Al­ler­gan faces fresh woes with Resta­sis patents as Wal­green, re­tail­ers file law­suit over 'an­ti­com­pet­i­tive con­duc­t'

Al­ler­gan’s patent trou­bles with Resta­sis mush­roomed on Wednes­day when four ma­jor US re­tail­ers teamed up to sue the drug­mak­er for a string of al­leged an­titrust vi­o­la­tions.

Plain­tiffs Wal­green, Kroger, Al­bert­sons and HEB put it this way in a scathing com­plaint:

Al­ler­gan un­law­ful­ly main­tained its mo­nop­oly through a scheme that in­clud­ed, in­ter alia, mak­ing ma­te­r­i­al mis­rep­re­sen­ta­tions and omis­sions to the Unit­ed States Patent and Trade­mark Of­fice (“PTO”) that al­lowed it to ob­tain patents to which it was not en­ti­tled; im­prop­er­ly list­ing those patents in the FDA’s Or­ange Book; su­ing gener­ic com­peti­tors for al­leged in­fringe­ment of those in­valid and un­en­force­able patents; and then trans­fer­ring own­er­ship of the in­valid patents to a sov­er­eign Na­tive Amer­i­can tribe in or­der to avoid ju­di­cial scruti­ny of the patents.

Brent Saun­ders

It’s no se­cret that Al­ler­gan has been keen to pro­tect its Resta­sis fran­chise, con­sid­er­ing that the dry eye drug brought in $1.5 bil­lion in US sales last year. When the patent was due to ex­pire in 2014, the Dublin-based drug­mak­er filed — and re­ceived af­ter some hic­cups — new patents to keep gener­ics at bay. CEO Brent Saun­ders al­so OK’d a wide­ly crit­i­cized scheme to trans­fer the IP to a Mo­hawk tribe and then es­sen­tial­ly lease it back in an at­tempt to get around the dread­ed in­ter partes re­view of its patents.

With gener­ic com­peti­tor My­lan bring­ing its own law­suits, the ad­di­tion­al patents were lat­er in­val­i­dat­ed, the Mo­hawk deal tossed out by the Patent Tri­al and Ap­peal Board. And now the re­tail­ers, hav­ing born the brunt of “ar­ti­fi­cial­ly in­flat­ed” prices, want their mon­ey back.

If not for Al­ler­gan’s “an­ti­com­pet­i­tive con­duct,” Wal­green et al rea­sons, gener­ics would have been avail­able on or short­ly af­ter the patent ex­pi­ra­tion date of May 17, 2014. Not on­ly should the scheme stop now; it should al­so en­ti­tle the re­tail­ers to triple the dam­ages in ad­di­tion to costs of suit and at­tor­ney’s fees.

The case, num­bered 18-02907, was filed in the fed­er­al court in the East­ern Dis­trict of New York, which over­sees na­tion­wide lit­i­ga­tion against Resta­sis.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Nurses star in J&J's campaign centered on the importance of nurses who are increasingly stressed, burnt out and quitting the profession (via Johnson & Johnson)

Thank­ful for nurs­es: J&J's new cam­paign aims to re­set pan­dem­ic clock back to grat­i­tude

In the early days of the pandemic, people cheered for nurses – delivering food, writing thank you notes and ringing bells nightly to show their appreciation. But something shifted this summer, and now Johnson & Johnson wants to remind people of the gratitude that nurses still deserve.

Call it politics or pandemic weariness or the result of almost two years of a deadly pandemic, but nurses today face threats and mistreatment from patients and their angry family members. And nurses are leaving the profession in record numbers.

Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Drug­mak­ers cut prices on av­er­age by more than 60% to get on Chi­na's 2022 NDRL list — re­port

China’s National Reimbursement Drug List (NRDL) is a crystal clear example of the country’s bargaining power in the biotech and pharma market, as more firms have reportedly agreed to cut their prices for 67 new medicines to be included in its national medical insurance coverage starting in January.

Being on the list is lucrative. Essentially, if a biotech or pharma company gets on this list, they’re covered by the biggest insurance network in the country. Given China’s vast population, the Chinese government has significant leverage to decide which medicines can make a profit. While domestic drugmakers are quite willing to play that game, cutting prices significantly in exchange for getting on the list, international companies don’t do it as often.