A lot has been happening at the USPTO over the past six months! Join me along with an interesting panel of patent law experts for a 1-hour discussion sponsored by the LAIPLA.
Patrick Maloney (Cork Maloney) organized the event and the panel includes Jessica Hudak (Edwards Lifesciences); David Bailey (KPPB); and Dennis Crouch (Me).
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.
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…)
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…)
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.
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.
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.
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).
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:
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.
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.
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…)
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.