Patents Archives - Page 19 of 105

Patents

Heart-to-Heart on Reduction to Practice: When It Comes to Testing, How Much Is Enough?

by Thomas DaMario | Jun 1, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board decision that the patent owner successfully demonstrated that the claimed heart catheter invention was conceived and reduced to practice prior to the effective date of the reference, by record evidence of adequate testing to demonstrate that the invention would work for its intended purpose. Medtronic, Inc. v. Teleflex Innovations S.Á.R.L., Case Nos. 21-2356; -2358; -2361; -2363; -2365 (Fed. Cir. May 24, 2023) (Moore, C.J.; Lourie, J.) (Dyk, J., dissenting).

Teleflex Innovations owns five patents directed to guide extension catheters that use a tapered inner catheter that runs over a standard coronary guidewire to reduce the likelihood that a guide catheter will dislodge from the coronary artery’s opening. All of the patents are related and share a common specification. Around the time of the challenged patents’ priority date, the applicant was working to develop two commercial variants of similar technology: the “rapid exchange” (or “RX”) version of the GuideLiner product, which Teleflex claims practices the challenged patents, and an “over-the-wire” (or “OTW”) variant, which does not practice the challenged patents.

Medtronic petitioned for inter partes review (IPR), challenging all five patents on the basis that they were predated by a patent to Itou. During the IPR proceedings, Teleflex claimed that conception and reduction to practice occurred prior to Itou’s priority date and submitted several declarations and exhibits such as lab notebooks, internal company memoranda, presentations, invoices, sales orders, photographs, engineering drawings and documents from outside patent counsel in support of its contentions. Ultimately, the Board found that Itou did not constitute prior art and therefore Medtronic had failed to demonstrate that the challenged claims were unpatentable. Medtronic appealed.

On appeal, Medtronic did not challenge conception but argued that the Board’s findings on actual reduction to practice and reasonable diligence toward constructive reduction to practice should be reversed. To establish an actual reduction to practice, the patent owner must show that the inventors constructed an embodiment that met all the limitations of the claimed invention and determined that the invention would work for its intended purpose. Medtronic’s arguments were based on the grounds that the Board erred in three ways:

Incorrectly identifying the intended purpose of the claimed invention
Not requiring comparative testing to demonstrate that the invention worked for that purpose
Relying solely on uncorroborated inventor testimony.

On the first issue, Medtronic argued that the Board incorrectly found an over-broad intended purpose of the claimed invention by relying too heavily on extrinsic evidence. The Federal Circuit acknowledged that while “the patents themselves are the most important” evidence, “it is appropriate to consider extrinsic evidence, particularly when it does not contradict the patents themselves.” The Court went on to conclude that the intended purpose here was broader than the narrow purpose argued by Medtronic (relating to difficult occlusions)—“[t]he very title of the patents themselves, ‘Coaxial Guide Catheter for Interventional Cardiology Procedures,’ describes the purpose of the claimed inventions, and it is undisputed that the [...]

Continue Reading

Neither Narrow Proposed Claim Construction nor Work Product Claim Justify Withholding Material Factual Information

by Cecilia Choy, Ph.D. and Hannah Hurley | Jun 1, 2023 | Patents

The Patent Trial & Appeal Board of the US Patent & Trademark Office (PTO) canceled all challenged claims across five patents because the patent owner failed to meet its duty of candor by selectively and improperly withholding material information that was inconsistent with its patentability arguments. Spectrum Solutions, LLC v. Longhorn Vaccines & Diagnostics, LLC, IPR2021-00847; -00850; -00854; -00857; -00860 (PTAB May 3, 2023) (Braden, Yang, Derrick, Pollock, APJs) (per curiam) (Braden, APJ concurring).

The Board instituted inter partes reviews (IPRs) against five Longhorn patents based on petitions filed by Spectrum. During the proceedings, Longhorn filed motions to amend, after which the Board issued preliminary guidance suggesting that Spectrum established a reasonable likelihood that the proposed substitute claims were unpatentable. Longhorn engaged Assured Bio Labs (ABL) to conduct biological testing that would support its arguments distinguishing a prior art reference, but Longhorn made attorney work product objections in Spectrum’s ABL depositions and withheld testing data inconsistent with its arguments on the patentability of the original and proposed substitute claims. The Board subsequently allowed additional questioning on certain ABL testing, after which Spectrum filed a motion for sanctions, requesting judgment against Longhorn, a finding that the prior art reference taught the claim limitations and precluding Longhorn from contesting the finding, and an award to Spectrum of compensatory expenses, including attorneys’ fees.

The Board determined that sanctions of adverse judgment as to all challenged claims was appropriate because Longhorn failed to meet its duty of candor and good faith. The Board explained that parties have a duty of candor and good faith before the Board that requires any factual contentions to be well supported by evidence. Parties have “a duty to disclose to the [PTO] all information known . . . to be material to patentability.” (37 C.F.R. §1.56(a).) Information is material to patentability when it is “not cumulative to information already of record or being made of record in the application and . . . it refutes, or is inconsistent with, a position the applicant takes in . . . asserting an argument of patentability.” Taking a position contrary to any known fact while shielding factual information from the Board violates the duty of candor and good faith to the PTO, even if the party may otherwise withhold the information as being immaterial to patentability or privileged.

The Board criticized Longhorn’s proposed claim constructions as too narrow and contrary to the express language in both the original and proposed substitute claims. The Board explained that although Longhorn was free to maintain arguments grounded on Longhorn’s claim constructions, that did not excuse Longhorn’s duty of candor and good faith dealing, including disclosing material information relating to the Board’s preliminary claim constructions. Longhorn could not “simply withhold information” that the PTO would find material to patentability and should instead contest the Board’s constructions at trial.

The Board also explained that Longhorn took an overly strict view of what was material to claim patentability and a lax view as to the duty of candor [...]

Continue Reading

Analogous Art Must Be Compared to Challenged Patent

by Alexandra Cavazos, PhD | May 25, 2023 | America Invents Act, Patents

The US Court of Appeals for the Federal Circuit reversed a Patent Trial & Appeal Board obviousness decision, finding that a prior art reference relating to automotive engine parts was not analogous art to the challenged patent, which related to injection devices used for drug delivery. Sanofi-Aventis Deutschland GMBH v. Mylan Pharmaceuticals Inc., Case No. 21-1981 (Fed. Cir. May 9, 2023) (Reyna, Mayer, Cunningham, JJ.)

Sanofi-Aventis owns a patent directed to a drug delivery device that can be configured to allow for the setting of different dose sizes. The main independent claim of the patent recites a spring washer element with “at least two fixing elements configured to axially and rotationally fix the spring washer relative to the housing.”

Mylan initiated an inter partes review (IPR) proceeding against the patent, arguing that the challenged claims were obvious based on a combination of three prior art references: Burren, Venezia and de Gennes. Burren described a drug injection device that used a coiled spring, while Venezia described a hypodermic syringe with a spring washer having a tongue that fit into a collar to prevent the washer from rotating relative to the collar. The third prior art reference, de Gennes, disclosed a large spring-washer-like device used in automobile engines to maintain the alignment between the engine and the transmission. Sanofi argued that de Gennes was non-analogous art because it was not in the same field of endeavor as the injection devices described in the patent and was not reasonably pertinent to a problem faced by the inventor of the challenged patent.

The Board adopted Mylan’s definition of the problem to be solved, which was “axially fixing two components relative towards each other.” Under this broad definition, the Board found that de Gennes was reasonably pertinent to the challenged patent and that claims were obvious in view of Burren in combination with Venezia and de Gennes. Sanofi appealed.

Sanofi argued that the Board erred in determining that de Gennes was analogous art. The Federal Circuit explained that in evaluating whether a reference is analogous, a patent challenger must compare the reference to the challenged patent. Applying this test, the Court found that substantial evidence did not support the conclusion that de Gennes was analogous to the challenged patent. Although Mylan had mapped de Gennes to certain elements of the challenged claims, there was no evidence that de Gennes—an automobile-related patent—was analogous to the challenged patent—a drug delivery device. The Court also found that statements that de Gennes and the challenged patent were “both interested in solving the same issue . . . [of] accommodating various cartridge lengths” were insufficient to show that de Gennes was analogous to the challenged patent.

No Extra Life: Harmless Claim Construction Error Does Not Restart Invalidity Challenge

by Christian Tatum | May 18, 2023 | America Invents Act, Patents

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board decision, finding that under the harmless error rule, the challenged claims were invalid as obvious even if the Board erred in claim construction. Bot M8 LLC v. Sony Interactive Entertainment LLC, Case Nos. 22-1291 (Fed. Cir. May 9, 2023) (Prost, Reyna, Cunningham, JJ.).

Bot M8 owns a patent related to a gaming machine that authenticates certain data and includes both a board and a motherboard. The independent claims require that a “game program” is stored in memory on the board and written to the motherboard only after the game program has been authenticated by a central processing unit (CPU) on the motherboard (the Write Limitation). Sony Interactive Entertainment petitioned for inter partes review (IPR). Ultimately, the Board determined that the challenged claims were unpatentable as obvious. Bot M8 appealed.

The issue presented to the Federal Circuit was what data the Write Limitation precludes from being written to the motherboard prior to authentication: (1) the entire game program, (2) any portion of the game program and/or (3) any data (including data not related to the game program). It was undisputed that the claims at minimum preclude writing the entire game program to the motherboard before authentication (option 1). Both the Board and the Court rejected Bot M8’s argument that would preclude writing any data whatsoever before authentication (option 3). The question thus resolved into whether the Write Limitation also precluded writing any portion of the game program prior to authentication (option 2). Bot M8 argued that it did.

Bot M8 focused on a statement made by the Board as indicative that the Board applied an erroneous claim construction that would allow a portion of the game program to be written prior to authentication (rejecting option 2): “[Bot M8] seeks to read into claim 1 a requirement that nothing related to, or any portion of, the gaming information be read into [the motherboard’s] RAM … prior to authenticating the game program.”

The Federal Circuit rejected Bot M8’s argument, finding that even if the Board erred in construing the claim, Bot M8 failed to demonstrate that the alleged error was harmful. Specifically, the Court found that any such error was harmless because the Board never needed to apply an improper construction since it found the prior art disclosed writing only non-game program data prior to authentication, a protocol that both the Board and the Court found was not precluded by the Write Limitation. Deeming the Board’s potential claim construction error harmless, the Court affirmed the Board’s invalidity determination.

Practice Note: Parties seeking to appeal a Board decision based on an improper claim construction theory should demonstrate how the Board’s error resulted in harm.

Blunt Rejection of Attorney Fees in Stipulated Dismissal

by Lillian Spetrino | May 18, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed the rejection of attorney fees, finding that neither inequitable conduct nor a conflict of interest rendered the case exceptional given the limited factual record following a stipulated dismissal in a patent case. United Cannabis Corp. v. Pure Hemp Collective Inc., Case No. 22-1363 (Fed. Cir. May 8, 2023) (Lourie, Cunningham, Stark, JJ.).

United Cannabis Corporation (UCANN) sued Pure Hemp for patent infringement. After the litigation was stayed pending bankruptcy proceedings, the parties stipulated to the dismissal. Pure Hemp then sought attorney fees based on alleged inequitable conduct by UCANN during prosecution of the asserted patent due to nondisclosure of a prior art reference used in the patent’s specification and based on a purported conflict of interest by UCANN’s litigation counsel. The district court denied Pure Hemp’s request, finding that the case was not exceptional. Pure Hemp appealed.

Pure Hemp argued that the district court erred by (1) failing to find Pure Hemp to be the prevailing party in the litigation, (2) not concluding that the undisputed facts established inequitable conduct and (3) not recognizing that UCANN’s attorneys had a conflict of interest.

The Federal Circuit found that although the district court erred in not finding Pure Hemp to be the prevailing party, this was a harmless error. The Court explained that by fending off UCANN’s lawsuit with a stipulation dismissing UCANN’s claims with prejudice, Pure Hemp is a prevailing party under § 285. However, the Court concluded that this error was harmless because the district court ultimately concluded that this case was unexceptional.

The Federal Circuit found Pure Hemp’s arguments on inequitable conduct without merit. The Court explained that it had no findings to review because Pure Hemp voluntarily dismissed its inequitable conduct counterclaim and did not seek any post-dismissal inequitable conduct proceedings. Although Pure Hemp argued that it could prevail based on the undisputed facts in the record, the Court disagreed. It explained that even the limited record demonstrated at least a genuine dispute as to both the materiality and intent prongs of inequitable conduct and, therefore, the district court properly determined that Pure Hemp did not demonstrate that this case was exceptional.

The Federal Circuit also rejected Pure Hemp’s argument that copying and pasting portions from the prior art in the patent’s specification (but not disclosing the same prior art references) was inequitable conduct. The Court explained that unlike the nonbinding cases Pure Hemp relied on, the district court here did not find that the copied prior art was material, and the record gave no reason to disbelieve the explanation provided by UCANN’s prosecution counsel. The Court was also unpersuaded by Pure Hemp’s arguments to support inequitable conduct, explaining that the Court was not free to make its own findings on intent to deceive and materiality and, further, the district court was not required to provide its reasoning for its decision in attorney fee cases.

As to Pure Hemp’s argument that the case was exceptional because UCANN’s attorneys [...]

Continue Reading

Pending Appeal Does Not Divest Board of Statutory Authority to Institute IPRs

by Amol Parikh | May 18, 2023 | America Invents Act, Patents

In a case involving sua sponte review, the Director of the US Patent & Trademark Office (PTO) vacated an inter partes review (IPR) decision denying institution, found that the Patent Trial & Appeal Board had statutory authority to institute IPR review of a claim that had been previously found invalid by a district court under 35 U.S.C. § 101 (but under appeal), and remanded the proceeding for the Board to consider whether discretionary denial was appropriate. Volvo Penta of the Americas, LLC v. Brunswick Corp., IPR2022-01366, -01367, -01368, -01369, -01424 (PTO May 2, 2023) (Vidal, Dir.).

Brunswick owns several patents related to marine vessels. Volvo filed IPR petitions challenging the patents, which the Board ultimately denied. Prior to the Board’s decision, the District Court for the Eastern District of Virginia determined that claim 1 in each of the challenged patents was directed to patent-ineligible subject matter and thus was invalid under § 101. In denying institution, the Board concluded that it lacked authority to institute the IPRs because the challenged claims were no longer in effect and the America Invents Act (AIA) only permits a petitioner to challenge a claim, noting that “when given its plain and ordinary meaning, § 311(b) provides that only claims that are in effect may be annulled.” Although Brunswick appealed the district court’s decision, the Board determined that the challenged claims were finally adjudicated. Thus, the Board lacked authority to institute the requested IPR. The Board also determined that the multi-factor Fintiv analysis for discretionary denial under 35 U.S.C. § 214(a) was inapplicable here in view of the district court’s invalidity finding.

The Director reviewed the Board’s decision sua sponte and vacated the Board’s institution decision with instructions to analyze Fintiv factors 1 through 5 in view of the parallel district court proceeding.

The Director first addressed the Board’s § 311(b) analysis. The Director concluded that in finding the district court’s invalidity determination to be a final adjudication, the Board appeared to have borrowed from collateral estoppel principles. The Director found, however, that these principles do not apply to § 311(b) nor was there any assertion that Volvo was collaterally estopped from pursuing IPRs. The Director also determined that the challenged claims were not fully adjudicated since the district court’s decision was subject to further judicial review. Thus, the Director found that the Board had statutory authority to institute the IPRs.

Next, the Director addressed the Board’s Fintiv analysis, finding that the Board improperly interpreted Fintiv as limited to its exercise of discretion in the context of ongoing parallel district court litigation where final judgment has not yet been entered. The Director explained that the Fintiv analysis applied where, as here, the claims remain subject to further review on appeal. The Director instructed the Board to evaluate the Fintiv factors on remand and instructed that if the Board determines that these factors favor discretion to deny institution, the Board should then consider whether the case on the merits is compelling (consistent with the
Continue Reading

What’s Shakin’ Bacon? Not Inventorship—Contribution to Invention Can’t Be “Insignificant”

by James M. Oehler | May 11, 2023 | Patents

The US Court of Appeals for the Federal Circuit reversed a district court decision and found that an asserted inventor not named in the application was not a joint inventor because in the context of the entire invention his contribution was too insignificant to constitute joint inventorship. HIP, Inc. v. Hormel Foods Corp., Case No. 22-1696 (Fed. Cir. May 2, 2023) (Lourie, Clevenger, Taranto, JJ.)

Hormel owns a patent directed to precooking bacon and meat pieces. The patent claims a two-step method that involves a preheating step using a microwave oven, infrared oven or hot air, and then a higher-temperature cooking step. Prior to filing its patent application, Hormel and HIP entered into a joint agreement to develop an oven for the two-step cooking process. Hormel evaluated an HIP oven and learned, among other things, that preheating the bacon via a microwave oven prevented condensation from washing away the salt and flavor. HIP’s David Howard suggested an infrared oven (already known in the art) as a possibility for use in the preheating step. Hormel subsequently filed a patent application that did not name Howard as a joint inventor. HIP sued Hormel alleging that Howard was a joint inventor. The district court found that Howard was a joint inventor based solely on his alleged contribution of infrared preheating. Hormel appealed.

The inventors listed on an issued patent are presumed to be the only true inventors. Thus, a party must prove a claim to correct inventorship by clear and convincing evidence. A joint inventor must do the following:

Contribute in a significant manner to the conception or reduction to practice of the invention
Make a contribution to the claimed invention that is not insignificant in quality when that contribution is measured against the dimension of the full invention
Do more than explain well-known concepts or the current state of the art.

The Federal Circuit found that Howard’s alleged contribution of using an infrared oven for preheating the bacon was insignificant in quality when measured against the full invention, which it found to be clearly focused on preheating with a microwave oven. Preheating with an infrared oven was briefly mentioned in passing as an alternative to a microwave oven in the patent’s specification and in a single dependent claim. In contrast to using an infrared oven, the patent claims, specification and figures all prominently featured using a microwave oven for the preheating step. All the independent claims required or allowed using a microwave oven for the preheating step. The specification also repeatedly referred to preheating with a microwave oven, including in the background of the invention and the summary of the invention sections. Further, the examples and corresponding figures included procedures using a microwave oven to preheat, but no mention of using an infrared oven to preheat. Accordingly, the Court found that Howard’s infrared oven suggestion was insignificant in light of the full invention.

The Federal Circuit did not address the other requirements for joint inventorship, reasoning that since all three [...]

Continue Reading

Hanging Patentability on Written Description Cannot Be Truss-ted

by Courtney Seams | May 4, 2023 | Patents

The US Court of Appeals for the Federal Circuit upheld a Patent Trial & Appeal Board finding that the claims of a patent for a truss hanger were invalid for lack of written description because they claimed an undisclosed range despite the predictable nature of the technology. Columbia Insurance Company v. Simpson Strong-Tie Company Inc., Case Nos. 21-2145; -2157 (Fed. Cir. Mar. 31, 2023) (Prost, Hughes, JJ.) (Moore, C.J., dissenting) (non-precedential).

Truss hangers secure support beams to wall frames in buildings. These hangers normally accommodate layers of fire-resistant sheathing by cutting out the sheathing that overlaps with the hanger, but this can reduce fire resistance. Columbia owns a patent claiming a truss hanger that extends through the sheathing and does not decrease fire resistance. The extension for the sheathing, illustrated below, must be “sized large enough to permit two layers of ⅝ inch thick sheathing to be received between the rear edge plane and the back flange plane, but too small to permit three layers of ⅝ inch thick sheathing to be received.”

Simpson petitioned for a post-grant review of the patent at the Board. That proceeding resulted in a mixed decision. The Board found in favor of Simpson that certain original claims and certain substitute claims of the patent were unpatentable for lack of written description and that certain claims were obvious over the prior art. However, it found in favor of Columbia with regard to one claim. Both parties appealed.

The Federal Circuit affirmed the Board’s findings regarding written description. The claimed extension portion covered a range of extension sizes between the upper limit (three layers of five-eighths-inch-thick sheathing) and lower limit (two layers of five-eighths-inch-thick sheathing). The Court affirmed the Board’s finding that nothing in the specification covered the claimed upper limit. Columbia argued that a skilled artisan would read the claims to cover exactly two layers of five-eighths-inch-thick sheathing, but the Court found that this claim construction argument was forfeited because it was raised for the first time on appeal and, even if it weren’t, it was incorrect because it was akin to rewriting the claims.

The Federal Circuit also affirmed the Board’s finding that certain claims were obvious, concluding that the Board’s determination was supported by substantial evidence. The Court rejected Columbia’s argument that the Board’s claim construction violated the Administrative Procedure Act because the construction adopted by the Board was similar enough to Simpson’s proposed construction and not raised sua sponte.

Finally, the Federal Circuit affirmed the Board’s finding that the claim on which Simpson appealed was not indefinite because the term “large enough to permit the drywall to be received” informs a skilled artisan with reasonable certainty that the scope of this claim includes any extension portion sized larger than the smallest commonly known sheathing size. The Court also found that the claim was not obvious because the Board correctly interpreted the claim language [...]

Continue Reading

PTO Proposes Patent Fee Increases

by Amol Parikh | May 4, 2023 | Patents

The US Patent & Trademark Office (PTO) announced proposed patent fee increases. Patent fees would increase by about 5% across the board because of inflation.

Certain fees would be increased by substantially more than the 5% inflationary increase to reduce subsidization from other fee sources. For example, the overall design patent fees would increase by 48%, based on a 27% increase in filing, search and examination fees and a 76% issue fee increase. The PTO also proposes a 100% increase in the excess claim fee for each claim over 20, and a 25% increase in the fee for each independent claim over three. Because the costs of reviewing patent term extensions is complex, the PTO proposes fee increases of 196% to 468%. The PTO also proposes a fee of $500 for filing an After Final Consideration Pilot (AFCP) 2.0 request, and new fees for filing an information disclosure statement (IDS) that causes the number of applicant-provided citations to exceed 50, 100 or 200 citations, respectively.

To offset the loss of future maintenance fee payments, the PTO proposes fees of $1,500 for continuing applications filed more than three years from the earliest benefit date and $3,000 for continuing applications filed more than seven years from the earliest benefit date.

Other proposed fee increases are intended to expedite the patent examination process. For example, the PTO proposes a 25% increase in the fee for a second request for continued examination (RCE) and an 80% increase for a third or subsequent RCE. The fee for a terminal disclaimer filed after the first action on the merits and before a final rejection would increase by 194%. After a final rejection or notice of allowance, the fee would increase by 371%. On or after a notice of appeal, the increase would be 547%, and the proposed increase for filing a terminal disclaimer in an issued patent would be 724%.

The PTO further proposes increasing Patent Trial & Appeal Board America Invents Act (AIA) trial fees by 25%. The PTO also proposes new fees for inter partes review (IPR) and post grant review (PGR) petitions that exceed the word count limits. For example, the PTO proposes a 50% higher fee for petitions that exceed the word count limit by up to 50%, and a 100% higher fee for those that exceed the limit by up to 100%.

A public hearing is scheduled for May 18, 2023. Those wishing to present oral testimony at the hearing must submit a written request by May 11, 2023. Written comments on the proposed fees will be accepted until May 25, 2023.

The PTO anticipates that the fee changes will be implemented around January 2025.

More details, including a complete list of the proposed fee increases, can be found on the PTO website.

Breaking Up Is Hard to Do: Validity Upheld Based on Expert Separation Testimony

by Alexandra Cavazos, PhD | Apr 27, 2023 | Patents

The US Court of Appeals for the Federal Circuit affirmed a district court decision finding that two patents covering enantiomerically pure compositions of the psoriasis drug Otezla® (apremilast) were valid and one patent covering a dosage titration schedule was invalid as obvious. Amgen Inc. v. Sandoz Inc. Case No. 22-1147 (Fed. Cir. Apr. 19, 2023) (Lourie, Cunningham, Stark, JJ.)

Amgen markets apremilast, a phosphodiesterase-4 inhibitor that is used for treating psoriasis and related conditions, under the brand name Otezla®. Amgen has three patents covering Otezla®. Two of the patents are directed to orally administered pharmaceutical compositions of enantiomerically pure apremilast (composition patents), and one of the patents covers a dosage titration schedule for enantiomerically pure apremilast that ranges from a starting dose of 10 mg to a dose of 60 mg by the sixth day (dosage patent). Sandoz submitted an Abbreviated New Drug Application (ANDA) seeking approval from the US Food and Drug Administration (FDA) to market a generic version of apremilast. Amgen filed suit against Sandoz for infringement of its three patents covering Otezla®.

Sandoz asserted that the composition patents were invalid based on prior art that had an example (Example 12) that described a 50%:50% racemic mixture of apremilast but did not disclose the purified apremilast (+) enantiomer recited in the claims. The prior art did state that apremilast could be isolated from this racemic mixture using chiral chromatography, a well-known technique. The district court rejected Sandoz’s argument, finding that there was insufficient evidence to conclude that a skilled artisan would have had reason to believe that the desirable properties of Example 12 derived in whole or in part from the apremilast enantiomer (i.e., the (+) enantiomer). The district court also concluded that Sandoz had not demonstrated that a skilled artisan would have had a reasonable expectation of success in resolving Example 12 into its individual enantiomeric components. Furthermore, the district court looked to objective indicia of non-obviousness, finding that apremilast unexpectedly provided substantial improvement over previously known phosphodiesterase inhibitors in terms of both efficacy and tolerability, and a nexus existed between the unexpected potency and the asserted claims.

Sandoz also argued that the dosage patent was invalid based on prior art that taught various dosage schedules and amounts for apremilast. The district court found that it would have been within the ability of a skilled artisan to titrate apremilast for a patient presenting with psoriasis and that doing so would have been a routine aspect of treating psoriasis with a drug (such as apremilast) that was known in the art to require dose titration to ameliorate side effects. The district court therefore found that the dosage patent was invalid. Sandoz appealed with respect to the composition patents, and Amgen appealed with respect to the dosage patent.

The Federal Circuit affirmed the district court’s decision with respect to the composition patents, finding that Sandoz had not proven that a skilled artisan would have had sufficient motivation to purify apremilast’s (+) enantiomer from the racemic mixture disclosed in Example [...]

Continue Reading

Older Posts »

« Newer Posts

BLOG EDITORS

Paul Devinsky

Amol Parikh

Jodi Benassi

BLOG EDITORS

STAY CONNECTED

TOPICS

ARCHIVES

RECENT POSTS