Developments in Patent Disputes Between Apple and AliveCor
Earlier this year, AliveCor, Inc., a medical device and AI company producing electrocardiogram (ECG) hardware and software for consumer mobile devices, succeeded in convincing an International Trade Commission (ITC) judge that Apple Inc. infringed multiple, valid claims of three AliveCor patents on ECG technology. By December 12, 2022, the full ITC is expected to issue a final decision in that investigation (337-TA-1266).
With the final ITC decision just days away, Apple filed suit against AliveCor, Inc. in the Northern District of California on December 2. Apple alleges that the ECG functionality of several AliveCor products, including KardiaMobile, KardiaMobile 6L (pictured below), KardioMobile Card, and the related Kardia App, infringe one or two Apple patents: U.S. Patent Nos. 10,076,257 and 10,866,619. Apple also alleges that AliveCor’s KardiaPro service and Kardia App, in conjunction with various Kardia devices, infringe one or two additional patents: U.S. Patent Nos. 10,270,898 (titled “Wellness Aggregator”) and 10,568,533 (titled “User Interfaces for Health Monitoring”).
Less than a week after Apple filed suit, a panel of Patent Trial and Appeal Board (PTAB) administrative judges found that the three AliveCor patents asserted in the ITC investigation were invalid. According to Law360, an AliveCor spokesperson explained AliveCor is “deeply disappointed and strongly disagrees with the decision by the PTAB and will appeal.” Regarding whether the PTAB’s findings should impact the ITC’s decision, the AliveCor’s spokesperson added:
The PTAB and ITC are two, separate independent bodies and will make their own separate independent decisions. We look forward to the separate final determination from the ITC expected December 12 and are cautiously optimistic.
Cook Medical Petitions for Inter Partes Review (IPR) of Medtronic “Jervis” Patent
On November 9, 2018, Cook Medical LLC filed a petition with the Patent Trial and Appeal Board requesting inter partes review (IPR) of U.S. Patent No. 6,306,141, assigned to Medtronic Vascular, Inc. The ‘141 Patent is entitled “Medical Devices Incorporating SIM Alloy Elements.” The ‘141 Patent states that it relates to “a medical device containing a shape memory alloy element.”
The ‘141 patent discloses using stress and temperatures below body temperature to restrain a metal alloy. The alloy expands to its original shape after being released from its restraint and exposed to body temperature. In one example, the ‘141 Patent describes that the disclosed device enables doctors to treat damaged or diseased heart valves with a less invasive transcatheter heart valve procedure. Figures 3 and 4 of the ‘141 Patent, shown below, illustrate a “side elevation view of a partial section of a catheter” in stressed (Figure 3) and unstressed (Figure 4) configurations.
The petition seeks to review all claims of the ‘141 Patent. Cook Medical’s petition submits two grounds on which the claims of the ‘141 Patent should be found invalid due to obviousness. The status of the proceeding can be examined by searching for the patent on the Patent Trial and Appeal Board website.
This is not the first time that the ‘141 patent has been subject to a petition for inter partes review. On January 17, 2014, Edwards Lifesciences Corporation filed a petition with the Patent Trial and Appeal Board requesting inter partes review of the patent for review of all claims of the ‘141 Patent. According to a Medtronic press release, on May 20, 2014, Medtronic and Edwards reached a “global settlement agreement” to “dismiss all of the pending litigation matters and patent office actions between them.”
In May 2013, Lombard Medical filed a petition for inter partes review of Claims 1-10 and 18-22 of the ‘141 Patent. Lombard Medical’s products, according to its website, include the AORFIX™ endovascular stent graft. According to a Lombard press release, on October 17, 2013, Lombard was granted a non-exclusive license by Medtronic to the ‘141 Patent, and Lombard formally requested a withdrawal of its inter partes review petition with the USPTO.
The ‘141 Patent has also been previously litigated. The ’141 Patent, among others, was previously asserted by Medtronic against W.L. Gore & Associates, Inc. in 2006; Gore’s EXCLUDER® AAA, TAG, and VIABAHN SFA® endoprosthesis devices were at issue. The parties entered into a confidential settlement in 2009.
Medtronic also previously asserted the ’141 Patent, among others, against AGA Medical in 2007. AGA’s AMPLATZER® Septal Occluder, Duct Occluder, and Vascular Plug devices were at issue. The parties entered into a settlement in 2010 in which AGA received a non-exclusive license to patents including the ’141 Patent in exchange for $35 million. AGA Medical was subsequently purchased by St. Jude Medical in October 2010 for $1 billion.
Novartis’ Gilenya Patent Invalidated as Obvious
On April 12, 2017, the Federal Circuit affirmed the determination by the US Patent and Trademark Office (USPTO), Patent Trial and Appeal Board (Board) that the claims of U.S. Patent No. 8,324,283 (“the ’283 patent”) were invalid as obvious.
US Patent No. 8,324,283
According to public databases, Novartis AG is the assignee of the ’283 patent, directed to pharmaceutical compositions for the treatment of multiple sclerosis. The ’283 patent, according to its abstract, relates to sphingosine-1 phosphate (S1P) receptor agonists and a sugar alcohol suitable for oral administration. According to its label, Gilenya acts by internalizing S1P receptors, which sequesters lymphocytes in the lymph node, to prevent relapse of multiple sclerosis. According to the Food and Drug Administration (FDA), Gilenya, approved in 2010, became the first oral disease-modifying drug approved by the Food and Drug Administration (FDA) to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis. A Novartis website states that Gilenya had over $3 billion in sales in 2016.
Board Decision
According to the Federal Circuit Decision, Torrent Pharmaceuticals Limited filed inter partes review (IPR) proceedings of the ’283 patent in 2014. The Board determined that the claims of the ’283 patent were invalid as obvious in its Final Written Decision of September 24, 2015. Novartis appealed the decision to the Federal Circuit, and the Federal Circuit affirmed the Board’s decision.
Federal Circuit Decision
According to the Federal Circuit’s decision, Novartis argued on appeal that the Board “erred in its motivation to combine analysis because it failed to read the prior art as a whole and overlooked critical evidence of . . . known disadvantages” of a claimed active ingredient. However, the Federal Circuit affirmed the Board’s finding, concluding that “substantial evidence supports the Board’s finding that . . . a person of skill in the art would have been motivated to combine” the features of the cited art.
Sportbrain Sues Smartwatch Manufacturers, PTAB institutes IPR against Patent-in-Suit
Sportbrain Holdings LLC (“Sportbrain”) is a company that was previously engaged in the business of selling fitness trackers. Sportbrain recently sued eight smartwatch manufacturers for alleged infringement of its U.S. Patent No. 7,454,002 (“the ’002 patent”), which describes a method of capturing and analyzing personal data of a user and providing feedback to the user based on the analysis. FIGS. 1B and 3 of the ’002 patent are reproduced below. These defendants included Jawbone, Frédérique Constant, Apple, Michael Kors, HP, BLOCKS Wearables, Razer, and New Balance. The complaint in each case identified a smartwatch or fitness tracker (having an accelerometer, motion sensor, pedometer, calorie counter, and/or gyroscope) and its companion app as the accused product.
A day after Sportbrain filed its most recent lawsuit, the Patent Trial and Appeal Board (PTAB) granted a petition for inter partes review (IPR) of the ’002 patent. The IPR petition had been filed on July 22, 2016 by Unified Patents. According to its website, Unified Patents is a member-based organization seeking to deter non-practicing entity activity in specific technology areas. Unified Patents argued in its petition that the claims of the ’002 patent were obvious over four different combinations of prior art references.
In instituting the IPR proceeding, the PTAB concluded that the petitioner’s evidence established a reasonable likelihood that the combinations of prior art references would render all of the claims of the ’002 patent obvious.
The ’002 patent is now the subject of over 40 active cases brought by Sportbrain.
Boston Scientific Files Second IPR Petition Against UAB Patent
Boston Scientific Corporation (“Boston Scientific”) filed a petition with the Patent Trial and Appeal Board on April 10, 2015 requesting inter partes review of U.S. Patent No. 6,266,563 (“the ’563 Patent”). The petition states that the ’563 Patent is owned by the UAB Research Foundation. The petition has been assigned Case No. IPR2015-01038.
The ’563 Patent is entitled “Method and Apparatus for Treating Cardiac Arrhythmia,” and lists as inventors Bruce H. KenKnight, Raymond E. Ideker, Robert S. Booker, III, and Stephen J. Hahn. The ’563 Patent states that it “relates to methods and an implantable apparatus for treating cardiac arrhythmia, particularly ventricular fibrillation.” Figure 1 from the ’563 Patent is shown below.
The petition seeks review of all twenty of the ’563 Patent’s claims “as obvious under 35 U.S.C. § 103 based on U.S. Patent No. 5,181,511 (‘Nickolls’), U.S. Patent No. 5,433,729 (‘Adams’), and the knowledge of a person of ordinary skill in the art.”
The petition states that the ’563 Patent has been asserted by the Board of Trustees of the University of Alabama at Birmingham and the UAB Research Foundation against Boston Scientific and Cardiac Pacemakers, Inc. in a lawsuit filed on September 22, 2014 in the U.S. District Court for the Northern District of Alabama. The complaint alleges that Boston Scientific and Cardiac Pacemakers, Inc., a wholly owned subsidiary of Boston Scientific, infringe the ’563 Patent by making, using, offering to sell or selling cardiac resynchronization therapy defibrillators (“CRT-Ds”), “including but not limited to the Incepta, Enrgen, Cognis, and Livian CRT-Ds . . . .”
The petition also states that Boston Scientific previously filed a petition requesting inter partes review of the ’563 Patent, alleging that all twenty claims were invalid as anticipated under 35 U.S.C. § 102(b) by U.S. Patent No. 5,797,967 to KenKnight. The prior petition was filed on March 23, 2015, and was assigned Case No. IPR2015-00918.
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