Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Am­gen said it was en­cour­aged by the so­lic­i­tor gen­er­al’s an­tic­i­pat­ed re­view of its Supreme Court pe­ti­tion to re­hear a Repatha patent case. They’re like­ly much less op­ti­mistic about the out­come now.

So­lic­i­tor Gen­er­al Eliz­a­beth Prel­og­ar wrote in a re­cent 27-page brief that Am­gen’s ar­gu­ments “lack mer­it and fur­ther re­view is not war­rant­ed.”

The case traces back to a suit filed in 2014 against Sanofi and Re­gen­eron’s Pralu­ent, which end­ed up beat­ing Am­gen’s PC­SK9 block­buster Repatha to mar­ket by a month just a year lat­er.

Both an­ti­body drugs are de­signed to con­trol LDL cho­les­terol, of­ten called “bad cho­les­terol” be­cause it can in­crease pa­tients’ risk of heart dis­ease and stroke. They work by pre­vent­ing PC­SK9, a nat­u­ral­ly oc­cur­ring pro­tein, from bind­ing to and even­tu­al­ly caus­ing the de­struc­tion of LDL re­cep­tors in the liv­er.

Am­gen ini­tial­ly sued Sanofi and Re­gen­eron be­fore the drugs went to mar­ket, seek­ing to block the sale of Pralu­ent. De­spite sales com­ing in high­er than Pralu­ent’s, nei­ther drug reached ex­pec­ta­tions com­ing out of the gate, and both com­peti­tors cut their prices sig­nif­i­cant­ly a few years ago. Pralu­ent sales reached about $124 (€128 mil­lion) last quar­ter, while Repatha earned $154 mil­lion.

Am­gen scored a win in 2019, but a fed­er­al judge in Delaware lat­er over­turned that ver­dict and ruled in fa­vor of Sanofi and Re­gen­eron. That de­ci­sion was then up­held in the Court of Ap­peals for the Fed­er­al Cir­cuit.

“It has been our long­stand­ing be­lief that all of Am­gen’s as­sert­ed U.S. PC­SK9 patent claims are in­valid, and we are pleased that the So­lic­i­tor Gen­er­al rec­om­mends that the Supreme Court not grant Am­gen’s pe­ti­tion for cer­tio­rari,” a Re­gen­eron spokesper­son said in an email on Fri­day. Am­gen did not re­spond to a re­quest for com­ment as of press time.

Am­gen took the case all the way to the Supreme Court, which back in April called on the so­lic­i­tor gen­er­al to weigh in. The phar­ma gi­ant ar­gued in its pe­ti­tion that the low­er court’s de­ci­sion would have a dev­as­tat­ing im­pact on in­no­va­tion, and sev­er­al com­pa­nies filed a “friend of the court” brief in sup­port, in­clud­ing Bio­gen, Bris­tol My­ers Squibb and Mer­ck.

“If left un­changed, the de­ci­sion be­low could slow the pace of re­search and de­vel­op­ment and hin­der in­no­va­tion, to the detri­ment of pa­tients and the pub­lic at large,” they wrote. “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.”

A pan­el of judges pre­vi­ous­ly ruled that “[d]raw­ing a broad fence around sub­ject mat­ter, with­out fill­ing in the holes, is not in­vent­ing the genus.”

“Am­gen is en­cour­aged by the Supreme Court’s re­quest for the So­lic­i­tor Gen­er­al’s views on the is­sues pre­sent­ed in Am­gen’s pe­ti­tion,” a spokesper­son told End­points News in April. “Am­gen is seek­ing re­view by the Supreme Court be­cause we, and oth­ers in our in­dus­try, view the is­sues we present as vi­tal­ly im­por­tant in sup­port­ing in­no­va­tion.”

Now it’s up to the Supreme Court to de­cide whether to take the case — though if you ask Prel­og­ar, the an­swer is no, it shouldn’t.

“Pe­ti­tion­ers con­tend that the court of ap­peals erred by treat­ing en­able­ment as a ques­tion of law and by ex­am­in­ing the full scope of the claims in as­sess­ing whether they are ful­ly en­abled,” she wrote. “Those ar­gu­ments lack mer­it and fur­ther re­view is not war­rant­ed.”

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.

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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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.

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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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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PhRMA calls for more di­verse in­fra­struc­ture up­grades to US emer­gency tri­als frame­work

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.