THE REFILL: The Latest Dosage of Rx Patent Abuse

WHAT YOU NEED TO KNOW:

  • In an important step toward reining in Big Pharma, the Senate Judiciary Committee approved yesterday the bipartisan Affordable Prescriptions for Patients Act, sponsored by U.S. Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT), despite pushback from Big Pharma.
  • Matthew Lane, executive director of the Coalition Against Patent Abuse: “We thank Senators Cornyn and Blumenthal for their leadership in the face vigorous opposition from PhRMA and BIO who are determined to protect the ability of their member companies to abuse America’s patent system. There is more work to be done, and our Coalition looks forward to working with all stakeholders on this and other proposals to rein in Big Pharma’s rampant patent abuse.”
  • Jeffrey Francer, general counsel of the Association for Accessible Medicines: “The possibility of enhancing and accelerating the patent dance could make a great contribution to lowering drug prices….it makes much more sense for the brand to pick a subset of patents and litigate on that capped amount.”

WHAT WE SAID:

  • CAPA Statement: CAPA Calls Cornyn/Blumenthal Bill A First Step Towards Ending Big Pharma’s Patent Abuse “CAPA applauds Senators Cornyn and Blumenthal’s bipartisan legislation for its efforts to prevent the major drug companies from gaming the U.S. patent system in pursuit of higher profits. It’s a first step in the right direction, with significant future action by Congress still needed to end Big Pharma’s blatant patent abuses that protect their monopolies at the expense of suffering patients.”
  • CAPA Statement: CAPA Praises Another Bipartisan Effort To Stop Big Pharma’s Patent Abuse “CAPA praises Representatives Jeffries, Collins, Mucarsel-Powell and Cline for their bipartisan efforts to prevent Big Pharma from exploiting the U.S. patent system to block patients from accessing alternative and affordable medications and treatments. For far too long, Big Pharma has abused and manipulated the patent system at the expense of patients. With American patients paying up to 65% more for prescription drugs than patients in other Western countries, we need Congressional action to stop Big Pharma from exploiting the patent system in order to raise the healthcare costs of all Americans.”
  • CAPA Statement: New AARP Report Underscores Urgent Need For Patent Reform for Prescription Drugs “This report underscores the importance and urgency of patent reform. For decades, Big Pharma has been abusing the U.S. patent system in order to block patients from accessing alternative and affordable medications. They employ underhanded tactics that extend their monopolies far beyond what the law intended. As a result, drug makers have free reign to jack up the prices of life-saving treatments, leaving patients without the medicines they need to survive.”

WHAT YOU SHOULD BE READING:

BIG PHARMA’S LATEST GAME OF PATENTS

San Antonio Express News: Big Pharma Active In Blocking Patients From Affordable Medicine

Studies show that generic competition dramatically reduces drug prices. With access to generic and biosimilar drugs, the U.S. Food and Drug Administration estimates that costs reduce to just 20 percent on average of Big Pharma’s sticker prices. Generics saved American consumers a total of $265 billion in 2017. Not surprising, Big Pharma has already begun to fight tooth and nail to defeat this bill and mislead Americans because keeping the status quo intact serves its best interest. We witnessed that in a recent op-ed written by Texas Republican political consultant Matt Mackowiak who, despite having no apparent policy background or expertise in patent law or even health care, opined that patent protection is critical to innovation.

Real Clear Health: Tillis-Coons Bill Would Undo Major Supreme Court Rulings Preventing Big Pharma’s Patent Abuse

This attempt to promote Big Pharma’s interests by overturning decades of Supreme Court precedent will have disastrous impacts on competition, innovation and patients. Patents on knowledge itself gives groups like Big Pharma a de facto monopoly on new discoveries which they will extend using exploitive tactics like patent thickets. Furthermore, with no one else in the market to compete with, Big Pharma will be free to raise prices on lifesaving treatments and medications. For a bill that seeks to enhance innovation, the Tillis- Coons bill accomplishes the exact opposite. It will lead to increased prescription drug prices, reduced access to life saving treatments and medications and de-incentivize research and development. If Congress truly wishes to promote innovation, they should reject this counter-productive piece of legislation, authored by high-powered lobbyists of major drug companies and instead focus on ways to curb Big Pharma’s rampant abuse of the patent system.

Washington Times: Civil Liberties Groups Fear Congress Rewrite Of Patent Laws On Genetic Testing

Mr. Tillis, chairman of a subcommittee that oversees the latter, has held three hearings to get feedback on his draft bill, and received some warnings about the risks of expanding patenting. “Brand-name drug companies could seek to patent every conceivable implementation — from isolated genes to computerized methods of research and development — to lengthen their patent monopolies far beyond the periods contemplated by Congress,” Jeffrey Francer, general counsel for the Association for Accessible Medicines, told lawmakers. He said that could reverse attempts to lower drug prices and deny patients access to diagnostics and treatments. Mr. Tillis said the feedback they’ve gotten from the hearings will be incorporated in a final bill, which they expect to introduce in July. “We need further refinements,” he said.

IAM Media: Alice Inventor – Why More Needs To Be Done On The Tillis And Coons 101 Proposal
The reason I believe that, if implemented, the Bill would effectively eviscerate all current tests of patent eligibility is this: today, virtually no patent claim in any of the five proposed exclusion categories would be worded in a form that would not pass a ‘practical application’ test (whatever it eventually is). Consequently, virtually no claims would fall into the proposed ‘otherwise ineligible claim’ category. This means that the “Ensure that simply reciting generic technical language or generic functional language does not salvage an otherwise ineligible claim” test would rarely, if ever, be applied. Then, without a “new and useful” test, virtually all claims would be patent eligible.

POLICY PROGRESS

Bloomberg Government: Drug Patent Cap, Pharma Bills, Sail Through Senate Committee
Elliot Dube
The legislation is aimed at eliminating patent games, like when a drugmaker files additional patents for a product not because they’ve changed the product but to protect their exclusivity rights. Companies will be limited on the number of additional patents they can file for a product. Patents that fall under certain categories will be limited—for example, new patents filed for old products.

US Congressman Hakeem Jeffries: Rep. Jeffries Introduces Bipartisan Legislation To Lower Skyrocketing Cost Of Prescription Drugs
Yesterday, Representative Hakeem Jeffries (NY-08) and Representative Doug Collins (GA-09) introduced the bipartisan “Terminating the Extension of Rights Misappropriated” (TERM) Act of 2019. This legislation would address the rising cost of prescription drugs by significantly limiting the process known as “evergreening”, whereby pharmaceutical companies make minor changes to a drug and file for a new patent on those trivial changes in order to extend their exclusivity and maintain high prices. The bill is co-sponsored by Representative Debbie Mucarsel-Powell (FL-26) and Representative Ben Cline (VA-06).

Pink Sheet: Patent Thicketing Provision Cut From Bill Passed By US Senate Judiciary Committee
Brenda Sandburg
The Association for Accessible Medicines was pleased with the addition of the provisions on patent infringement litigation between biosimilar and brand manufacturers. “The possibility of enhancing and accelerating the patent dance could make a great contribution to lowering drug prices,” AAM general counsel Jeff Francer said in an interview. Rather than having to engage in litigation of 70 or more patents, “it makes much more sense for the brand to pick a subset of patents and litigate on that capped amount.” During the mark-up, bill co-sponsor Sen. John Cornyn, R-TX, said the manager’s amendment includes “important changes to ensure we are targeting only those bad actors and not meaningful developments in the biopharmaceutical field.”

Politico Pro: Tillis, Coons Promise Changes In Patent Reform Bill
Sens. Thom Tillis (R-N.C.) said today that he and Sen. Chris Coons (D-Del.) will rework the draft of their patent reform bill to assure that it does not sanction “vague business methods” or strangle research. A final draft will be ready sometime after the July 4 recess, he said. Some of the 45 witnesses invited to three hearings on the bill this week and last warned that the draft could allow companies to patent genetic information in a way that blocked medical research. Supreme Court precedent establishes that “abstract ideas” and “laws of nature” are not eligible for patents, but Tillis and Coons have said that it’s often up to patent examiners to decide whether inventions fall into those categories.