THE REFILL: Latest Dosage of Rx Patent Abuse


  • DID YOU KNOW: The Inter Partes Review (IPR) Process is a Low-Cost Alternative to Traditional Patent Litigation and is Regularly Used to Knock Down Erroneously Issued Patents?

    Bad patents hold up generic and biosimilar drug competition and keep prices high, costing billions every year.  Thankfully, IPR was created as part of the 2011 America Invents Act (AIA) and is an effective alternative to resolve disputes over whether a patent was properly granted.  This is a much faster process than district court litigation and is less costly.  However, some brand name companies have continued to abuse the patent system over the last decade to extend drug monopolies that can last decades and keep America’s drug prices the highest on Earth. 

    Fortunately, the “Restoring the America Invents Act” introduced by Senators Leahy (D-VT) and Cornyn (R-TX) will strengthen IPR process and correct certain interpretations of the AIA in ways that will address anti-competitive tactics used to abuse the patent system. 

Read more about the solution introduced Senators Leahy and Cornyn here

  • ICYMI: PCMA Released Recommended Policy Solutions to Lower Drug Prices, Points to Patent Abuse as Key Factor in Big Pharma’s Ability to Keep Drug Prices High
    This week, the Pharmaceutical Care Management Association (PCMA) released a report titled “Drug Manufacturer Strategies for Keeping Drug Costs High” with Visante in which they point to the strategies drug makers use to keep prices high.  Among these strategies are delaying generic and biosimilar competition through abusing the patent system, particularly through patent infringement litigation and patent thickets. 
    • “Drug manufacturers utilize a variety of patent strategies to extend their patent protection beyond the initial 20-year period.  One strategy is to create ‘patent thickets’ by filing additional patents on the same drug after the drug is approved by the FDA.” 

The report found that patent thickets for five blockbuster drugs – Humira, Enbrel, Keytruda, Revlimid and Imbruvica – created $500 billion in additional sales.  

Ultimately, it is crucial that Congress works to close patent loopholes exploited by some major pharmaceutical companies and increase avenues for generic and biosimilar drugs to enter the marketplace.

Read the full report here  


Bio Pharm International: Generic-Drug Makers Also Fight Price Controls
Jill Wechsler

  • The Democratic legislative proposal to authorize price negotiations on costly medicines covered by Medicare and to penalize firms that raise prices faster than inflation has drawn vehement opposition from brand pharmaceutical and biotech companies. More surprising is that manufacturers of generic drugs and biosimilars also are objecting loudly to those policy changes on the table. Dan Leonard, president of the Association for Affordable Medicines (AAM),says that the reforms under consideration by Congress would limit patient access to more affordable generics and biosimilars by thwarting competition.

American Journal of Managed Care: AAM Panel Of Manufacturers Says Drug Price Rebates Must Go 
Tony Hagen                                                                                                     

  • Drug price rebates negotiated between manufacturers and drug middlemen such as pharmacy benefit managers would have been halted under a policy sought by the former Trump administration; however, this initiative has been put on the back burner by President Joe Biden. Anshuman Patwardhan, PhD, MBA, senior vice president of biologics licensing and global development for Lupin Pharmaceuticals, said implementing the antirebate policy would have improved the competitive landscape for biosimilars, but the impact on the federal budget had not been clearly thought out, “so I’m not surprised it’s not getting implemented.”