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Take That Conception Out of the Oven – It’s CRISPR Even If the Cook Doesn’t Know

by Connor M. Larson | May 22, 2025 | America Invents Act, Patents

Addressing the distinction between conception and reduction to practice and the requirement for written description in the unpredictable arts, the US Court of Appeals for the Federal Circuit explained that proof of conception of an invention does not require that the inventor appreciated the invention at the time of conception. Knowledge that an invention is successful is only part of the case for reduction to practice. Regents of the Univ. of Cal. et al. v. Broad Inst. et al., Case No. 22-1594 (Fed. Cir. May 12, 2025) (Reyna, Hughes, Cunningham, JJ.)

The Regents of the University of California, the University of Vienna, and Emmanuelle Charpentier (collectively, Regents) and the Broad Institute, Massachusetts Institute of Technology, and the President and Fellows of Harvard College (collectively, Broad) were each separately involved in research concerning CRISPR systems that “are immune defense systems in prokaryotic cells that naturally edit DNA.” At issue was the invention of the use of CRISPR systems to modify the DNA in eukaryotic cells. Regents and Broad filed competing patent applications resulting in an interference proceeding under pre-AIA law at the US Patent & Trademark Office Board of Patent Appeals & Interferences to determine which applicant had priority to the invention.

The main issue before the Board was a priority dispute over who first conceived of the invention and sufficiently reduced it to practice under pre-AIA patent law. Regents submitted three provisional patent applications dated May 2012, October 2012, and January 2013 and moved to be accorded the benefit of the earliest filing date, May 2012, for the purpose of determining priority. Alternatively, Reagents sought to be accorded either October 2012 or January 2013 as its priority date. The Board found that Regents’ first and second provisional applications (filed in May and October 2012, respectively) were not a constructive reduction to practice because neither satisfied the written description requirement of 35 U.S.C. § 112. The third provisional application, filed in January 2013, was the first to amount to a constructive reduction to practice of the counts in interference. The Board then ruled that Broad was the senior party for the purposes of priority in the interference proceeding because Broad reduced the invention to practice by October 5, 2012, when a scientist submitted a manuscript to a journal publisher. The Board ruled that Regents failed to prove conception of the invention prior to Broad’s actual reduction to practice. Regents appealed.

Regents argued that in assessing conception, the Board “legally erred by requiring Regents’ scientist to know that their invention would work.” The Federal Circuit agreed and vacated the Board’s decision. As the Court explained, there are three stages to the inventive process: conception, reasonable diligence, and reduction to practice. At the conception stage, “an inventor need not know that his invention will work for conception to be complete.” Rather, knowledge that the invention will work, “necessarily, can rest only on an actual reduction to practice.” The Board therefore legally erred by requiring Regents to know its invention would work to prove [...]

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Clickbait: Actual Scope (Not Intended Scope) Determines Broadening Reissue Analysis

by Tim Dunker | May 15, 2025 | Patents

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s rejection of a proposed reissue claim for being broader than the original claim, denying the inventors’ argument that the analysis should focus on the intended scope of the original claim rather than the actual scope. In re Kostić, Case No. 23-1437 (Fed. Cir. May 6, 2025) (Stoll, Clevenger, Cunningham, JJ.)

Miodrag Kostić and Guy Vandevelde are the owners and listed inventors of a patent directed to “method[s] implemented on an online network connecting websites to computers of respective users for buying and selling of click-through traffic.” Click-through links are typically seen on an internet search engine or other website inviting the user to visit another page, often to direct sales. Typical prior art transactions would require an advertiser to pay the search engine (or other seller) an upfront fee in addition to a fee per click, not knowing in advance what volume or responsiveness the link will generate. The patent at issue discloses a method where the advertiser and seller first conduct a trial of click-through traffic to get more information before the bidding and sale process. The specification also discloses a “direct sale process” permitting a seller to bypass the trial and instead post its website parameters and price/click requirement so advertisers can start the sale process immediately.

The independent claim recites a “method of implementing on an online network connecting websites to computers of respective users for buying and selling of click-through traffic from a first exchange partner’s web site.” The claim requires “conducting a pre-bidding trial of click-through traffic” and “conducting a bidding process after the trial period is concluded.” A dependent claim further requires “wherein the intermediary web site enables interested exchange partners to conduct a direct exchange of click-through traffic without a trial process.”

The patent was issued in 2013, and the inventors filed for reissue in 2019. The reissue application cited an error, stating that the “[d]ependent claim [] fails to include limitations of [the independent] claim,” where the dependent claim “expressly excludes the trial bidding process referred to in the method of [the independent] claim,” which would render it invalid under 35 U.S.C. § 112. To fix the error, the inventors attempted to rewrite the dependent claim as an independent claim that omitted a trial process.

The examiner issued a nonfinal Reissue Office Action rejecting the reissue application as a broadening reissue outside of the statutory two-year period. The examiner found that the original dependent claim is interpreted to require all steps of the independent claim, including the trial period, and further to require a direct sale without its own trial, beyond the trial claimed in the independent claim. The inventors attempted to rewrite the dependent claim as the method of independent claim with “and/or” language regarding the trial process versus direct to sale process. The amendment was rejected for the same reasons. The Board affirmed on appeal.

Whether amendments made during reissue enlarge the scope of [...]

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No Article III Appellate Standing Under the Sun

by Anisa Noorassa | May 15, 2025 | Patents

The US Court of Appeals for the Federal Circuit dismissed Incyte’s appeal of a Patent Trial & Appeal Board decision, holding that a disappointed validity challenger lacked appellate standing to challenge the Board’s final written decision. Incyte Corp. v. Sun Pharmaceuticals Industries, Inc., Case No. 23-1300 (Fed. Cir. May 7, 2025) (Moore, C.J.; Hughes, Cunningham, JJ.) (Hughes, J., concurring).

After the Board upheld the validity of challenged claims of a patent owned by Sun Pharmaceuticals in a post-grant review proceeding (PGR), Incyte appealed and sought a determination that the claims were unpatentable. Sun Pharmaceuticals challenged whether Incyte had Article III standing to support an appeal to the Federal Circuit based on a lack of injury-in-fact.

The Federal Circuit focused on its jurisdiction to hear the appeal as a threshold issue and whether Incyte, as the party seeking review, met its burden of establishing Article III standing at the time it filed its appeal.

As context, the Federal Circuit noted that standing requires a concrete, actual, or imminent injury that is traceable to the challenged conduct and likely to be redressed by the court’s decision. Incyte asserted it had standing to appeal based on potential infringement liability and under the competitor standing doctrine.

Addressing potential infringement liability, the Federal Circuit noted Incyte’s reliance on a supplemental declaration from an in-house business development leader submitted during briefing. Noting that Incyte’s Article III standing was “not self-evident,” the Court ruled that Incyte should have presented evidence prior to its reply brief and declined to consider the supplemental evidence. Incyte was on notice that its appellate standing was challenged, and that evidence of its standing should have been submitted at the earliest possible opportunity. Finding no good cause for the delay, the Court declined to exercise its discretion to consider Incyte’s supplemental evidence and, based only on earlier submitted evidence, found that Incyte failed to establish that it had “concrete plans for future activity” that would create a “substantial risk of future infringement.”

In its discussion of the competitor standing doctrine, which allows competitors to challenge patents that could harm their competitive position, the Federal Circuit found the doctrine inapplicable because Incyte failed to show it would suffer economic harm from the Board’s ruling on patent validity. Rather, the Board’s ruling upholding specific patent claims “does not, by the operation of ordinary economic forces, naturally harm a [challenger] just because it is a competitor in the same market as the beneficiary of the government action (the patentee).” As the Court explained, “it is not enough to show a benefit to a competitor to establish injury in fact; the party seeking to establish standing must show a concrete injury to itself.”

The Federal Circuit held that because Incyte had not shown it was currently engaged in or had non-speculative plans to engage in conduct covered by the challenged patent, it was unable to establish injury-in-fact.

In his concurrence, Judge Hughes stated that while Incyte lacked Article III standing, he believed that Federal Circuit precedent was [...]

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Designated Informative: PTO Director Declines IPR Institution Following District Court § 101 Invalidation

by Jodi Benassi | May 15, 2025 | Patents

The US Patent & Trademark Office (PTO) designated a recent Director Review decision as informative, signaling its significance for future proceedings. The decision emphasizes that a final district court ruling invalidating a patent weighs heavily against instituting inter partes review (IPR) under the Fintiv framework, reinforcing the agency’s stance on minimizing duplicative litigation. Hulu LLC v. Piranha Media Distribution LLC, IPR2024-01252; -01253 (PTAB Director Review Apr. 17, 2025) (Stewart, PTO Dir.)

Piranha requested Director Review of the Patent Trial & Appeal Board’s decision granting institution of two IPRs filed by Hulu. Piranha argued that the decision should be reversed and the IPRs denied institution, citing a district court final judgment invalidating the challenged claims under 35 U.S.C. § 101 issued before the institution decision was made. Hulu argued that Director Review was unwarranted.

In the district court litigation, Piranha asserted that Hulu infringed claims from two patents related to integration of advertising content into digital media streams. Hulu moved to dismiss the complaint, arguing that the asserted patents were ineligible for patenting under § 101. The district court determined that the asserted claims were directed to the abstract idea of “displaying an advertisement in exchange for access to copyrighted material, as well as the abstract idea of receiving, organizing, and displaying data,” and contained no inventive concept. The district court granted Hulu’s motion to dismiss and held the claims patent ineligible and therefore invalid under § 101.

The Director explained that since a district court had already ruled the patent claims invalid, launching separate IPRs to assess their patentability on other grounds was unnecessary. The Director noted that if the Federal Circuit overturned the district court’s decision, Hulu could still pursue its invalidity arguments during remand proceedings. Declining to institute review was the more efficient and practical path under the circumstances, the Director said.

While the Board applied the Fintiv framework in its institution decision, the Director observed that the framework does not align neatly with the facts of this case, where a final district court judgment under § 101 preceded the Board’s decision. The Director ultimately concluded that a second review proceeding was unwarranted given the claims’ current invalid status.

Breaking New Grounds to Limits of IPR Estoppel

by Amol Parikh | May 15, 2025 | Patents

In a matter of first impression, the US Court of Appeals for the Federal Circuit found that inter partes review (IPR) estoppel does not preclude a petitioner from relying on the same patents and printed publications as evidence in asserting a ground that could not have been raised during the IPR proceeding, such as that the claimed invention was known or used by others, on sale, or in public use. Ingenico Inc. v. IOENGINE, LLC, Case No. 23-1367 (Fed. Cir. May 7, 2025) (Dyk, Prost, Hughes, JJ.)

IOENGINE owns patents directed to a portable device, such as a USB thumb drive, that includes a processor that causes communications to be sent to a network server in response to user interaction with an interface on a terminal. Ingenico filed a declaratory judgment action against IOENGINE after one of Ingenico’s customers was sued for infringement based on Ingenico’s products. Ingenico filed IPR petitions challenging the asserted patents, which resulted in final written decisions that held most of the challenged claims unpatentable.

Back at the district court, IOENGINE proceeded with the remaining claims. At summary judgment, IOENGINE moved, under 35 U.S.C. § 315(e)(2), to preclude Ingenico from relying on “documentation related to DiskOnKey Upgrade software,” arguing that Ingenico reasonably could have been expected to raise that prior art during the IPR proceedings. The district court ruled that “Ingenico will be estopped from relying on those documents [to prove invalidity] except to the extent . . . that they form part of a substantively different combination of references that could not reasonably have been raised in the IPRs.”

At trial, Ingenico introduced evidence of a prior art USB device known as the DiskOnKey. The DiskOnKey device was offered with various software applications, including an application called Firmware Upgrader, and was equipped with capabilities described in a Software Development Kit (together, the DiskOnKey system). Ingenico argued that the DiskOnKey system invalidated the asserted claims as anticipated or obvious because it was either “on sale” or “in public use” under 35 U.S.C. § 102(b), or “known or used by others . . . before the date of the invention” under 35 U.S.C. § 102(a). The jury returned a verdict finding the patents were infringed but invalid as anticipated and obvious. Both parties appealed.

IOENGINE did not dispute the jury’s finding that the DiskOnKey system invalidated the claims-at-issue as anticipated or obvious if the DiskOnKey system was prior art, but instead argued that the jury’s finding that the Firmware Upgrader portion of the DiskOnKey system was either “on sale” or “in public use,” or “known or used by others . . . before the invention.”

The Federal Circuit found that the jury’s finding that the Firmware Upgrader was accessible to the public was supported by substantial evidence. Specifically, Ingenico had introduced a press release promoting the launch of the Firmware Upgrader and a website from which the Firmware Upgrader was available for download. IOENGINE argued that this evidence did not show actual use, but the Court rejected [...]

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Hatch-Waxman or Not, Clinical Trials Aren’t Subject to Injunction

by Christopher M. Bruno | May 15, 2025 | Patents

Analyzing the permissible scope of an injunction under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit reversed the district court’s prohibitions on an open-label extension (OLE) of a then-running clinical trial and new clinical trials and remanded for further consideration of whether prohibiting a request for an additional indication was appropriate. Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals LLC, Case No. 24-2274 (Fed. Cir. May 6, 2025) (Lourie, Reyna, Taranto, JJ.)

This appeal is one of several disputes between Jazz and Avadel regarding their competing sodium oxybate products. Jazz markets two such products: Xyrem, approved for treating excessive daytime sleepiness and certain cataplexy, and Xywav, which, in addition to Xyrem’s indications, also may be used for treating idiopathic hypersomnia. Avadel filed a § 505(b)(2) new drug application (NDA) to market its own product, Lumryz. During the pendency of the Lumryz application, Jazz obtained a patent and asserted that Avadel infringed it under 35 U.S.C. § 271(e)(2), part of the Hatch-Waxman Act, based on its filing of the Lumryz NDA. The patent was never Orange Book listed, so Avadel did not need to submit any patent certification.

The US Food & Drug Administration (FDA) approved Lumryz. Avadel launched the product, and Jazz amended its complaint to assert traditional § 271(a) – (c) infringement. Ultimately, Avadel and Jazz stipulated infringement, the patent was determined not invalid, and the jury awarded damages based on the post-launch infringement. After further proceedings, the district court permanently enjoined Avadel from seeking an idiopathic hypersomnia indication for Lumryz, offering an OLE phase of its then-running Lumryz idiopathic hypersomnia clinical trial, and against initiating new clinical trials. Avadel appealed, arguing that each of these restrictions was improper.

The Federal Circuit largely agreed with Avadel, reversing the first two prohibitions, and remanded the case back to the district court for further consideration of the prohibition against any new clinical trials. Turning first to the prohibition on new clinical trials, the Court held that initiating new trials for the purposes of submission to the FDA fell squarely within the Hatch-Waxman Safe Harbor for experimentation (under § 271(e)(1)) and thus could not be enjoined (per §271(e)(3)). Jazz unsuccessfully argued that Avadel had waived its Safe Harbor position, which required factual development.

Next, the Federal Circuit rejected the district court’s injunction against an OLE, concluding that the district court had not applied the Supreme Court’s four-factor eBay (2006) test for injunctions when deciding the appropriateness of such extraordinary relief. Refusing to determine whether an OLE extension qualified as safe-harbored activity in the first instance, the Court explained that only if such activity were deemed to be infringing on an appropriate record could it be enjoined.

Finally, with respect to prohibiting Avadel from seeking an idiopathic hypersomnia indication for Lumryz, the Federal Circuit concluded that the propriety of that restriction may turn on whether the infringement qualified under the Hatch-Waxman Act, reasoning that an injunction might run afoul of the § 271(e)(4) limitation on the scope of injunctive relief. [...]

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No Green Light to Register Color Mark for Medical Gloves

by Eleanor B. Atkins | May 8, 2025 | Trademarks

Addressing for the first time the test for determining whether a color mark is generic, the US Court of Appeals for the Federal Circuit adopted the Trademark Trial & Appeal Board’s Milwaukee test as the appropriate standard, affirming the Board’s determination that a dark green color mark used on medical examination gloves was generic. In re PT Medisafe Technologies, Case No. 2023-1573 (Fed. Cir. Apr. 29, 2025) (Prost, Clevenger, Stark, JJ.)

PT Medisafe filed an application to register a dark green color mark for use in connection with medical examination gloves:

The US Patent & Trademark Office (PTO) examining attorney refused registration, alleging that the mark was not inherently distinctive and therefore required a showing of acquired distinctiveness. In response, Medisafe submitted evidence in support of acquired distinctiveness, including a declaration from a Medisafe vice president, promotional literature, and examples of competitive goods. The examining attorney was not swayed, issuing another office action stating that the mark had not acquired distinctiveness and was generic. Medisafe submitted additional evidence in support of acquired distinctiveness, including additional declarations, but the examining attorney ultimately issued a final office action refusing registration.

On appeal, the Board applied a two-step test to determine whether the applied-for color mark was generic:

What is the genus of the goods or services at issue?
Is the color “so common within the relevant genus that consumers would primarily associate it with the genus rather than as indicating a unique source of goods [or services] within the genus?”

This test, which was first articulated in the Board’s 2019 decision in Milwaukee Electric Tool v. Freud America, is a “slight variation” of the standard test for genericness set forth in the Federal Circuit’s 1986 decision in H. Marvin Ginn v. International Ass’n of Fire Chiefs, modified for use specifically with color marks.

The Board found that the appropriate genus was “all chloroprene medical examination gloves” and the relevant public included “all such people or businesses who do or may purchase chloroprene medical examination gloves.” The Board likewise agreed with the examining attorney that the color mark was generic because “it is so common in the chloroprene medical examination glove industry that it cannot identify a single source.”

The Board cited 25 examples of third parties using the same or a similar dark green color on medical examination gloves. Medisafe claimed that 15 of those 25 examples were Medisafe gloves, but the Board nonetheless affirmed the refusal, noting that “Medisafe made no such claim as to the other 10,” and “all 25 screenshots [are] probative of genericness because the relevant consumer – even including unspecified ‘authorized resellers’ – could be exposed to . . . gloves that appear under a large number of third-party marks without identifying [Medisafe] as the source or manufacturer.” Medisafe appealed to the Federal Circuit.

Medisafe argued that the Board applied the wrong standard in determining that [...]

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“Payment Handler”: A Nonce Term Without Instructions

by Jodi Benassi | May 8, 2025 | Patents

The US Court of Appeals for the Federal Circuit affirmed a district court’s ruling that a software term was a “nonce” term that invoked 35 U.S.C. § 112, sixth paragraph (i.e., a means-plus-function claim element). The Court further found that the patent specification did not recite sufficient corresponding structure, rendering the claim element indefinite. Fintiv, Inc. v. PayPal Holdings, Inc., Case No. 23-2312 (Fed. Cir. Apr. 30, 2025) (Prost, Taranto, Stark JJ.)

Fintiv sued PayPal for infringing four patents related to cloud-based transaction systems, also known as “mobile wallet platforms,” “mobile financial services platforms,” or “electronic payment systems.” During claim construction, the district court ruled that the terms “payment handler” and “payment handler service” were indefinite. The court concluded that both terms were means-plus-function limitations governed by § 112, sixth paragraph. Although the claims did not use the word “means,” the district court found that PayPal had demonstrated that the terms were drafted in a format consistent with traditional means-plus-function language, effectively substituting “payment handler” for the word “means.” The court also found that the patent specifications failed to disclose corresponding structure capable of performing the claimed functions. As a result, the court held the claims invalid for indefiniteness and entered final judgment. Fintiv appealed.

Fintiv argued that the district court erred in concluding that the payment handler terms invoked § 112(f) and that the specifications failed to disclose the structure for the claimed functions. The Federal Circuit disagreed.

The Federal Circuit analyzed the “payment-handler” terms, which did not explicitly use the word “means.” Under § 112(f), there is a rebuttable presumption that a claim term does not invoke means-plus-function treatment unless the challenger can show that the term is a nonce term that lacks “sufficiently definite structure” or only recites a function without providing enough structure to perform that function. Fintiv contended that the payment handler terms, both individually and collectively, identified the required structure. However, the Court found that PayPal had successfully rebutted the presumption since the payment handler terms recited functions without reciting sufficient structure to perform those functions. The Court agreed with the district court that the term “handler” did not convey sufficient structure to a person of ordinary skill in the art.

Having determined that the payment handler terms invoked § 112(f), the Federal Circuit sought to identify the corresponding structure described in the specifications for performing the payment handler function but found none. The Court concluded that “without an algorithm to achieve these functionalities – and, more generally, given the specifications’ failure to disclose adequate corresponding structure – we hold the payment-handler terms indefinite.”

Transatlantic Terminology: Skilled Artisan Could Equate UK, US Word Meanings

by Anisa Noorassa | Apr 24, 2025 | Patents

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board unpatentability determination, finding that a skilled artisan would have found the term “sterile” in a UK publication to mean the same as the term “sterilized” in the United States. Sage Products LLC v. Stewart, Case No. 23-1603 (Fed. Cir. Apr. 15, 2025) (Reyna, Cunningham, Stark, JJ.)

Sage owns two patents related to a sterilized chlorhexidine product in a package, such as an applicator filled with an antiseptic composition for disinfecting skin. Becton, Dickinson and Company petitioned for inter partes review (IPR) of both patents. The Board relied on four key pieces of prior art, including one that was a UK publication, to find the challenged claims unpatentable. In instituting the IPR and evaluating the petition, the Board construed the term “sterilized” to mean that “the component or composition has been subjected to a suitable sterilization process such that sterility can be validated.” In the final written decision, the Board found that a skilled artisan at the time of the invention would have known, through education and experience, that the term “sterile,” as used in the UK prior art publication, is equivalent to the term “sterilized,” as used in the US and particularly in the Sage patents. Reviewing the totality of the evidence before it, including both parties’ experts’ reports and testimony, the Board determined the challenged claims were unpatentable. Sage appealed.

The Federal Circuit declined to overturn the Board’s findings, affirming the Board’s definition of a person of ordinary skill in the art and their understanding of the term “sterilized” at the time of the invention. The Court found that the Board did not ignore or disregard evidence but properly weighed the evidence before it, concluding that a skilled artisan having the education and experience required by the Board’s definition would know the differences between the US and UK regulatory standards for “sterile” and therefore would know that UK references to “sterile” items would satisfy the challenged claims’ requirement for “sterilized” items.

New Rx for High Drug Prices? Senate Judiciary Committee Advances Six Bills With Heavy Dose of Options

by Christopher M. Bruno | Apr 17, 2025 | Life Sciences, Patents

The US Senate Judiciary Committee advanced to the full Senate six bills intended to reduce pharmaceutical prices and enhance market competitiveness. The package collectively targets several aspects of the pharmaceutical landscape, including pharmaceutical benefit manager (PBM) pricing practices, next-generation drug releases, patent portfolio assertions, and use of US Food and Drug Administration (FDA) regulatory mechanisms. Many of the bills’ proposals have been proposed before, but it is significant that the six bills were moved to the full Senate with bipartisan support.

The Affordable Prescriptions for Patients Act, if passed, would limit how many patents a reference product sponsor can assert in a Biologics Price Competition and Innovation Act (BPCIA) litigation against a biosimilar applicant, although such limits could be surpassed with court approval. A biologics license holder could assert up to 20 patents in a BPCIA case. Certain patents, such as method of treatment patents, would fall outside the limitation.

Against the backdrop of the Supreme Court’s 2013 holding in FTC v. Watson that certain “pay for delay” agreements are prohibited as anticompetitive, the Preserve Access to Affordable Generics and Biosimilars Act would add precision to the boundaries of permissible settlements in the pharmaceutical industry. The Federal Trade Commission (FTC) would have specific authority to institute a civil action to recover penalties, and certain presumptions would apply. For example, any agreement providing a generic or biosimilar applicant with “anything of value, including an exclusive license,” would be presumptively anticompetitive, with certain exceptions and exclusions. Terms that would remain permissible include a pre-expiration launch date, reasonable litigation expenses, and covenants not to sue for patent infringement.

Targeting the concern that branded small molecule and biologics drug manufacturers release new products with patent protection and withdraw or unfairly disincentivize older products to avoid generic competition, the Drug Competition Enhancement Act would deem the alleged practice of “product hopping” unfair competition subject to enforcement actions. The bill would define a hard switch as when a branded or biologics manufacturer discontinues or withdraws an application and introduces a follow-on product within a certain period relative to generic or biosimilar approval. It would define a soft switch as when the brand manufacturer took actions that “that unfairly disadvantage the listed drug or reference product relative to [a] follow-on product.” The bill would provide specific exclusions and justifications for branded manufacturer actions that would otherwise constitute a hard or soft switch.

Seeking to curb perceived abuses of the FDA citizen petition process, the Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act would grant the FTC the authority to bring a civil action against those filing “sham petitions” with the FDA, with penalties up to $50,000 per calendar day of review or the revenue earned by the seller of the branded product, whichever is greater. A petition could be classified as a sham based on its own objective unreasonableness, an intention to delay approval of a generic or biosimilar product, or as part of a series of covered petitions.

Based on [...]

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