Halozyme Therapeutics Incorporated (HALO) News

Yes, of course. No one knows the future with 100% certainty. But investing is all about assigning the best educated probabilities to future events.
So far and based on the share price action of Halozyme (outperforming its XBI and IBB peers) since the post-registration filling from Merck and also since the lawsuit , it is clear that market participants think Halzoyme has the upper hand. So do the patent attorney and the 4 AI platforms that I submitted all Merck and Halo's legal filings to.

As I’ve previously noted. Litigation is risky for both sides and could go either way. I hope Biotech investor and biotech bold guy are right and that halo will prevail but trying to guess what is going to happen is a waste of time. I really feel this is the end of uncertainty for halo one way or another. If they prevail then the stock will quickly finds new highs in at least the low hundreds per share.
If they lose we could see low forties again and a long time to climb back. Last time Helen lost with peg she was well prepared and stock went up and hasn’t really changed that ascent. Curious what plan B is for this pivotal moment.

Anyway the bickering back and forth is entertaining for now so keep it up.

Why don't post what AI in korea says? 

please, instead of AI answer, please send me the opinion of a patent expert. In Korea, if you use ChatGP, Merck will win.

You said you have been active on this board for 15 years. Then you must have studied and know a lot about Halozyme. However, you must have been deeply immersed in Halozyme and not even considered other people's opinions. You will only believe that what you think is right and it may be full of errors.

Merck knows they started Alteogen right after finding HALO had the perfect solution. They started Alteogen in S. Korea to
make this complicated...it's not! Spending a decade to change a peptide doesn't make it anything but a copy of HALO's
perfect patents.

Here is the latest AI legal analysis having reviewed all submitted legal documents by both parties:
"Impact on Licensing AgreementThe lawsuit shifts the licensing dynamics:- Increased Pressure on Merck: The April 24 lawsuit, seeking damages and an injunction, threatens SC Keytruda’s September 2025 launch. With Keytruda’s $29.5 billion 2024 sales and $12 billion SC market potential, an injunction could cost Merck significantly. Halozyme’s 70%+ PGR success odds strengthen its litigation position, as surviving PGRs uphold patent validity.- Halozyme’s Leverage: The ’035 POPR’s strength, mirroring prior filings, signals Halozyme’s confidence. Its $7.3 billion market cap, 76.5% margin, and Enhanze revenue ($1.015 billion 2024) support litigation, while nine licensed products (e.g., Darzalex SC) prove its deal-making model. Torley’s licensing push (3-7% royalties) aligns with analyst views (Evercore’s 1% as “modest” for Merck, “windfall” for Halozyme).- Merck’s Risks: Merck’s 10 PGRs and Alteogen partnership ($4.317 billion ALT-B4 deal) show commitment to fighting, but PGR failures and litigation make a $870 million–$2 billion royalty deal (3-7%) attractive. Alteogen’s claim of patent clearance is untested in court, and FDA approval looms (September 23, 2025).-
Updated Licensing LikelihoodThe lawsuit escalates tensions but paradoxically increases settlement likelihood by raising Merck’s risks. Halozyme’s strong PGR defenses (70% average success) and litigation leverage (injunction threat) outweigh Merck’s PGR aggression and Alteogen reliance. I adjust the likelihood of a licensing agreement to 70%, up from 60%, reflecting:- PGR Strength: Halozyme’s 75% chance in PGR2025-00009 and 70% overall bolster patent validity, pressuring Merck to settle.- Litigation Pressure: The injunction threat and litigation costs make a 3-7% royalty deal ($870 million–$2 billion annually, with $130–$160 million milestones) more appealing than fighting, especially with SC Keytruda’s launch deadline.- Strategic Timing: Halozyme’s fillings suggests a calculated push for negotiations before PTAB decisions (July 2025) or FDA approval. Merck may settle to avoid delays.
Caveats:- If PTAB institutes PGRs (30% chance), Merck may delay settlement, hoping for invalidity by July 2026, though Halozyme’s substantive arguments remain strong.- If the court denies a preliminary injunction, Merck’s resolve to fight could harden, lowering settlement odds to ~50%.- Alteogen’s role and Merck’s confidence in non-infringement (untested in court) introduce uncertainty.
ConclusionHalozyme’s PGR2025 strengthens its defense, giving a 75% chance of blocking institution, driven by Merck’s date error and discretionary denial arguments, with robust §112 and §103 rebuttals. Across all PGRs, Halozyme’s success is ~70%, reinforcing patent validity. The April 24 lawsuit boosts the likelihood of a licensing agreement to 70%, as Merck faces mounting pressure from PGR risks, litigation costs, and SC Keytruda’s launch timeline. A 3-7% royalty deal remains the most likely outcome, potentially by Q3 2025, before FDA approval or PTAB rulings. Monitor PTAB decisions (July 2025), court filings (e.g., injunction motions), and Merck’s Q2 2025 earnings for settlement signals."

No. What you are saying is not common industry practice at all. Most corporations prefer to make deals/agreements and have ongoing royalty payments and postive business relationships than make enemies and spend money on attorneys unless they have no other choice. 
You, Alteogen fan boys really know how to post comments that are completely opposite of common sense, don't you? 
I'm getting tired of correcting you guys. I hope some of the other fellow posters can do more than just liking my posts and respond to your nonsense.

Apparenty YOU are!
Which is it then: MDASE is too broad and therefore MDASE patents should be revoked (Merck's claim) or it's not broad enough as to cover the Hybrozyme? You can't have it both ways. If there was no overlap between MDASE and Hybrozyme patents, Merck would not have appealed to revoke MDASE patents.
I know you are feeling bamboozled and frustrated when I point out the obvious self-contradictions and comedy in your position but keep it civil or I will ask to have you removed from this board.
I am not a patent attorney and neither are you. But I have been on this board for over 15 years and as a biopharma investor since early 1990's and a physician with decent attorney connections, I have feeling I know at least a bit more than you do. As a newbie to this board, all you have done so far is to regurgitate the self-contradictory arguments of Alteogen and Merck which of course are biased and baseless. Any one with common sense can see this.

If Halozyme was confident, it should have filed a lawsuit instead of requesting a royalty agreement from the beginning. If Merck clearly infringed Halozyme's technology, it would have been able to receive a larger amount of royalty through a lawsuit rather than a settlement.

HEY, You're not stupid enough to not be able to distinguish between the first and 600 patents, are you?

If I've talked about the patent content, you should mention seq id no:3 or P or F, ask a patent attorney's friend who doesn't even exist Be sure to ask him what I said. Not AI.

That's comical, on one hand you (Merck) claim that halozyme's MDASE are too broad (per Merck's post-regstrstion apeal), on the other hand, you (Alteogen) claim that there is no overlap between MDASE and hybrozyme.
You are talking from both sides of your mouth. You are the one who needs to consult an expert. Everyone I have talked to says Merck infringed and will pay for it.

It's fun to keep insisting without knowing the patent content.
Give evidence and say it doesn't make sense ROFL.
As HALO claims, The 600 patent may be included in the scope of ALT-B4, but this is a clear violation of the enablement requirement,

And Merck's PGR claim is purely a patent strategy,
If Halozyme files a lawsuit, it can interfere with the release date at any time due to a ban on sales, but if the PGR is in progress, the lawsuit will be suspended.
You're really looking at it in pieces.

DO NOT INSIST AND GO and ASK TO YOUR FREIND OF PATENT ATTORNY.
AND REPLY ME BY PATENT.

Actually, I think we got some evidence today that the market thinks halo will get a slice, albeit most likely a small one, of SC Keytruda. Bad news for Summit’s drug, a competitor to keytruda, around 11:30 am ET seems to have caused gains for both Merck and Halo soon after.

You know what you claim makes zero sense. Ask yourself, if Hybrozyme (Alteogen) is so materially distinct and different from MDASE as you claim, why on earth would Merck go through the trouble of appealing to US patent review board to invalidate/revoke MDASE patents? The answer is simple, Merck knows it and alteogen are infringing on MDASE patents and they are trying (and failing) to get away with it.

I didn't want to talk about the patent details because I was lazy, but I'm telling you because you keep mentioning it.
Well, you don't know anything about patents, but you should ask patent attorney friend.
According to the scope of the MDASE initial application patent right (claim paragraph 1), F at the 204th position of SEQ ID NO: 3 of the protein structure is replaced by P.

However, ALT-B4 did not use seqid no:3, nor did it change the F in position 204 to P.
It is a completely different material from the first patent.

Next, 600patent is -> The seq id no :3 and no:32-36 is a number greater than 63 wins of 10, which is a violation of the enablement requirement. Now in litigation with Merck.
The reason why it is not being sued as an initial patent but is being PGR with 600 patents is because it is a material different from the MDASE first patent.

BTW, I'm sure you know but for the sake of anyone else reading this who might not know (eg, Alteogen fan club) the documents for MDASE were filed back in 2011 and long before Alteogen was granted the patent for Hybrozyme (I believe in 2019).
So when you say "prior art never considered or read by the original, ex parte examiner before issuance of the patent," I assume you meant the hybrozyme (Apteogen) patent was issued erroneously and without the careful considerations of the existing prior art (MDASE). 

No opinion at this time. I did add more shares of HALO to our portfolio. We have had LTCGs in both HALO and MRK for many years. I became interested in HALO because of much earlier holdings in CDMO, a supplier of raw material for use in HALO's pipeline. I'm basically finished deploying the 650k LTCG derived from those 2 hedge funds acquisition of CDMO and taking it private. I'm still wondering whether HALO will ultimately buy some or all of the manufacturing facilities Avid (trading as CDMO) had built in California. 
I bought MRK shares after completion of expert witness work on its behalf in litigation. 

It's nothing new. He has been pessimistic since Halozyme was trading at eight dollars a share. Hence the title parmabear.

Why so pessimistic???
Some really good news could come out of this.
Just so HAPPY to see the shares going up.

If they do settle out of court, HALO will probably have to accept a 1% royalty. Helen would then call that "lower mid-single digits". 🤥

The fact that Merck has much more at stake to loose than HALO increases the odds that they might not be willing to chance it and pay the licensing fee.

There is plenty of tell, you choose not to see:
1) Halozyme has outperfomed XBI over the past 3, 6 and 12 months (and past 1 and 5 year) as well as today and yesterday (since the law suit news broke out). You can see this dor yourself on a comparison charts
2) Halozyme has outperformed both Merck and Alteogen since the law suit news. Alteogen is down 5% since the news.
3) One of the most bearish analysts on halozyme, JP Morgan's Jeasica Fye, is now including Merck's Keytruda SC into her halo earnings forecast for 2025.
4) AI and patent attorneys give halo the upper hand in the post-registration and think an an MDASE licensing agreement between Merck and Halo is the most likely outcome.
5) Not a single dollar in halozyme's guided earnings/profits through to 2030 are at risk with the outcome of this patent dispute. Halo has not included any earnings from MDASE in its guidance yet. If halo wins, the additional earnings will be icing on the top of the cake. Once Merck signs a deal or loses in court, Astra Zeneca and other Alteogen partners will sign as well (additional icing)
6) It is possible that some new (Enhanze only) potential partners might wait to see what happens with this patent dispute. But remeber that no one else has thd the rapid HVAI technology but halo. Rapid HVAI is the innovation that will bring multiple new partners and ensure earnings growth past mid 2030's.

If Keytruda has so many nasty side effects: (see website)
https://www.keytruda.com/side-effects/?cid=PPC-accountype:MICROSOFT-campaign:Keytruda+Pan+Tumor_Brand_BRND_NA_ENGM_EXCT_TEXT_NA-searchterm:keytruda+side+effects-adgroup:Side+Effects_General-keywordid:p29663041378&utm_source=bing&utm_medium=cpc&utm_campaign=Keytruda%20Pan%20Tumor_Brand_BRND_NA_ENGM_EXCT_TEXT_NA&utm_term=keytruda%20side%20effects&utm_content=Side%20Effects_General&utm_kxconfid=sq7irm3mh&gclid=f674638cf67f137b431e0b877b841002&gclsrc=3p.ds&
What would the local area's immediate reaction be where a subq. injection is administered?

I'm learning as we go. MS cut the MRK PT from $106 to $99 for MRK, but tariffs were the main cause I believe.
(Interestingly, I read that Keytruda represents about 50% of MRK's total sales.)

So far there is no market tell as to how the patent case will go, so that leads me to think it's 50-50.
Another tell is the fact that there have been no new deals; so that also says potential partners are waiting to see what happens.
This says, to my mind anyway, 50-50 chance of failure/success. Not great odds and I don't like gambling.

Alteogen is down 5%

It's hard to tell how the market feels about all of this. JPM raised their PT only by $3 to $58. Both Halo and Merck closed higher today.

"The New Jersey pharma is challenging seven of the Mdase patents with the U.S. Patent and Trademark Office. However, the outcome of that proceeding won’t affect Halozyme's lawsuit, which claims infringement of a broader range of patents.

Halozyme is best known for its Enhanze subcutaneous delivery technology based on the recombinant human hyaluronidase PH20 enzyme. As the company studied PH20, its scientists created a library of more than 6,700 additional proteins with modified amino acid chains. That library and further research led to the Mdase portfolio of patents starting in 2016.

Although ATL-B4 itself is not in Halozyme’s library, the company claims that many amino acid modifications used in the Alteogen product are actually covered by those 15 Mdase patents.

Merck has been aware of Halozyme’s work on PH20s since at least 2009, when the two first had collaboration discussions, according to the complaint. In 2015, Halozyme shared with Merck its ability to subcutaneously deliver Keytruda. During those negotiations, Merck became aware of Halozyme’s patent plans covering modified PH20s."

https://www.fiercepharma.com/pharma/halozyme-sues-merck-over-subcutaneous-keytruda-licensing-talks-fall-through

Same here.

Maybe halozyme should sue Alteogen too. But I think it is because Merck is the one who will be selling the product (SC Keytruda) in US, Europe, etc.

I don't understand why they are not suing Alteogen.

https://firstwordpharma.com/story/5952473

From ChatGpt: "The Lawsuit Itself May Actually Increase Likelihood of a Deal (Mid-Term): • While Grok lowered the probability from 65% to 60% due to the chilling effect of litigation, I’d argue the lawsuit acts more as a negotiation accelerant. Injunction threat + timing of FDA review + PTAB uncertainty = stronger hand for Halozyme. • In that light, a 65–70% probability might still hold unless the court denies the injunction or PTAB institutes both PGRs with favorable outlooks. • PTAB Denial Would Be a Game-Changer: • If either of the PGRs is denied in July, Halozyme’s leverage balloons. That makes it more likely Merck folds and signs a royalty-bearing agreement to protect its 2025 launch timeline."

I found it interesting when I asked "duck duck go" for "Merck acquiring intellectual property".
Seems this company has a long history of BUYING entire companies or using their $ & attorneys to get what they want.
David & Goliath story over & over again. SAD actually.

Let me say again, welcome to our board. Glad to have someone with your expertise joining us. Would love to know your thoughts on the post-registration. Have you had a chance to look at the sur-reply by halozyme? Here is the link all legal documents submitted by Merck and Halozyme. I showed them to a patent attorney friend and had, Grok, ChatGPT, perplexity, etc. review them. They all said Halo has the more compelling arguments especially procedurally. 
https://portal.unifiedpatents.com/ptab/case/PGR2025-00009

From Grok: "Given the breaking news that Halozyme filed a patent infringement lawsuit against Merck on April 24, 2025, in the U.S. District Court in New Jersey over the subcutaneous (SC) Keytruda formulation’s alleged infringement of its Mdase patents (,), I’ll reassess the likelihood of Merck signing a licensing agreement with Halozyme for the Mdase technology. This updates my prior estimate of a 65% settlement likelihood, factoring in the lawsuit, the provided PGR documents (PGR2025-00003 sur-reply, PGR2025-00042 petition), and recent public information as of April 24, 2025. Below, I analyze the impact of the lawsuit, the ongoing PGR challenges, and commercial pressures to determine if an agreement remains likely.[](https://www.prnewswire.com/news-releases/halozyme-sues-merck-for-patent-infringement-over-subcutaneous-keytruda-formulation-302437331.html)[](https://www.stocktitan.net/news/HALO/halozyme-sues-merck-for-patent-infringement-over-subcutaneous-5uylk2ljqcpy.html)
### Context Recap- **Halozyme’s Position**: Halozyme claims Merck’s SC Keytruda (MK-3475A), which uses Alteogen’s berahyaluronidase alfa, infringes its Mdase patents, including U.S. Patent Nos. 11,952,600 and 12,037,618 (targeted in PGR2025-00003 and -00042). Halozyme seeks damages and an injunction to block SC Keytruda’s launch, expected post-FDA approval on September 23, 2025 (). CEO Helen Torley has consistently pushed for a licensing deal with 3-7% royalties, citing Halozyme’s 20-year hyaluronidase expertise and 100+ Mdase patents (,).[](https://www.fiercepharma.com/pharma/merck-lays-out-subcutaneous-keytruda-data-lung-cancer-amid-patent-brawl-halozyme)[](https://www.fiercepharma.com/pharma/patent-clash-over-injectable-keytruda-merck-and-halozyme-dig-fight)[](https://www.investing.com/news/transcripts/halozyme-at-td-cowen-healthcare-strategic-moves-and-legal-challenges-93CH-3913033)- **Merck’s Position**: Merck denies infringement, asserting its enzyme was “developed independently” via Alteogen’s ALT-B4 platform, which it claims doesn’t violate Halozyme’s patents (). Merck has filed 10 PGRs since November 2024, including PGR2025-00003 and -00042, arguing Halozyme’s Mdase patents are invalid for lacking §112 support (written description, enablement) and being obvious under §103 (,). Merck aims to clear patent hurdles for SC Keytruda’s 2025 launch.[](https://www.pearceip.law/2025/03/05/merck-sharp-dohme-and-halozyme-in-us-patent-dispute-as-subcutaneous-pembrolizumab-launch-approaches/)[](https://www.mk.co.kr/en/it/11175155)[](https://www.pearceip.law/2025/03/05/merck-sharp-dohme-and-halozyme-in-us-patent-dispute-as-subcutaneous-pembrolizumab-launch-approaches/)- **Prior Assessment**: I estimated a 65% chance of settlement, driven by Merck’s need to launch SC Keytruda before intravenous Keytruda’s patents expire (2028) and Halozyme’s strong patent portfolio and licensing model. A 3-7% royalty deal was seen as cost-effective for Merck ($29.5 billion Keytruda sales in 2024) and lucrative for Halozyme ($1.15–$1.225 billion 2025 revenue) (,).[](https://www.fiercepharma.com/pharma/merck-lays-out-subcutaneous-keytruda-data-lung-cancer-amid-patent-brawl-halozyme)[](https://www.prnewswire.com/news-releases/halozyme-reiterates-2024-financial-guidance-and-raises-2025-and-multi-year-financial-guidance-302345137.html)
### Impact of the LawsuitThe lawsuit escalates the dispute, shifting dynamics:- **Halozyme’s Aggression**: Filing in New Jersey, where Merck is headquartered, signals Halozyme’s confidence in its Mdase patents and willingness to enforce them through litigation rather than waiting for PGR outcomes (due July 2025 for PGR2025-00003 and -00042). The injunction request is a high-stakes move, as blocking SC Keytruda’s launch could disrupt Merck’s $12 billion market expansion plan (analyst estimates for SC uptake) ().[](https://www.investing.com/news/analyst-ratings/hc-wainwright-maintains-halozyme-stock-buy-rating-72-target-93CH-3911856)- **Merck’s Pressure**: The lawsuit increases Merck’s risk, as an injunction could delay SC Keytruda, costing market share to competitors like Bristol Myers Squibb’s Opdivo Qvantig (using Halozyme’s Enhanze) (). Merck’s PGR filings suggest it views Halozyme’s patents as a threat, as noted by patent expert Zachary Silbersher (). Litigation costs and uncertainty may push Merck toward settlement.[](https://www.fiercepharma.com/pharma/patent-clash-over-injectable-keytruda-merck-and-halozyme-dig-fight)[](https://www.biospace.com/business/mercks-injectable-keytruda-plans-create-legal-dispute-with-halozyme-wsj)- **Precedent for Licensing**: Halozyme’s history of licensing Enhanze to Roche, Pfizer, and others (nine commercial products by 2025) shows its preference for deals over prolonged litigation (). The lawsuit may be a tactic to force negotiations, as Torley reiterated a licensing preference at the TD Cowen conference ().[](https://www.prnewswire.com/news-releases/halozyme-reiterates-2024-financial-guidance-and-raises-2025-and-multi-year-financial-guidance-302345137.html)[](https://www.investing.com/news/transcripts/halozyme-at-td-cowen-healthcare-strategic-moves-and-legal-challenges-93CH-3913033)
### PGR DynamicsThe PGRs remain critical:- **Halozyme’s Strength**: In PGR2025-00003, Halozyme’s sur-reply leveraged Merck’s procedural error (using a 2011 date for §112 analysis) and weak expert testimony, giving Halozyme a 70% chance of blocking institution (prior analysis). For PGR2025-00042, Halozyme can likely reuse these arguments, though the ’618 patent’s focus on I309N aligns more with Merck’s obviousness case, slightly lowering Halozyme’s odds to ~60% (prior analysis). If PTAB denies institution by July 2025, Halozyme’s patents stand, strengthening its litigation leverage.- **Merck’s Challenges**: Merck’s PGR2025-00042 petition is robust (18,688 words, detailed I309N analysis), but Halozyme can attack potential date errors, hindsight in Dr. Park’s testimony, and claim misreadings (e.g., overemphasizing activity requirements). Additional arguments (prior response) like estoppel (§ 325(d)) for repetitive PGRs or distinguishing *Amgen v. Sanofi* could further weaken Merck’s case.
### Commercial and Strategic Factors- **Merck’s Incentives**: SC Keytruda’s phase 3 success (noninferior to IV,) and FDA priority review (decision September 23, 2025) make a 2025 launch critical. Keytruda’s $29.5 billion 2024 sales face erosion post-2028 patent expiry; SC extends market dominance (). A 3-7% royalty ($870 million–$2 billion annually) is a fraction of Keytruda’s revenue, making a deal financially viable compared to litigation costs or an injunction ().[](https://www.fiercepharma.com/pharma/merck-lays-out-subcutaneous-keytruda-data-lung-cancer-amid-patent-brawl-halozyme)[](https://www.reuters.com/business/healthcare-pharmaceuticals/new-version-mercks-cancer-drug-faces-patent-battle-wsj-reports-2025-03-05/)[](https://www.oncologypipeline.com/apexonco/halozyme-pushes-add-merck-its-subq-partners)- **Halozyme’s Position**: Halozyme’s $7.3 billion market cap and 76.5% gross margin () support its litigation war chest. Mdase patents (valid until 2034) don’t affect Enhanze revenue ($1.015 billion in 2024), so Halozyme can afford to fight while pursuing royalties (). Success with VYVGART Hytrulo and Darzalex SC bolsters its licensing model ().[](https://www.investing.com/news/analyst-ratings/hc-wainwright-maintains-halozyme-stock-buy-rating-72-target-93CH-3911856)[](https://www.prnewswire.com/news-releases/halozyme-sues-merck-for-patent-infringement-over-subcutaneous-keytruda-formulation-302437331.html)[](https://www.prnewswire.com/news-releases/halozyme-reiterates-2024-financial-guidance-and-raises-2025-and-multi-year-financial-guidance-302345137.html)- **Market Sentiment**: Analysts like Evercore’s Umer Raffat see a 1% royalty as a “modest” cost for Merck but a “major windfall” for Halozyme (). H.C. Wainwright and JMP Securities maintain Buy ratings on Halozyme ($72–$78 targets), viewing the dispute as a potential stock catalyst ().[](https://www.oncologypipeline.com/apexonco/halozyme-pushes-add-merck-its-subq-partners)[](https://www.investing.com/news/analyst-ratings/hc-wainwright-maintains-halozyme-stock-buy-rating-72-target-93CH-3911856)
### Likelihood of an AgreementThe lawsuit complicates but doesn’t derail a licensing agreement:- **Arguments for Agreement**:  - **Economic Sense**: A 3-7% royalty is cheaper for Merck than litigation, potential damages, or an injunction delaying SC Keytruda. For Halozyme, royalties align with its business model and avoid prolonged legal costs.  - **PGR Risks**: If PTAB denies Merck’s PGRs (60-70% chance for Halozyme), Merck faces stronger infringement claims, incentivizing a deal. Even if instituted, PGR trials take 12-18 months, risking launch delays past September 2025.  - **Halozyme’s Strategy**: Torley’s public statements (,) and the lawsuit’s timing suggest Halozyme is pressuring Merck to negotiate before FDA approval. Past Enhanze deals show Halozyme’s deal-making savvy.[](https://www.fiercepharma.com/pharma/astrazeneca-signs-135b-alteogen-deal-subcutaneous-cancer-drugs-despite-merck-halozyme-patent)[](https://www.investing.com/news/transcripts/halozyme-at-td-cowen-healthcare-strategic-moves-and-legal-challenges-93CH-3913033)  - **Industry Precedent**: AstraZeneca’s $1.35 billion Alteogen deal despite Halozyme’s threats () shows competitors may license to avoid disputes, setting a model for Merck.[](https://www.fiercepharma.com/pharma/astrazeneca-signs-135b-alteogen-deal-subcutaneous-cancer-drugs-despite-merck-halozyme-patent)- **Arguments Against Agreement**:  - **Merck’s Defiance**: Merck’s claim of independent development and 10 PGR filings signal confidence in invalidating Halozyme’s patents or proving non-infringement (). Alteogen’s assertion that ALT-B4 avoids Halozyme’s patents () may embolden Merck to fight.[](https://www.pearceip.law/2025/03/05/merck-sharp-dohme-and-halozyme-in-us-patent-dispute-as-subcutaneous-pembrolizumab-launch-approaches/)[](https://www.mk.co.kr/en/it/11175155)  - **Litigation Escalation**: The lawsuit hardens positions, potentially delaying talks until PGR or court rulings clarify patent strength. An injunction, if granted, could force Merck to pivot but also prolong the fight.  - **Alteogen Factor**: Merck’s $4.317 billion ALT-B4 contract () ties it to Alteogen, which claims patent clearance. Merck may prioritize defending this partnership over licensing Mdase.[](https://www.mk.co.kr/en/it/11175155)
### Updated LikelihoodThe lawsuit raises stakes but reinforces settlement incentives. Merck faces mounting pressure from the FDA timeline, PGR risks, and injunction threats, while Halozyme’s strong patents and licensing track record make a deal attractive. However, Merck’s PGR aggression and Alteogen reliance introduce uncertainty. I adjust the likelihood of a licensing agreement to **60%**, down from 65%, reflecting litigation’s chilling effect but still favoring a deal due to economic and timing pressures. A 3-7% royalty structure remains likely, with milestones ($130–$160 million,) possible. Key factors to watch:[](https://www.investing.com/news/transcripts/halozyme-at-td-cowen-healthcare-strategic-moves-and-legal-challenges-93CH-3913033)- PTAB’s PGR decisions (July 2025).- Court’s response to Halozyme’s injunction request.- Merck’s FDA approval progress (September 23, 2025).
If you have the complaint’s details or new filings, I can refine this further[](https://www.stocktitan.net/news/HALO/halozyme-sues-merck-for-patent-infringement-over-subcutaneous-5uylk2ljqcpy.html)[](https://www.fiercepharma.com/pharma/merck-lays-out-subcutaneous-keytruda-data-lung-cancer-amid-patent-brawl-halozyme)
_Disclaimer: Grok is not a lawyer; please consult one."

https://t.co/K6W4hkF0Nb

Halozyme Sues Merck for Patent Infringement over Subcutaneous Keytruda Formulation
April 24 2025 - 8:30AM
PR Newswire (US)
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Complaint filed in New Jersey alleges Merck uses Halozyme's patented MDASE technology to develop SC Keytruda

Halozyme is seeking damages and injunctive relief to stop the infringement

SAN DIEGO, April 24, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme), a biotechnology company that pioneered the use of human hyaluronidase for subcutaneous drug delivery, today filed a patent infringement lawsuit against Merck Sharp & Dohme Corp. (Merck) in U.S. District Court in New Jersey.

Halozyme believes the subcutaneous formulation of Merck's cancer medicine, Keytruda, infringes multiple patents that Halozyme filed beginning in 2011 to protect its groundbreaking MDASE subcutaneous delivery technology. Subcutaneous (SC) Keytruda has completed phase 3 clinical testing and Merck has publicly commented on its intention to launch the SC product in 2025. Merck has used Halozyme's technology to develop SC Keytruda without Halozyme's permission.

"We are filing this lawsuit to protect the innovative technology that we pioneered through years of painstaking research and development," said Dr. Helen Torley, president and chief executive officer of Halozyme. "Our technology can ease the burden of treatment and improve patient outcomes by making possible rapid, high-volume subcutaneous drug delivery for patients with serious medical conditions."

Halozyme partners with pharmaceutical companies to make subcutaneous versions of important medicines available for the benefit of patients. Halozyme's MDASE hyaluronidase technology is protected by a robust patent portfolio. Halozyme expected Merck to obtain a commercial license for the intellectual property it is using, but Merck has failed to do so and instead plans to launch SC Keytruda while knowingly infringing on Halozyme's MDASE patents.

The patents at issue arise from Halozyme's extensive research into nearly 7,000 modifications to human hyaluronidases. Among their uses, these hyaluronidases pioneered by Halozyme provide a mechanism for the rapid subcutaneous administration of therapeutic drugs. Halozyme's research and development resulted in a roadmap for selecting potential modifications to human hyaluronidases that can impact their activity and stability. Halozyme's comprehensive studies and innovations were a significant advancement to the field of human-derived hyaluronidases.

"Merck has long been aware of Halozyme's patents and still proceeded to appropriate Halozyme's technology in order to develop SC Keytruda," said Halozyme's Chief Legal Officer, Mark Snyder. "Based on their public comments, it appears they intend to launch SC Keytruda later this year despite the clear infringement of our patents. In our lawsuit, we are seeking damages and injunctive relief to stop the infringement."

None of the MDASE patent rights which Halozyme is seeking to enforce in this suit relate to the Company's ENHANZE® licensing program. The MDASE patents are not licensed to any of Halozyme's licensees. Therefore, the outcome of this dispute will not impact ENHANZE®, the ability of any licensee to use ENHANZE®, or revenues Halozyme receives from ENHANZE® licensees.

Hmmmm, a SC Satralizumab Enhanze-AI combo, interesting but why. Oh great, now a compression-gas HVAI to sell, what a team.....U go HALOoo...

Agreed. Likely to be Korean employees of Alteogen.

Thank you for weighing in. Do you have an opinion as to who will prevail?

I can tell the way they phrase the sentences, etc. that it's their second language.

You are right. Confabulations from Alteogen employees/investors don't always deserve a response . 

Gads! Now you're stuck answering these stupid posts from CS6 !!

Already answered. Read my earlier posts.

So is there a company that has contracted with the mdase patent? Why is there no contract? Isn't it because it is a non-existent substance? Are you ignoring the company called Merck? Merck is the world's best-selling company. Are you smarter than Merck? Is your friend smarter than Merck's patent legal team?

Welcome to our board. Glad to have someone with your expertise joining us. Would love to know your thoughts on the post-registration. Have you had a chance to look at the sur-reply by halozyme? Here is the link all legal documents submitted by Merck and Halozyme. I showed them to a patent attorney friend and had, Grok, ChatGPT, perplexity, etc. review them. They all said Halo has the more compelling arguments especially procedurally.
https://portal.unifiedpatents.com/ptab/case/PGR2025-00009

My patent attorney friend said Merck is in trouble and they know it. He said they will sign an agreement with halozyme.

In my experience sitting as a PTAB member some 40 years ago, claims of issued patents were often found unpatentable("invalid") in light of prior art never considered or read by the original, ex parte examiner before issuance of the patent. I see that happening today as well. Sometimes, that novelty-negating prior art lies buried among pages of prior art submitted by prosecuting attorneys in information disclosure statements. Perfection and photographic memories are often hard to find, IMO.

You're making so many absurd answers for consulting a patent lawyer.
So what did the real human patent attorney say other than AI patent attorney?

and AstraZeneca's Global Head noted that there is no problem with patents at all.

I know that no matter how many tens of thousands of words I say, your thoughts will never change anyway.

So everyone should avoid mentioning each other.
If you don't mention it, At least i won't bother you by showing up on this bulletin board.

That makes zero sense! Are you an Alteogen employee or just an Alteogen investor?