New Nurses` Research Report on California Prop. 61: How Big

For Immediate Release
October 4, 2016
Contact: Charles Idelson, 510-273-2246 or Don Nielsen, 559-647-7732
New Nurses’ Research Report on California Prop. 61:
How Big Pharma Manipulates Patent Laws to Protect
Enormous Profits
Major pharmaceutical corporations exploit patent law, including with minor
variations on existing drugs, to protect and expand their windfall profits, according to
the latest in a series of research reports released today by the California Nurses
Association/National Nurses United (CNA/NNU).
“Game of Patents,” the new research study, notes that “pharmaceutical companies
are gaming the patent process to maintain and prolong their drug monopolies, adding
billions to the costs of health care every year” – at the expense of patients harmed by
skyrocketing drug prices.
The report may be read online at:
http://nurses.3cdn.net/6122b37c9e91af0fbd_35m6b5a24.pdf
“What this report helps expose is a corporate shell game,” said CNA/NNU CoPresident Deborah Burger, RN. “The pharmaceutical companies get government
protection through patents and ‘market exclusivity’ rights for high cost, brand name
drugs. As a result, the drug companies are handed a monopoly with a blank check to
inflate their prices and accumulate enormous profits while blocking patient access to
cheaper, often life saving generic medications.”
Campaigning for Prop. 61 to lower drug costs in Fresno
“In California, we can set a national model for how to begin to rein in the drug
companies by passing Prop. 61 on the California November ballot to lower drug
prices,” Burger said.
“Game of Patents” is the third in the series of pharmaceutical research policy
statements from NNU’s research arm, the Institute for Health and Socio-Economic
Policy (IHSP). The further IHSP research reports can be viewed at:
http://www.nationalnursesunited.org/pages/research
Here’s how the “Game of Patents” works—a four-part scheme in the view of the
nurses.
1.
The initial patents have a 20-year life span. With pharmaceuticals, the
Food and Drug Administration can grant the companies exclusive marketing
rights for up to an additional seven years. During that long span, the drug firm
has monopoly control, meaning no cheaper generic version can be introduced
into the market, permitting the drug manufacturer to “make huge profits
because they are able to charge high prices without fear of competition,” the
paper notes.
2.
“Evergreening.” The drug company makes a very minor modification on
an existing brand name drug, such as tweaking one molecule, which does little
to make the drug more effective, but is considered to be “better than a
placebo.” That can re-start the monopoly protection time span all over for the
“new” drug.
3.
Improving the medical device that administers the drug. Through this
approach the drug company treats the drug and the device as an inseparable
pair, allowing it to also extend the patient protection and delay introduction of
the cheaper generic alternative.
4.
“Pay-to-delay.” As the monopoly patent protection is about to finally
expire, the drug company will pay off a competitor to delay release of the
generic version of the drug. In 2010 the Federal Trade Commission estimated
that the pay-to-delay scheme cost consumers over $3.5 billion a year alone,
primarily through the increased costs of the original brand name drug.
Here’s one example of how the “Game of Patents” can play out:
Suprenza, a weight loss drug is currently owned by Alpex Pharma and distributed by
Citius Pharma. Alpex filed the patent in July, 1998, with it set to expire in July 2018.
But in 2009, Alpex Pharma filed another patent making a slight change in the
appearance.
Alpex described the change this way: “Orally disintegrating tablets containing
colored granules of a water-soluble sugar which give them a speckled appearance are
described. The orally disintegrating tablets with speckled appearance are readily and
easy identifiable by physicians, nurses and patients.” Not a new, improved drug, just
a change in appearance.
The patent was granted, extending monopoly protection to 2029, an extra 11 years
for “colored granules of a water-soluble sugar which give them a speckled
appearance.” For a grand total of 31 years of higher priced patent protection for
Seprenza.
“It may be a game to the drug companies, but it can mean life and death to patients
who are unable to afford the inflated costs of these high-priced medications. We can
take a stand against the drug companies by passing Prop. 61,” Burger said.
Under Prop. 61, the state would be required to pay no more for prescription drugs for
patients it covers than the discount prices, which can be up to 40 percent less, paid by
the Department of Veterans Affairs. CNA, the largest nurses organization in
California, has been campaigning for Prop. 61, citing the calamitous effects on
patients harmed by high drug prices.
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