Am­gen los­es ap­peal in patent suit against Sanofi/Re­gen­eron’s Pralu­ent. It’s a bum­mer for Bris­tol My­ers Squibb and Mer­ck, too

In a co­da to a six-year le­gal fight on the PC­SK9 ter­rain, the US Fed­er­al Court of Ap­peals has ruled that Am­gen’s patent claims for PC­SK9 an­ti­bod­ies as a class are in­valid, hand­ing a win to Sanofi and Re­gen­eron.

The im­pli­ca­tions, though, may re­ver­ber­ate far be­yond Am­gen.

The Thou­sand Oaks, CA-based com­pa­ny, whose Repatha was ap­proved a month af­ter Pralu­ent in 2015, may take com­fort in the fact that its sales have con­sis­tent­ly eclipsed Sanofi or Re­gen­eron’s, al­though nei­ther has climbed any­where near the block­buster ex­pec­ta­tions de­vel­op­ers and an­a­lysts had.

Am­gen first took Sanofi and Re­gen­eron to court be­fore those drugs went on the mar­ket, seek­ing to block the sale of Pralu­ent. While a ju­ry and a judge have pre­vi­ous­ly sided with Am­gen — go­ing so far as to grant an in­junc­tion against Sanofi and Re­gen­eron (a stay was soon is­sued) — in late 2019, a US judge over­turned that ver­dict and ruled in fa­vor of the heavy­weight drug part­ners. It was a bit­ter loss for Am­gen’s fa­mous­ly ag­gres­sive lawyer corps, which has scored high-pro­file vic­to­ries such as the megablock­buster case against No­var­tis’ gener­ics arm San­doz.

That de­ci­sion, by the US Dis­trict Court in Delaware, was up­held in the Court of Ap­peals for the Fed­er­al Cir­cuit.

Joseph LaRosa, EVP, gen­er­al coun­sel and sec­re­tary at Re­gen­eron, said the rul­ing helps to “pro­vide clo­sure” on the patent is­sue now that they have fend­ed off all five of Am­gen’s as­sert­ed claims against Pralu­ent.

But in an am­i­cus brief filed in March, Bris­tol My­ers Squibb and Mer­ck sug­gest­ed it sends an un­wel­come mes­sage not just for Am­gen but oth­er “in­no­va­tor com­pa­nies” who care about patent pro­tec­tion.

The tough­est part of cre­at­ing a suc­cess­ful an­ti­body drug, they ar­gued, is to find the right tar­get and ap­pli­ca­tion; once those are iden­ti­fied, “it is easy to cre­ate vari­a­tions.” From the fil­ing:

The paten­tee, hav­ing in­vest­ed enor­mous sums in dis­cov­er­ing the un­der­ly­ing tar­get, has pro­vid­ed a blue­print for oth­ers who, now aware of the tar­gets, can quick­ly make their own ver­sion of an ef­fec­tive an­ti­body. The scope of the in­ven­tion in this space is there­fore the genus of an­ti­bod­ies that suc­cess­ful­ly binds the tar­get, rather than any par­tic­u­lar an­ti­body that serves as an ex­am­ple. […]

The Court’s con­clu­sion ig­nores the in­volved time, ef­fort, and cre­ativ­i­ty that it took the in­ven­tors to come up with the con­cept in the first place, to test it again and again to make sure it is ro­bust, and then to pro­vide their roadmap to the world.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

NIH re­jects an­oth­er at­tempt to 'march-in' on prostate can­cer drug over ex­ces­sive price

The National Institutes of Health (NIH) has declined to use so-called “march-in” rights to lower the price of Astellas’ prostate cancer drug Xtandi even as the federal government helped to pay for its development.

NIH told prostate cancer patients Robert Sachs and Clare Love, in a NIH Decision Letter and shared with Endpoints News, the institutes’ analyses found Xtandi “to be widely available to the public” and “given the remaining patent life and the lengthy administrative process involved for a march-in proceeding, NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug.”

No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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Mar­ket­ingRx roundup: What could a US Tik­Tok ban mean for phar­ma? Pfiz­er, Lil­ly lead phar­ma March Mad­ness ad­ver­tis­ers

Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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European Commissioner for Health Stella Kyriakides (AP Photo/Francisco Seco, Pool)

One fi­nal push: EU phar­ma in­dus­try group de­mands com­pe­ti­tion check on in­com­ing leg­isla­tive over­haul

The Brussels-based European Federation of Pharmaceutical Industries and Associations (EFPIA) this morning called on the European Commission to ensure that it adequately assesses how its re-writing of the 20+-year-old pharma legislation, which is due to be released before the end of the month, damages the competitiveness of the pharma industry.

EFPIA’s opposition to the changes has lingered since the beginning, and its latest estimate is that the rewritten legislation could cost the industry €640 million ($688 million).

FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

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