U.S. Government: NPEs Deserve Injunctive Relief when their Patents Are Infringed

Patent

by Dennis Crouch

I learned of this significant development from Michael Shapiro's Bloomberg article reporting that the U.S. government took the unusual step of filing a statement of interest in a district court patent case, urging consideration of preliminary injunctive relief for a non-practicing entity (NPE). Radian Memory Systems LLC v. Samsung Electronics Co., No. 2:24-cv-1073 (E.D. Tex. 2025). The June 24, 2025 filing represents a notable intervention by both the Department of Justice Antitrust Division and the U.S. Patent and Trademark Office in what is part of its "America First Antitrust Enforcement" efforts.

Read the documents:

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Seeds of Doubt: Sexual Reproduction and Territorial Limits in Plant Patent Law

Patent

by Dennis Crouch

Driscoll's operates as the world's largest berry company, controlling about one-third of the $6 billion U.S. berry market.  For the most part, however, Driscoll's does not grow the berries itself, but rather develops new varieties and then licenses their use through local farmers across dozens of countries. These agreements include anti-breeding provisions layered on top of their plant patent rights.

The defendant in this case, California Berry Cultivars, LLC (CBC), was founded by Dr. Doug Shaw, a former UC Davis professor who led the university's strawberry breeding program for decades.  In 2017 Shaw was found liable for infringing several UC Davis strawberry patents.  During the UC litigation, some documents apparently revealed that CBC had used Driscoll's varieties in their breeding programs.

Driscoll then sued Shaw and CBC for infringement of their patents.  PP 18,878; PP 22,247; and PP 23,400. Ultimately, however, the district court sided with the accused infringer -- granting summary judgment based upon Driscoll’s failed to produce sufficient evidence that patented plants were specifically used as maternal plants (i.e., the plant bearing the seeds) in the crosses, or that any seeds derived from patented plants were imported or used within the United States.

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USPTO Implements Penalty System for False Small/Micro Entity Status Claims

Patent

by Dennis Crouch

The USPTO has begun implementing a comprehensive enforcement system for false assertions of small entity and micro entity fee status. This is continuation of a process began under Director Vidal and implementation of statutory changes in 2023.  See Statutory Penalties for False Assertions or Certifications of Small and Micro Entity Status (June 2025).  The memo explains a notice-and-order process that removes applications from examination pending resolution and can result in significant financial penalties, examination delays, and patent term adjustment reductions for applicants who improperly claim small or micro entity status.

2023 legislation added a penalty provisions to 35 U.S.C. § 41(j) for small entity violations and § 123(f) for micro entity violations. A subsequent December 2024 amendment added explicit good faith exceptions to both penalty provisions.  The statute provides for a penalty of "not less than 3 times the amount that the entity failed to pay as a result of the false certification" and does not provide a timeline for enforcement - noting that the fine applies "whether the Director discovers the false certification before or after the date on which a patent has been issued."

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Label-Plus Infringement: The Tinderbox Theory of Generic Inducement

Patent

by Dennis Crouch

The Supreme Court recently issued a Call for the Views of the Solicitor General (CVSG) in the “skinny label” inducement case, Hikma v. Amarin.  I expect the CVSG brief will be filed in late fall by the Trump-appointed Solicitor General (currently D. John Sauer).  Behind the scenes lobbying will be ongoing between  the Republican populists (seeking lower drug prices) and more traditional Republicans (promoting innovator businesses).

At issue is Hikma’s generic version of Amarin’s Vascepa (icosapent ethyl). Initially approved to treat severe hypertriglyceridemia (SH), Amarin subsequently secured FDA approval and patent protection for using Vascepa to reduce cardiovascular (CV) risk, a second indication constituting the majority of sales. Hikma launched its generic with an FDA approved “skinny label” explicitly carving out the patented CV. Doctors have a strong incentive to prescribe the generic version for the patented CV use due to significantly lower costs, leading to broader patient access. Additionally, insurers and pharmacy benefit managers actively encourage or require the use of lower-priced generics whenever available, further motivating physicians to prescribe generic alternatives for patented indications.  We also know the unpatented SH use is closely related to the patented CV use.  Severe hypertriglyceridemia (very high triglyceride levels) typically coincides with increased cardiovascular risk.

Background Materials:

Amarin’s infringement lawsuit was initially dismissed by the district court, but the Federal Circuit reversed, holding that Amarin plausibly alleged induced infringement by Hikma. Despite the skinny label, the court pointed to Hikma’s statements describing its product as a “generic version” of Vascepa, press releases citing total sales dominated by the patented use, and removal of certain disclaimers in its label, concluding that collectively these actions could actively encourage infringement by healthcare providers.

This scenario exemplifies the “label-plus” theory of inducement, wherein a generic drug’s label alone, even if it suggests infringing use, cannot constitute infringement because it falls within a congressionally authorized regulatory scheme. However, when a generic label closely aligns with an infringing use and is combined with additional active steps, inducement liability may arise. In my view, the label itself is not part of the active step, but instead creates the underlying fragile conditions that make it easy to induce infringement. In Hikma’s case, Federal Circuit concluded these active steps involved explicitly highlighting parallels to the branded drug Vascepa—such as marketing it as a “generic version” and emphasizing sales data strongly associated with the patented cardiovascular use—while omitting any explicit mention of the label’s carve-out.  Note here that this was all at the motion-to-dismiss stage of the case; Amarin has not yet proven infringement but has alleged enough to allow the case to proceed into discovery. (more…)

USPTO Discontinues Accelerated Examination Program for Utility Applications (Design Patent Rocket Docket is also Suspended)

Patent

by Dennis Crouch

The USPTO is discontinuing its Accelerated Examination program on July 10, 2025.  The program has received fewer than 100 petitions in recent years, compared with 10,000+ Track One prioritized examination requests.  The USPTO anticipates further raising the annual limit on Track One requests in 2025.  The USPTO also recently terminated the Climate Change Mitigation Pilot Program on January 28, 2025. See Discontinuation of the Accelerated Examination Program for Utility Applications, 90 Fed. Reg. 24324 (June 10, 2025).

The Accelerated Examination program allowed applicants to advance their applications out of turn by filing a petition to make special along with a pre-examination search and examination support document.  The program was designed to provide expedited examination for applicants willing to invest significant effort in preparing detailed examination support materials, including prior art searches and claim charts mapping the prior art to each pending claim.  However, the program’s popularity plummeted following the introduction of Track One prioritized examination in 2011.  Unlike Accelerated Examination, Track One requires only payment of a fee—currently $4,200 for large entities—without the burden of preparing examination support documents or conducting pre-examination searches. (more…)

Prosecution Laches from Woodbridge to Sonos: A 170-Year Continuation?

Patent

By Dennis Crouch,

I did a double-take earlier this week as I read the 1923 Supreme Court case of Woodbridge v. U.S., 263 U.S. 50, 44 S.Ct. 45. Although the case was decided after WWI, the facts center on a cannon projectile patent originally filed in 1852 – well before the U.S. Civil War.  The 70 year saga involved the inventor’s prolonged quest for a patent (and later for compensation). The Supreme Court’s ultimate decision, delivered by the former U.S. President and Chief Justice Taft, planted the seeds for what we now call prosecution laches – the equitable doctrine barring patents obtained after unreasonable, prejudicial delay in prosecution.

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Article III, the PTAB, and Expired Patents: Constitutional Analysis After Oil States

Patent

by Dennis Crouch

The Supreme Court is being asked to decide whether the PTAB can invalidate expired patents through inter partes review, in a case that could limit the reach of the landmark Oil States decision that found IPRs constitutionally permissive. In Apple Inc. v. Gesture Technology Partners, the Federal Circuit ruled that PTAB retains jurisdiction over expired patents, but the patentee argues in its petition that once patents expire, they become purely private property rights that require traditional court adjudication rather than administrative review. Certiorari petition - Gesture v. Apple.

In Oil States Energy Services, LLC v. Greene’s Energy Group, LLC, 584 U.S. 325 (2018), the Supreme Court upheld the constitutionality of inter partes review (IPR) proceedings under Article III and the Seventh Amendment.  Older property rights cases had barred administrative action to eliminate private property rights.  But Oil States distinguished those cases -- holding that the patent is “the grant of a public franchise” – a government-conferred right to exclude others for a limited time.  Because a patent “did not exist at common law” but is a creature of statute, Congress may condition or qualify that grant, including by providing for administrative reconsideration of the patent’s validity.

Under this framework, Oil States placed patent validity determinations within the Court’s public-rights doctrine, which permits adjudication in non-Article III forums for matters “closely integrated into a public regulatory scheme” involving the government. The Court explained that IPR “does not make any binding determination regarding ‘the liability of [one individual] to [another] under the law’” – instead, it remains a matter between the patent owner and the government (acting to correct its own grant). Because of this public-rights framing, the Court found no Article III violation in assigning patent reconsideration to the PTAB.  Likewise, the Seventh Amendment jury right was not triggered: the IPR was not a “Suit at common law” between private parties, but an administrative proceeding reviewing a public franchise grant. Oil States ultimately likened IPR to a specialized extension of the patent examination process.

Notably, Oil States emphasized the narrowness of its holding. The Court explicitly reserved judgment on “whether other patent matters, such as infringement actions, can be heard in a non-Article III forum.”  But, Oil States does not discuss the extent its reasoning would apply once a patent’s term had ended.

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Cert Petition Preview: Federal Circuit’s Broad Reading of TrafFix in CeramTec

Patent

by Dennis Crouch

CeramTec GmbH v. CoorsTek Bioceramics LLC, (formerly known as C5 Medical Werks, LLC)

CeramTec GmbH has requested a 30-day extension to file a petition for certiorari in its dispute with CoorsTek Bioceramics LLC over pink ceramic hip implants, setting up what could be a significant Supreme Court review of the intersection between expired utility patents and trademark protection. The case presents a fairly clean vehicle for resolving a circuit split over the proper interpretation of TrafFix Devices, Inc. v. Marketing Displays, Inc., 532 U.S. 23 (2001).

In TrafFix, the Court held that when features are claimed in an (expired) utility patent, this constitutes "strong evidence" that those claimed features are functional and thus ineligible for trademark protection. In CeramTec, the Federal Circuit took this holding a step further -- holding that a feature (pink coloration) that could result from practicing an expired patent was presumptively functional, regardless of whether the patent actually teaches advantages for that specific feature.

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The $1 Million Bounty Clause and Unreviewable Sanctions Order

Patent

by Dennis Crouch

The new Realtek decision highlight an interesting quirk of ITC appeals: a jurisdictional gap associated with review of ITC sanctions decisions.  Here, court dismissed Realtek's appeal from the ITC's denial of sanctions against Future Link Systems, finding it lacked jurisdiction to review sanctions decisions that are not ancillary to a final determination. Realtek Semiconductor Corporation v. International Trade Commission, 2023-1187 (Fed. Cir. June 18, 2025).

The case involved a litigation financing arrangement that included a lump sum payment from MediaTek to Future Link if Future Link filed suit against Realtek.  Realtek called this the "$1 million bounty clause." While the administrative law judge expressed "alarm" at this agreement and questioned its lawfulness, no sanctions were ultimately imposed. The Federal Circuit's dismissal for lack of jurisdiction means this potentially improper arrangement will not receive appellate review.

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Federal Circuit Offers Some Loosening of the Nexus Standard for Objective Indicia of Nonobviousness

Patent

by Dennis Crouch

In Ancora v. Roku, the Federal Circuit relaxed the rigid nexus requirement for objective evidence of non-obviousness -- but only for patent licensing evidence.  The court emphasized that actual patent licenses (those worth > litigation costs) inherently reflect the validity of the patented technology. This decision contrasts with stricter standards still imposed on other types of objective indicia.  Ancora Technologies, Inc. v. Roku, Inc., 2023-1674 (Fed. Cir. June 16, 2025).

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Federal Circuit Vacates $300 Million Jury Verdict on Multiple Grounds

Patent

In a significant decision with implications for patent litigation practice, the Federal Circuit has vacated both infringement and damages judgments totaling $300 million in Optis Cellular Technology v. Apple Inc., finding multiple errors by the Eastern District of Texas that undermined the validity of the jury's verdict. Judge Prost's opinion identified four distinct areas of reversible error:

  1. Improper verdict form construction that violated Apple's Seventh Amendment right to jury unanimity,
  2. Incorrect patent eligibility analysis under 35 U.S.C. § 101,
  3. Erroneous means-plus-function determination under 35 U.S.C. § 112 ¶ 6, and
  4. Abuse of discretion in admitting prejudicial settlement evidence under Federal Rule of Evidence 403.

Optis asserted several standard-essential patents (SEPs) covering Long-Term Evolution (LTE; aka 4G) technology against various Apple devices including iPhones, iPads, and Watches. After an initial jury verdict awarding $506.2 million, the district court granted a new trial on damages only, finding that the jury had not heard evidence regarding Optis's FRAND (fair, reasonable, and non-discriminatory) licensing obligations. The second jury awarded $300 million as a lump sum for past and future sales.

Competing jury form proposals
(patentee in green; accused in blue): 

Single Broad Verdict Form from Judge Gilstrap

How Much is Hidden in the Jury Black Box: Patent cases are extremely complicated. And, this one involved five separate patents, including allegations of both literal and DOE infringement, willful infringement, and invalidity. In situations like this, district court judges look for ways to simplify the jury decision making. Judges often have legitimate concern that lay jurors will be overwhelmed by highly technical claim constructions and complex infringement theories across multiple patents, potentially leading to decisions based on confusion rather than careful consideration of the evidence. And, judges worry that overly detailed verdict forms increase the risk of logically inconsistent findings, which can complicate post-trial proceedings and create appellate complications.

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The Federal Circuit’s Shifting Political Balance

Patent

by Dennis Crouch

The United States Court of Appeals for the Federal Circuit stands today with a dramatically different judicial composition than at any point in its 43-year history. As of June 2025, the court comprises eleven active judges—only three appointed by Republican presidents and eight by Democratic presidents, representing a 73% Democratic majority. This represents a complete reversal from the court’s peak Republican era in the early 1990s, when Republican appointees held ten of eleven active seats. The court’s current composition has taken on heightened significance as it confronts one of the most politically charged cases in its history: V.O.S. Selections v. Trump, challenging President Trump’s global tariff program under the International Emergency Economic Powers Act (IEEPA). The Federal Circuit’s response so far has been as a collective institution—proceeding en banc from the outset and issuing unanimous per curiam orders—reflects institutional awareness of political vulnerabilities that historically patent-focused courts rarely confront.

The chart above illustrates the evolution of the Federal Circuit’s composition since its inception. The court began in October 1982 with a modest Democratic edge of six to five active judges. However, the subsequent span of Reagan and Bush administrations rapidly transformed the court’s ideological balance.  This culminated in an extraordinary 10-1 Republican majority by 1990—the most lopsided partisan composition in the court’s history. Republican dominance persisted throughout the 1990s, with the court maintaining between seven and ten Republican appointees against only one to four Democratic appointees. The turning point came in the early 2000s as senior status and retirements began reshuffling the court’s composition. Democratic appointees steadily increased from 2000 onward, reaching parity around 2010 and achieving majority status by 2015. The trend has continued unabated, with the current 8-3 Democratic majority representing the inverse of the court’s 1990s Republican dominance. Notably, none of the three remaining Republican appointees were named by President Trump, leaving the court without any judges appointed by the current president whose policies it must now review.  The court’s partisan balance has been further complicated by the ongoing suspension of Judge Pauline Newman, the longest-serving non-senior federal appellate judge, who was suspended by her colleagues in September 2023.

USPTO Hiring Examiners (for non-union role without telework)

Patent

by Dennis Crouch

After a six-month hiring freeze and DOGE strong push for voluntary retirements, the USPTO has announced that it is again hiring patent examiners.  There are some key changes: (1) the new examiners will work in the Alexandria HQ – these are explicitly designated as non-remote, non-telework eligible positions; (2) according to the announcement, these jobs fall outside the bargaining unit covered by the Patent Office Professional Association (POPA).  Although these limitations narrow the potential candidate pool, the USPTO is one of the first agencies beginning to hire STEM candidates in the DC area and so will hopefully be able to attract competitive candidates.

The USPTO obtained an exemption from the federal hiring freeze specifically to post these positions, citing the agency’s priority of addressing its patent application backlog of over 820,000 pending applications—the highest backlog in a decade according to USPTO statistics.  The agency did not indicate how many examiners will be hired, but it will likely be in the hundreds if they can find qualified “gold”  level candidates.  I expect more information will flow once John Squires is confirmed as USPTO director (likely within the next 2 weeks). (more…)

Federal Circuit Reverses Equitable Estoppel Defense: Reliance Requires More Than Business Pragmatism

Patent

by Dennis Crouch

Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. v. Sirius XM Radio Inc., 2023-2267 (Fed. Cir. June 9, 2025)

In this infringement case, Judge Bataillon (D.Del) sided with the accused infringer on summary judgment -- finding that Fraunhofer's infringement claim was barred by equitable estoppel. The Federal Circuit reversed on appeal - finding genuine disputes of material fact on the key estoppel issue of detrimental reliance. Although equitable estoppel remains an important defense, the case makes clear that it requires more than post-hoc rationalization of business decisions.  Instead, defendants must show they actually considered and relied upon the patentee's conduct when making key infringement decisions.

The case involves a fairly complex licensing dispute regarding multicarrier modulation technology used in satellite radio systems. Fraunhofer is a German research organization and patent holder that licensed its MCM patents to WorldSpace back in 1998. WorldSpace then sublicensed the technology to XM Satellite Radio (now SXM) for use in developing the XM DARS satellite radio system. WorldSpace filed for bankruptcy in 2008 and its trustee used the bankruptcy powers to reject reject the Fraunhofer agreement. Fraunhofer claims that rejection eliminated the sublicense to SXM.  (The legal status is disputed.) Fraunhofer waited until 2015 to notify SXM of potential infringement, and ultimately sued in 2017 over the now-expired patents.

In the past, defendants raised the equitable defense of laches in cases (like this  one) involving significant delays by patentees in asserting their rights. However, the Supreme Court's decision in SCA Hygiene v. First Quality, 580 U.S. 328 (2017), eliminated laches as a defense to damages claims for patent infringement. The Court held that Congress's enactment of a specific six-year limitations period precluded application of the judge-made laches doctrine within that statutory window. By eliminating that previously common defense, SCA Hygeine heightened the importance of the somewhat parallel defense of equitable estoppel.

But, as discussed below, equitable estoppel requires proof beyond simply unreasonable enforcement delay.

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Federal Circuit Sets Quick Schedule for Trump Tariff Constitutional Challenge

Patent

by Dennis Crouch

The Federal Circuit today issued a detailed scheduling order expedited resolution of the constitutional challenge to President Trump's global tariff program. V.O.S. Selections, Inc. v. Trump, Nos. 2025-1812, 2025-1813 (Fed. Cir. June 13, 2025). The per curiam order, issued by all participating active judges sitting en banc (excluding Judge Newman), establishes a six-week briefing schedule culminating in oral arguments on July 31, 2025—less than two months after the Court of International Trade's permanent injunction against the tariffs.  The court allocated 45 minutes per side for oral argument, double the typical time, signaling recognition of the case's exceptional constitutional significance.

The case consolidates two separate CIT cases - one filed by commercial actors led by V.O.S. and the other led by the State of Oregon.   The scheduling order explicitly authorized separate response briefs for the two plaintiff groups, rather than requiring coordination.  The order also permits amicus participation by waiving the usual consent and leave requirements -- there will likely be extensive third-party briefing.

Although the CIT issued a permanent injunction against President Trump's tariffs, earlier this week the Federal Circuit issued an emergency stay pending resolution of the appeal. This means that the White House can move forward with its tariffs.

Timeline for the appeal:

  • Opening brief by US and any supporting amici: June 24.*
  • Responsive briefs by V.O.S. and Oregon and any supporting Amici: July 8.
  • Reply: July 18.
  • Full Appendix: July 23.

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The Federal Circuit and the Trump Tariff En Banc Ruling

Patent

by Dennis Crouch

In a significant development that places the Federal Circuit at the center of a major  political debate and constitutional question, the court recently issued a rare en banc order granting the United States' motions for stays of permanent injunctions that had halted President Trump's sweeping tariff program. The unanimous per curiam order in V.O.S. Selections, Inc. v. Trump allows the contested tariffs to remain in effect while the court considers what it characterized as "issues of exceptional importance warranting expedited en banc consideration of the merits in the first instance." [ORDER].

The Federal Circuit's decision comes against a backdrop of contradictions between the Trump administration's public posture and its private legal arguments as detailed in recent NYTimes reporting. While Commerce Secretary Howard Lutnick publicly dismissed the lower court's adverse ruling as costing them only "a week, maybe" and insisted that other countries "came right back to the table," the government's emergency filings argued that the injunction could "catastrophically harm our economy" and create a "foreign policy disaster scenario."  Similarly US Trade Representative Jamieson Greer publicly characterized the court challenge as "just kind of a bump in the road," while simultaneously filing sworn declarations arguing that halting the tariffs would deal a devastating blow to sensitive trade negotiations."

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Federal Circuit Clarifies Enablement Standards: Amgen Doesn’t Apply to Anticipatory Prior Art

Patent

The Federal Circuit delivered an important clarification on the enablement standard for prior art Agilent Technologies, Inc. v. Synthego Corp., No. 2023-2186 (Fed. Cir. June 11, 2025), affirming PTAB decisions that invalidated all claims of two CRISPR gene-editing patents. The case featured arguments by IP luminaries Mark Lemley and Edward Reines, with the patent challenger, Reines, coming up on top this time.  The case distinguishes Amgen Inc. v. Sanofi, 598 U.S. 594 (2023): establishing clear boundaries between the enablement requirements for patent validity under 35 U.S.C. § 112 and the enablement standards for anticipatory prior art under § 102.

The unanimous Judge Prost decision also establishes that abandoned patent applications and research projects retain their full potency as prior art, rejecting arguments that abandonment should diminish their anticipatory effect.  The patentee's appellant brief had pointedly asked:

Did the Board err in finding that the claims were anticipated by and obvious over a prior art reference that never worked, was ultimately withdrawn, and which offered quadrillions of possible art combinations with no guidance to choose one that might work?

In rejecting the appeal, the court reinforced that prophetic examples in prior art can serve as anticipating references even in unpredictable fields, provided they contain sufficient enabling disclosure, and also concluded that the PTAB's decision was based upon substantial evidence.

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SCOTUS: Pairing RADesign’s Discovery Rule with Jem’s Laches Defense

Patent

by Dennis Crouch

The Supreme Court has rescheduled its consideration of the copyright statute of limitations petition in RADesign v. Michael Grecco (No. 24-768), moving the conference from May 29, 2025, to June 5, 2025. This delay appears strategic, as the Court has simultaneously distributed for the same June 5 conference another intellectual property limitations case: Jem Accessories, Inc. v. Harman International Industries, Inc. (No. 24-1011), which presents questions about laches in trademark law.  Both of these cases are sparked by prior statute of limitations cases - particularly the two laches cases of Petrella v. Metro-Goldwyn-Mayer, Inc., 572 U.S. 663 (2014) (copyright) and SCA Hygiene Products Aktiebolag v. First Quality Baby Products, LLC, 580 U.S. 328 (2017) (patent) alongside the 2024 SOL case of Warner Chappell Music, Inc. v. Nealy, 601 U.S. ___ (2024).

The pairing of these cases suggests the Court may be considering extending its trans-doctrinal approach to limitations and laches doctrines across intellectual property law. Both petitions raise basic questions about when rights holders must act to preserve their claims, though they approach the issue from different statutory frameworks.

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Discovering the Crown Jewels: Irreversible Harm in the Digital Age

Patent

by Dennis Crouch

Micron Technology has petitioned the Supreme Court for a writ of mandamus to reverse a discovery order requiring the company to produce 73 pages of its most sensitive source code in paper form to Chinese state-owned semiconductor manufacturer Yangtze Memory Technologies Company (YMTC). The case, In re Micron Technology Inc., presents significant questions about the enforcement of protective order terms and the consideration of national security concerns in patent litigation discovery.  The dispute centers on YMTC's request for printed copies of source code from Micron's "150 Series Traveler Presentation," which apparently describes the company's most technologically advanced 3D NAND semiconductor products and contains code that fewer than a dozen of Micron's 50,000+ employees have access to.  Micron is seeking to turn this into a national security and competitiveness issue based upon the fact that YMTC was only founded in 2016 but has already become the global leader in 3D NAND flash based upon strong support from the Chinese government.  The company is also listed in the "Entity List."

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