Litigation Details for Pharmacyclics LLC v. Sandoz Inc. (D. Del. 2018)

Pharmacyclics LLC v. Sandoz Inc. (D. Del. 2018)

Docket		Date Filed	2018-02-01
Court	District Court, D. Delaware	Date Terminated	2021-05-11
Cause	35:271 Patent Infringement	Assigned To	Colm Felix Connolly
Jury Demand	Defendant	Referred To	Christopher J. Burke
Parties	ZYDUS WORLDWIDE DMCC
Patents	10,004,746; 10,010,507; 10,016,435; 10,106,548; 10,125,140; 10,213,386; 10,294,231; 10,294,232; 7,514,444; 8,008,309; 8,476,284; 8,497,277; 8,697,711; 8,735,403; 8,754,090; 8,754,091; 8,952,015; 8,957,079; 8,999,999; 9,125,889; 9,181,257; 9,296,753; 9,540,382; 9,655,857; 9,713,617; 9,725,455; 9,795,604; 9,801,881; 9,801,883
Attorneys	Jayadeep R. Deshmukh
Firms	Smith, Katzenstein, & Jenkins LLP
Link to Docket	External link to docket

Biologic Drugs cited in Pharmacyclics LLC v. Sandoz Inc.

Details for Pharmacyclics LLC v. Sandoz Inc. (D. Del. 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-02-01				External link to document
2018-02-01	1		United States Patent Nos. 8,008,309 (“the ’309 Patent”); 7,514,444 (“the ’444 Patent”); 8,697,711 (“…(“the ’711 Patent”); 8,735,403 (“the ’403 Patent”); 8,957,079 (“the ’079 Patent”); 9,181,257 (“the ’257…’257 Patent”); 8,754,091 (“the ’091 Patent”); 8,497,277 (“the ’277 Patent”); 8,952,015 (“the ’015 Patent…37 PageID #: 2 Patent”); 9,296,753 (“the ’753 Patent”); 9,725,455 (“the ’455 Patent”); 9,540,382 (“the… 1. This action for patent infringement, brought pursuant to the patent laws of the United States	External link to document
2018-02-01	103		’548 Patents, and U.S. Patent Nos. 8,999,999 (“the ’999 Patent”); 9,801,881 (“the ’881 Patent”); 9,801,883… 16304 Patent”); 10,125,140 (“the ’140 Patent”); and 10,106,548 (“the ’548 Patent”). Sun has submitted… 1. This action for patent infringement, brought pursuant to the patent laws of the United States… the expiration of the U.S. Patent Nos. 9,296,753 (“the ’753 Patent”) 9,725,455 (“the ’455 Case 1:18…26. This civil action for patent infringement arises under the patent laws of the United States	External link to document
2018-02-01	104		Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,296,753 B2 ;9,725,455 B1 ;8,999,999 B2 ;9,801,881… 2018 11 May 2021 1:18-cv-00192 835 Patent - Abbreviated New Drug Application(ANDA) Defendant	External link to document
2018-02-01	128	Answer to Counterclaim	including but not limited to U.S. Patent No. 8,952,015 (“the ’015 Patent”). ANSWER: Denied. …’753 Patent, the ’455 Patent, the ’382 Patent, the ’617 Patent, the ’090 Patent, the ’889 Patent, the…’753 Patent, the ’455 Patent, the ’382 Patent, the ’617 Patent, the ’090 Patent, the ’889 Patent, the…’753 Patent, the ’455 Patent, the ’382 Patent, the ’617 Patent, the ’090 Patent, the ’889 Patent, the…753 Patent, the ’455 Patent, the ’382 Patent, the ’617 Patent, the ’090 Patent, the ’889 Patent, the	External link to document
2018-02-01	161	Patent/Trademark Report to Commissioner of Patents	the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 10,016,435 B2 . (Blumenfeld, … 2018 11 May 2021 1:18-cv-00192 835 Patent - Abbreviated New Drug Application(ANDA) Defendant	External link to document

Pharmacyclics LLC v. Alvogen Pine Brook LLC and Its Implications for Similar Cases Like Pharmacyclics LLC v. Sandoz Inc.

While the specific case of "Pharmacyclics LLC v. Sandoz Inc." is not directly detailed in the provided sources, we can analyze the similar case of "Pharmacyclics LLC v. Alvogen Pine Brook LLC" to draw relevant insights and implications for ANDA (Abbreviated New Drug Application) litigation involving generic drug manufacturers like Sandoz Inc.

Background of ANDA Litigation

ANDA litigation often arises under the Hatch-Waxman Act, which allows generic drug manufacturers to seek FDA approval for generic versions of branded drugs before the expiration of the original patents. This process frequently leads to patent infringement disputes between the original drug manufacturers and the generic manufacturers[1][3][4].

Pharmacyclics LLC v. Alvogen Pine Brook LLC: Key Points

• Patent Infringement Claims: Pharmacyclics LLC filed a suit against Alvogen Pine Brook LLC for the infringement of eighteen patents related to Imbruvica® Tablets. The case was narrowed down to nine claims across four patents (U.S. Patent Nos. 8,008,309, 8,754,090, 9,655,857, and 9,725,455)[1].

• Pretrial and Trial Proceedings: Before the trial, Pharmacyclics reduced the number of asserted claims multiple times. By the time of the pretrial order, they were asserting fifteen claims across nine patents, which was further reduced to nine claims across four patents. Alvogen stipulated that its ANDA product infringed one claim in each of the #309, #090, and #455 patents but contested the validity and infringement of the #857 patent claims[1].

• Trial Outcome: The court ruled that Alvogen infringed the asserted claims of the #857 patent. In a post-trial memorandum opinion, the court found that all asserted claims of the four patents were valid and not invalid. The final judgment was entered in favor of Pharmacyclics on August 30, 2021, and was affirmed by the Federal Circuit in November 2022[1].

Implications for Pharmacyclics LLC v. Sandoz Inc.

Patent Assertion and Litigation Strategy

• Claim Narrowing: Similar to the Alvogen case, if Pharmacyclics were to litigate against Sandoz, they might initially assert a large number of claims but narrow them down as the case progresses to focus on the most critical patents and claims. This strategy helps in managing the complexity and cost of litigation[1].

Stipulations and Settlements

• Infringement Stipulations: Sandoz, like Alvogen, might stipulate to infringement of certain claims, especially if the patents are strong and the infringement is clear. This can simplify the litigation process and focus the court's attention on validity and other defenses[1][4].

Validity and Non-Infringement Defenses

• Validity Challenges: Sandoz would likely pursue various invalidity defenses, as Alvogen did, to challenge the patents' validity. This could include arguments based on prior art, obviousness, or other grounds for invalidity[1].

Jurisdiction and Venue

• Personal Jurisdiction: The court's jurisdiction over Sandoz would be established based on Sandoz's business activities and engagement in patent litigation within the judicial district, similar to the reasoning in the Exela Pharma Sciences case against Sandoz[3].

Settlements and Appeals

• Settlement Agreements: The case could result in a settlement where Sandoz is enjoined from infringing the patents until their expiration, unless the patents are found invalid or unenforceable. This is a common outcome in ANDA litigation, as seen in other cases involving Sandoz[4].

• Appeals: Any adverse judgment could be appealed to the Federal Circuit, as was done in the Alvogen case. The appellate court's decision would be crucial in determining the final outcome and setting precedents for future ANDA litigation[1].

Key Takeaways

• Strategic Claim Assertion: Pharmaceutical companies should strategically narrow down their claims to focus on the most critical patents.
• Stipulations and Settlements: Infringement stipulations and settlement agreements can simplify and resolve cases efficiently.
• Validity Defenses: Generic manufacturers should thoroughly prepare and argue validity defenses to challenge the patents.
• Jurisdiction and Venue: Personal jurisdiction and venue are crucial aspects that must be established to ensure the court's authority over the defendant.
• Appeals: Adverse judgments can be appealed to higher courts, and the outcomes of these appeals can have significant implications for future litigation.

FAQs

Q: What is the Hatch-Waxman Act, and how does it relate to ANDA litigation?

A: The Hatch-Waxman Act allows generic drug manufacturers to seek FDA approval for generic versions of branded drugs before the expiration of the original patents, often leading to patent infringement disputes.

Q: How do pharmaceutical companies typically narrow down their claims in ANDA litigation?

A: Pharmaceutical companies often start by asserting a large number of claims and then narrow them down as the case progresses to focus on the most critical patents and claims.

Q: What are common defenses used by generic manufacturers in ANDA litigation?

A: Generic manufacturers commonly use invalidity defenses, such as arguing that the patents are invalid due to prior art or obviousness.

Q: Can ANDA litigation result in settlements that enjoin the generic manufacturer from infringing the patents?

A: Yes, settlements in ANDA litigation often include provisions that enjoin the generic manufacturer from infringing the patents until their expiration, unless the patents are found invalid or unenforceable.

Q: What is the role of the Federal Circuit in ANDA litigation appeals?

A: The Federal Circuit is the appellate court that hears appeals from district court decisions in patent cases, including ANDA litigation, and its decisions are crucial in determining the final outcome and setting precedents.

Cited Sources

1. Pharm.clics LLC v. Alvogen Pine Brook LLC - Casetext
2. Migrant Justice v. Nielsen - Civil Rights Litigation Clearinghouse
3. Exela Pharma Sciences, LLC v. Sandoz, Inc. - Insight.RPXCorp
4. ANDA Litigation Settlements Spring 2020 - Robins Kaplan