaysia, prohibited countries under the Trade Agreements Act. The specific devices at issue were related to cardiac treatment and spinal surgery.
The Star Tribune quoted Medtronic spokeswoman Cindy Resman as stating that Medtronic “makes no admission that any of its activities were improper or unlawful.”
Four Mile Bay, LLC recently sued Zimmer Holdings, Inc. in the United States District Court for the Northern District of Indiana. The complaint alleges that Zimmer Holdings’ hip implants, such as the “Trabecular Metal Primary Hip Prosthesis,” infringe U.S. Patent Nos. 8,506,642 and 8,821,582, which issued in 2013 and 2014, respectively. Both patents are entitled “Hip Implant with Porous Body.”
Last year, Indiana Intellectual Property Law News reported on another suit filed by Four Mile Bay against Zimmer in the Northern District of Indiana. In its complaint, Four Mile Bay alleged that Zimmer infringed U.S. Patent No. 8,684,734, entitled “Dental Implant with Porous Body.” The case is still pending.
Four Mile Bay seeks a judgment of infringement, reasonable royalties, and both pre-judgment and post-judgment interest in both cases.
USPTO Assignment Database records show that all of the ‘642, ‘582, and ‘734 patents were assigned by the inventor (and IP attorney), Philip Lyren, to William Lyren on November 1, 2013. William Lyren then assigned the patents to Four Mile Bay, LLC on February 1, 2014. According to the USPTO search page, Philip Lyren is a listed inventor on a number of patents and applications having broadly varying subject matter, including:
- Home appliance that can operate in a time range (Pat. No. 8,954,199)
- User Agent with Personality (Pat. Pub. No. 2014/0359439)
- Displaying Targeted Advertisements to Users (Pat. Pub. No. 2014/0330649)
- Determine a Product from Private Information of a User (Pat. Pub. No. 2014/0316853)
- Cover for Handheld Portable Electronic Device (Pat. Pub. No. 2014/0313551)
- Peer-to-Peer Data Storage (Pat. Pub. No. 2014/0297742)
- Methods and apparatus for generating recommendations for gifts (Pat. No. 8,577,741)
- Marketing and selling feature length movies over networks (Pat. No. 8,521,601)
- Portable electronic device for receiving and playing feature length movies (Pat. No. 8,424,048)
According to its website, Zimmer designs and manufactures a variety of joint replacement products. Zimmer states that the “Trabecular Metal Primary Hip Prosthesis” uses a material with a “highly porous, strut configuration nature” and “open pore-configuration” to enable biological growth. According to the complaint, Four Mile Bay is a Nevada limited liability company having its principal place of business in Wadsworth, Ohio. Nevada Business Entity records indicate that William J. Lyren is the sole officer of the company.
EndoVention, Inc. sued AngioDynamics, Inc. in the Western District of Michigan on November 21, 2014. The lawsuit alleges that AngioDynamics’ AngioVac™ Cannula and Circuit infringes U.S. Patent No. 5,908,435, entitled “Expandable Lumen Device and Method of Use,” which issued on June 1, 1999, and U.S. Patent No. 6,159,230, entitled “Expandable Lumen Device and Method of Use,” which issued on December 12, 2000.
AngioDynamics is based in New York. The complaint is available here.