On October 9, 2025, Novo Nordisk confirmed that FDA had given its Bloomington, Indiana plant an Official Action Indicated (OAI) classification [1]. The plant came to Novo through its Catalent deal, which Novo Holdings closed in December 2024 [1]. Regeneron made its high-dose Eylea at that plant [1]. Scholar Rock’s spinal muscular atrophy drug, apitegromab, had already received a complete response letter that cited the site [1][2]. Incyte says the site is the primary fill-finish manufacturer for its Zynyz commercial supply [4]. No purchase order for any of these three products showed the risk.
A purchase order (PO) tells a contract development and manufacturing organization (CDMO) what a customer wants to make. A docket tells the CDMO whether the customer can sell the product, when it can start, and whether the CDMO itself carries legal or regulatory exposure. This article uses documented court and FDA events to show how dockets change the volume, timing, and risk of a CDMO contract.
We make one limit clear early. Most of the Eylea biosimilar developers we discuss made their own product. We use their cases to show how a docket moves demand for anyone who makes a drug, in-house or under contract. The Bloomington cases show the contract-manufacturer side directly.
The Short Answer: What a Docket Tells a CDMO That a Purchase Order Cannot
A purchase order records quantity, price, and delivery date. A docket records the events that decide whether those quantities ever ship. The best CDMOs read both. The rest read only the first.
What does a CDMO purchase order record?
A PO records what the customer wants. It states a product, a batch count, a price, and a delivery window. It does not record whether a court has blocked the product, whether a settlement has set a launch date, or whether FDA has flagged a plant.
What does a patent litigation docket record?
A docket records filings, rulings, and deadlines in a legal case. For a drug product, those entries can fix the first date of commercial sale. They can also show that a patent owner has named a manufacturer as a party.
Which docket events matter most to a CDMO?
Five matter most: an injunction, a settlement with a license entry date, a denied injunction that opens the market, a claim aimed at the manufacturer, and a regulatory action against a plant. We classify these later in this article.
Question a CDMO must answer
Does the PO answer it?
Where the answer sits
When can the customer start commercial sales?
No
Court orders, settlement terms, FDA approval records
Could a court block the product after we validate it?
No
Injunction motions and rulings
Could a patent owner name us as a defendant?
No
Complaints, 35 U.S.C. 271 analysis [8]
Does our plant carry an open FDA action?
No
Form 483, inspection classification, complete response letters [1][2]
Does the customer have a second filler or second site?
No
Customer SEC filings and earnings calls [3][5]
The Findings That Matter
These findings use documented facts. Findings marked as calculations are our analysis. We did not take them from any source.
FDA published more than 200 complete response letters in July 2025 [17]. In an analysis of 202 letters from 2020 to 2024, 150 (74%) involved quality or manufacturing issues [15].
FDA classified the Bloomington, Indiana plant as OAI, its most serious inspection category, and Novo confirmed notice on October 9, 2025 [1].
Calculation: about 340 days passed between Novo’s OAI notice on October 9, 2025 and FDA approval of Scholar Rock’s apitegromab in mid-September 2026, after Scholar Rock moved its application to a second fill-finish site [1][4][6].
Calculation: Formycon’s aflibercept biosimilar FYB203 received FDA approval on June 28, 2024, and its US license entry date is Q4 2026. That is a gap of about 27 months [9][11].
Calculation: Amgen launched Pavblu 84 days after FDA approval and 53 days after a court denied Regeneron’s preliminary injunction request [9].
In Amgen v. Hospira, the jury found that only 7 of 21 batches fell inside the patent safe harbor, and the Federal Circuit upheld that result [7].
FDA guidance says each party in drug manufacture is responsible for CGMP compliance for its own activities. The owner’s quality unit stays ultimately responsible for contracted work [18].
Methodology: How We Built the Timelines and Calculations
What data did we analyze?
We used 22 public sources. They include FDA guidance, a US statute, a federal appeals court summary, company SEC filings, a company press release, and trade and law-firm reporting. The period runs from 2019 to September 2026.
How did we select records?
We included an event only if a source gave a date and a named party. We counted a record once, even if two sources reported it. We did not use any figure that a source gave without a stated basis.
How did we calculate intervals?
We counted calendar days between two dated events. We converted days to months by dividing by 30.44. Where a source gave only a quarter, we used the first day of that quarter. That choice gives the shortest possible gap. Where a source gave only a month, we say so.
What are the limits?
This is not a database study. We did not review every CDMO contract, and contract terms differ. We do not assume that any CDMO named here bore any financial loss. Court status can change after publication. This article is not legal advice.
Definitions: Five Terms That Decide the Analysis
What is a patent litigation docket?
A docket is the court’s running list of filings, orders, and hearing dates in one case. In US federal cases, the public record sits in the PACER system.
What is the 35 U.S.C. 271(e)(1) safe harbor?
The safe harbor says it is not infringement to make, use, offer to sell, sell, or import a patented invention “solely for uses reasonably related to the development and submission of information” under a federal drug law [8]. It protects work for FDA submissions. It does not protect work done to build commercial inventory [7].
What is an Official Action Indicated classification?
OAI is the most severe of FDA’s three inspection classifications. FDA describes it as an “unacceptable state of compliance” [1].
What is a complete response letter?
A complete response letter (CRL) is FDA’s notice that it will not approve an application in its present form. Sponsors can resubmit after they fix the cited problems.
What is a license entry date?
A license entry date is the date a settlement lets a challenger sell its product. Parties sometimes allow an earlier date under undisclosed conditions [11].
How Does a Patent Injunction Turn a Forecast Into Idle Capacity? The Eylea Biosimilar Case
Regeneron’s aflibercept (Eylea) litigation gives the clearest public record of how a docket changes launch timing. A common set of 13 patents was asserted across the actions, and U.S. Patent No. 11,084,865 (the ‘865 patent) was central [9]. Regeneron used the ‘865 patent for its preliminary injunction motions against Samsung Bioepis and Formycon [9].
Eylea biosimilar litigation timeline
The table lists each defendant as of the Loeb & Loeb summary dated February 19, 2025, with later events from other sources.
Defendant (product)
Complaint filed
FDA approval
District court result
Later events
Source
Mylan/Biocon (Yesafili)
Aug. 2, 2022
May 20, 2024
Permanent injunction, June 11, 2024
Settled April 2025 during appeal
[9][10]
Celltrion
Nov. 8, 2023
Not approved as of Feb. 2025
Preliminary injunction, June 28, 2024
Federal Circuit affirmed March 5, 2025
[9][10]
Samsung Bioepis (Opuviz)
Nov. 21, 2023 and Dec. 27, 2023
May 20, 2024
Preliminary injunction, June 14, 2024
Federal Circuit affirmed Jan. 29, 2025
[9][10]
Formycon (Ahzantive)
Nov. 29, 2023
June 28, 2024
Preliminary injunction, June 21, 2024
Federal Circuit affirmed Jan. 29, 2025; settled Oct. 2, 2025
[9][11]
Amgen (Pavblu)
Jan. 10, 2024
Aug. 23, 2024
Preliminary injunction denied, Sept. 23, 2024
Launched Nov. 15, 2024; Federal Circuit affirmed denial March 14, 2025
[9][10]
Sandoz (Enzeevu)
Aug. 26, 2024
Aug. 9, 2024
Pending as of Feb. 2025
Not stated in our sources
[9]
What does the table show?
As of February 19, 2025, four of the six defendants faced an injunction [9]. Two of those injunctions had been affirmed on appeal by January 29, 2025 [9][10]. Amgen alone had launched in the US as of that date [9].
How long did approved products wait for the market?
The calculations below use the dates in the table.
Interval (analysis)
Days
Months
Formycon: complaint to preliminary injunction
205
6.7
Samsung Bioepis: first complaint to preliminary injunction
206
6.8
Celltrion: complaint to preliminary injunction
233
7.7
Mylan/Biocon: FDA approval to permanent injunction
22
0.7
Samsung Bioepis: FDA approval to preliminary injunction
25
0.8
Formycon: FDA approval to settlement announcement
461
15.1
Formycon: FDA approval to start of Q4 2026 license date
825
27.1
Amgen: FDA approval to launch
84
2.8
Amgen: injunction denial to launch
53
1.7
What does a 27-month gap mean for a manufacturer?
A company can finish validation, hold an approved license, and still have no right to sell for more than two years. Any manufacturer that planned commercial batches for the approval date faced a forecast error of that size. This is analysis. The PO would have looked normal until the court acted.
What happened when the court denied the injunction?
The Federal Circuit affirmed the denial of Regeneron’s request against Amgen on March 14, 2025. It held that Regeneron had not shown a likelihood of success on infringement, because Amgen’s formulation lacked the claimed buffer element [10]. Amgen had launched on November 15, 2024 [9]. The same patent family produced opposite outcomes for different formulations. A docket reader would have seen that difference in the claim-construction arguments before launch.
What Does a Settlement License Entry Date Do to a Production Schedule?
A settlement turns an uncertain date into a fixed one. That helps anyone who plans capacity, if the product is also approved.
Formycon, Klinge, and Valorum: a Q4 2026 US date
Formycon, Klinge Biopharma, and Valorum Biologics announced a settlement with Regeneron on October 2, 2025 [11]. The agreement says Valorum may launch Ahzantive in the US in Q4 2026, “or earlier under certain undisclosed circumstances” [11]. The settlement resolved all US patent disputes about FYB203 and vacated the injunction [11]. Valorum holds the US and Canada commercial license from Klinge [11].
Why do the undisclosed circumstances matter?
An earlier-entry clause can pull demand forward without a new order. A manufacturer cannot see that clause in a PO. A manufacturer that knows such clauses are common can ask the customer how much notice it will give.
Alvotech and Teva: a date that depends on a plant
Alvotech and Teva have a US license entry date of Q4 2026 for AVT06, a proposed Eylea biosimilar, under a December 2025 settlement with Regeneron and Bayer [12]. FDA issued a CRL for AVT06 in November 2025 and tied it to deficiencies at the Reykjavik facility [12]. A pre-approval inspection ran from June 26 to July 4, 2025, and the resulting Form 483 cited manufacturing operations, quality procedures, documentation, laboratory controls, and materials management [12]. A second inspection ended May 8, 2026, with another Form 483 [12].
What is the gap between the CRL and the license date?
Analysis: if we count from mid-November 2025 to October 1, 2026, the gap is about 10.5 months. Alvotech expects a six-month FDA review after its resubmission, which the source says would likely end near the end of 2026 [12]. The court docket set the date. The FDA docket decides whether the date holds.
Is this a one-time problem for Alvotech?
No. FDA rejected Alvotech’s Humira biosimilar candidate AVT02 in September 2022, April 2023, and June 28, 2023, and cited deficiencies at a Reykjavik facility in the third letter [13]. In November 2025, Alvotech also reported a CRL for AVT05, a proposed Simponi biosimilar [14]. The sources we reviewed do not state the cause of the AVT05 letter.
Can a Patent Owner Sue the Contract Manufacturer? What 35 U.S.C. 271 Says
Yes, the statute reaches manufacturers. Whether a patent owner would sue a CDMO instead of the customer is a strategy question. The statute leaves the door open.
Section 271(a): who “makes” a patented invention?
Section 271(a) says that whoever “without authority makes, uses, offers to sell, or sells” a patented invention in the United States, or imports one, during the patent term, infringes the patent [8]. A contract manufacturer that makes a patented product, or uses a patented process, performs the act of making.
Section 271(g): what about products made abroad by a patented process?
Section 271(g) makes a person liable who imports into the United States, offers to sell, sells, or uses within the United States a product made by a patented US process, during the process patent’s term [8]. A CDMO that exports a drug substance to a US customer should know which process patents cover the customer’s route.
Section 271(b): can a CDMO be liable for helping a customer?
Section 271(b) says whoever “actively induces infringement of a patent shall be liable as an infringer” [8]. The statute does not say how that applies to a given CDMO. That depends on the facts and on counsel.
How far does the safe harbor go? Amgen v. Hospira
In Amgen Inc. v. Hospira, Inc., No. 2019-1067 (Fed. Cir. Dec. 16, 2019), Amgen asserted U.S. Patent No. 5,856,298, which covers methods of producing erythropoietin [7]. The Federal Circuit looked at each act of manufacture, not at how Hospira later used the batches [7]. The jury found that 7 of Hospira’s 21 batches fell inside the safe harbor, and the court held that substantial evidence supported the verdict [7]. Evidence included testimony that Hospira made some batches and ran stability testing that FDA did not require, and documents showing that parts of some batches were meant as commercial inventory [7].
What does this mean for validation batches at a CDMO?
Analysis: the reason for each batch matters. A batch made to support an FDA filing has a stronger safe-harbor position than a batch made to stock a launch. A CDMO that cannot tell which is which from the PO cannot judge its own exposure. The summary we used is a law-firm blog, not the opinion. Read the opinion before you rely on it.
A Swiss example: a patentee aimed at the manufacturer
On January 3, 2023, the Swiss Federal Patent Court decided a measures procedure, Judgment S2022_003, that concerned a pharmaceutical contract manufacturer [21]. According to the law firm Vischer, whose lawyers represented parties in the case, patentees may sue the manufacturer instead of the customer to seek a precautionary injunction that blocks a competing product at the development stage [21]. The firm writes that contract manufacturers “have a duty to ensure that their activities do not infringe any patent rights of third parties” [21].
What did the court say about risk control?
The Vischer summary says an independent freedom-to-operate analysis can avert the risk, and an internal one is not enough [21]. It also says contracts should separate regulatory activities from commercialization, and that commercial work should wait until the customer provides an independent analysis [21]. It recommends a comprehensive indemnification clause [21].
Does the Swiss decision apply in the United States?
No. It is Swiss law, and it applies Swiss safe-harbor rules. We include it because it shows a patentee choosing a CDMO as the target. A US CDMO should read Section 271 and ask counsel how a similar claim would work here.
Why Do FDA Dockets Matter as Much as Court Dockets? The Bloomington Case
A court can block a launch. FDA can block a plant. For a CDMO, the second event can hit many customers at once.
Bloomington timeline, 2024 to 2026
Date
Event
Source
December 2024
Novo Holdings completes its $16.5 billion Catalent acquisition and sells three Catalent plants, including Bloomington, to Novo Nordisk for $11 billion
[1]
Summer 2025
FDA inspection of the site finds multiple failings
[2]
About August 2025
FDA extends the Aug. 19 target date for two Eylea HD applications because of inspection issues at the site
[1][3]
September 2025
Scholar Rock receives a CRL for apitegromab that cites site issues “not specific to apitegromab”
[1][2]
October 9 to 10, 2025
Novo confirms OAI notice (Oct. 9); Scholar Rock tells investors about the Form 483 (Oct. 10)
[1]
October 28, 2025
Regeneron discloses a CRL for the Eylea HD prefilled syringe, tied to the Bloomington filler
[3]
March 2026
Scholar Rock refiles with two fill-finish facilities, including the Catalent Indiana site
[4]
August 7, 2026
Scholar Rock drops the Catalent site and shifts the application to the second facility; PDUFA date is Sept. 30, 2026
[4][5]
Mid-September 2026
FDA approves apitegromab (Isembyld), about two weeks before the PDUFA date
[6]
Who was exposed?
Three customers show up in the public record. We do not know the full client list, and we do not claim these are the only ones.
Regeneron: Eylea HD and a second filler
Regeneron said it expected to apply in January 2026 for an alternate third-party facility for prefilled syringe production, and that FDA review would take about four months [3]. It also asked FDA to add an alternate vial filler to its RVO supplement [3]. It is expanding its Tarrytown campus by $3.6 billion and building a fill-finish facility in Rensselaer, New York [3]. Chief executive Len Schleifer said on the Q3 2025 call, “We’ve been talking about the need for domestic manufacturing since 2014” [3].
Scholar Rock: two paths to one decision
Scholar Rock told investors on August 6, 2026 that it had “two independent paths to an FDA approval decision”: one through Catalent Indiana, where the classification was still pending after an April 2026 inspection, and one through a second fill-finish site [5]. One day later it dropped the Catalent site from its US application [4].
Incyte: a commercial product on the same site
Incyte confirmed that “Catalent Indiana is the primary fill-finish manufacturer” for Zynyz commercial supply [4].
What did analysts say about timing?
Citi analyst Geoffrey Meacham wrote that “The OAI makes further delays likely.” He said that if the site stayed under OAI at the PDUFA dates, CRLs would likely follow [1]. He also said approval of an alternate filler could take more than 9 to 12 months [1].
Is Bloomington an isolated case?
No. FDA completed an inspection of the Emergent BioSolutions Bayview facility on April 20, 2021 and cited a failure to thoroughly investigate cross-contamination of a client’s viral vaccine drug substance batch [19]. About 15 million potential Johnson & Johnson COVID-19 vaccine doses were ruined, according to the report [19]. The pattern repeats: a finding at one plant reaches every client that depends on it.
What Do the 202 Published CRLs Say About Outsourced Manufacturing?
FDA published more than 200 CRLs on July 10, 2025. They cover applications submitted from 2020 to 2024 [17]. FDA said it would publish more [17].
150 of 202 complete response letters (74%) issued between 2020 and 2024 involved quality or manufacturing issues, including manufacturing processes, facility inspections, or chemistry, manufacturing and controls. (Slabodkin, Pharma Manufacturing, July 14, 2025) [15]
How many small biopharma companies outsource manufacturing?
A William Blair estimate from 2024, as cited by Outsourced Pharma, says 85% of small biopharma companies outsource API production and 77% outsource finished dose manufacturing [16]. We did not review the William Blair report itself.
Which companies appear more than once?
The Pharma Manufacturing review lists Alvotech, Azurity Pharmaceuticals, Celltrion, Coherus BioSciences, Dr. Reddy’s Laboratories, Eli Lilly, Pfizer, Sun Pharma, and Teva Pharmaceuticals as companies with multiple CRLs [15]. Jefferies analysts flagged nine applications as of interest for CMC issues, including Regeneron’s Eylea HD [15].
What is the limit of the 74% figure?
The letters cover products that FDA later approved [17]. The sample may not represent all CRLs. The 74% figure counts any quality or manufacturing issue. It does not tell you how many involved a contract site.
A Taxonomy: Five Docket Events That Change a CDMO’s Volume Forecast
This is an original framework. It is not an industry standard. It sorts docket events by what they do to a manufacturing schedule.
Sets a start date, sometimes with an early-entry clause
Formycon/Valorum, Alvotech/Teva, Q4 2026
[11][12]
3. Open door
Injunction denied or at-risk launch
Starts demand at once; litigation risk continues
Amgen Pavblu, launched Nov. 15, 2024
[9][10]
4. Direct hit
Claim or measure aimed at the manufacturer
Creates liability and may stop work
Swiss Judgment S2022_003; Amgen v. Hospira batches
[7][21]
5. Plant flag
FDA inspection finding, OAI, or CRL tied to a site
Stops approvals for every client at the site
Bloomington; Alvotech Reykjavik; Emergent Bayview
[1][12][19]
How should a CDMO use the taxonomy?
Tag every customer product with the current type. Review the tag when a docket changes. A Type 1 product needs a deferral plan. A Type 2 product needs its date checked against the plant schedule. A Type 3 product needs a litigation-risk review. A Type 5 flag needs a client-by-client call.
PO-Only CDMO vs. Docket-Tracking CDMO: A Comparison
Practice
CDMO that tracks the PO
CDMO that tracks the docket
Capacity planning
Uses the delivery dates on the order
Compares delivery dates with injunction, settlement, and approval dates
Customer calls
Asks about batch status
Asks about a pending injunction ruling and any early-entry clause
Validation batches
Makes what the customer orders
Records why each batch is made, as Amgen v. Hospira rewards [7]
Legal exposure
Assumes the customer holds all risk
Reads 35 U.S.C. 271 and asks for an independent freedom-to-operate analysis [8][21]
Plant risk
Waits for the client to report
Maps clients to sites and tests for a second site [3][5]
Sales pipeline
Follows approvals
Follows approvals and license entry dates
What Do the Quality Agreement Rules Say About Who Is Responsible?
FDA’s November 2016 guidance says “Each party engaged in the manufacture of a drug is responsible for ensuring compliance with CGMP” for the activities it performs [18]. The owner’s quality unit is legally responsible for approving or rejecting drug products from a contract facility, including final release [18]. Quality agreements cannot delegate statutory or regulatory CGMP responsibilities [18].
What does this mean for a CDMO’s own docket?
The CDMO is responsible for its own CGMP compliance, so an FDA finding at its plant is its own problem. The owner remains responsible too. Both parties therefore have a stake in the inspection record.
What This Means for CDMO Business Development
Analysis begins here. We label inferences as inferences.
What this means for a CDMO sales team
A product with an approval date and a pending injunction ruling is a different lead from a product with an approval date and no litigation. The first lead has a downside the second does not. It also has an upside: a favorable ruling pulls demand forward.
Which questions should a sales team ask a prospect?
Ask whether a patent case is pending and where. Ask whether a settlement exists. Ask whether it has an early-entry clause. Ask whether the product has a second approved filler. These questions use public facts. A prospect can answer them in minutes.
What this means for a CDMO quality and operations team
The Bloomington record shows that clients moved to other sites over months, not days. Regeneron planned about four months of FDA review for an alternate prefilled-syringe facility [3]. Citi’s analyst put an alternate filler at 9 to 12 months or more [1]. A CDMO with spare qualified capacity may win that work. A CDMO under its own OAI may lose it.
Why did capacity deals grow at the same time?
On April 22, 2025, Fujifilm Diosynth Biotechnologies and Regeneron signed a 10-year US manufacturing agreement valued at over $3 billion, centered on the Holly Springs, North Carolina site [20]. We found no mention of Bloomington in the announcement, and we draw no causal link. It shows that sponsors with supply exposure sign long contracts with US sites.
What this means for a CDMO legal team
Ask counsel four questions. Does the master agreement allocate third-party patent risk? Does it require the customer to supply a freedom-to-operate analysis before commercial work starts? Does it separate regulatory batches from commercial inventory? Does it say what happens if a court enjoins the product? The Swiss summary recommends these steps for the Swiss setting [21]. US counsel should judge their fit here.
What this means for sponsors
Sponsors can read the same dockets. A sponsor that tells its CDMO about a pending ruling gives the CDMO time to move slots. A CDMO that receives that notice early can offer the freed slot to another client.
Scenario Analysis: What Three Docket Outcomes Do to Units Delivered
This is illustrative arithmetic, not a forecast. We assume a flat 100 units per year of commercial demand from the entry date, no ramp, no share loss, and a 36-month window that starts at FDA approval. We use the three intervals documented above.
Scenario
Months from approval to entry
Months of sales in 36-month window
Units (analysis)
Basis
A. Open door
2.8
33.2
277
Amgen, 84 days [9]
B. One-year lockout
12.0
24.0
200
Assumed round figure
C. Formycon-type lockout
27.1
8.9
74
Formycon approval to Q4 2026 [9][11]
What does the scenario show?
Scenario C delivers about 27% of the units in Scenario A over the same 36 months (74 divided by 277). The gap is a docket outcome. It has nothing to do with the customer’s demand or the CDMO’s performance. Who bears that gap depends on the contract, and we do not assume any terms.
How Do You Track a Docket Without a Legal Department?
Regeneron and Scholar Rock disclosed site dependence in public statements [3][5]
FDA approvals, CRLs, inspection results
Site named in CRL, OAI status, 483 findings
Sets Type 5 events [1][15]
Patent databases
Expiry dates, patent families, challenges
Shows which products face a docket before a complaint is filed
Where does DrugPatentWatch fit?
DrugPatentWatch describes its service as biopharmaceutical intelligence drawn from primary sources. Its site lists expiring and expired patents, global patent data for 134 countries, litigation records with complaints and court documents, FDA Orange Book data, ANDA filings, custom alerts, and data exports [22]. A CDMO business development team can use it to find which customer products have patents and litigation attached, then check each court filing against the primary record. It supplies context. It does not replace the court record.
What is a sensible review rhythm?
Review active customer products on a fixed schedule and again on any docket event. Keep one row per product: current type from the taxonomy, key date, source, and the next expected event.
Key Takeaways
A PO records what a customer wants to make. A docket records whether and when the customer may sell.
In the 202 CRLs analyzed, 74% involved quality or manufacturing issues [15].
FDA’s OAI classification at Bloomington on October 9, 2025 touched at least three named companies: Regeneron, Scholar Rock, and Incyte [1][3][4].
The time from OAI notice to Scholar Rock’s approval was about 340 days (our calculation) [1][6].
Formycon’s approved biosimilar waited about 27 months from approval to a Q4 2026 license date (our calculation) [9][11].
Amgen launched 84 days after approval, after a court denied an injunction [9].
The safe harbor protects batches made for FDA submissions. It does not protect commercial inventory. In Amgen v. Hospira, 7 of 21 batches qualified [7].
The owner and the contract facility each carry CGMP responsibility [18].
FAQ
1. Can a US patent owner sue a CDMO for infringement?
The statute allows it. Section 271(a) reaches anyone who makes a patented invention without authority, and Section 271(g) reaches imports and sales of products made by a patented process [8]. Whether a patentee chooses to sue a CDMO is a strategy choice. Ask counsel about your facts.
2. Does the safe harbor cover validation batches?
It can, depending on why each batch was made. In Amgen v. Hospira, 7 of 21 batches fell inside it, and parts of some batches meant as commercial inventory fell outside [7].
3. What does an OAI classification mean for a CDMO’s clients?
FDA calls OAI an unacceptable state of compliance [1]. At Bloomington, it was followed by delayed or rejected applications for Regeneron and Scholar Rock, and Incyte confirmed the site as the primary filler for Zynyz [1][3][4].
4. How often do CRLs involve manufacturing?
In one analysis of 202 letters from 2020 to 2024, 150 (74%) involved quality or manufacturing issues [15].
5. Who is responsible for quality when a CDMO makes a drug?
Both parties are. Each is responsible for CGMP compliance for its own activities, and the owner’s quality unit is ultimately responsible for contracted work [18].
6. What is a license entry date, and why does it matter?
It is the date a settlement lets a challenger sell its product. For Formycon’s FYB203 and Alvotech’s AVT06, the US dates are in Q4 2026, with an early-entry option for Formycon [11][12].
7. How long did Eylea biosimilars wait between approval and market?
By our calculation, Formycon’s FYB203 waits about 27 months from approval to a Q4 2026 date. Amgen’s Pavblu launched 84 days after approval [9][11].
8. How fast can a sponsor move to a second filler?
It varies. Regeneron expected about four months of FDA review for an alternate prefilled-syringe facility [3]. Citi’s analyst said an alternate filler could take more than 9 to 12 months [1]. Scholar Rock moved its application on August 7, 2026 and received approval about five weeks later [4][6].
9. How many small biopharma companies outsource manufacturing?
A William Blair estimate cited by Outsourced Pharma says 85% outsource API production and 77% outsource finished dose manufacturing [16].
10. Should a CDMO ask for a freedom-to-operate analysis?
A Swiss law-firm summary of a 2023 court judgment says an independent analysis can avert risk and that an internal one is not enough [21]. That is Swiss law. A US CDMO should ask counsel whether a similar request fits its contracts.
References
[1] Dunleavy, K. (2025, October 13). Novo plant hit with FDA’s most serious inspection classification, portending possible delays for partners. Fierce Pharma. https://www.fiercepharma.com/manufacturing/fda-slaps-novo-nordisks-indiana-plant-oai-label-which-bad-news-regeneron-scholar-rock
[2] European Pharmaceutical Review. (2025, October 15). Novo Nordisk manufacturing facility, and clients, hit by FDA action. https://www.europeanpharmaceuticalreview.com/news/267113/novo-nordisk-manufacturing-facility-catalent-fda-regeneron-eylea
[3] Dunleavy, K. (2025, October 28). Regeneron reports another manufacturing-related rejection for Eylea HD but says help is on the way. Fierce Pharma. https://www.fiercepharma.com/manufacturing/regeneron-reports-another-manufacturing-related-crl-eylea-hd-says-help-way
[4] Fierce Biotech. (2026, August 10). Scholar Rock ditches Novo’s legacy Catalent plant in FDA refiling of SMA drug. https://www.fiercebiotech.com/pharma/scholar-rock-ditches-novo-legacy-catalent-plant-fda-refiling-sma-drug
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[7] Weil, J., & Elsby, R. J. (2019, December 23). How safe is the safe harbor for methods of manufacturing biosimilar products: It depends on why each batch is made. Akin Gump Strauss Hauer & Feld LLP. https://www.akingump.com/en/insights/blogs/ip-newsflash/how-safe-is-the-safe-harbor-for-methods-of-manufacturing
[8] 35 U.S.C. § 271. Legal Information Institute, Cornell Law School. https://www.law.cornell.edu/uscode/text/35/271
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[10] Goodwin Procter LLP. (2026, January). Year in review: Top legal developments of 2025. https://www.goodwinlaw.com/en/insights/blogs/2026/01/year-in-review-top-legal-developments-of-2025
[11] Pearce IP. (2025, October 2). Formycon, Klinge, Valorum set for Q4 2026 biosimilar aflibercept US launch following Regeneron settlement. https://www.pearceip.law/2025/10/02/formycon-klinge-valorum-set-for-q4-2026-biosimilar-aflibercept-us-launch-following-regeneron-settlement/
[12] Eyes on Eyecare. (2026, June 9). Alvotech resubmits BLA for proposed Eylea biosimilar. https://glance.eyesoneyecare.com/stories/2026-06-09/alvotech-resubmits-bla-for-proposed-eylea-biosimilar/
[13] Pharmaceutical Technology. (2023). FDA rejects Alvotech Humira biosimilar third time. https://www.pharmaceutical-technology.com/news/fda-rejects-alvotech-humira-biosimilar-third-time/
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[15] Slabodkin, G. (2025, July 14). FDA’s CRLs reveal 74% of applications rejected for quality, manufacturing issues. Pharma Manufacturing. https://www.pharmamanufacturing.com/all-articles/article/55302937/fdas-crls-reveal-74-of-applications-rejected-for-quality-manufacturing-issues
[16] Garguilo, L. (2025, September 2). What FDA’s complete response letters say about outsourcing. Outsourced Pharma. https://www.outsourcedpharma.com/doc/what-fda-s-complete-response-letters-crl-say-about-outsourcing-0001
[17] Regulatory Affairs Professionals Society. (2025, July 10). FDA publishes 200 complete response letters. https://www.raps.org/resource/fda-publishes-200-complete-response-letters-in-tra.html
[18] U.S. Food and Drug Administration. (2016, November). Contract manufacturing arrangements for drugs: Quality agreements (Guidance for industry). https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/FDA/Contract-Manufacturing-Arrangements-for-Drugs–Quality-Agreements.pdf
[19] CBS News Baltimore. (2021, April 21). FDA completes inspection of J&J vaccine maker Emergent BioSolutions, cites concerns over cross-contamination, sanitation. https://www.cbsnews.com/amp/baltimore/news/fda-inspection-emergent-biosolutions-bayview-johnson-johnson-covid-vaccine-cites-concerns-processing
[20] FUJIFILM Diosynth Biotechnologies & Regeneron. (2025, April 22). FUJIFILM Diosynth Biotechnologies and Regeneron sign a 10-year U.S. manufacturing agreement valued at over $3 billion [Press release]. Business Wire. https://www.businesswire.com/news/home/20250422165205/en/FUJIFILM-Diosynth-Biotechnologies-and-Regeneron-Sign-a-10-Year-U.S.-Manufacturing-Agreement-Valued-at-Over-3-Billion
[21] Vischer (Transatlantic Law International). (2023, April 20). Switzerland update: Patent risks of pharmaceutical contract manufacturers (CMOs). https://www.transatlanticlaw.com/content/switzerland-update-patent-risks-of-pharmaceutical-contract-manufacturers-cmos/
