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Covered Business Method Threshold Review Is Not Appealable

The US Court of Appeals for the Federal Circuit found that in view of the Supreme Court of the United States’ 2019 decision in Thryv v. Click-to-Call, the Patent Trial and Appeal Board’s threshold determination that a patent qualifies for covered business method (CBM) review is closely tied to the institution decision and is therefore not appealable. SIPCO, LLC v. Emerson Electric Co., Case No. 18-1635 (Fed. Cir. Nov. 17, 2020) (Chen, J.)

SIPCO owns a patent directed to a communication device that uses a two-step communications path, where a remote device first communicates through a low-power wireless connection to an intermediate node, which in turn connects to a central location. Emerson filed a CBM petition arguing that the claims were obvious over the prior art. The Board instituted a CBM review and issued a final written decision finding the challenged claims obvious over the prior art. SIPCO appealed.

SIPCO argued that the Board overstepped its authority to institute a CBM review because the patent was directed to a “technological invention” and was statutorily excluded from CBM review. The Federal Circuit initially found that the Board’s threshold analysis was flawed because it focused solely on the second portion of the “technological invention” definition set forth in 37 CFR § 42.301(b). The Court vacated the Board’s decision and remanded for it to consider both parts of the definition, and to reconsider whether the patent qualified for CBM review (IP Update, Vol. 22, No. 20).

Emerson filed a petition for a writ of certiorari in the Supreme Court, arguing that the Board’s decision to institute a CBM review is not appealable under the “no appeal” provision of 35 USC § 324(e). The Supreme Court granted the petition, vacated the Federal Circuit opinion and remanded for further consideration in light of the Supreme Court’s decision in Thryv, which found that the one-year time bar for instituting an inter partes review is bound up with the decision to institute and therefore is not appealable under a similar “no appeal” provision.

On remand, the Federal Circuit found that Thryv made clear that the Board’s threshold determination as to whether a patent qualifies for CBM review is a decision that is non-appealable. Availability of the CBM review process is conditioned on whether the patent qualifies for CBM review, and patents that are directed to “technological inventions” are excluded from CBM review. The Court concluded that the determination of whether a patent qualifies for CBM review is inextricably tied to the decision to institute and is thus not appealable. Turning to the merits, the Court found the Board’s claim construction correct and its obviousness determination supported by substantial evidence.

Practice Note: In a footnote, the Federal Circuit recognized that Thryv implicitly abrogated the Court’s prior practice of reviewing whether the Board’s institution determination breached the limits of the Board’s authority.




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Wave Goodbye to Lost Arguments: Waiver Versus Forfeiture Law

The US Court of Appeals for the Federal Circuit concluded that a patent owner forfeited claim construction arguments on appeal by not presenting them first to the Patent Trial and Appeal Board for consideration. In re: Google Tech. Holdings LLC, Case No. 19-1828 (Fed. Cir. Nov. 13, 2020) (Chen, J.)

Google submitted an application to the US Patent and Trademark Office (PTO) seeking patent claims covering certain means and methods for transferring content to video-on-demand systems. During examination, the examiner rejected Google’s proposed claims based on obviousness in light of certain references. After receiving a final rejection, Google appealed to the Board, relying heavily on block quotes from the references and proposed claims to argue that the examiner improperly found obviousness.

The Board affirmed the examiner’s rejection. Applying the broadest reasonable interpretation standard, the Board construed two claim terms: “costs” and “network impact.” In defining those terms, the Board noted that Google had not, in the course of appealing the examiner’s decision, “cited to a definition of ‘costs’ or ‘network impact’ in the [s]pecification that would preclude the [e]xaminer’s broader reading.” Google appealed.

Google argued that the Board erred in its constructions. The Federal Circuit never reached the merits, however, instead concluding that Google had not properly presented its arguments first to the PTO. The Court described the oft-forgotten difference between waiver (the voluntary and knowing relinquishment of a right) and forfeiture (the failure to make a timely assertion of a particular right). This case, the Court reasoned, was an example of forfeiture, because Google had failed to urge the claim constructions to the PTO in the first instance.

Google contended that the Federal Circuit should nonetheless review the Board’s determination, because the Board actually ruled on the claim constructions and those issues were ripe for decision before the Court. The Court rejected these arguments, largely because Google identified no excuse for failing to raise the issue earlier, and because the Board’s final decision was not unexpected in the course of the proceedings.

Practice Note: Ultimately, the Court’s opinion presents one approach (perhaps not one consistently followed) regarding what an appellant must do in order to maintain its right to review. Appellees seeking to foreclose appellate review should consider whether, regardless of the Board’s ultimate decision, the appellant appropriately pressed the arguments on the error for which it later seeks appellate review.




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“Gradual” and “Continuous” Includes Step-Wise

The US Court of Appeals for the Federal Circuit affirmed a priority decision in favor of the senior party, upholding a claim construction that was based upon a verbatim definition set forth in the patent specification of the application from which the count in interference was copied. Chevron U.S.A. Inc. v. University of Wyoming Research Corp., Case No. 19-1530 (Fed. Cir. Nov. 4, 2020) (Schall, J.) (Newman, J., dissenting).

Wyoming Research provoked a patent interference proceeding by copying into its pending application a claim from Chevron’s pending patent application. Under the now-discontinued interference statute, the patent for an invention claimed by more than one party was awarded to the first-to-invent party. If the Patent Trial and Appeal Board (Board)determined there was an interference in fact—that is, two patent applications claimed the same subject matter—then the Board could proceed to determine priority of inventorship. A finding of interference in fact required the copying party’s patent specification to contain adequate written description and enablement to support the copied claim.

The copied claim was directed to a method of fractioning asphaltenes from crude oil. The technology used a mobile phase into which an alkane solvent was introduced and its concentration “gradually and continuously” changed over time, and the resulting eluted fractions were analyzed. The disputed claim limitation was: “gradually and continuously changing the alkane mobile phase solvent to a final mobile phase solvent.”

Chevron argued that “gradually and continuously changing” referred to the act of feeding alkane mobile phase solvent into the inlet of the column. Relying on intrinsic evidence, the Board instead adopted Wyoming’s construction, concluding that the limitation’s “gradually and continuously changing” referred to the change of solvents in the column and not to changes at the inlet to the column. The distinction was important because at the inlet, the Wyoming invention introduced solvent in a step-wise manner. The parties agreed that Wyoming’s specification supported only the construction adopted by Board, and Wyoming was declared to be the senior party for the priority contest.

Because Chevron had filed a priority statement that indicated that its earliest corroborated conception coupled with diligence date was later than Wyoming’s priority date, the Board determined that Chevron was unable to prevail on priority and entered judgment in favor of Wyoming. Chevron appealed.

On appeal, Chevron argued that the Board’s construction was inconsistent with Chevron’s patent specification. Chevron contended that its application disclosed that the solvent was “gradually and continuously” changed at the column’s inlet and that the Board’s construction rendered the limitation meaningless because it encompassed even “sudden, abrupt immediate solvent switches.”

The Court affirmed the Board’s construction, holding that the broadest reasonable construction of “gradually and continuously changing” did not require a change of solvents at the column inlet. The Court reasoned that the Board’s construction was consistent, and indeed tracked verbatim, with the Chevron application’s express definition of “gradually.” While the Court acknowledged that certain examples in the Chevron application illustrated that one way to implement a “gradual and continuous change” of the [...]

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Summary Judgment Foreclosed when There Is More than One Possible Inference from Evidence

Reversing a summary judgment ruling that barred a correction of inventorship claim, the US Court of Appeals for the Federal Circuit, found issues of material fact foreclosed summary judgment and warned that where an issue is a “quintessentially fact-laden one” such as equitable issue involving possible equitable estoppel on inventorship, summary judgement is likely not appropriate.. Ferring B.V. et al. v. Allergan, Inc. et al., Case No. 20-1098 (Fed. Cir. Nov. 10, 2020) (O’Malley, J.)

From 1998 to 2002, Dr. Seymour Fein worked as a consultant for Ferring Pharmaceuticals to develop a drug that helps regulate the body’s retention of water. That work apparently did not include any obligation by Fein to assign any inventions. As a result, both Ferring and Fein ultimately filed dueling patent applications directed to aspects of the drug and its use. In correspondence that took place while patent prosecution was pending, Fein indicated to Ferring that his application would be directed to a low dose administration route for the drug. Ferring responded that it believed that aspect (i.e., the low dose route) to be disclosed by prior art. Both sides eventually obtained patents, and Fein assigned his patents to Allergan.

In 2012, Ferring filed a state court action for correction of inventorship, seeking to add its researchers to Fein’s patents. Allergan counterclaimed with its own inventorship claim seeking to add Fein to Ferring’s patents, and also asserted an equitable estoppel defense based on the above-noted correspondence between the parties that occurred during patent prosecution. Allergan then moved for summary judgment on its equitable estoppel defense, which was granted. The judge subsequently held a bench trial and rejected Allergan’s inventorship claim. Ferring appealed the summary judgment decision.

On appeal, the Federal Circuit rejected Ferring’s argument that the trial court should not have considered any conduct that preceded issuance of the patents for purposes of equitable estoppel. However, the Federal Circuit held that the trial court’s summary judgment decision had improperly resolved issues of material fact regarding that pre-issuance conduct. According to the Federal Circuit, the pre-issuance discussions did not lead to only one possible inference, but rather were subject to interpretation because the claim scope discussed (low dose administration) did not necessarily match the claim scope ultimately granted. As a result, the Federal Circuit vacated the summary judgment decision and remanded to the district court.




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Printed Matter Is Patentable If It’s Functional, Not Just Communicative

In a tour de force of issues related to the printed matter doctrine, the US Court of Appeals for the Federal Circuit reversed various rulings that the patents-in-suit were not infringed, not willfully infringed and invalid as directed to printed matter. Instead, the Court held that there was substantial evidence in the record to support a jury finding of infringement and willfulness, and that the asserted claims were not directed solely to printed matter and thus were patent eligible under 35 USC § 101 (thereby raising a genuine dispute of material fact that precludes summary judgment as to anticipation). C R Bard Inc. v. AngioDynamics, Inc., Case Nos. 19-1756, -1934 (Fed. Cir. Nov. 10, 2020) (Reyna, J.)

This dispute began when Bard sued AngioDynamics for infringing three patents directed to identifying a vascular access port that is suitable for power injection, which is a medical procedure requiring injecting fluids into a patient at a high pressure and flow rate. Generally, the identification was accomplished by certain markings on the vascular access port that can be detected during an x-ray scan.

Prior to trial, AngioDynamics moved for summary judgment on patent eligibility, novelty and enablement. This summary judgment motion was initially denied, but the district court sought a report and recommendation prior to trial regarding whether certain limitations relating to radiographic marker images were entitled to patentable weight under the printed matter doctrine. The magistrate judge concluded that the limitations were not entitled to patentable weight, and the district court adopted the recommendation. At trial and at the end of Bard’s case-in-chief, AngioDynamics moved for judgment as a matter of law (JMOL) on non-infringement and no willfulness. Ultimately, the district court terminated the trial and granted AngioDynamics’ JMOL motion for non-infringement and no willfulness. The district court further held that the claims were invalid because they were directed to printed matter and were not inventive. Bard appealed, challenging each of the district court’s findings.

In reversing the summary judgment of no infringement, the Federal Circuit explained that Bard’s expert’s reliance on an incorrect understanding of the district court’s claim construction was alone insufficient to grant judgment as a matter of law. Instead, the expert’s misunderstanding went to credibility, and the Court found the record reflected that the expert properly testified that the various claim elements were met under the proper claim constructions. The Court further explained that Bard did not have an affirmative duty to test AngioDynamics products, but rather was entitled to rely on AngioDynamics’ representations to the US Food and Drug Administration and to its customers. With regard to induced infringement, the Court explained that if an alleged infringer instructs its users to use the product in an infringing way, there is sufficient evidence for a jury to find infringement. Because the district count found no inducement based on its erroneous summary judgment of no infringement, that ruling was similarly reversed.

The Federal Circuit also reversed the district court on its summary judgment of no willfulness, concluding that Bard [...]

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Transfer Motions Must Take Top Priority

The US Court of Appeals for the Federal Circuit granted an accused infringer’s mandamus petition to transfer a case from the Western District of Texas to the Northern District of California, concluding that the district court “barreled ahead” on the merits before addressing the transfer motion and clearly abused its discretion in denying transfer. In re. Apple, Inc., Case No. 20-135 (Fed. Cir. Nov. 9, 2020) (Prost, C.J.) (Moore, J., dissenting). In re. Apple, Inc

In September 2019, Uniloc sued Apple in the Western District of Texas alleging that several Apple products infringed one of Uniloc’s patents. In November 2019, Apple moved to transfer the case to the Northern District of California on the basis that it would be clearly more convenient to litigate the case in that district. In January 2020, Apple moved to stay all activity in the case unrelated to its transfer motion pending a decision on that motion. The district court denied the stay motion without explanation. In May 2020, the district court held a hearing on Apple’s transfer motion during which the court stated that it would deny the motion and issue a written order as soon as possible. After the hearing, but before issuing a written order, the court held a Markman hearing, issued its claim construction order, held a discovery hearing and issued a corresponding discovery order. In response to these advances in the case, in June 2020 Apple filed a petition for writ of mandamus requesting that the Federal Circuit transfer the case to the Northern District of California. One week after Apple filed its petition, the district court issued its written order denying transfer.

The Federal Circuit granted Apple’s mandamus petition and directed the district court to transfer the case to the Northern District of California. The Federal Circuit explained that the US Court of Appeals for the Fifth Circuit assesses transfer requests using private and public interest factors. The private interest factors are: “(1) the relative ease of access to sources of proof; (2) the availability of compulsory process to secure the attendance of witnesses; (3) the cost of attendance for willing witnesses; and (4) all other practical problems that make trial of a case easy, expeditious and inexpensive.” The public interest factors are: “(1) the administrative difficulties flowing from court congestion; (2) the local interest in having localized interests decided at home; (3) the familiarity of the forum with the law that will govern the case; and (4) the avoidance of unnecessary problems of conflict of laws [or in] the application of foreign law.” The parties agreed that the third and fourth public interest factors were neutral, but disputed whether the remaining factors weighed for or against transfer.

The Federal Circuit found numerous errors in the district court’s analysis. As to the first private factor (access to sources of proof), the Court found that the district court erred in determining that the location of witnesses weighed in favor of transfer. The Court explained that the “access to proof” factor [...]

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Analogous Art Includes Reference a Skilled Artisan Would Reasonably Consult

Addressing the standard for determining whether a prior art reference constitutes analogous art for purposes of an obviousness analysis, the US Court of Appeals for the Federal Circuit vacated and remanded a Patent Trial and Appeal Board decision that a reference was not analogous. The Court explained that the Board did not consider the purpose and problems to which the prior art and challenged patent relate. Donner Tech., LLC v. Pro Stage Gear, LLC, Case No. 20-1104 (Fed. Cir. Nov. 9, 2020) (Prost, C.J.)

Pro Stage owns a patent directed to an improved guitar effects pedalboard. Guitar effects pedals are electronic devices that affect the amplified sound of a guitar. The pedals are controlled by foot operation switches in order to leave the user’s hands free to play the instrument. When multiple pedals are used, they must be interconnected by cables, which are typically daisy-chained between each separate pedal. Once interconnected, the pedals are placed on a wooden pedalboard and covered with foam so that the cables are not exposed. This leads to difficulty when swapping or adding new pedals because the foam must be removed from the board and the cables repositioned. Pro Stage’s patent attempts to remedy this issue by elevating one side of the pedalboard from the stage floor and providing a mounting surface and cable connection openings such that cables can pass beneath the mounting surface, as demonstrated by the patent figures shown below.

Donner petitioned for inter partes review of the patent, challenging various claims as obvious under 35 USC §103. Donner asserted three grounds of invalidity, all relying at least in part on the teachings of the Mullen patent. Mullen relates to an improved structure for supporting one or more electrical relays and for providing wiring-channel space for receiving wires connected to the relays in order to connect the relays to various control circuits. As part of its petition, Donner claimed that certain embodiments of Mullen (below), disclose a structure that is analogous to the structure claimed in the challenged patent.

The Board rejected that Donner’s obviousness challenges, finding that Donner did “not put forth any argument or evidence to explain what would have compelled a pedalboard inventor in 1999 or 2000 to consider potential solutions arising from early 1970s-era relay technologies,” notwithstanding arguments, expert and other testimony, and other evidence submitted by Donner to the contrary. Donner appealed.

The Federal Circuit reversed, explaining the relevant tests to analyze whether a prior art reference is analogous. The two separate tests are (1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is [...]

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PTO Exam Guide: Post Booking.com, Generic.com Terms Still Face Uphill Battle for Registration

Addressing the Supreme Court of the United States’ ruling in USPTO v. Booking.com B.V., the US Patent and Trademark Office (PTO) recently issued guidance on the examining procedures for “generic.com terms.” (Examination Guide No. 3-20, Generic.com Terms after USPTO v. Booking.com, October 2020.)

Booking.com had been engaged in a prolonged battle to secure registration for its BOOKING.COM trademark in connection with hotel reservation services. Earlier this year, the Supreme Court addressed the issue in Booking.com, rejecting the PTO’s proposed per se rule that a generic term combined with a generic top-level domain (a “generic.com term”) is necessarily generic and therefore ineligible for trademark protection. As the Supreme Court concluded, “[W]hether any given ‘generic.com’ term is generic . . . depends on whether consumers in fact perceive that term as the name of a class or, instead, as a term capable of distinguishing among members of the class.”

In light of this holding, the PTO issued Exam Guide 3-20, which outlines new guidance for examining generic.com terms. The PTO emphasized that the registrability of generic.com terms should be assessed on a case-by-case basis, but that these terms would often face an uphill battle for registration: “[G]iven the nature of these terms, the available evidence will likely support a conclusion that they are, at least, highly descriptive, and thus consumers would be less likely to believe that they indicate source in any party. Thus, for generic.com terms, applicants will generally have a greater evidentiary burden to establish that the proposed mark has acquired distinctiveness.”

The procedure for refusing registration of a generic.com term remains largely unchanged. Typically, an examining attorney cannot issue an initial refusal for genericness; the office action should instead refuse registration for mere descriptiveness under Trademark Act Section 2(e)(1). Depending on the examining attorney’s assessment of whether the relevant generic.com term is even capable of serving as a source identifier, the office action may include language suggesting (or advising against) a claim of acquired distinctiveness under Section 2(f) or amendment to the supplemental register.

Applicants seeking registration for a generic.com term on the principal register under Section 2(f) should be prepared to present substantial evidence that consumers recognize the mark as a source identifier, including, for example:

  • Consumer surveys
  • Consumer declarations
  • Evidence as to the duration, extent and nature of the mark’s use
  • Advertising expenditures.

The PTO warned that evidence of five years’ use or reliance on a prior registration alone is likely insufficient. Additionally, surveys should be accompanied by a report outlining “the procedural aspects of the survey and statistical accuracy of the results, . . . [i]nformation regarding how the survey was conducted, the questionnaire itself, the universe of consumers surveyed, the number of participants surveyed, and the geographic scope of the survey.” If the examining attorney believes the generic.com term is capable of functioning as a trademark but the proffered evidence is insufficient to establish acquired distinctiveness, the examining attorney may allow the applicant to amend the registration to the supplemental register.

A [...]

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Federal Circuit Will Not Second-Guess IPR Institution Denials

In a series of non-precedential orders, the US Court of Appeals for the Federal Circuit reiterated that it lacks jurisdiction to hear appeals on whether the Patent Trial and Appeal Board properly decided to deny inter partes review (IPR) petitions based on parallel district court litigation. Cisco Systems Inc. v. Ramot at Tel Aviv University, Case Nos. 20-2047, -2049 (Fed. Cir. Oct. 30, 2020); Google LLC v. Uniloc 2017 LLC, Case No. 20-2040 (Oct. 30, 2020); In re: Cisco Systems Inc., Case No. 2020-148 (Fed. Cir. Oct. 30, 2020); Apple Inc. v. Maxell, Ltd., Case No. 20-2132, -2211, -2212, -2213, 21-1033 (Fed. Cir. Oct. 30, 2020).

The 2011 Leahy-Smith America Invents Act (AIA) created various mechanisms for challenging the validity of issued patents in post-grant proceedings before the US Patent and Trademark Office PTO) by adding transitional covered business method and post-grant review proceedings to existing ex parte re-examination, and expanding and renaming inter partes re-examination to inter partes review (IPR).

Under 35 USC §§ 311, 312, a petition for IPR must identify all real parties in interest, identify and support the prior art grounds for challenges to the claims, and provide “such other information as the Director may require by regulation.” Under 35 USC § 314 and 37 CFR 42.4(a), the Board institutes a trial on behalf of the PTO Director, and a “determination by the Director whether to institute an inter partes review under this section shall be final and nonappealable.” In deciding whether to institute the trial, the Board considers, at a minimum, whether a petitioner has satisfied the relevant statutory institution standard. Even when a petitioner has satisfied the institution standard, the Director has statutory discretion under 35 USC 314(a) and 324(a) to deny a petition.

In 2016, the Supreme Court of the United States held in Cuozzo Speed Techs. v. Lee that “the agency’s decision to deny a petition is a matter committed to the Patent Office’s discretion,” and that there is “no mandate to institute review.” The Supreme Court also found that the Director is given broad discretion under 35 USC 315(d) and 325(d) to determine the manner in which “multiple proceedings” before the PTO involving the same patent may proceed, “including providing for stay, transfer, consolidation, or termination of any such matter or proceeding.” Subsequent PTO policies and precedential Board decisions set forth factors affecting the case-specific analysis of whether to institute an AIA proceeding, and particularly a follow-on or serial petition, or discretionary denial due to the timing of parallel district court proceedings.

In Cisco v. Ramot, the Board denied Cisco’s petitions to institute IPRs against two patents that Ramot had asserted against it in a district court case. The decisions denying Cisco’s petitions cited the Board’s discretion under 35 USC § 314(a) not to institute review and relied on the factors determining whether efficiency, fairness and the merits support the exercise of authority to deny institution in view of an earlier trial date in the parallel proceeding. Specifically, the Board [...]

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Venue in Hatch-Waxman Cases Limited to District Where ANDA Is Submitted

The US Court of Appeals for the Federal Circuit found that in cases brought under the Hatch-Waxman Act, for purposes of determining venue, infringement occurs only in districts where actions related to the submission of an abbreviated new drug application (ANDA) occur, and not in all locations where future distribution of the generic products specified in the ANDA is contemplated. Valeant Pharmaceuticals North American LLC v. Mylan Pharmaceuticals Inc., Case No. 19-2402 (Fed. Cir. Nov. 5, 2020) (O’Malley, J.).

Valeant holds a new drug application for the brand name drug Jublia®, which is used to treat toenail fungal infections. In 2018, Mylan Pharmaceuticals Inc. (MPI) executed an ANDA seeking approval to market a generic version of Jublia®. MPI sent the ANDA from its West Virginia corporate office to the US Food and Drug Administration, located in White Oak, Maryland. The ANDA included a Paragraph IV certification that the Orange-Book-listed patents for Jublia® were invalid, unenforceable or would not be infringed by the ANDA product. After the ANDA was filed, Valeant filed suit in the District of New Jersey against MPI, Mylan Inc. and Mylan Laboratories Ltd. (MLL) pursuant to the Hatch-Waxman Act, alleging infringement of the Orange-Book-listed patents. Valeant also filed an essentially identical lawsuit in the Northern District of West Virginia against the same three defendants. MPI is a West Virginia corporation with a principal place of business in Morgantown, West Virginia. Mylan Inc. is a Pennsylvania corporation with a principal place of business in Canonsburg, Pennsylvania. MLL is an Indian corporation with a principal place of business in Hyderabad, India.

The Mylan entities moved to dismiss the New Jersey litigation, arguing that venue was improper under 28 USC § 1400(b) because none of the Mylan defendants reside or have a regular and established place of business in New Jersey, and the only alleged act of infringement (submission of the ANDA) did not occur in New Jersey. In response, Valeant argued that it was unduly narrow to limit “act of infringement” to the act of submitting the ANDA, and that the court should consider the Mylan entities’ planned future acts, which included acts of infringement in New Jersey. The district court granted the Mylan entities’ motion based on improper venue, finding that the ANDA was submitted from West Virginia and thus venue was proper there. Valeant appealed.

The two issues presented on appeal were the proper venue in Hatch-Waxman cases after TC Heartland v. Kraft Foods, and the proper venue for patent cases brought against foreign entities. Starting with the first issue, the Federal Circuit explained that determining whether venue is proper under § 1400(b) in a district other than the state in which a defendant is incorporated requires determining where the defendant committed acts of infringement. Under the Hatch-Waxman Act, it is an act of infringement to submit an ANDA for a drug claimed in a patent if the purpose of the submission is to obtain approval to engage in commercial activities related to the drug before [...]

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