Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosim­i­lars in­dus­try has gen­er­al­ly been a dis­ap­point­ment since its in­cep­tion, with FDA ap­prov­ing 33 biosim­i­lars since 2015, just a frac­tion of those have im­me­di­ate­ly fol­lowed their ap­provals with launch­es. And more than a hand­ful of biosim­i­lars for two of the biggest block­busters of all time — Ab­b­Vie’s Hu­mi­ra and Am­gen’s En­brel — re­main ap­proved by FDA but still have not launched be­cause of le­gal set­tle­ments.

Part of the rea­son that many of these brand-name bi­o­log­ic com­pa­nies have proven suc­cess­ful at block­ing biosim­i­lar com­pe­ti­tion is through their use of patent fortress­es, de­signed to make it im­pos­si­ble, or ex­treme­ly ex­pen­sive, to wage le­gal bat­tle.

In 2018, for ex­am­ple, Ab­b­Vie’s Hu­mi­ra was cov­ered by 132 patents, Roche’s Avastin (which now has biosim­i­lar com­pe­ti­tion) was cov­ered by 86 patents and Her­ceptin (which al­so now has biosim­i­lar com­pe­ti­tion) by 108 patents.

Re­searchers are now un­cov­er­ing the ex­tent to which sec­ondary patents (i.e., not the ones cov­er­ing the ac­tive in­gre­di­ent) have played a ma­jor role in stunt­ing the growth of the biosim­i­lars in­dus­try.

“Among patents as­sert­ed in US biosim­i­lar lit­i­ga­tion, on­ly 6% cov­ered the ac­tive in­gre­di­ent in the bi­o­log­ic drug, while the vast ma­jor­i­ty cov­ered us­es or pe­riph­er­al fea­tures of the drug, such as its man­u­fac­tur­ing process­es or de­liv­ery de­vices. The me­di­an time of patent fil­ing was more than a decade af­ter ap­proval of the orig­i­na­tor bi­o­log­ic, and one-fifth of the patents had no equiv­a­lents — ei­ther patents or patent ap­pli­ca­tions — in the Eu­ro­pean Union, Cana­da or Japan,” re­searchers at Har­vard Med­ical School and the Cum­ming School of Med­i­cine at the Uni­ver­si­ty of Cal­gary wrote in a new Na­ture Biotech­nol­o­gy in­ves­ti­ga­tion.

While not­ing that sec­ondary patents filed a me­di­an of more than a decade af­ter a bi­o­log­ic’s ap­proval “were pre­dom­i­nant­ly in­volved in the lit­i­ga­tion af­fect­ing the mar­ket en­try of biosim­i­lars for nine key bi­o­log­ic drugs,” they al­so said their find­ings un­der­score con­cerns about the weak­ness­es of the US patent sys­tem, adding:

Al­though patent­ing stan­dards are sim­i­lar across ju­ris­dic­tions, their ap­pli­ca­tion by US patent ex­am­in­ers can be less strin­gent, a trend that has been at­trib­uted to sub­op­ti­mal re­source al­lo­ca­tion among oth­er rea­sons. For ex­am­ple, three ex­am­in­ers eval­u­ate a patent ap­pli­ca­tion in the Eu­ro­pean Union com­pared to one in the Unit­ed States. Patent ex­am­in­ers in the Unit­ed States al­so process more than dou­ble the num­ber of patents or claims an­nu­al­ly than Eu­ro­pean Patent Of­fice ex­am­in­ers. While our study found that many sec­ondary patents are at is­sue in biosim­i­lar ef­forts to en­ter the US mar­ket, an­oth­er study found the main hur­dle to mar­ket en­try of biosim­i­lars for 9 top-sell­ing mon­o­clon­al an­ti­bod­ies in Eu­rope was the key patent on the orig­i­na­tor prod­uct, not sec­ondary patents.

But some who track the biosim­i­lar in­dus­try close­ly don’t have near­ly as omi­nous of an out­look as oth­ers, some of whom think biosim­i­lars should just be scrapped for bi­o­log­ic price con­trols af­ter a cer­tain cut-off date.

Ron­ny Gal

Bern­stein an­a­lyst Ron­ny Gal said in a note last sum­mer that while the US mar­ket has been stag­nant re­cent­ly, he pre­dict­ed it will re­turn to growth as new mol­e­cules launch, with biosim­i­lars to Lu­cen­tis and Hu­mi­ra com­ing in the next 12 months.

“If this sounds to some of you like the gener­ic mar­ket cir­ca 2005, we tend to agree,” he wrote. “Fur­ther, we sus­pect this was not lost on some of some of the ear­ly win­ners in the biosim­i­lar mar­ket. They seem to be be­gin­ning to pur­sue next-stage strate­gies, e.g. No­var­tis go­ing to mid-size biosim­i­lars, Co­herus en­try to fol­low-on PD1, Pfiz­er and Am­gen launch­ing late-en­trant biosim­i­lars at prices above the mar­ket. There is an­oth­er decade of growth here (the gener­ics peaked in 2015) but the days of just de­vel­op­ing the largest five drugs and be­ing suc­cess­ful be­cause com­peti­tors made mis­takes are prob­a­bly reach­ing their end.”

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

(Credit: Shutterstock)

Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Rep. Katie Porter (D-CA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

House Dems to Sen­ate lead­er­ship: Quick­ly move a rec­on­cil­i­a­tion bill with drug price ne­go­ti­a­tion re­forms

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.

Phillip Gomez, SIGA CEO

UP­DAT­ED: On the back of SIGA Tech­nolo­gies' win with the FDA, the mon­key­pox virus sees the com­pa­ny spring­ing to fur­ther ac­tion

As the cases of monkeypox now sit at well over 100 worldwide and have spread to multiple continents, the orders for any type of vaccine against monkeypox are seeing nations and medical bodies looking to get their hands on anything and everything. And now SIGA Technologies seems to be getting in on the action.

According to Euronews, SIGA Technologies, a pharmaceutical company that is focused on providing medical countermeasures to biological and chemical attacks, is now in talks with several European authorities looking to stockpile its antiviral that can counter monkeypox. The drug known as tecovirimat or Tpoxx was approved by the FDA in 2018 as a vaccine for smallpox but was approved by the European Medicines Agency to also act against monkeypox, cowpox and complications from immunization with vaccinia.

Bris­tol My­ers Squibb sues No­var­tis for roy­al­ties sur­round­ing the use of trans­genic mice

Two Big Pharma companies are going to the mat over genetically modified mice in a licensing dispute.

Bristol Myers Squibb is suing Novartis in New York over a dispute concerning an evaluation, research and commercialization agreement stretching back to the late ’90s initially inked between Novartis and BMS’ predecessor Medarex. The deal in question allowed Novartis to use Medarex’s patented transgenic mice to develop therapeutic drugs. Novartis agreed to pay Medarex – and subsequently BMS – a royalty on sales of drugs it developed using the mice.