Halozyme Therapeutics Incorporated (HALO) Options

Look in the comments on this site 2009 & earlier...that's what I did. Alteogen's incorporation date is on THEIR web page.
Fred Kadiddlehopper was moderator way back then...maybe he could re-read all the comments like I did most of last week.

Very interesting! Thanks for sharing. Is a there a link?
If this goes to court, you can bet that Halozyme attorneys will make a point of the meeting you mentioned. The argument that Alteogen came up with Hybrozyme without using the breakthrough knowledge pioneered by Halo is a joke.

For Merck to succeed, it will have to not only win the post-registration appeal with the USPO but also win the NJ court decision for every single one of the 15 patents that Merck is accused of infringing. Halozyme needs to win just one.  Odds favor halozyme from this perspective in addition to halo's more complimg legal arguments.

Biotechinvestor1:
Less than a year after meeting Randal Kirk & Greg Frost & getting a sample...Alteogen is incorporated in S. Korea.
HMmmmm?

Jury trial?
Merck STOLE Halo's technology! It's quite evident.

Merck Breaks Ground on New $1 Billion Biologics Center of Excellence in Wilmington, Delaware
April 29 2025 - 6:45AM
Business Wire
https://ih.advfn.com/stock-market/NYSE/merck-MRK/stock-news/95929783/merck-breaks-ground-on-new-1-billion-biologics-ce
Merck Wilmington Biotech will serve as a launch and commercial production facility and the future U.S. home for KEYTRUDA

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today the start of construction for a $1 billion, 470,000-square-foot state-of-the-art biologics center of excellence in Wilmington, Delaware.

A cornerstone of Merck’s continued commitment to investing in American innovation and infrastructure, Merck Wilmington Biotech will comprise laboratory, manufacturing and warehouse capabilities to enable the launch and commercial production of next-generation biologics and therapies including potent antibody-drug conjugates (ADCs), reinforcing Merck’s focus on expanding and diversifying its pipeline.

The site will also have the capability to manufacture KEYTRUDA® (pembrolizumab), and our intent is to establish it as the future U.S. home for producing KEYTRUDA for U.S. patients. This is part of a significant investment to not only bring the world’s best-selling medicine closer to the American patients who rely on it, but to also establish a home for our biologics portfolio of products serving U.S. patients. Merck is planning further expansion beyond the initial investment at the site to continue to serve our growing biologics pipeline.

“The Merck Wilmington Biotech site represents our continued commitment to growing our investments in U.S. manufacturing and has the potential to create thousands of high-paying American jobs while ensuring that we can produce and distribute products close to patients right here in the U.S.,” said Robert M. Davis, chairman and chief executive officer, Merck.

Establishing a biologics center of excellence

The new facility, located at Chestnut Run Innovation & Science Park (CRISP), will help foster growth in Wilmington’s biotechnology sector, creating more than 500 full-time roles and roughly 4,000 construction jobs. The laboratory component is expected to be fully operational by 2028, with production of investigational compounds anticipated to start by 2030. Potential further expansion of the site would create an additional 1,500 full-time roles and 26,000 construction jobs.

“This new site in Delaware is on the cutting edge of innovation, helping lead the way as we transform medicine and technology,” said Delaware Gov. Matt Meyer. “Merck is pioneering the next generation of care right here in Wilmington, and they couldn’t have picked a better place to do it. The positive impact this will have on Wilmington and the state of Delaware is exciting, and this is the just the beginning.”

With proximity to Delaware and Pennsylvania universities, Merck Wilmington Biotech will also attract talented students and professionals, supporting community growth and development. The site’s proximity to Merck’s existing facilities across neighboring New Jersey and Pennsylvania will expand its nexus of talent and create broad and engaging opportunities for current and future Merck team members.

“The decision to build a new biologics facility in Wilmington demonstrates our commitment to advancing U.S. manufacturing and partnering in communities where our employees live and work,” said Sanat Chattopadhyay, executive vice president and president, Merck Manufacturing Division. “As a hub for life science, research and development, and pharmaceutical manufacturing, CRISP offers unparalleled opportunities for future expansion.”

A continuing commitment to investing in the U.S.

For more than 130 years, Merck, a leading American biopharmaceutical company, has been committed to saving and improving lives by developing and delivering life-changing medicines and vaccines to treat diseases in both humans and animals.

Since the advent of the 2017 Tax Cuts and Jobs Act, Merck has allocated more than $12 billion to enhance our domestic manufacturing and research capabilities, with additional planned investments of more than $9 billion over the next four years:

In March, Merck announced the completion of construction on a $1 billion, 225,000-square-foot state-of-the-art facility to expand vaccine production capacity in Durham, North Carolina, generating nearly 400 full-time roles and roughly 4,000 construction jobs.
The company plans to invest $3.5 billion in biologics and small molecule manufacturing sites and capabilities in the U.S., creating an anticipated 650 additional full-time roles.
Our efforts across the U.S. are forecasted to create more than 37,600 construction-related employment opportunities by 2028.
Merck remains committed to bolstering the communities in which we operate through substantial investments in innovation in U.S. manufacturing and research and development, investing approximately $3 billion in New Jersey and Pennsylvania alone since 2018. In that time, we have created more than 7,500 full-time U.S.-based meaningful employment opportunities, a nearly 26% increase in our workforce. We also boast a robust network of U.S.-based Animal Health sites that manufacture a broad portfolio of vaccines and large molecule therapies made end to end in the U.S.

We are committed to continuing our efforts to stimulate economic growth in the U.S., allowing for the domestic production and distribution of medicines and vaccines to patients here and around the world.

Please visit the Merck media library for additional materials and information about our ongoing commitment to investing in U.S. manufacturing and innovation.

This was another example of how absurd the thinking process and claims of alteogen fan club are. Notice that he said he thinks not that halozyme would loose in court but that the case would be dismissed. Dissmisal means that the court won't even hear the case. This is only done when there is lack of jurisdiction or failure to state a claim.
No one in their right mind would think that the case would be dismissed!!! Most think that Merck will sign an agreement with halo and if not, halo will win in court. A dismissal is an absurd conjecture and only serves to reveal your biased mindset. 
Are you employed by Alteogen?!

Dream on! Only Alteogen fan club would think the lawsuit could be dismissed. Majority of analysts, investors and anyone with common sense know halozyme has the upper hand and a far more comelling legal argument. 
Even the most bearish of halozyme analysts (JPM's Jessica Fye) has included earnings from Keytrus SC (Merck) into their 2025 halozyme estimates.

Halozyme filed a lawsuit against Merck. Do you think Halozyme will win the lawsuit? If so, please explain why. I expect the lawsuit to be dismissed.

argenx Announces Positive CHMP Opinion for VYVGART (efgartigimod alfa) Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
https://ih.advfn.com/stock-market/NASDAQ/argenx-ARGX/stock-news/95915530/argenx-announces-positive-chmp-opinion-for-vyvgart

VYVGART® is first-and-only targeted IgG Fc-antibody fragment for CIDP
First novel mechanism of action for CIDP treatment in more than 30 years
CHMP positive opinion based on ADHERE data, the largest ever CIDP clinical trial
European Commission (EC) decision on marketing authorization application (MAA) expected within approximately two months
April 28, 2025, 07:00 AM CET

Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended European Commission (EC) approval of VYVGART® 1000mg (efgartigimod alfa) for subcutaneous (SC) injection as a monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins.

“Our mission is to develop innovative, targeted treatments for patients with rare and severe autoimmune diseases, who continue to face significant unmet needs. The positive CHMP opinion for VYVGART in CIDP brings us one step closer to providing patients across Europe with a transformational new treatment option that provides meaningful functional improvement,” said Luc Truyen M.D., Ph.D., Chief Medical Officer, argenx. “VYVGART is the first and only targeted IgG Fc-antibody fragment for CIDP and if approved, would mark the first treatment in Europe with a novel, precision mechanism of action for CIDP patients in 30 years.”

VYVGART for subcutaneous injection is available as a vial or prefilled syringe and can be administered by a patient, caregiver, or healthcare professional. Treatment is initiated with a weekly dose regimen and may be adjusted to every other week based on clinical evaluation.

The CHMP recommendation is based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date. In the ADHERE study, 66.5% (214/322) of patients treated with VYVGART, regardless of prior treatment, demonstrated evidence of clinical improvement, including improvements in mobility, function and strength. ADHERE met its primary endpoint (p1-point), grip strength (>17 kPa) and I-RODS scale (>8 points) at week 36 compared to baseline at entry to standard of care withdrawal phase. Ninety-nine percent of trial participants elected to participate in the ADHERE open-label extension. The safety results were generally consistent with the known safety profile of VYVGART in previous clinical studies.

"For the patient population represented by the European Patient Organisation for Dysimmune and Inflammatory Neuropathies (EPODIN) and for those affected by CIDP, this is excellent news," said Jean-Philippe Plançon, President of EPODIN. "There are still considerable unmet medical needs in the management of CIDP, and the CHMP’s recommendation brings renewed hope for improved treatment options and quality of life."

The positive CHMP opinion is a scientific recommendation for marketing authorization, serving as a basis for the EC’s final decision on argenx’s CIDP application for subcutaneous VYVGART. The EC is expected to make a decision following CHMP recommendation and the decision will apply to all 27 European Union Member States, and also to Iceland, Norway and Liechtenstein. Currently, VYVGART is indicated as an add-on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

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

Excerpts from Gemini's analysis:
 * PGR Eligibility (Date Error): Halozyme's strong argument that Merck used an incorrect date for assessing PGR eligibility, which could lead to the PTAB denying institution of the PGR.  * Claim Construction: Halozyme's focus on the structural definition of the claims and criticism of Merck's alleged improper importation of functional requirements is seen as a strong defense against §112 challenges.  * Obviousness: Halozyme's arguments against obviousness, particularly concerning the lack of motivation to make specific amino acid substitutions and the reliance on hindsight, have a 65% chance of success. * Expert Credibility: potential weaknesses in the credibility of Merck's experts, which could undermine Merck's overall case. * Discretionary Denial: The filing of a patent infringement lawsuit by Halozyme is seen as a significant factor that could lead the PTAB to exercise discretionary denial of the PGRs, assigning an 80% probability to this outcome.Considering the supporting evidence from the legal documents, my updated assessment of Halozyme's likelihood of success in blocking PGR institution is higher. * Overall PGR2025-00003 Success: I now estimate Halozyme has a 70-75% chance of blocking institution in PGR2025-00003, primarily due to the date error argument and the potential for discretionary denial, with strong substantive arguments as a backup.
Updated Assessment of Licensing Agreementanalysis also impacts the assessment of the likelihood of a licensing agreement: * Increased Pressure on Merck: The patent infringement lawsuit increases the pressure on Merck, especially given the potential impact on the launch of SC Keytruda. * Halozyme's Leverage: Halozyme's strong PGR defenses and the threat of an injunction enhance its negotiating position. * Strategic Timing: Halozyme's strategic timing of the lawsuit suggests a calculated effort to leverage the PGRs and upcoming deadlines to secure a favorable licensing deal. 

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
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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...