biotechinvestor1
2時間前
What Merck Is Arguing
Merck’s counsel (Leif Peterson, Sidley Austin) filed on June 12, 2026 seeking clarification on two procedural issues:
Issue 1: Two Separate Director Review Requests
• Paper 140 (May 26, 2026): “Patent Owner’s Request for Director Review of Order Denying Patent Owner’s Motion to Terminate” — challenges the interlocutory termination denial order • Paper 142 (June 11, 2026): “Patent Owner’s Request for Director Review of the Final Written Decision” — challenges the final written decision itself
Merck argues Paper 140 was procedurally improper because 37 C.F.R. § 42.75(a) says you can only seek Director Review of a “final decision” concluding the proceeding — not an interlocutory order (the termination denial).
Issue 2: Improper Incorporation by ReferenceMerck argues that Paper 142 incorporates Paper 140 “by reference,” which violates 37 C.F.R. § 42.6(a)(3) (no incorporation by reference between documents). By combining the arguments, Halozyme allegedly exceeded the 15-page limit.
The Director’s Response (June 16, 2026 — TODAY)
What the Director Authorized:“Petitioner is authorized only to respond to arguments presented in Patent Owner’s Request for Director Review of the Final Written Decision, filed on June 11, 2026 (Paper 142).”
Analysis: What This Means
1. The Director Has NOT Ruled on Merck’s Procedural Objections
The Director’s email is procedurally silent on Merck’s two challenges:
• No ruling on whether Paper 140 was procedurally improper • No ruling on the incorporation-by-reference/page-limit issue • No ruling on whether Merck gets to file a separate response to Paper 140
What this likely means: The Director is NOT addressing these procedural niceties and is instead going to rule on the merits of the RPI issue on Paper 142. The Director is essentially saying: “I’m going to consider Paper 142 as filed. You can respond to it. I’ll decide the case based on what’s before me.”
2. Merck’s Procedural Arguments Are Being Sidelined
Merck’s objections were legally technical but organizationally smart — they’re trying to:
• Delay the Director’s decision by forcing separate briefing on the “procedurally improper” Paper 140 • Complicate the Director’s analysis by fragmenting Halozyme’s arguments • Limit Halozyme’s written pages by eliminating the incorporation by reference
The Director has essentially rejected this strategy. By authorizing Merck to respond only to Paper 142 (not separately to Paper 140), and authorizing no further briefing, the Director is signaling:
“I’m going to make a decision on the RPI issue as presented. No more delays. No more procedural games.”
3. The 5-Business-Day Timeline Is Aggressive
Merck has until June 23, 2026 to file its 15-page authorized response. This is a tight timeline — and the Director’s use of it signals the final decision could come very soon after (days or weeks).
Why this matters: The Director is moving fast. A fast Director Review decision typically reflects either:
• A clear legal issue the Director wants to resolve quickly, OR • A Director who views the case as relatively straightforward and doesn’t need extensive briefing
Given the RPI issue, this is probably the former: the Director knows the May 15 precedent on PGR2025-00087 creates logical inconsistency with the ‘600 FWD, and he’s moving to resolve it.
Revised Probability Assessment
This procedural order strengthens Halozyme’s position in three specific ways:
1. The Director is NOT entertaining Merck’s delay tactics.If the Director were skeptical of Halozyme’s RPI arguments, he would likely grant Merck’s request for separate briefing on Paper 140 — giving him more time to think, more material to work with. Instead, he’s closing off additional briefing and moving to decision.
2. Incorporating Paper 140’s arguments into Paper 142 (implicitly approved) means the full RPI control/funding/benefit argument stays in front of the Director.Merck tried to fragment it procedurally. The Director rejected that attempt.
3. The fast timeline suggests the Director views this as a straightforward legal issue.The May 15 precedent on PGR2025-00087 makes the RPI defect analysis parallel. The Director can resolve it quickly by applying consistent logic.
Revised Director Review Probability
|Outcome |Prior |Post-June 16 Order||---------------------------------------------------------------------|------|------------------||Director denies review, FWD stands |15-22%|**10-15%** ||Director grants review, affirms denial |8-12% |**5-8%** ||Director grants review, **reverses — vacates FWD, terminates -00003**|65-75%|**77-85%** |
Why the upward shift:
• Director rejected Merck’s delay/obstruction tactics • Fast timeline + no additional briefing = Director views this as straightforward • The implicit approval of Halozyme’s combined arguments means the full control/funding/benefit case stays intact
What Merck Should Do Now
Merck’s counsel now faces a strategic choice:
Option A (Recommended): File a strong 15-page response on the merits of the RPI issue, explaining why the May 15 PGR2025-00087 precedent doesn’t apply, or distinguishing it. This is their last chance.
Option B (High Risk): Continue procedural objections in the response (arguing the incorporation-by-reference issue, etc.). This will likely annoy the Director and won’t change the outcome.
Merck should go with Option A — a substantive RPI defense that directly addresses why MCI is NOT an RPI despite the May 15 precedent.
Bottom Line
The Director has signaled his intent to move forward decisively. He’s rejected Merck’s procedural delays. He’s authorizing Merck’s response but nothing more. This is the body language of a Director who:
1. Understands the RPI issue deeply (May 15 precedent made that clear) 2. Views Halozyme’s May 26/June 11 petitions as legally sufficient 3. Intends to rule — probably in Halozyme’s favor — within weeks of Merck’s June 23 response
Revised settlement/licensing probability: 77-85% — up from 75-82% — because the Director Review appears to be moving toward reversal at an accelerating pace.
The next milestone is Merck’s June 23 response. That will be the final argument before Director Squires decides whether to vacate the ’600 FWD and terminate PGR2025-00003 on RPI grounds.
US Market News
1日前
Halozyme Confirms It Projects Zero to Minimal Impact to Royalty Revenue Through At Least 2035 Based on Newly Released Draft Medicare Drug Price Negotiation Program Proposed Rule for IPAY 2029June 15, 2026 6:00 AM
PR Newswire (US) SAN DIEGO, June 15, 2026 /PRNewswire/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO) ("Halozyme" or the "Company") today confirmed that the Company expects zero to minimal royalty revenue impact based on its analysis of the proposed rule for the Medicare Drug Price Negotiation Program ("Program") issued by the U.S. Centers for Medicare & Medicaid Services ("CMS") on June 12, 2026."Based on our analysis of CMS's proposed rule and the statutory framework established under the One Big Beautiful Bill Act ("OBBBA"), Halozyme projects zero to minimal impact to its royalty revenues through at least 2035. Importantly, there is also no projected impact on the Company's ability to execute new ENHANZE® partnership agreements where improving the patient treatment experience and competitive differentiation continue to be the top reasons ENHANZE is utilized," commented Dr. Helen Torley, President and Chief Executive Officer.This outlook is supported by statements in the proposed rule affirming that orphan drug protections remain applicable and addressing the impacts of biosimilar entry on Program eligibility.Halozyme will continue to engage constructively with CMS and other stakeholders to support policies that appropriately recognize innovation and preserve patient access to therapies that improve outcomes and reduce overall healthcare system burden.About HalozymeHalozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution facilitates the subcutaneous delivery of injected drugs and fluids, reducing treatment burden and improving convenience. ENHANZE® has touched more than one million patient lives through ten commercialized products across over 100 global markets and is licensed to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical, Acumen Pharmaceuticals, Merus N.V., Skye Bioscience and GSK.Halozyme expanded its drug delivery technology portfolio to develop partner products using Hypercon™ and Surf Bio's hyperconcentration technology. Hypercon™ is an innovative microparticle technology expected to set a new standard in hyperconcentration of drugs and biologics by reducing injection volume for the same dosage and enabling administration in at-home and healthcare-provider settings. The addition of Surf Bio's polymer-based hyperconcentration technology further broadens the range of biologics that can be delivered subcutaneously, meaningfully expanding the scope of opportunities across therapeutic modalities. Together, Hypercon™ and Surf Bio's technology complement ENHANZE® by enabling creation and delivery of highly concentrated biologics. The Hypercon™ technology has been licensed to leading biopharmaceutical partners, including Janssen, Eli Lilly, argenx, Vertex Pharmaceuticals and Oruka Therapeutics.Halozyme also develops, manufactures and commercializes drug-device combination products using advanced auto-injector technologies designed to improve convenience, reliability and tolerability, enhancing patient comfort and adherence. The Company has two proprietary commercial products, Hylenex® and XYOSTED®, partnered commercial products and ongoing development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc.Halozyme is headquartered in San Diego, CA, with offices in Ewing, NJ; Minnetonka, MN; and Boston, MA. Minnetonka is also the site of its operations facility.For more information, visit www.halozyme.com and connect with us on LinkedIn.Forward Looking StatementsIn addition to historical information, the statements set forth in this press release include forward-looking statements including, without limitation, statements concerning the Company's expected future financial performance, the Company's expectations of the impact to future royalty revenue and its ability to enter into new ENHANZE® partnership agreements based on its analysis of the proposed rule for the Medicare Drug Price Negotiation Program issued by CMS on June 12, 2026 including statements concerning expectations of the impact on future royalty revenues as a result of implementation of IPAY price negotiations for Part B drugs, and the assumptions used in deriving these projections, and factors such as orphan drug status and the potential launch of biosimilars resulting in exclusion from Medicare price negotiation. Forward-looking statements regarding the Company's ENHANZE® drug delivery technology include the possible benefits and attributes of ENHANZE® including its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and facilitating more rapid delivery and administration of higher volumes of injectable medications through subcutaneous delivery and potential to decrease treatment burden and provide clinically meaningful benefits to patients, and lowering healthcare system and Medicare costs including enabling administration at lower cost sites of care. These forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "can," "durable," "growth," "innovate," "develop," "vision," "potential," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including possible differences between relevant provisions of the proposed rule used by the Company in its analysis of the potential impact on future royalty revenues and the provisions of the final rule ultimately issued by the CMS, unexpected changes in the exclusions to Medicare price negotiations or delays in the launch of biosimilars referred to in this presentation, unexpected delays in the Company's ability to enter into new ENHANZE® partnership agreements, unexpected adverse events or patient outcomes, competitive conditions and uncertainties related to future pharmaceutical pricing policies. These and other factors that may result in differences are discussed in greater detail in the Company's most recent Annual Report on Form 10-K and Forms 10-Q filed with the Securities and Exchange Commission, including under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". The Company undertakes no obligation to update or revise any forward-looking statements or any other information contained hereinContacts: Tram Bui
VP, Investor Relations and Corporate Communications
609-333-7668
tbui @jcamp-8407
sydney.charlton@teneo.com View original content to download multimedia:https://www.prnewswire.com/news-releases/halozyme-confirms-it-projects-zero-to-minimal-impact-to-royalty-revenue-through-at-least-2035-based-on-newly-released-draft-medicare-drug-price-negotiation-program-proposed-rule-for-ipay-2029-302799891.htmlSOURCE Halozyme Therapeutics, Inc. Original: Halozyme Confirms It Projects Zero to Minimal Impact to Royalty Revenue Through At Least 2035 Based on Newly Released Draft Medicare Drug Price Negotiation Program Proposed Rule for IPAY 2029
biotechinvestor1
3日前
The Case for Merck Settling NOW (Before Director Review)
1. The Director’s May 15 Precedent Is Genuinely Threatening
Merck’s counsel cannot ignore the fact that Director Squires personally denied institution of PGR2025-00087 on May 15 — three days after the ’600 FWD issued — based on the identical RPI defect. The Director has now established a clear precedent:
“This RPI defect is fatal to institution.”
Extrapolating: if it’s fatal to institution, it’s fatal to an FWD issued on a defective petition. The logical inconsistency is real, and a competent Federal Circuit appellate counsel would exploit it relentlessly if this goes up on appeal.
Merck’s risk: The Director vacates the ‘600 FWD, and opens the door to cascading terminations across all PGRs and IPR’s. Suddenly Merck’s “winning” PTAB strategy becomes worthless.
2. Settlement Locks in Current Leverage While It Exists
Right now, Merck has maximum leverage:
• FWD in hand showing all claims invalid on §112 • more FWDs coming June–November that will likely follow the same blueprint • Director Review decision still pending (unknown outcome) • D.N.J. trial not until December 1, 2026
If Merck waits for the Director Review decision:
• Downside scenario (65-75% probability): Director vacates ‘600 FWD, terminates PGRs, Merck’s PTAB leverage evaporates overnight. Now they’re negotiating from a position of weakness with a trial 5 months away. Halozyme’s ask goes from “reasonable royalty” to “injunction relief.” • Base case scenario (25-35% probability): Director affirms FWD. Merck’s position improves but hasn’t meaningfully changed from today. They could have settled at a better rate 3 months earlier.
The optionality argument: By settling now, Merck eliminates downside risk and locks in favorable terms before the 65-75% probability event that reverses their position.
3. Keytruda Qlex Revenue Is Accelerating — Settlement Becomes Cheaper Than Litigation
The numbers are compelling:
Merck’s current position:
• Keytruda Qlex: $128M Q1 2026 (annualizing ~$500M, accelerating toward $3-4B) • Litigation costs: Sidley Austin + Dechert across 18 PTAB proceedings + D.N.J. district court = massive spend through 2027-2028
A 3-5% royalty rate:
• At $500M annual run-rate: $15-25M/year • At $3B product: $90-150M/year • Payable over 5-10 years = $450M-$1.5B total
But the alternative cost:
• Continue litigation: another $50-100M+ in legal fees through 2027-2028 • Risk Federal Circuit reversal on RPI grounds • Risk D.N.J. jury verdict with treble damages exposure • Risk injunction blocking Keytruda SC in key markets (Germany PI already in place)
The math: A settlement at 3-4% royalty for 10 years costs Merck less in NPV terms than litigating to a potentially adverse verdict AND paying royalties anyway.
4. The German Munich PI Creates Ongoing Commercial Damage
This is the factor I may have underweighted:
• Keytruda SC is blocked in Germany right now under the Munich PI on EP 622 • Germany is Merck’s largest single European market • Every quarter the PI remains in place = lost revenue that cannot be recovered • The German Federal Patent Court preliminary opinion (now overdue) could go either way
If the German court upholds EP 622 validity: Merck faces multi-year litigation in Germany while Halozyme has European enforcement leverage. Settlement becomes strategically necessary.
If the German court invalidates EP 622: The PI lifts, but Merck is still fighting multiple PGRs in the US. The European resolution doesn’t solve the US problem.
The strategic point: The German PI creates ongoing pressure that settlement eliminates completely.
My Honest Assessment: Merck Should Settle Now — But They Won’t
Why They Should Settle:
The Director’s May 15 precedent is too dangerous to ignore. Merck’s legal counsel should be running worst-case scenarios:
Scenario A (65-75% probability per my analysis): Director reverses ‘600 FWD ? cascading terminations ? Halozyme’s leverage surges ? Merck forced to settle at 5-6% rate on $3B+ product = catastrophic value destruction
Scenario B (25-35% probability): Director affirms ? Merck’s position unchanged ? could have settled 6 months earlier at 3% rate
Expected value of waiting = negative.
A rational financial analysis would show: Settlement now at 3-4% rate, locked for 10 years, eliminates downside risk and costs less than litigation to a potentially adverse outcome.
Why They Will Probably Wait:
Behavioral economics and organizational dynamics:
1. Sunken cost fallacy: 18 PTAB proceedings, massive legal spend already invested. Walking away feels like admitting the strategy failed. 2. Escalation of commitment: Senior Merck leadership has publicly committed to the PTAB strategy. Settling now = public admission it didn’t work. Board optics are bad. 3. Recency bias: The ‘600 FWD issued on May 12. It’s fresh. The momentum feels real. Waiting for more FWDs feels rational, not dangerous. 4. Organizational silos: The PTAB litigation team is separate from the business/licensing team. The litigation team benefits from continuing litigation (more billable hours, more “wins”). The business team bears the royalty cost. These incentives aren’t aligned. 5. Lawyer bias: Patent litigators are trained to fight to the end. Settlement = “losing.” Most PTAB counsel will argue for maximum trial before accepting defeat.
biotechinvestor1
5日前
The Director’s Own Precedent Now Cuts in Halozyme’s Favor:
What happened on May 15, 2026:Director Squires personally denied institution of PGR2025-00087 — the 15th PGR — on RPI grounds. He found the same MCI/MSD RPI issue present, and denied institution without reaching the merits. Same petitioner, same lead counsel, same parent company and same failure to disclose in all of the 14 other Merck’s PGR’s against Halozyme.
Why Halozyme’s Director Review Petition Has Dramatically Increased Probability of Success
1. Director Consistency DoctrineThe Director cannot plausibly maintain that:
• PGR2025-00087: “This petition fails to comply with statutory RPI requirements and should not have been instituted” (May 15).
It would be a logical impossibility to not apply the same RPI standards to the rest of the PGR’s. The Director has just established that an RPI defect is a threshold statutory violation that defeats institution. He cannot then say it doesn’t defeat the finality of a final written decision issued on the same defective petition.
2. Aylo Freesites Precedent Halozyme CitesHalozyme’s petition cites Aylo Freesites (IPR2024-00940, Director Feb. 3, 2026) — a case where the Director sua sponte vacated a final written decision after discovering an RPI defect. The Director exercised authority to go back and undo proceedings that were tainted by improper RPI disclosure.
The Director has already established he will do exactly what Halozyme is asking: vacate an FWD on RPI grounds. PGR2025-00087’s denial on May 15 is a fresh demonstration that the Director is serious about this.
3. Sun Pharm. Precedent (Very Recent)Halozyme also cites Sun Pharm. Industries v. Biofrontera (PGR2026-00021, May 26, 2026) — a Director decision issued on May 26, 2026 (the same day Halozyme filed its May 26 Director Review Request on the termination motion). The Director found in that case that “the Petitioner here likewise has failed to provide sufficient evidence that its parent company did not have the ability to control this proceeding.”
This is a fresh, contemporaneous Director precedent establishing that parent company control/RPI issues are being taken seriously at the Director level right now.
4. The Timing Creates Institutional PressureDirector Squires personally denied institution of PGR2025-00087 on May 15, 2026.
Revised Director Review Probability Assessment
The Director has now established that the same RPI defect is fatal to institution in PGR2025-00087. He cannot maintain institutional credibility by allowing the nearly-identical defect to stand in the other 14 PGR’s.
Consistency requires reversal of the already issued FWD.
The Cascading Effect Across All 14 PGRs
This creates a domino problem for Merck:
If the Director vacates the ’600 FWDs:
• All 14 remaining PGRs are tainted by the same RPI defect • The Director has now established that RPI defects are fatal even post-FWD • Halozyme has precedent (the Director’s own May 15 decision) for terminating all 14 proceedings • Merck’s entire PTAB strategy collapses
The Most Likely Scenario Now
Based on the Director’s May 15 decision on PGR2025-00087 and the May 26 Sun Pharm. decision, the most probable outcome is:
Director grants Halozyme’s Director Review petition, vacates the ’600 FWDs, and terminates the rest of PGR’s on RPI grounds.
This immediately triggers:
1. Halozyme’s ability to file Director Review petitions on all remaining 13 PGRs (using -00003 as precedent) 2. Probable cascading terminations across the 14-proceeding portfolio 3. Collapse of Merck’s PTAB strategy 4. Shift of all leverage to the district court and the 3 PGR-ineligible patents
Bottom Line
The Director has already ruled that the exact same RPI defect is sufficient to deny institution. He cannot now plausibly maintain that the identical defect does not invalidate an FWD that issued on a defective petition.
Revised overall termination probability (final): 75% Director reversal on PGR2025-00003 ? cascading terminations across 14 PGRs ? Merck’s PTAB strategy collapses ? settlement/licensing probability rises to 75-82% as Merck’s negotiating position deteriorates.