Halozyme Therapeutics Incorporated (HALO) 옵션

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)
Alert
Print
Share On Facebook
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?

You are not a patent attorney either! As an Alteogen investor, you are biased as well.
Maybe you should be consulting a patent attorney. I did already. 
By the way, JP Morgan's (one of the largest banks in the world) has more resources and connections with patent attorneys than the one or two that you and I might know. So if JPM is including Keytruda SC earnings in their forecast for Halozyme in 2025, especially when JPM has been one of the most bearish on halo, I would take their opinion over an Alteogen fan boy like you.

Thank you. Your answer reaffirms my confidence that Alteogen will win.

Please don't wrap shallow knowledge like you have deep knowledge.

https://ipwatchdog.com/2024/06/25/recent-statistics-show-ptab-invalidation-
rates-continue-
climb/id=178226/#:~:text=%E2%80%9CSince%202021%2C%20the%20invalidation
%20rate%20has%20been%20increasing,claims%20were%20found%20invalid%2068
%25%20of%20the%20time.

First, USTPO encourages patent registration, and there is a widespread atmosphere to resolve disputes through judgment/litigation. Second, when each country's examiners examine three cases a day, (i) inventing each of the three cases
Understand the contents, (ii) search for prior art, and (iii) prepare OA (notice of reasons for rejection)
If so, how little time will there be to search for advanced technologies.

AND does the analyst qualify as a patent attorney?

Don't say it's just Merck's claim, but if you're an investor, make sure to ask a competent patent attorney to analyze it like an investor.

Nonsense!
1) MDASE was introduced and offered for licensing agreement for the first time last year and never before.
2) Merck's claim that MDASE is too broad is pure conjecture and not a fact. US patent office could have rejected the MDASE patents if their experts thought they were too broad. They did not. They approved the MDASE patents over a 100 times.. The people who are claiming it's too broad are the people who are infringing on the MDASE patents. Of course Merck and alteogen fan boys will try to claim it's too broad because they know they are violating it. Merck's claim or your opinion are not what counts. It's the US patent office that will make the decision on Merck's appeal.They already approved MDASE patents once so you know they did not think they were too broad at least in thr past.
3. No, Merck is doing it because they know they are violating approved patents. Halozyme has over 100 patents on MDASE. Merck has only appealed to invalidate 7 or 8 of them. Halozyme's chief legal officer said Merck is violating a lot more MDASE patents that just the few Merck is trying to invalidate. So you are wrong again; Halozyme will sue Merck, no matter what happens with US patent office with Merck's post-registration appeals. But we won't get there at all since US patent office will reject Merck's appeals and Merck will sign an agreement with halozyme. JPM's, Jessica Fye thinks so and she is no fan of halo.

1. There has been no case of contract for mdase for 10 years since the mdase patent application.
(Why hasn't a contract using mdase been issued for 10 years? Halozyme shareholders would know better.)

2. The mdase patent is too broad to prove the substance in the scope. Some parts of the mdase patent will be invalidated, and there will be no problem in launching Keytruda sc.

3. The reason Merck requested a trial to invalidate the Halozyme patent is to prevent Halozyme from filing a lawsuit to delay the launch of Keytruda sc.

The Alteogen fan club (2 names that appear on this board typically in synchrony every few weeks who likely to be the same individual) make arguments that are inherently contradictory to one another:
1) Hybrozyme (Alteogen) which is a modified hyaluronidase is distinct from Enhanze (Halozyme). This is why they claim Alteogen rightfully has a patent for Hybrozyme.
2) MDASE which is also modified hyaluronidase is not different from Enhanze, and therefore halozyme has no right to have any patents on it. 
Another contradiction in their posts:
Halozyme should not be able to have an MDASE licensing agreement with Merck without violating BMS exclusivity agreement because modified hyaluronidase is not that different from hyaluronidase. Yet Hybrozyme which is nothing but a modified hyaluronidase (same as MDASE) is sufficiently different that it does not infringe on halozyme's Enhanze patents.
These contradictions are comical and amateurish. 
Bottom line, ask yourself if Merck did not think Hybrozyme is violating halo's patents, why make a petition to revoke halo's MDASE patents. Merck and Alteogen know they are infringing otherwise they would not have made the post-registration apeal to the US patent office.
Clearly, halo longs are not the onky ones who think halo will win. Even one of the most bearish analysts on halo, JPM's Jessica Fye, is now forecasting halozyme earnings from Keytruda SC (Merck) and including it in her her 2025 earning estimates for halo.

Companies try to get away with infringing on other's patents from time to time. This is  common (see examples below) in biopharma due to the high stakes involved—massive R&D costs, long development timelines, and the potential for blockbuster drugs. The complexity of biological and chemical innovations, coupled with broad or overlapping patents, often leads to disputes. Infringement cases typically arise when a company develops a product or process that allegedly violates an existing patent, whether intentionally (e.g., generics challenging branded drugs) or unintentionally (e.g., similar biologics). Estimates suggest thousands of patent disputes occur annually in these sectors globally, with the U.S. being a hotspot due to its robust patent system and large market.
### Examples of Patent Infringement Cases:1. **Amgen vs. Sanofi/Regeneron (PCSK9 Inhibitors, 2014-2020)**:   - **Issue**: Amgen held patents for antibodies targeting PCSK9, used in cholesterol-lowering drugs like Repatha. Sanofi and Regeneron’s Praluent was accused of infringing these patents.   - **Outcome**: U.S. courts initially ruled in Amgen’s favor, banning Praluent, but the decision was overturned in 2020 due to invalidity of Amgen’s broad patent claims. The case highlighted challenges in patenting biologics.
2. **Pfizer vs. Roche/Genentech (Herceptin, 2017)**:   - **Issue**: Pfizer’s biosimilar to Roche’s Herceptin (trastuzumab), a breast cancer drug, was challenged for infringing Roche’s patents on the drug’s formulation and use.   - **Outcome**: The case settled before trial, with Pfizer agreeing to delay its biosimilar launch until Roche’s patents expired, illustrating how patent disputes can delay market entry.
3. **Gilead vs. Merck (Sovaldi/Harvoni, 2013-2016)**:   - **Issue**: Merck claimed Gilead’s hepatitis C drugs Sovaldi and Harvoni infringed its patents on sofosbuvir, a key compound. Gilead argued the patents were invalid.   - **Outcome**: A jury awarded Merck $200 million, but the court later invalidated Merck’s patents, reversing the decision. This case underscored the high financial stakes in pharma patent litigation.
4. **AbbVie vs. Amgen (Humira Biosimilars, 2016-2023)**:   - **Issue**: AbbVie’s Humira, a top-selling arthritis drug, was protected by a “patent thicket” of over 100 patents. Amgen’s biosimilar Amjevita was accused of infringement.   - **Outcome**: Amgen settled, delaying its U.S. launch until 2023, while AbbVie extended Humira’s exclusivity. This case exemplifies how patent strategies can delay generic or biosimilar competition.
### Trends and Context:- **Frequency**: Litigation is frequent, with hundreds of cases filed yearly in the U.S. alone, often under the Hatch-Waxman Act for generics or BPCIA for biosimilars. Global disputes are also common in Europe and Asia.- **Drivers**: High profit margins (e.g., Humira generated $20 billion annually), complex biologics, and patent “evergreening” (extending protection via new patents) fuel conflicts.- **Impact**: Infringement lawsuits can delay drug launches, increase costs, or lead to settlements that balance innovation and access. 

Assuming your argument is correct, then why did big pharmas sign contracts with Alteogen instead of MDase? Rebut.

With ENHANZE's “patent cliff” visible without binoculars, Halozyme is turning to “MDASE.” The company posits MDASE as distinct from ENHANZE, representing a broader set of modified hyaluronidase structures with potentially different properties. However, when asked about MDASE's distinctive qualities compared to ENHANZE, Halozyme, in my view, was scant on details. It is feasible to think that some companies will develop hyaluronidase alternatives once ENHANZE's patents expire, bypassing ENHANZE and MDASE. It is early, so it's difficult to ascribe concrete value to MDASE until we have further clarity on its differentiation and how much interest it's getting from drug developers. Finally, I believe that Halozyme's interest in Evotec signals that they don't have a lot of faith in MDASE. This is conjecture on my part.

https://seekingalpha.com/article/4740158-halozyme-growth-amid-uncertainty-after-failed-acquisition-rating-downgrade

Alteogen Founded May 13, 2008 (more than coensidence)

Oops. Wrong guy. You are not a permabear. You are an Alteogen guy.

That's funny coming from the permabear who has consistently been predicting doom and gloom for halozyme on this board for over a decade all the while the stock has outperformed indexes and had a 6x run since you started on posting.  

Plenty of evidence. Will post when I'm done playing Bandon Dunes and Pacific dunes.

You always insist that you're always always always right(nice try! nice try! rofl), but in fact you don't have any knowledge of patents, so you don't do anything but ask AI questions LOL!

Anyway, ENHANZE and HYBROZYME are completely different in patent material.
search the both patent and take a look at the details. Be sure to ask your patent attorney about the patent.
AZ SANDOZ Merck DAIICHI 'S patent attorneys are more smarter than you and AI.(in the field of patents)

In addition, MDASE claims extended rights as much as Earth's grains of sand, which is a big difference from the recent USTPO trend in the scope of rights.
Don't make any predictions, let's wait for the end of the dispute.

I've made this point before and I'm still of the opinion that BMY might still object to a deal with MRK on the same target, even if they use Mdase instead of Enhanz. BMY might choose to argue that the variations between the two are too small to be meaningful and thus constitute a breach of contract in regards to exclusivity.

This is undeniably true, but the Mdase patent issue might be cleared up by June of this year.

What evidence do you have of this?

Nice try. But you are 100% wrong and you know it. You are confusing ENHANZE and MDASE. Two different sets of molecules, patents and agreements. BMS has an exclusive contract for  Enhanze/hyaluronidase and PD-1's. This exclusivity does not extent to modifies hyaluronidase (i.e. MDASE)

Halozyme cannot proceed with additional contracts for pd-1 while it has an exclusive contract for pd(L)-1 target. That is why Impinji and Enhertu came to Alteogen. You are finished now.

You're sharp biotechinvestor1 !! I'm still pretty sure Merck STARTED Alteogen to copy Halo tech! (In S. Korea to try &
pull this off!)

You are clouding the point.
In recent years, Halozyme has not had a history of contracts, while Alteogen has concluded contracts with Daiichi Sankyo and AstraZeneca.

Yes, I remember now. You are the Alteogen share holder who posts here from time to time!

Nonsense!

Daiichi Sankyo and AstraZeneca have already completed the payment of the contract deposit. The contract deposit is not small, but did the global big pharma really make such a risky decision? If we look into it, it can be indirect evidence that the patent stability of Alteogen technology is considerably high.

So does the mdase patent have actual substances?
As far as I know, it is a broad scope with no actual substances.

The mdase patent is an empty patent with only a shell as an extension of the improved concept of the enhanze patent.

You are confusing ENHANZE and MDASE. Two different sets of molecules, patents and agreements. BMS has an exclusive contract for  Enhanze/hyaluronidase and PD-1's. This exclusivity does not extent to modifies hyaluronidase (i.e. MDASE)