Apple flexes lobbying power as Apple Watch ban comes before Biden next week

 Apple is boosting its lobbying might as President Biden nears a decision next week on whether to block a potential Apple Watch ban. 

The U.S. International Trade Commission (ITC) ruled in December that Apple infringed on medical device company AliveCor’s wearable electrocardiogram patents. The commission’s ruling could result in an import ban on popular Apple Watch models, unless the Biden administration steps in.

Apple responded by contracting with Shara Aranoff, a lobbyist at Covington & Burling who chaired the ITC during the Obama administration.

The former Democratic commissioner has been lobbying on trade, intellectual property and health issues since her hiring in early January, according to a recent document filed with Congress.

The apparent effort to win over the White House is the latest lobbying push by Apple, which leans on former congressional staffers and federal officials to relay its message in the nation’s capital. 

“Apple has unlimited resources. They’re gonna go after everyone they can get and that’s what they’re doing,” said Priya Abani, CEO of AliveCor. “We are just a startup.”

White House decision looms

Biden must decide by Monday whether to veto the ITC ruling or let the dispute move forward in court.

AliveCor has filed lawsuits accusing Apple of stealing its technology and taking part in “monopolistic conduct.”

The Mountain View, Calif., startup, which employs around 150 people, first shared its wearable electrocardiogram (ECG) sensor with Apple in 2015.

AliveCor told The Hill that it believed that it had a good relationship with the Silicon Valley giant and went on to sell an ECG accessory for the Apple Watch. 

But in 2018, Apple launched an Apple Watch with a built-in ECG sensor and made third-party heart monitoring software incompatible with the product, forcing AliveCor to cancel sales of its product.

“We come up with new technologies, and instead of the ecosystem letting us thrive and continue to build on top of the innovations we already have, Apple cuts us out up front, steals our technology, uses their platform power to scale it, and now is basically saying it’s scaled so it can’t be cut off,” Abani said.

Various app developers and startups have accused Apple of “Sherlocking,” where the Silicon Valley giant monitors an innovative technology, then copies it once the use case is demonstrated, rather than pay startups to license their technology. 

In a statement to The Hill, Apple noted that the ITC’s import ban is on hold due to December rulings from the Patent Trial and Appeal Board finding that AliveCor’s patents are invalid. 

AliveCor appealed those decisions and hopes to bring the various legal battles — including a recent Apple lawsuit accusing AliveCor of infringing on its patents — before a federal appeals court. 

If Biden upholds the ITC ruling, litigation would continue, while a veto would ensure that an Apple Watch ban will not take place. 

Startups are closely watching Biden’s decision, given that the president has railed against powerful companies for using their market dominance to crush competition, Abani said.

“You want to make sure that the government and the processes in the country give a fair chance for startups to not just survive, but thrive,” she said. 

Why Apple is a lobbying powerhouse

Long a darling on Capitol Hill, Apple has aggressively bolstered its lobbying presence in recent years as lawmakers began to closely scrutinize its market dominance. 

Apple spent nearly $9.4 million on lobbying in 2022, the highest figure in the company’s history, according to nonpartisan research group OpenSecrets. 

Apple deployed 50 lobbyists, including former aides to Speaker Kevin McCarthy (R-Calif.), former Speaker Nancy Pelosi (D-Calif.) and Senate Minority Leader Mitch McConnell (R-Ky.), as it successfully defeated bipartisan legislation aimed at lessening the company’s grip on app store purchases. 

“Given Apple’s log history of utilizing these revolving door lobbyists and, frankly, the success they’ve had with this strategy, it’s not surprising at all that they’re doing the same thing to try and skirt this decision coming out of the International Trade Commission,” said Cheyenne Hunt, big tech accountability advocate at Public Citizen. 

Apple secured a veto in the past

Presidents typically don’t veto ITC rulings, but they have made an exception for Apple.

In 2013, then-President Obama vetoed an ITC ban on Apple iPhone and iPad imports after the commission found that Apple infringed on Samsung’s patents. The administration said that it considered the ban’s “effect on competitive conditions in the U.S. economy and the effect on U.S. consumers.”

At the time, phone carriers and a bipartisan coalition of lawmakers urged Obama to overrule the ITC. It marked the first presidential veto of an ITC product ban since 1987. 

This time around, Apple recruited a smaller group of allies in Congress. 

Seven House Democrats warned the ITC in October that an import ban “could result in severe negative impacts to businesses and millions of Americans,” pointing to the popularity of the Apple Watch’s heart monitoring system. 

Reps. Eric Swalwell (D-Calif.), Zoe Lofgren (D-Calif.), Don Beyer (D-Va.), Anna Eshoo (D-Calif.), Jimmy Panetta (D-Calif.), Linda Sánchez (D-Calif.) and Lou Correa (D-Calif.) authored the letter. 

“Leading up to the ITC’s final determination in this case, we encourage close consideration of the public health benefits which Apple’s heart-health monitoring devices bring to the American consumer,” they wrote. 

More than 500 individuals wrote to the ITC crediting the Apple Watch’s heart monitor with saving their lives. 

Just two lawmakers sided with AliveCor in ITC briefs, along with the Medical Device Manufacturers Association and a handful of companies.  

“The lack of enforcement of our patent laws is of grave concern to us, especially as markets continue to consolidate, competition from foreign countries grows, and larger firms exert their influence over smaller firms and start-ups in anti-competitive ways,” Reps. Hank Johnson (D-Ga.) and Lucy McBath (D-Ga.) wrote to the ITC. 

https://thehill.com/lobbying/3862071-apple-flexes-lobbying-power-as-apple-watch-ban-comes-before-biden-next-week/

Lithium miner Sigma jumps on report Tesla considering buyout

 U.S.-listed shares of Sigma Lithium Corp rose 21% in extended trading on Friday after Bloomberg News reported that Tesla Inc was weighing a takeover of the Canada-based battery metals miner.

Tesla has been speaking with potential advisers about a bid, the report said, citing people with knowledge of the matter, and added that Sigma Lithium is one of the many mining options the electric-vehicle maker is exploring as it mulls its own refining.

Tesla and Sigma Lithium did not immediately respond to Reuters requests for comment.

Sigma is finishing construction of a hard rock lithium mine in Brazil that it expects to open by April. The mine will produce spodumene concentrate, which can be used to make lithium hydroxide, a type of the metal preferred by some automakers including Tesla and BMW.

The project would use hydroelectric power, thus helping to greatly reduce its carbon footprint.

U.S. stock of Sigma Lithium, which has a market capitalization of $3.21 billion, nearly trebled in value last year.

Chief executive Elon Musk said last year Tesla was open to buying a mining company if producing its own supply of electric vehicle metals would speed up worldwide adoption of clean energy technologies.

Tesla and other automakers routinely talk to mining companies of all sizes about potential supplies of lithium and other EV metals without necessarily signing contracts.

Last month, Tesla signed an agreement with Piedmont Lithium Inc for supply of spodumene concentrate from Quebec, starting later this year.

Tesla also has supply contracts for nickel, lithium and a range of other EV metals from suppliers across the globe.

https://finance.yahoo.com/news/tesla-considering-bid-sigma-lithium-221747925.html

Abbott gets FTC notice for information on infant formula products

 Abbott Laboratories said on Friday it received a civil investigative demand in January from the Federal Trade Commission related to a probe of the companies participating in bids for women, infants and children formula contracts.

The FTC had launched an inquiry last year into the shortage for infant formula in the United States and had said it would examine the pattern of mergers and acquisitions in the formula market.

In January, Abbott's Michigan plant, which was at the center of the U.S. baby formula shortage last year, faced a criminal investigation by the Justice Department, the Wall Street Journal had reported.

The FTC did not immediately respond to a Reuters request for comment.

https://www.yahoo.com/news/abbott-gets-ftc-notice-information-222145991.html

U.S. to select 10 costliest drugs for Medicare pricing negotiation

 The U.S. government will select the 10 costliest prescription medicines to Medicare for negotiating prices with drugmakers starting early next year, the program's top official said on Friday.

President Joe Biden in August signed into law the Inflation Reduction Act, allowing the federal Medicare health plan for people age 65 and older and the disabled to negotiate prices on some of its most costly drugs.

The law grants the government the right to choose any 10 from a list of the 50 medicines responsible for the highest Medicare spending that qualify for negotiation, but does not specify the exact criteria for choosing them.

Dr. Meena Seshamani, director of the Center for Medicare, outlined in an interview how Medicare will select the initial drugs for negotiation after first determining which medicines are eligible and not subject to one of several exemptions outlined in the law.

"Then from there, we rank the negotiation-eligible drugs according to total expenditures for that 12-month period, and we will select drugs with the highest ranking," Seshamani said.

To produce that list, the agency first needs to decide whether to use gross Medicare spending or net spending, which takes into account often sizeable after-market discounts.

Seshamani did not comment on which way the agency was leaning, but pointed to a proposed rule published in December in which the Centers for Medicare and Medicaid Services (CMS), which oversees Medicare, redefines the term "gross covered prescription drug costs" within Medicare Part D.

"We have proposed a clarification to maintain better consistency with gross expenditures. So that is a proposal that is out there, and the comment period closed on February 13," Seshamani said. "We are processing those comments as we work to finalize that regulation."

CMS said in January it would announce the list of 10 drugs in September. The agency will make its initial offers in February 2024 and the negotiation period will end that Aug. 1. It will publish the final prices a month later, and they will take effect on Jan. 1, 2026.

https://www.yahoo.com/now/u-select-10-costliest-drugs-194436475.html

Travere: Accelerated Approval of FILSPARITM (sparsentan) for Proteinuria in IgA Nephropathy

 First single molecule Dual Endothelin Angiotensin Receptor Antagonist (DEARA) approved for use in patients with

IgA nephropathy (IgAN)

Interim results from the ongoing Phase 3 PROTECT head-to-head trial demonstrated a rapid, sustained and clinically meaningful reduction in proteinuria vs. active control, irbesartan

Company to host conference call February 17, 2023 4:30pm ET

Travere Therapeutics will host a conference call and webcast today, Friday, February 17, 2023 at 4:30 p.m. ET to discuss the FDA accelerated approval and launch of FILSPARI. To participate in the conference call, dial +1 (888) 204-4368 (U.S.) or  +1 (323) 994-2093 (International), confirmation code 6927185. The webcast can be accessed on the Investor page of Travere’s website at ir.travere.com/events-presentations. Following the live webcast, an archived version of the call will be available for 30 days on the Company’s website.

https://finance.yahoo.com/news/travere-therapeutics-announces-fda-accelerated-210400628.html

FBI investigating hack of its own computer network

 The FBI is investigating a hack of its computer network, in an isolated incident that was now contained, the agency said on Friday.

“The FBI is aware of the incident and is working to gain additional information,” the agency said in an emailed statement to Reuters, without providing further details.

CNN, which first reported the incident citing people briefed on the matter, said FBI officials believe it involved computers at its New York office which were used to investigate child sexual exploitation.

It was not immediately clear when the incident occurred. One source told CNN the origin of the hack was still being probed.

The FBI breach is the latest in a series of high-profile U.S. government hacking incidents over the last decade. In late 2020, officials discovered a widespread cyber espionage operation within numerous federal networks by hackers tied to Russian intelligence.

In 2015, the Office of Personnel Management (OPM) announced it too had been hacked and that federal employee records were stolen. The OPM breach was later attributed to Chinese hackers.

https://www.yahoo.com/news/fbi-investigating-hack-own-computer-163741254.html

External backers pour billions into Ukraine to counter war damage

 Pictures of devastation in Ukraine following Russia's invasion have sparked urgent questions over how its reconstruction can be paid for. But before they can even begin to be answered, Kyiv is seeking billions just to ride out this year.

After a 30% contraction in its economy in 2022, Ukraine will need $38 billion by the end of year to cover its budget deficit alone.

"We need these funds for critical costs: funding of salaries and pensions, education and medicine," Prime Minister Denys Shmyhal told a government meeting this week.

"For economic stability and a successful fight against the enemy, Ukraine needs more help."

On top of that, Kyiv said it will need $17 billion this year for urgent energy repairs and de-mining and rebuilding some of its critical infrastructure.

While the EU is expected to provide the lion's share of funds to cover the budget deficit at $18 billion, and Washington a further $10 billion, Kiev has yet to identify sources of funding to meet those additional costs.

It is now pressing for a multi-billion dollar borrowing program from the International Monetary Fund, with the fund meeting the country's officials in Warsaw this week.

The fund approved a four-month monitoring program for Ukraine in December aimed at maintaining economic stability and helping promote donor financing, which should eventually pave the way towards "a possible full-fledged IMF-supported program", it said.

The scope of that program is a source of ongoing debate. This is complicated by the premise that IMF financing is extended to countries that have the "institutional and political capacity and commitment to implement" a fund program, and generally does not include countries at war.

In the past 12 months, Ukraine has received $36.4 billion from external sources, of which nearly 60% were concessional loans and the remainder grants, according to ministry of finance data.

Washington was Kyiv's top lender, providing nearly $13 billion in grants over the period, while the European Union extended just over $11 billion in a mix of grant and loans. Number three was the IMF, with the Washington-based lender providing $2.7 billion.

PRIVATE SECTOR

Aside from help on a national level, a number of multilateral lenders focussed on extending financing to the private sector have also helped shore up Ukrainian firms since the start of the year.

The European Bank for Reconstruction and Development (EBRD) deployed some 1.7 billion euros to Ukraine for investments in vital infrastructure, energy and food security and support for the private sector in 2022.

This has included providing hundreds of millions to Ukraine's railway company Ukrzaliznytsia, power grid operator Ukrenergo and gas firm Naftogaz, as well as private-sector companies.

The lender says it is on track to take the total amount to 3 billion euros by the end of 2023.

The World Bank's private investment arm, the International Finance Corp, also signed off a plan for a $2 billion support package in December, which foresees the lender co-financing in equal measure with governments.

It did not give details of the governments potentially involved, or on the timetable for funds to be released.

Lisa Kaestner, regional manager for Ukraine at the IFC, said the lender was looking for projects in the transportation and communications sector, as well as agribusiness, as Ukrainians work to resurrect businesses disrupted by war.

"Understanding the risk is really challenging," Kaestner told Reuters. "But to me, one of the surprises has been how the private sector has been so resilient."

Both the IFC and EBRD are also among investors in a fund managed by private equity firm Horizon Capital, which in turn invests in tech and export oriented businesses in Ukraine and Moldova. The fund had raised $125 million in a first closing in September, and plans to reach $200 million soon.

Ukraine's costs will only mount from here. The Kyiv School of Economics last month estimated that the total amount of damage the war has caused to the country's infrastructure has risen to $138 billion.

The cost of rebuilding will be dramatically higher.

In September the World Bank estimated rebuilding the country could cost nearly $350 billion. That was before major bombing campaigns by Russia launched in October, and experts predict this number will multiply when the lender publishes its updated assessment in April.

Arup Banerji, World Bank country director for Ukraine, said the nation will need continued financial support going forward.

"An economically weak Ukraine is also militarily weak. If there's hyperinflation, the economy's going under," said Banerji.

"Supporting Ukraine now is critical to avoid a devastating humanitarian crisis and to strengthen Ukraine for what it's doing for the rest of the world."

https://finance.yahoo.com/news/graphic-external-backers-pour-billions-050000811.html