News roundup 16 Oct: Walgreens shuts 1,200 stores–500 in ’25, CVS exiting core infusion biz, Masimo v. Apple update, DEA recommends 3rd telehealth extension, Change hack costing UHG $705M, Owlet back in NYSE compliance

October 16, 2024 | by

A roundup of chickens coming home to roost? But some chickens are just happy to come home.

Walgreens’ Mound of Misery just grew a little higher. The headlines today were all about Walgreens’ closing 1,200 stores over the next three years. Their current store location roster is about 9,000, according to their website. 500 of these will be closed during their upcoming FY2025.  Their release stated this would be “immediately accretive to adjusted EPS and free cash flow”. (Were they making any money at all?) This helped to give their share price a nice bump from $9 to above $10 at market close today. Last year, Walgreens’ shares were priced above $22.

Q4 (closing 31 August) closed with a 6% boost in retail sales. However, losses were $3.0 billion versus a net loss of $180 million in the prior year’s Q4. The reasons cited in their release were a higher operating loss, a $2.3 billion non-cash charge for valuation allowance on deferred tax assets primarily related to opioid liabilities recognized in prior periods, and a non-cash impairment charge related to equity investment in China. The operating loss related to a non-cash goodwill impairment charge for CareCentrix. 

The full year was not cheery. Sales were $147.7 billion, an increase of 6.2% from a year ago (in constant currency, 5.7%). But losses in their FY2024 were $14.1 billion, a stunning increase of 104.5% compared to prior year.

VillageMD is being monetized along with other assets. “CEO Tim Wentworth said in the earnings call that the company is focused on “monetizing non-core assets to generate cash,” naming VillageMD as an example, to focus on its core retail pharmacy business.” HIStalk 16 Oct Can Walgreens shrink itself to profitability? Fierce Healthcare

Over at CVS, they’re doing their own shrinking. CVS is closing its core infusion services business, with plans to either close or sell 29 related regional pharmacies. Infusion services were bought from Coram LLC in 2013 for $2.1 billion. This Reuters exclusive was based on an 8 October memo and confirmed by a CVS press representative. Patients relying on antibiotics, drugs supporting muscular health, and intravenous nutrition services will be transferred to other providers. CVS will continue to provide certain services: specialty medications and enteral nutrition, or tube feeding, at pharmacies in Minnesota, Pennsylvania and San Diego, with nationwide nursing services. Hat tip to HIStalk 16 Oct.

Masimo wins one big patent challenge, loses one (or four), to Apple. 

The Win: Apple had sued Masimo in the US District Court of Delaware for patent infringement of Apple’s utility patent 10,942,491 B2 (“the ‘491 patent”). Masimo was charged as violating Apple’s patent on 19 features. Masimo appealed to the Patent Trial and Appeal Board (PTAB) of the US Patent and Trademark Office (USPTO) for an inter partes review (IPR) of the patent on the grounds of ‘unpatentability’, a very high proof. Masimo succeeded in this, rendering Apple’s ‘491 patent useless. Apple can appeal but the likelihood of success against the PTAB ruling that required three administrative patent judges to review, at this level of proof, is low. In this Editor’s view, this may spur other developers to come up with innovations now that these 19 features have been deemed unpatentable.

The Loss (I think): In review in the Delaware District Court are four complicated lawsuits between the two combatants, with Apple’s premise that Masimo has infringed upon other patents. Masimo alleged “inequitable conduct” by Apple in their patent filings with the PTO, essentially alleging fraudulent filings on multiple patents. Apple has been granted a summary judgment on Masimo’s claims, throwing them out.

Interestingly, Masimo–never shy to announce wins versus their foe Apple under the prior leadership of Joe Kiani–has remained strangely mum. (Perhaps everyone is waiting for the takeover dust to settle?) Will the ‘new’ Masimo be so combative against Apple? A far more detailed analysis for the patent mavens is in Strata-gee. A very large hat tip and bow to their editor, Ted Green, who writes about marketing primarily in the audio/visual business but has been 100% on top of The Masimo Saga–thank you!

To no one’s surprise, DEA kicks the telehealth waiver can down the road–for the third time. The Drug Enforcement Administration (DEA) sent to the White House’s Office of Management and Budget (OMB) a proposed rule to extend telehealth prescribing of Schedule II and higher controlled substances without changes. These waivers which removed the in-person examination requirement under the Ryan-Haight Act were instituted during the Covid pandemic and extended twice [TTA 11 Oct 23, 11 May 23] with a final expiration of 31 December 2024. In September, reports indicated that DEA not only wanted to restore prior restrictions but also wished to introduce additional ones. However, their timing (September!) given Federal standards of publishing draft rules and lengthy comment periods before a final rule was impossible to be achieved by year’s end. [TTA 13 Sept]

Whether OMB will approve the extension (to a date that cannot be confirmed since the text is unavailable, but reportedly one year) is not certain, as it may be disputed by the Department of Health and Human Services (HHS). Since the waiver is due to expire at the end of the year, this may help to assure the multitude of mental health and other telehealth companies dependent on legal remote diagnosis and prescribing controlled substances that their businesses can continue. FierceHealthcare

UHG didn’t have a happy quarter either due to Change. The total hit to UnitedHealth Group of the Change Healthcare hack is now estimated at $705 million, or 75 cents a share. Their 2025 guidance on profit is a lackluster $30 per share–below Wall Street estimates of $31.18. Government plans’ cuts in payments for Medicare Advantage plus and low state payment rates for Medicaid are affecting UHG as well as nearly every other payer. UHG’s share price on the news reacted negatively, falling 9% and dragging down other payers as well. UHG must rue the day they bought Change Healthcare, as it has been largely bad news ever since. CNBC

And winding up on a happy note–Owlet is back in good graces with the NYSE. Last year, they faced a NYSE notification that they were out of compliance with the $50 million minimum valuation of the company over a consecutive 30-day trading day period. They are now in compliance and their Class A shares can trade without the ‘BC’ black mark and no longer be listed as such on the NYSE website. The NYSE will be following its standard procedure of a 12-month follow-up on compliance. Release, Mobihealthnews

The baby sock and baby monitoring company has had a rough couple of years between a cracked SPAC (2021), FDA notifying them at the end of 2021 that they considered the Smart Sock a medical device, forcing the company to pull it from distribution [TTA 4 Dec 21], mounting losses, layoffs, and rebuilding with an FDA-cleared BabySat and enhanced Dream Sock [TTA 21 June 23]. Usually, this concatenation of events means the company either shuts or sells, but Owlet has done neither and bootstrapped itself. Revenue in their Q2 ending 30 June was up 58% year over year with a narrower operating loss of $2.2 million, compared with $6.7 million in prior year. It recently expanded their European distribution of the Dream Sock after CE Mark certification in May to a total of 11 countries [TTA 18 Sep]. 

US International Trade Commission initial determination: Apple infringed AliveCor’s patents (updated)

June 28, 2022 | by

If affirmed, a David versus Goliath win. AliveCor, the developer of the KardiaMobile ECG devices, announced late today that Administrative Law Judge (ALJ) Cameron Elliot of the US International Trade Commission (ITC) issued an Initial Determination that Apple infringed certain AliveCor technology patents. If affirmed by the full ITC in a Final Determination by 26 October (!), it could lead to an exclusion order barring the importation of certain Apple devices infringing on AliveCor patents from the US.

The initial complaint was filed in May 2021 [TTA 29 April] concerning Apple’s infringement in the Apple Watch 4, 5, and 6 of three AliveCor ECG technology US patents: No. 10,595,731 (“the ’731 patent”); No. 10,638,941 (“the ’941 patent”); and No. 9,572,499 (“the ’499 patent”). Last February, AliveCor successfully moved with the ITC to have the investigation terminated on certain claims on the three patents, but a considerable number remained. This is what ITC terms an “unfair import” or Section 337 investigation. These regard intellectual property rights, including “allegations of patent infringement and trademark infringement by imported goods.”

Updated for links: AliveCor press release, ITC Public Notice which details what parts of what patents have been infringed. Both the 731 and the 941 patents have been found to be infringed under Section 337. The 499 patent has not been violated. This Editor will assume we have to wait till October for any exclusion orders.

Jawbone bites back: Fitbit loses three patents (updated)

July 27, 2016 | by

The wearables war continues, and the Law of Unintended Consequences seems unbreakable. This one was decided in a US International Trade Commission court, with the judge ruling that the three patents in question “don’t cover ideas eligible for protection” and dismissed the August trial between Fitbit and Jawbone. This is a reversal of fortune for the two competitors as a similar patent challenge to Jawbone was won by Fitbit back in April in the same court. In the new ruling, the judge said that Fitbit “seek(s) a monopoly on the abstract ideas of collecting and monitoring sleep and other health-related data.”

The skirmishing has a deeper context. Jawbone has accused Fitbit of hiring former employees and purloining trade secrets like product design and marketing plans, and alleges that the suits were “brought improperly by Fitbit in an attempt to burden Jawbone with having to defend invalid patents in multiple venues.” Fitbit reportedly has 300 patents, so that is a lot of defending for a company that has issues of its own.  Jawbone has struggled in past months with its products, with various (and contradictory) reports indicating it’s exiting the wearable business, working on a new wearable and selling its audio business (which has also been crushed by competition.) Undoubtedly this will continue as Fitbit plans to challenge the ruling. Your Editor suspects that their legal and IP offense/defense activity is a substantial budget line for them. Bloomberg (20 July and April), The Verge

Update: Jawbone is rumored to be up for sale, with reports that they have approached at least one hardware manufacturer about a purchase. Reportedly they missed an August payment to a business partner. Investor BlackRock has marked down their shares, formerly valued at $5.97 a share, to less than a single penny. Since 1999, Jawbone has had funding of over $900 million.  9to5Mac, The Verge  Even the much-publicized hiring of high-profile exec Adam Pellegrini from Walgreens to Fitbit to lead digital health has a Jawbone twist, as both the former and latter were partners. MedCityNews

Finally a curb on ‘patent trolls’? (US)

May 9, 2014 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/09/TROLLS-1992-008.jpg” thumb_width=”150″ /] Those nasty patent trolls–those (largely) non-practicing entities (NPEs) which buy up patents to license them. Yet most of their revenue stream comes from pouncing on startup and early-stage companies to challenge their patents and systems, extracting la mordida to avoid further legal action. Now the Federal Trade Commission (FTC) has moved to curb one egregious practice: deceptive demand letters. The FTC issued an order to MPHJ Technology Investments LLC (MPHJ) banning its allegedly deceptive letters to companies which MPHJ considered to be infringing on its scanning technology. MPHJ filed first a draft complaint, and now a legal action against the FTC in the US District Court for the Western District of Texas, alleging violations of the First Amendment on free speech. Under US law, ‘deceptive’ may not be good enough–their letters threatening lawsuits must be shown to be ‘objectively baseless.’ The FTC requested dismissal of MPHJ’s suit this past Monday. Their rejoinder: the suit would disrupt its work.  National Law Review, Law360 (subscription/Lexis Nexis access required).

Previously in TTA on patent troll strategies and how companies defend themselves:  TTA 13 Sep 13, 10 Feb 13. (Also search on ‘patent troll’, ‘MMRGlobal’ and ‘patent infringement’.

How startups are being damaged by patent trolls–and turning the tables

September 13, 2013 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/09/TROLLS-1992-008.jpg” thumb_width=”150″ /]In February and for a few months, this Editor was on a tear about the quaintly dubbed patent trolls–primarily (but not always) non-practicing entities (NPEs) which don’t create or market products, but buy up other people’s/companies’ patents and then seek out opportunities to license them. These NPEs target and challenge vulnerable startups and early-stage companies to defend their patents and systems; the suit for royalties, the financial threat, the papers filed, the attorneys called, the money spent and the eventual settlement (or licensing) is in reality just a form of what’s called in Latin America la mordida. It becomes cheaper to settle than to fight–and the cost can be six or seven figures. 

The shots over the bow were in 2012: Bosch’s February lawsuits against Waldo Health, ExpressMD/Authentidate and MedApps (now Alere Connect) [TTA 16 Feb 2012] and then the strange practice of PHR developer/patent accumulator MMRGlobal [TTA 23 Oct 2012] in sending hundreds, perhaps thousands, of letters out to EHR/EMR users to advise them of possible patent violations and demanding licensing. This Editor observed then and during the spring this year that it was only a matter of time that NPEs would pounce on healthcare tech as investment action accelerated. Yet discussions by this Editor with companies in some public venues indicated a certain level of obliviousness to the threat–that there were not enough assets to go after, thus healthcare startups made poor targets–though side conversations with IP specialist attorneys indicated otherwise.

Well, the trolls have reared their fuzzy heads again, uglier than ever, in this drama-laced article in Wired. (more…)