@usefewersyllables @usefewersyllables @usefewersyllables

The Chinese patent system is different than the Western one. I know several people who have been successful patenting their ideas there and getting paid for them. The Chnese enforce their own laws, not necessarily, foreign countries'. Ive also, as I am sure you have, heard some really horrible stories from Western companies about counterfeiting of western goods or copying their names and then claimning to be them, or other forms of outright fraud is common.

But the advice is always to get a Chinese lawyer to help you navigate their system, first.

NASA has publicized how dangerous the counterfeiting of electronic parts can be. Sometimes causing catastrophic failures. Sometimes its almost comical how much effort is put into a counterfeit.

And so on. Its normal now for US companies to manufacture goods in China but is it always the best idea? You are exposing your technology to them. As far as electronics, Its become so affordable to make your own PCBs and even populate them yourself, home manufacturing makes more sense sometimes.

You can do pick and place at home. I know of one guy who set up an entire highly automated factory in his garage.

ex-Senator from MBNA was never going to do a damned thing about debt of any flavor: he's always made his living by fellating the lenders. Many of us pointed out his history at the time of his anointment, to no avail.

However, I would suggest that people tread more carefully when slagging off "IP Enforcement" as a monolithic entity aimed strictly and only at fleecing them.

It is currently quite fashionable to use IP as a club against the drug companies, and I can't speak to that. On the other hand, I can speak to the impact of patent and IP violations in other industries. As an example, the last consumer product I designed was knocked off verbatim by nameless Chinese companies within 4 months of its introduction into the marketplace. Identical products (right down to the marks on the PC boards, and the code loaded in the microprocessor) appeared on the docks in Chengdu with only the logo on the outside changed, FOB for less than half our wholesale price- in 4 months!

My (US-based) employer had paid me (and the rest of the technical staff) for the year it took to do the design, and to get all the regulatory approvals and other niceties that go into making a viable product. But they immediately lost significant market share, and the revenue needed to recoup that investment, as a result. And other than getting the FTC to ban the import of the knockoffs to the US, they had no recourse.

IP enforcement can keep the lights on at companies, and that keeps people employed. People- people like you, and me. It is not a uniformly bad thing; it is not merely a cudgel used to pound the consumer into a pulp and milk them for their last dimes.

It certainly can be abused, and definitely is being abused in some cases. But please do not make the mistake of throwing the baby out with the bath water. There is a lot of gray here, much of it actually beneficial, in what is often now being presented as a black-and-white they-only-exist-to-screw-us issue.

@usefewersyllables @usefewersyllables @usefewersyllables

Created by deals between countries, contracts. For example, to get such high drug prices, we must trade away the jobs,that other countries want.

Are you familiar with the Xandi story?

https://www.latimes.com/business/story/2022-02-10/xtandi-pricing-prostat...

Column: The government could force a price cut for this prostate cancer
drug by as much as 80%. Why hasn’t it acted?

BY MICHAEL HILTZIK

FEB. 10, 2022 6 AM PT

Xtandi, a wonder drug for prostate cancer, was developed at UCLA with
substantial funding from the taxpayers through the Pentagon and the
National Institutes of Health.

UCLA has profited handsomely from the drug, to the tune of more than $520
million in royalties. The drug companies that acquired the manufacturing
license, including Pfizer and the Tokyo firm Astellas Pharma, have also
raked in billions in sales.

American taxpayers and prostate cancer patients haven’t done as well.
Xtandi’s average wholesale price in the U.S. comes to $189,800 a year.

Prostate cancer is disproportionately a disease of older men, so much of
the cost falls on Medicare, which has become the largest single customer
for the drug; Medicare spent more than $5.8 billion on Xtandi from its
introduction in 2012 through 2019, the last year for which the figure is
available. In some years, the drug has been among the top 10 costliest
drugs for Medicare.

Deductibles and co-pays can bring the out-of-pocket cost of Xtandi even for
Medicare enrollees to nearly $10,000 a year. “For many people who are
contending with prostate cancer, that’s real hardship,” says Robert Sachs,
a retired telecommunications executive who has been an Xtandi patient.

The drug is so expensive at the wholesale level that private insurers place
it in the highest co-pay categories; some won’t allow doctors to prescribe
it without their prior approval, further narrowing patients’ access.

The excruciating problem of high drug prices in the U.S. arises from
multiple dysfunctions of our healthcare system, including unrestrained
profiteering by drug companies, overly indulgent patent policies and the
failure of the government to get tough with the pharmaceutical industry.

The case of Xtandi — or enzalutamide, to use its generic name — is a nearly
perfect illustration of how these ailments magnify one another.

Accordingly, it has become a test case for the government’s willingness to
exploit its legal rights to force drugmakers to slash U.S. prices. Bringing
those prices down to the level seen in countries such as Canada, Australia
and Japan could reduce spending on Xtandi by as much as 80%.

The tools to achieve these discounts are arguably available to the U.S.
government today.

Sachs and other cancer patients, supported by the nonprofit consumer group
Knowledge Ecology International, have petitioned the Department of Health
and Human Services to exercise its legal right to unilaterally license the
manufacture of drugs that have been partially funded by the public but that
aren’t being commercialized in the public interest.

The agency has hinted that it might make a decision on the request as early
as this month, whether by approving or rejecting the petition or scheduling
hearings on the request.

HHS rejected a similar petition during the Obama administration, but the
political ground may have shifted since then, as frustration with
prescription prices has only intensified. In July, President Biden signaled
in an executive order that he may be open to more aggressive government
approaches to reducing drug prices.

The government’s ability to force drugmakers to bring U.S. prices down,
therefore, is now very much in play.

UCLA no longer has a dog in the Xtandi fight: Its sale of the license
rights in 2016 ended its role in the drug’s marketing or sales. Pfizer
obtained a share of the rights through a corporate acquisition in 2016.

The drug has become a major product for Pfizer and Astellas, so any
reduction in the price could have an impact on the companies’ revenues.

Pfizer referred questions to Astellas, which told me through a U.S.
spokesperson that Xtandi “is priced in line with other oral therapies for
advanced prostate cancer available in the U.S. today and is widely
available for patients across the health insurance marketplace.” Astellas,
which controls the pricing of Xtandi, has raised the price by nearly 90%
over the last eight years, according to calculations by Knowledge Ecology.

The key factor in the debate is the Bayh-Dole Act of 1980, which governs
the exploitation of products developed with federal funding. Bayh-Dole
allowed private companies to commercialize inventions that grew out of
federally funded research, but it reserved certain rights for the
government to protect the taxpayers’ investments.

Chief among them are “march-in rights,” which allow the government to
require that a federally funded drug be licensed to other manufacturers, or
to offer a license itself to alternative drugmakers to ensure that the drug
is widely accessible, if it concludes that a manufacturer hasn’t taken
sufficient steps to make a product publicly available or hasn’t brought it
out on “terms that are reasonable.”

The government has never exercised its march-in rights, though it has
occasionally threatened to do so to extract concessions from manufacturers.
HHS, the NIH and industry lobbyists have maintained that march-in rights
were not designed to be used to bring prices down, but that’s disputable.

The debate hinges on how to define “reasonable” terms. The law’s authors,
former Sen. Birch Bayh (D-Ind.) and the late Sen. Bob Dole (R-Kan.),
maintained in 2002 that the language had nothing to do with “the pricing
... or the profitability of a company” that held a license for a product
developed with government support.

Rather, they said, the march-in rights were aimed at cases in which a
company hadn’t commercialized the product at all.

But others suggest that the law goes further than Bayh or Dole
acknowledged. The obstacle hasn’t been the law’s intent, but the
unwillingness of government agencies to exercise it fully in the public
interest.

“In general, it’s hard to imagine that price is not a ‘reasonable term,’”
says Aaron Kesselheim of Harvard Medical School, the coauthor of a memo to
HHS Secretary Xavier Becerra supporting the Xtandi petition.

“You could imagine that there could be a price at which a product was
unobtainable,” Kesselheim told me. “Certainly the high prices of drugs
these days are causing substantial strains for payers leading to high
out-of-pocket costs. That’s relevant to the availability of a drug.”

Several factors make Xtandi a perfect test case for these issues. One is
the enormous discrepancy between its prices overseas and what Americans
pay: The $189,800 average wholesale price for a year’s supply in the U.S.
is more than 5.5 times the roughly $33,000 cost in Canada or Australia and
six times the $31,600 price in Japan.

Another is that the expense falls heavily on federal taxpayers, who have
shouldered Medicare’s $5.8 billion in Xtandi spending through taxes,
co-pays or higher Medicare premiums.

Furthermore, the U.S. government’s rights to Xtandi are indisputable. Its
role in the invention, through the funding provided by the NIH and Defense
Department, is cited on each of the three patents covering the drug, which
expire in 2026 and 2027. Each states forthrightly that “the Government has
certain rights in the invention.”

Such rights are becoming ever more important because the government’s role
in biomedical research is growing.

A 2020 study found that “NIH funding contributed to research associated
with every new drug approved from 2010-2019, totaling $230 billion.” Much
of that may be basic research that doesn’t necessarily contribute to
specific new drugs, but Kesselheim and colleagues at Harvard have shown
that “publicly supported research had a major role in the late stage
development of at least one in four new drugs” approved by the Food and
Drug Administration from 2008 through 2017.

March-in rights aren’t the only tool available to the government. According
to an analysis published Wednesday in the New England Journal of Medicine
by philanthropist Alfred Engelberg, with the collaboration of Kesselheim
and Jerry Avorn of Harvard, Bayh-Dole entitles the government to “an
irrevocable, automatic license that vests in the government” when it has
funded a patented product.

That allows the government to authorize manufacturing by generics firms,
which could bring versions at a steep discount compared with the branded
price.

Drugs manufactured under the government license may only be used by
government programs — Medicare, Medicaid and the Department of Veterans
Affairs, for instance.

But that could be enough to provide the government with immense leverage to
force Pfizer and Astellas to bring down the U.S. price. As it happens, two
companies have already received tentative approval from the FDA to
manufacture generic enzalutamide.

The licensing provision can be taken up without the administrative hurdles
that the march-in provision might require — “it’s just a matter of the
government using this power,” Kesselheim told me.

The NIH has long taken the position that any use of march-in rights or
government licensing rights to force prices down would choke off industry
collaboration with government science agencies. But that’s scarcely
plausible, given the magnitude of public funding.

Indeed, the Xtandi petitioners observed in a recent memo to Becerra that
the federal government’s contract with Pfizer for the COVID-19 treatment
paxlovid contains a “most favored nation” clause requiring the company to
offer the drug to the U.S. at the lowest price charged in Canada, Japan, or
five European countries.

The same clause applied to Xtandi would cut its average annual price from
$189,800 to about $30,000, the price in Japan.

The government has never directly exploited its license rights. But it did
wield them as a cudgel in 2001, when Bayer, the manufacturer of the
antibiotic ciprofloxacin, placed a high price on the drug when the
government was trying to build a stockpile for use against potential
anthrax attacks. In that case, the threat prompted Bayer to cut its price
in half.

Xtandi obviously isn’t the only drug raising the question of whether the
public is getting its money’s worth from its billions of dollars in support
for the pharmaceutical industry. The petition for march-in rights may face
an uphill path.

But Sachs maintains that if the agency at least holds a hearing and
“there’s a finding that Astellas has grossly discriminated against U.S.
patients, it would send a clear message that if you’re going to develop a
drug with U.S. taxpayer funding, that doesn’t give you freedom to charge
whatever you want and gouge people.”

ex-Senator from MBNA was never going to do a damned thing about debt of any flavor: he's always made his living by fellating the lenders. Many of us pointed out his history at the time of his anointment, to no avail.

However, I would suggest that people tread more carefully when slagging off "IP Enforcement" as a monolithic entity aimed strictly and only at fleecing them.

It is currently quite fashionable to use IP as a club against the drug companies, and I can't speak to that. On the other hand, I can speak to the impact of patent and IP violations in other industries. As an example, the last consumer product I designed was knocked off verbatim by nameless Chinese companies within 4 months of its introduction into the marketplace. Identical products (right down to the marks on the PC boards, and the code loaded in the microprocessor) appeared on the docks in Chengdu with only the logo on the outside changed, FOB for less than half our wholesale price- in 4 months!

My (US-based) employer had paid me (and the rest of the technical staff) for the year it took to do the design, and to get all the regulatory approvals and other niceties that go into making a viable product. But they immediately lost significant market share, and the revenue needed to recoup that investment, as a result. And other than getting the FTC to ban the import of the knockoffs to the US, they had no recourse.

IP enforcement can keep the lights on at companies, and that keeps people employed. People- people like you, and me. It is not a uniformly bad thing; it is not merely a cudgel used to pound the consumer into a pulp and milk them for their last dimes.

It certainly can be abused, and definitely is being abused in some cases. But please do not make the mistake of throwing the baby out with the bath water. There is a lot of gray here, much of it actually beneficial, in what is often now being presented as a black-and-white they-only-exist-to-screw-us issue.

@gjohnsit

is illegal to put into the laws of any country that has joined the WTO GATS, right? We joined it in 1994.

If a country that joined WTO already had it they can probably keep it as long as its completely noncommercial and they have no competition for it, and they don't change anything. But if they do change anything it has to conform to the new rules that we signed in 1994.

and ending the wars.