Sen. Patrick Leahy, D-Vt. (Bonnie Cash/Pool Photo via AP)

Sen­a­tors call on USP­TO to ad­dress phar­ma patent thick­ets be­fore they start

Three Re­pub­li­can and three De­mo­c­rat sen­a­tors on Wednes­day called on the US Patent and Trade­mark Of­fice to at­tack phar­ma patent thick­ets be­fore they start.

Kathi Vi­dal

The let­ter points to these patent thick­ets, or “large num­bers of patents that cov­er a sin­gle prod­uct or mi­nor vari­a­tions on a sin­gle prod­uct,” which can sti­fle com­pe­ti­tion. An ex­am­ple of such a thick­et can be seen with Ab­b­Vie’s Hu­mi­ra, which has been pro­tect­ed by a fortress of more than 100 patents, al­low­ing it to be mar­ket­ed with­out com­pe­ti­tion for more than 20 years as the first biosim­i­lar is com­ing from Am­gen in Jan. 2023.

“In the drug in­dus­try, with the most mi­nor, even cos­met­ic, tweaks to de­liv­ery mech­a­nisms, dosages, and for­mu­la­tions, com­pa­nies are able to ob­tain dozens or hun­dreds of patents for a sin­gle drug. This prac­tice im­pedes gener­ic drugs’ pro­duc­tion, hurts com­pe­ti­tion, and can even ex­tend ex­clu­siv­i­ty be­yond the con­gres­sion­al­ly man­dat­ed patent term,” the let­ter from Sens. Patrick Leahy (D-VT), John Cornyn (R-TX), Richard Blu­men­thal (D-CT), Su­san Collins (R-ME), Amy Klobuchar (D-MN) and Mike Braun (R-IN) said.

So what do they want the USP­TO to do?

Specif­i­cal­ly, the sen­a­tors ask that Kathi Vi­dal, PTO di­rec­tor, con­sid­er changes to its reg­u­la­tions and prac­tices “to ad­dress these prob­lems where they start, dur­ing ex­am­i­na­tion,” adding:

While we still need con­sis­tent av­enues to ad­dress poor qual­i­ty patents af­ter is­suance, this is an op­por­tu­ni­ty to take prompt ac­tion at the preis­suance stage. We are in­ter­est­ed in your views and those of the pub­lic. We there­fore ask that your of­fice is­sue a no­tice of pro­posed rule­mak­ing or a pub­lic re­quest for com­ments by Sep­tem­ber 1, 2022 based on the fol­low­ing ques­tions, with re­spons­es due with­in six­ty days.

The ques­tions fo­cus on elim­i­nat­ing so-called “ter­mi­nal dis­claimers,” which al­low ap­pli­cants to re­ceive patents that are ob­vi­ous vari­a­tions of each oth­er as long as the ex­pi­ra­tion dates match.

“Should the USP­TO re­quire a sec­ond look, by a team of patent qual­i­ty spe­cial­ists, be­fore is­su­ing a con­tin­u­a­tion patent on a first of­fice ac­tion, with spe­cial em­pha­sis on whether the claims sat­is­fy the writ­ten de­scrip­tion, en­able­ment, and def­i­nite­ness re­quire­ments of 35 U.S.C. § 112, and whether the claims do not cov­er the same in­ven­tion as a re­lat­ed ap­pli­ca­tion?” they ask. “Should there be height­ened ex­am­i­na­tion re­quire­ments for con­tin­u­a­tion patents,2toen­sure that mi­nor mod­i­fi­ca­tions do not re­ceive sec­ond or sub­se­quent patents?”

Michael Car­rie

The sen­a­tors al­so seek to con­sid­er whether the USP­TO might im­ple­ment a rule change that re­quires any con­tin­u­a­tion ap­pli­ca­tion for a patent to be filed with­in a set time frame of the ul­ti­mate par­ent ap­pli­ca­tion.

“We are con­cerned about the preva­lence of con­tin­u­a­tion and oth­er high­ly sim­i­lar patents,” they added. “The Patent Act en­vi­sions a sin­gle patent per in­ven­tion, not a large port­fo­lio based on one cre­ation. But con­tin­u­a­tions now ac­count for al­most a quar­ter of all patent fil­ings. We are con­cerned this could mean the USP­TO is grant­i­ng mul­ti­ple patents for one in­ven­tion, in con­tra­ven­tion of the statu­to­ry text.”

Michael Car­ri­er, dis­tin­guished pro­fes­sor at Rut­gers Law School, told End­points News on the sen­a­tors’ re­quests, “Some of the leg­is­la­tion Con­gress has con­sid­ered ad­dress­es con­duct far down the line, in the lit­i­ga­tion con­text, and wouldn’t ad­dress the fun­da­men­tal prob­lem. This could have a more di­rect ef­fect, tak­ing aim at a cen­tral as­pect of patent prac­tice that some have crit­i­cized for lead­ing to too many patents.”

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Am­gen takes next step with its Chi­na am­bi­tions, out-li­cens­ing drugs to Fo­s­un Phar­ma

In a bid to increase its market share in China, Amgen has agreed to a partnership with a Shanghai biotech — a collaboration and out-licensing agreement for two of its drugs.

Amgen and Fosun Pharma announced a deal Monday in a bid to increase Amgen’s presence in the country. The stated goal so far is to commercialize Amgen’s blockbuster psoriasis drug Otezla alongside Parsabiv, a drug for secondary hyperparathyroidism in adults with chronic kidney disease and on a specific type of dialysis.

As court case looms, Bris­tol My­ers touts la­bel ex­pan­sion for Breyanzi

As Bristol Myers Squibb braces for a court battle over a costly delay — at least for Celgene shareholders — for its CAR-T lymphoma treatment Breyanzi, the pharma giant is touting a label expansion in the second-line setting.

Breyanzi, also known as liso-cel, snagged a win on Friday in adults with large B-cell lymphoma (LBCL) who: don’t respond to chemotherapy, or relapse within 12 months; don’t respond or relapse after 12 months; or are not eligible for hematopoietic stem cell transplant after chemo due to their age or comorbidities.

Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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