Blue­bird bio was hit with a patent in­fringe­ment law­suit last week from a Chica­go-based biotech it has had an on­go­ing beef with call­ing for $2 bil­lion to help cure the “ir­repara­ble harm” caused by al­leged will­ful in­fringe­ment.

Blue­bird bio is fac­ing a law­suit from Er­rant Gene Ther­a­peu­tics for vi­o­lat­ing patent law in two in­stances, the com­pa­ny says.

The suit al­leges that blue­bird in­fringed the rights of EGT’s re­com­bi­nant vec­tors used in the gene ther­a­py treat­ment of rare dis­eases such as sick­le cell dis­ease and be­ta tha­lassemia for its drugs Zyn­te­glo and Lenti­Glo­bin. EGT has an ex­clu­sive li­cense from the Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter to patents ti­tled “vec­tor en­cod­ing hu­man glob­al gene and use there­of in treat­ment of He­mo­glo­binopathies.”

Nick Leschly

In 2016, Er­rant said that blue­bird and Third Rock, a ven­ture cap­i­tal firm co-found­ed by blue­bird CEO Nick Leschly, blocked their gene ther­a­py from reach­ing the mar­ket. In 2010, Er­rant was set to start clin­i­cal tri­als with MSK and NIH, and Third Rock met with MSK and “ad­mit­ted” that the Er­rant vec­tor was bet­ter than blue­bird’s.

That, Er­rant al­leges, led to a se­cret agree­ment to stall the de­vel­op­ment of Er­rant’s vec­tor. MSK de­mand­ed that Er­rant find a com­mer­cial part­ner as a con­di­tion be­fore start­ing clin­i­cal tri­als — but de­spite Er­rant ful­fill­ing that con­di­tion, MSK re­ject­ed the con­tract and in­stead ini­ti­at­ed ar­bi­tra­tion against Er­rant, the drug de­vel­op­er claimed in the law­suit.

EGT, which changed its name to San Roc­co Ther­a­peu­tics in May, was es­tab­lished in 1993 by CEO Patrick Giron­di af­ter his son Roc­co was di­ag­nosed with be­ta tha­lassemia, an in­her­it­ed blood dis­or­der. Er­rant de­vel­oped the vi­ral vec­tor along­side MSK in 2000. Er­rant con­tact­ed MSK sci­en­tist Michel Sade­lain, who pub­lished a pa­per show­ing the po­ten­tial of the gene ther­a­py in mice, and start­ed to fund his re­search. Five years lat­er, Er­rant bought ex­clu­sive rights of the tech for blood dis­or­ders, and the com­pa­ny patent­ed the vec­tor in 2009.

MSK grant­ed Er­rant an ex­clu­sive com­mer­cial li­cense in 2005, the law­suit states.

The lat­est suit al­leges that blue­bird will­ful­ly in­fringed on two of Er­rant’s patents. In Sep­tem­ber, blue­bird was grant­ed break­through des­ig­na­tion for its gene ther­a­py for be­ta tha­lassemia.

“Blue­bird has en­gaged and con­tin­ues to en­gage in non-reg­u­la­to­ry con­duct and post-FDA sub­mis­sion ac­tiv­i­ties re­lat­ed to the com­mer­cial­iza­tion of the BB305 vec­tor, which in­fringes on the ‘179 and ‘061 patents,” the law­suit states.

This cur­rent law­suit high­lights blue­bird’s ramp-up of com­mer­cial man­u­fac­tur­ing in the US for the BB305 vec­tor, as well as stock­pil­ing and oth­er com­mer­cial­iza­tion ac­tiv­i­ties for the vec­tor that Er­rant says “are not rea­son­ably re­lat­ed to ob­tain­ing FDA ap­proval.”

Ac­cord­ing to the law­suit, EGT claims it has suf­fered ir­repara­ble harm, and asks for $2 bil­lion. It says that its own gene ther­a­py is slat­ed to cost more than $1 mil­lion less than blue­bird’s, which is pro­ject­ed to cost $2 mil­lion per pa­tient. Leschly caused jaws to drop in 2019 when he an­nounced that it would have a price tag of $1.8 mil­lion per pa­tient, just be­hind No­var­tis’ spinal mus­cu­lar at­ro­phy ther­a­py treat­ment Zol­gens­ma for the crown of most ex­pen­sive treat­ment.

The law­suit has been a long time com­ing. In Au­gust 2019, the New York Supreme Court sanc­tioned blue­bird for $25,000, and re­ject­ed its ef­forts to pre­vent EGT from pro­ceed­ing with a law­suit by hold­ing the com­pa­ny in con­tempt.

Despite the controversy of housing it in NIH, HHS Secretary Xavier Becerra on Wednesday afternoon formally announced the establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the NIH, as HHS had previously stipulated that “NIH may not subject ARPA-H to NIH policies.”

Becerra also announced the appointment of ARPA-H’s inaugural employee, Adam Russell, who will serve as acting deputy director.

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.