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How Big Pharma Plays Games with Drug Patents and How to Combat it

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July 23, 2019

President Donald Trump came into office promising to do something about the inflated prices Americans pay for prescription drugs. He considered limiting rebates to the middlemen between insurance plans and drug companies but recently concluded that the complex plan was unworkable.

This leaves policymakers back at square one. And it leaves Americans with a number of questions. Should they just resign themselves to paying more for their meds? Should they insist on price controls? Is there something in between?

One reason Americans pay more for drugs is the same as why they pay more for overnight hospital stays, or lab tests, or catheters, or just about anything related to health care. The American system gives providers enormous powers to dictate prices by socializing costs.

But drug companies overcharge in ways that are unique to their industry. And many of these can and should be addressed in ways that would lower prices, at least marginally. The most promising involve combating the games drug companies play with patents.

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Patents on drugs are generally good for 20 years. That includes the time it takes to get the proper approval, so companies expect anywhere from seven to 12 years of protection.

The length balances two conflicting interests: rewarding drugmakers that develop useful medicines, and getting less expensive generics into the hands of users.

PhRMA: Patents yield real benefits for patients

The pharmaceutical industry has shown contempt for this attempt at balance through a range of abusive tactics. Two common, and sometimes related, maneuvers are called “evergreening” and “thicketing.”

Evergreening involves making small alterations to a drug — a slight change to its chemical composition, say, or an external change as minor as adding a stripe to a pill — and then filing a new patent application.

Thicketing involves deluging the Patent and Trademark Office and the courts with so many patents and applications, the system essentially locks up.

AbbVie, a recent spinoff from Abbott Laboratories, uses this tactic to extraordinary advantage, surrounding its wildly profitable anti-inflammatory drug Humira with a fortress of more than 100 patents.

Perhaps the most shameless gamesmanship — fortunately rejected in a recent Supreme Court ruling — was Allergan’s ruse for protecting its eye medication Restasis. It transferred nominal control of the drug to the St. Regis Mohawk Tribe, then claimed that the tribe’s sovereign immunity shielded it from any review by the patent office.

To some degree the answer to abuses like these is to give the patent office considerably more resources to review — and reject — spurious patents. But that will require lawmakers to stand up to an industry that plied them with campaign contributions even as it fueled the opioid crisis and jacked up prices for long-established medications such as insulin.

Date: 23/07/2019

Source : Usa Today

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