Oncolytics Biotech Inc T.ONC

On GLP-1 agonists US Senate passes anti-patent thicket bill

[Noteable]

July 12, 2024 - The Federal Trade Commission has challenged the validity of over 100 drug product patents, focusing on devices used to deliver medicines, like inhalers and autoinjectors, in an effort to increase competition and potentially lower some prices. 

The targeted patents cover devices that propel medicines for asthma and emphysema into the lungs or inject epinephrine to treat a severe allergic attack. Drugmakers list them in the FDA’s “Orange Book,” which can afford the products greater protection from generic competition. 

Many of the medicines delivered by the devices are decades old, years off patent. But manufacturers have long tweaked the delivery methods, patenting the changes, in ways that sometimes make the drugs more convenient to administer. 

They might, for example, change the propellant in an inhaler or add a counter that tells a patient how many doses are left. Autoinjectors mean patients don’t see a needle or syringe but merely press a device with a hidden needle against the skin to deliver the medicine. Some autoinjectors even talk patients through the process. 

The move is critically important because drugmakers frequently extend the 20-year patent protection of a drug by changing the delivery device or method. For example, instead of a pill, they make a capsule. Or instead of a dose every six hours, they create a longer-acting, once-a-day version. They can also alter the process by which a drug is made — so-called “process patents.”

https://kffhealthnews.org/news/article/federal-trade-commission-fda-orange-book-drug-patents-epipen/

https://www.pharmalive.com/senate-unanimously-passes-bill-to-reduce-big-pharma-patent-thickets-increase-competition/

[Noteable]

Such action will impact and preclude certain biologics like antibody-drug conjugates (ADC) and engineered vaccines / viruses from adding varius payloads or seperate transgenes to their original patented products, all in an effort to expand their product's effectiveness or expand their market share / product lifecycle through strategies like "product hopping" or "evergreening

[Noteable]

In advance of the US Senate's action against patent thickets, Big Pharma such as Sanofi had 'front-run' this devvelopment by announcing the off-loading of their consumer healthcare divisions, which are heavily protected by patent thickets, in favor of increasingly pronounced investments in biologic therapeutics that target unmet needs and rare diseases in the immunology and oncology

[Noteable]

The US Senate's passing of the anti-patent thicket bill impacts all biotech/pharma companies who previously relied on establishing a patent thicket strategy to protect their market exclusivity. Going forward, the original product will be patentable, while subsequent claims on variations to the origibal product will not.  Consequently, the 13 years of market exclusivity from the date of

[Noteable]

As a result of the US Senate's passing of the anti-patent thicket bill on July 12, 2024, a common tactic of layering patents on top of a single producr to extend marketing protections, "process" or "utility" patents that had been used in the past and filed on incremental improvements of the original product in an effort to extend patent exclusively, will no longer hold

[Noteable]

July 15, 2024 - "While patent cliffs are looming for many of biopharma’s top-selling products, the industry has enormous capacity to respond as “conditions for M&A are favorable,” according to a research note from Morgan Stanley.  The US Senate's passing of the anti-patent thicket bill on July 12, 2024 will consequently prompt Big Pharma to accelerate and expedite their M&A

[CaseyL]

I dont think ONCY's results and improvements are going to be a incremental help. It should be profound? 

[Peladawn]

I believe I remember Matt Coffee saying during Asco , that pela wasn't going to be game-changing.....it was going to be revolutionary! (or something along those lines)....

[Peladawn]

Sorry,,,, that should read....'Asco 2023'.

[Peladawn]

Well, looks like Schumer and Obama and all their cronies have figured out how to get rid of Biden.....all it takes is a little Covid juice injected into Biden's weekly IV, and he gets sick, right when the Dems are pushing hard for him to leave....if they do their job really well, the old guy could die from covid.

[Azzak34]

Maybe we shouldn't be getting silly with the death comments right now.  Serious question and I'm genuinely interested in a conservatives opinion. How can Trump be against the "deep state" when he makes Peter Thiels boy his running mate and is going to install Jamie Demon as Fed Chairman? Make that make sense. 

[Peladawn]

The Dems don't care what happens to Biden....all they care about is power....who is Peter Thiels?.....btw, JD Vance is an ex Marine.....he ain't anyone's "boy"....but go ahead and try to trash him.....the Dem's can't run on any policy successes, so all they have is insulting Republicans...

[itntdf]

btw, lee harvey oswald was an ex-marine.

[Azzak34]

It's painful how uninformed you are, yet you're so diehard with this stuff.  Oh he's his boy alright, look it up. You right leaning folks love a conspiracy.... Thiel is an open member of Bilderberg. What do you think that means?  What about Jamie Demon for Fed chair? Is that draining the swamp?  Stop following the crowd.... look in to things and form your own

[Peladawn]

It's not painful how completely uninformed you are because it's so hilarious that all you have are insults....you're completely blind to the corruption in the Biden family, and make out like some mindless attack dog against anyone Republican the second they step up....save your ridiculous accusations and insults for the image in the mirror 

[Azzak34]

I'm all in on their corruption.... it should absolutely be investigated. I've been consistent about that the entire time. Everyone should be held to a single standard. If you're not going to Indict JB for the documents you can't indict DT for it.... you must be consistent. All I want is consistency, integrity and fairness in the application of the law and/or morality. 

[Peladawn]

What a shame that you and so many others are so brainwashed that you totally ignore the 20% inflation, the two completely avoidable wars going on right now because of Biden's failures, the disgusting ongoing criminal border crisis that has allowed over ten million illegals to simply walk in to this country, many of whom have been sexually assaulting and murdering innocent Americans, and all

[13X2413]

Yep, it was game changing....he's no longer involved. 

[Buckhenry]

We would feel much better if the fda  said it was revolutionary... we can see what the price has done with Matt's words and fireside chats...  

[Noteable]

August 28, 2024 - The USPTO’s May 2024 proposed anti-patent thicket rule, which promotes competition by lowering the cost of challenging groups of patents linked by terminal disclaimers, is also proposed to result in reduced barriers to market entry. Under the proposed USPTO rule, “if you invalidate one, the whole thing falls,”  On the legislative side, currently there are two major

[Noteable]

February 23, 2024, -  The latest chapter in the complex and multifaceted Daiichi Sankyo Inc. v. Seagen Inc.[Pfizer] patent dispute — concerning antibody-drug conjugate technology, or ADC, and pitting Seagen against Daiichi and its collaborator, AstraZeneca — concluded recently. On Jan. 16, the Patent Trial and Appeal Board issued a final written decision in a post grant review proceeding

[Noteable]

For Pfizer and it's US$43 Billion acquisition of Seagen and the subsequent invalidation of Seagen's U.S. Patent No. 10,808,039, which is the cornerstone of the trastuzumab-deruxtecan ADC product,  [ comprised of an anti-human HER2 (anti-HER2) antibody, an enzymatically cleavable peptide-linker, and a proprietary topoisomerase I inhibitor payload (exatecan derivative or

[Noteable]

The board's decision in Seagen is not surprising. Rather, it is consistent with the U.S. Patent and Trademark Office's guidelines for assessing enablement in utility applications and patents. The PTO guidelines were issued on Jan. 10 in view of the U.S. Supreme Court's May 2023 decision in Amgen Inc. v. Sanofi. The guidelines provide for continued application of the Wands factors in

[Noteable]

As lawyers at Sullivan IP Solutions see it, Pfizer shouldn’t have gone to the federal court, because “an arbitrator’s award is rarely overturned,” especially as the arbitrator was a retired federal court judge who has tried numerous pharmaceutical cases. Seagen [and by implication Pfizer's due diligence] should have been more vigilant in monitoring its collaborator’s activities in the first

[Noteable]

Should read: " ... Pfizer's right to its trastuzumab-deruxtecan ADC product will now have to be under license from Daiichi-Sanyo ..." with royalties having to be paid from Pfizer to Daiichi Sanyo on any negotiated licensing agreement.

[Noteable]

By example - July 12, 2024 - "Pfizer inadvertently gave a leg up to two obesity biotechs yesterday with the announcement that an extended-release formulation of oral med danuglipron will be advanced into dose optimization studies. The New York-based Big Pharma is hoping to recover from earlier data that showed a twice-daily formulation of oral danuglipron led to modest weight loss with a