•         By Sherri Oslick

    Gavel About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

    Fresenius Kabi USA, LLC. v. Par Sterile Products, LLC et al.
    2:15-cv-03852; filed June 9, 2015 in the District Court of New Jersey

    • Plaintiff:  Fresenius Kabi USA, LLC
    • Defendants:  Par Sterile Products, LLC; Par Pharmaceutical, Inc.; Par Pharmaceutical Companies, Inc.

    Infringement of U.S. Patent No. 9,006,289 ("Levothyroxine Formulations," issued April 14, 2015) following a Paragraph IV certification as part of Par's filing of an ANDA to manufacture a generic version of Fresenius' levothyroxine sodium powder for injection product (levothyroxine sodium, used as replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis).  View the complaint here.


    Actavis Laboratories UT, Inc. v. UCB, Inc.
    2:15-cv-01001; filed June 8, 2015 in the Eastern District of Texas

    Infringement of U.S. Patent No. 7,921,999 ("Peelable Pouch for Transdermal Patch and Method for Packaging," issued April 12, 2011) based on UCB's manufacture and sale of its Neupro® (rotigotine transdermal systm, used to treat the signs and symptoms of idiopathic Parkinson's disease and moderate-to-severe Restless Legs Syndrome).  View the complaint here.


    Bayer Pharma AG et al. v. Macleods Pharmaceuticals Ltd. et al.
    1:15-cv-00464; filed June 5, 2012 in the District Court of Delaware

    • Plaintiffs:  Bayer Pharma AG; Bayer Intellectual Property GmbH; Bayer HealthCare Pharmaceuticals Inc.
    • Defendants:  Macleods Pharmaceuticals Ltd.; Macleods Pharma USA, Inc.

    Infringement of U.S. Patent No. 8,613,950 ("Pharmaceutical Forms With Improved Pharmacokinetic Properties," issued December 4, 2013) following a Paragraph IV certification as part of Macleods filing of an ANDA to manufacture a generic version of Bayer's Staxyn® (vardenafil hydrochloride, used to treat erectile dysfunction).  View the complaint here.


    Mallinckrodt LLC et al. v. Watson Laboratories, Inc.- Florida et al.
    2:15-cv-03800; filed June 5, 2015 in the District Court of New Jersey

    • Plaintiffs:  Mallinckrodt LLC; Mallinckrodt Inc.; Depomed, Inc.
    • Defendants:  Watson Laboratories, Inc.- Florida; Actavis Laboratories FL, Inc.

    Infringement of U.S. Patent Nos. 8,597,681 ("Methods of Producing Stabilized Solid Dosage Pharmaceutical Compositions Containing Morphinans," issued December 3, 2013), 8,658,631 ("Combination Composition Comprising Oxycodone and Acetaminophen for Rapid Onset and Extended Duration of Analgesia," issued February 25, 2014), 8,741,885 ("Gastric Retentive Extended Release Pharmaceutical Compositions," issued June 3, 2014), 8,980,319 ("Methods of Production Stabilized Solid Dosage Pharmaceutical Composition Containing Morphinans," issued March 17, 2015), 8,992,975 ("Methods of Producing Stabilized Solid Dosage Pharmaceutical Compositions Containing Morphinans," issued December 3, 2013), 7,976,870 ("Gastric Retentive Oral Dosage Form with Restricted Drug Release in the Lower Gastrointestinal Tract," issued July 12, 2011), and 8,668,929 ("Gastric Retentive Extended-Release Dosage Forms Comprising Combinations of a Non-Opioid Analgesic and an Opioid Analgesic," issued March 11, 2014) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of Mallinckrodt's Xartemis XR (acetaminophen and oxycodone, used for the management of acute pain severe enough to require opioid treatment and for which alternative treatment options are inadequate).  View the complaint here.


    Bausch & Lomb Inc. et al. v. Apotex Inc. et al.
    1:15-cv-03879; filed June 5, 2015 in the District Court of New Jersey

    • Plaintiffs:  Bausch & Lomb Inc.; Bausch & Lomb Pharma Holdings Corp.; Senju Pharmaceutical Co., Ltd.
    • Defendants:  Apotex Inc.; Apotex Corp.

    Infringement of U.S. Patent Nos. 8,784,789 ("Aqueous Liquid Preparations and Light-Stabilized Aqueous Liquid Preparations," issued July 22, 2014) and 8,877,168 (same title, issued November 4, 2014) following a Paragraph IV certification as part of Apotex's filing of an ANDA to manufacture a generic version of Bausch & Lomb's Bepreve® (bepotastine besilate ophthalmic solution, used for the treatment of itching associated with allergic conjunctivitis).  View the complaint here.

  • CalendarJuly 14, 2015 – Patent Quality Chat webinar series – Face-to-face Examiner Interviews: A Demonstration of USPTO Tools – noon to 1:00 pm (EDT)

    July 16-17, 2015 - "Advanced Patent Prosecution Seminar 2015: Claim Drafting & Amendment Writing" (Practising Law Institute) – New York, NY

    July 20-21, 2015 – Patent Cooperation Treaty Seminar (American Intellectual Property Law Association) – San Francisco, CA

    July 22, 2015 – "Navigating Ex Parte Reexamination and Reissue Applications — The Mechanics of Preparation and Interplay with AIA Post-Grant Proceedings and Litigation" (American Intellectual Property Law Association) – 12:30 – 2:00 pm (Eastern)

    July 23, 2015 – "Section 103 and Non-Obviousness Post-AIA — Navigating Timing Changes, Federal Court Treatment, and Secondary Considerations to Meet Patent Validity Requirements" (Strafford) – 1:00 to 2:30 pm (EDT)

    July 23-24, 2015 – Patent Cooperation Treaty Seminar (American Intellectual Property Law Association) – Alexandria, VA

    July 29, 2015 – "Teva: The Real Impact on Claim Construction Tactics in the PTAB, Federal Courts, and ITC" (American Intellectual Property Law Association) – 12:30 – 2:00 pm (Eastern)

    July 29, 2015 – "Protecting Your Trade Secrets: Strategies and Tools to Avoid Costly Litigation" (Commercial Law WebAdvisor) – 1:00 to 2:30 pm (Eastern)

    July 29, 2015 – "Sweeping Developments in Patent Reform Agenda: The Innovation Act and the PATENT Act — A 2015 Perspective" (The Knowledge Group) – 3:00 to 5:00 pm (ET)

    August 6, 2015 – "Maximizing Patent Prosecution Opportunities in Europe: Tactics for Counsel When Drafting U.S.-Origin Applications — Navigating Differing USPTO and EPO Legal Standards While Maintaining U.S. Patent Strategy" (Strafford) – 1:00 to 2:30 pm (EDT)

    August 10-11, 2015 – "Advanced Patent Prosecution Seminar 2015: Claim Drafting & Amendment Writing" (Practising Law Institute) – San Francisco, CA

    August 11, 2015 – Patent Quality Chat webinar series – Measuring Patent Quality – noon to 1:00 pm (EDT)

    August 12-14, 2015 – Advanced Patent Law Seminar (Chisum Patent Academy) – Seattle, WA

    September 10-11, 2015 - "Advanced Patent Prosecution Seminar 2015: Claim Drafting & Amendment Writing" (Practising Law Institute) – Chicago, IL

    September 24-25, 2015 - Advanced Patent Law Seminar (Chisum Patent Academy) – Washington, DC

    ***Patent Docs is a media partner of this conference or CLE

  • AIPLA #1The American Intellectual Property Law Association (AIPLA) will be offering a webinar on "Navigating Ex Parte Reexamination and Reissue Applications — The Mechanics of Preparation and Interplay with AIA Post-Grant Proceedings and Litigation" on July 22, 2015 from 12:30 – 2:00 pm (Eastern).  Paromita Chatterjee of Paul Hastings, Daniel Chung of Finnegan, and Thomas Ho of Bookoff McAndrews will explore strategies surrounding ex parte reexamination and reissue proceedings, and the mechanics of preparing the associated requests and applications, and will also take participants through the most common filing errors that get these applications denied or that detrimentally affect co-pending litigations.

    The registration fee for the program is $145 (AIPLA member rate) or $195 (non-member rate).  Those interested in registering for the program, can do so here.

  • Strafford #1Strafford will be offering a webinar/teleconference entitled "Maximizing Patent Prosecution Opportunities in Europe: Tactics for Counsel When Drafting U.S.-Origin Applications — Navigating Differing USPTO and EPO Legal Standards While Maintaining U.S. Patent Strategy" on August 6, 2015 from 1:00 to 2:30 pm (EDT).  Rebecca M. McNeill of McNeill Baur and Jens Viktor Nørgaard of HØIBERG (Denmark) will provide guidance for patent counsel in drafting U.S.-origin patent applications to maximize prosecution opportunities in both the U.S. and Europe, and offer best practices for U.S. patent application drafters to protect inventions in Europe without sacrificing U.S. strategy.  The webinar will review the following questions:

    • What are the key considerations for patent counsel drafting U.S. applications when global patent protection is anticipated or desired?
    • What are the significant differences between the U.S. and European approaches to patent applications?
    • What steps should counsel take when drafting U.S. patent applications to maximize protection in Europe?

    The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those interested in registering for the webinar, can do so here.

  • AIPLA #1The American Intellectual Property Law Association (AIPLA) will be offering a webinar on "Teva: The Real Impact on Claim Construction Tactics in the PTAB, Federal Courts, and ITC" on July 29, 2015 from 12:30 – 2:00 pm (Eastern).  Cory Bell of Finnegan, Robert Counihan of White and Case, and Jonathan Stroud of Unified Patents will explore the implications of the Teva Supreme Court decision on claim construction in both district courts and at the PTAB, whether the adoption of clear error review will have a significant impact on claim construction practices, and other best practices and strategies for developing a winning claim construction.

    The registration fee for the program is $145 (AIPLA member rate) or $195 (non-member rate).  Those interested in registering for the program, can do so here.

  • Commercial Law WebAdvisorCommercial Law WebAdvisor will be offering a webinar entitled "Protecting Your Trade Secrets: Strategies and Tools to Avoid Costly Litigation" on July 29, 2015 from 1:00 to 2:30 pm (Eastern).  James H. McQuade and Matthew Kugizaki of Orrick, Herrington & Sutcliffe LLP will cover a range of important components of an effective trade secret protection strategy, sharing tips for how to implement each element effectively and maximize its usefulness.  The webinar will address the following components of a trade secret protection:

    • Confidentiality or non-disclosure terms and provisions in employee agreements and handbooks.
    • Post-employment restrictive covenants, such as non-compete and non-solicitation provisions.
    • Access limitations to sensitive information.
    • Effective electronic use policies, such as using personal devices and the cloud to store company data.
    • Data theft prevention strategies.
    • Exit interviews and procedures to recover proprietary information.
    • Forensic investigations to evaluate the risk of trade secret dissemination.
    Documentation and other factors that support your litigation activities and reduce costs.

    The registration fee for the webinar is $199.  Those interested in registering for the webinar, can do so here.

  • The Knowledge GroupThe Knowledge Group will offer a live webcast entitled "Sweeping Developments in Patent Reform Agenda: The Innovation Act and the PATENT Act — A 2015 Perspective" on July 29, 2015 from 3:00 to 5:00 pm (ET).  Mark J. Thronson of Dickstein Shapiro LLP, Keith Grady of Polsinelli PC, and Peter Lambrianakos of Brown Rudnick LLP will review and discuss the latest issues surrounding the sweeping developments in the patent reform agenda: The Innovation Act and the PATENT Act, suggest why the changes may or may not be beneficial for one party or another, and identify the most common pitfalls and risks to avoid future litigation and costs.  The panel will cover the following issues:

    • Pleading requirements, customer suits
    • Discovery limitations, demand letters
    • Venue
    • Fee shifting provisions, transparency
    • AIA reforms

    The registration fee for the webcast is $299 to $349 (regular rate) or $149 (government/nonprofit rate).  Those registering by July 19, 2015 will receive a $100 discount of the regular rate.  Those interested in registering for the webinar can do so here.

  • The Chisum Patent Academy will be offering its next Advanced Patent Law Seminar on September 24-25, 2015 in Washington, DC.  The seminar is co-taught by Donald Chisum, author of the treatise Chisum on Patents (LexisNexis), and Janice Mueller, who was a tenured full Professor at the University of Pittsburgh School of Law from 2004-2011.  The registration fee for the seminar is $1,500; a maximum of ten registrations will be accepted for the seminar.  Those interested in registering for the seminar can do so here.  Additional information regarding the seminar can be obtained here or by e-mailing info@chisum.com.

    Chisum Patent Academy

  • By James Lovsin and Andrew Williams

    Federal Circuit SealEarlier this week, the Federal Circuit issued an order denying a petition for rehearing en banc in the In re Cuozzo Speed Technologies, LLC case.  As we have previously reported, this case was the first appeal of the first IPR Final Written Decision for the first IPR ever filed.  The original opinion not only addressed the substance of the underlying case, but it also approved of some of the most contentious rules promulgated by the Patent Office for these proceedings.  Moreover, Judge Newman provided a strongly worded dissent.  As such, many commentators believed that the entire Court would take up such issues as whether the "Broadest Reasonable Interpretation" (BRI) is the correct claim construction standard in these post-grant proceedings.  Nevertheless, when the poll was requested and taken for rehearing en banc, it failed.  The Order was accompanied by a concurring opinion authored by Judge Dyk, the author of the original opinion, and was joined by Judges Lourie, Chen, and Hughes.  Chief Judge Prost, and Judges Newman, Moore, O'Malley, and Reyna provided a joint dissent from the petition denial.  Finally, Judge Newman provided her own dissent.  Interestingly, the original panel (Judges Newman, Clevenger, and Dyk) issued an order granting a petition to clarify the underlying decision, withdrawing that decision, and replacing it with the revised opinion and dissent accompanying the order.  The changes made to that decision will be the subject of an upcoming post.

    The closeness of the vote is intriguing, and presents some interesting issues.  It would have taken a vote of six judges in active service to rehear the case en banc, given that a majority of active judges must agree to rehear the case, and at the time of the poll the Court had eleven active circuit judges.  The poll therefore failed by only one vote, with the five dissenting judges indicating that they would have reheard the case en banc.  Of course, the Senate recently confirmed Kara Stoll to be the next Circuit Judge of the Federal Circuit, so the Court will soon have its maximum number of twelve active judges.

    If Cuozzo decides to petition the Supreme Court to hear its case, the close en banc vote may indicate to the Supreme Court that there is an intra-circuit split on the application of the BRI standard in post-grant proceedings.  In addition, the principal dissent from the denial of the petition is unusual in that it is a joint dissent of five judges rather than an opinion authored by one judge and joined by others (like the concurrence from the denial of the petition).  Such a joint dissent may also indicate the importance of the issue to the Supreme Court.  Given that the Supreme Court addressed the standard of review for claim construction in district court litigation last Term in Teva v. Sandoz, the Court may be inclined to address the related issue of the standard of claim construction for Patent Office proceedings.  The Supreme Court has also not yet granted certiorari in a patent case for next Term.

    It will also be interesting to see if future litigants will petition the Federal Circuit again to rehear en banc the broadest reasonable interpretation standard.  The Court declining this week to consider the issue en banc in this case does not mean it will not do so in the future.  For instance, of the six judges that did not dissent from the denial of the petition, two of them did not join the concurrence from the denial of the petition, Circuit Judges Wallach and Taranto.  In addition, Judge Stoll will also likely be available to consider a future petition directed to the BRI standard.  Perhaps a different majority of the Court will decide to address the issue en banc in a future case.

    Judge Dyk's Concurence

    Judge Dyk concurred in the per curiam order to address the dissenting opinions' arguments why BRI should not be applied in IPR proceedings.  First, BRI has been used by the Office for more than a century.  Second, there is no demonstrated congressional intent in the America Invents Act (AIA) to change the use of this claim construction standard.  Curiously, the concurrence did note that Congress is seeking to correct this "lack-of-intent" oversight.  Nevertheless, the fact that curative legislation is now pending in both the House and Senate is insufficient to demonstrate congresses' prior intent that BRI should not be the standard.

    The Joint Dissent

    As mentioned above, five Federal Circuit Judges issued a joint dissent.  Their position can be summed up in the two sentences near the end of the dissent:

    But in IPRs, as in district court litigation, an already issued claim is being analyzed solely for the purposes of determining its validity.  In this context, it makes little sense to evaluate the claim against the prior art based on anything than the claim's actual meaning.

    Joint Dissent from Denial of Petition, at 9.  Instead, these Judges would have required that claims in these new post-grant proceeding be given their actual meaning.

    The joint dissent first took issue with the panel majority's conclusion that Congress "implicitly approved" the claim construction standard adopted by the Patent Office.  Instead, they would have applied the rule that silence means just that — silence.  The new post-grant review proceedings established by the America Invents Act were a "wholly novel procedure," meant to be more adjudicatory than examinational, as most every other Patent Office proceeding is.  Because these proceedings have no real counterpart at the Office, nothing can be gleaned from congressional inaction.  In fact, the dissent challenged the panel majority for failing to explain why congressional silence did not, instead, signal that it had intended the same legal framework as used in district courts.

    Second, the joint dissent asserted that existing case law not only failed to support the panel majority's conclusion, but it supported the opposite conclusion.  The prior cases made clear that the BRI standard was appropriate before issuance of a patent to clarify "the metes and bounds of an invention during the back-and-forth between the applicant and examiner when claims are not yet in their final form."  Id. at 3 (citing In re Prater, 415 F.2d 1393, 1405 (CCPA 1969)).  It is this same "give-and-take" that has existed in previous post-grant proceedings in which BRI has been approved.  In contrast, in district court adjudications, the courts arrive at a "'concise statement[] of the subject matter for which the statutory right to exclude is secured by a grant of the patent.'"  Id. at 4 (quoting Multiform Desiccants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1476 (Fed. Cir. 1998)).  In other words, it is the difference between the use of the BRI standard and determining what the patent claims actually mean.  And because an IPR is a "curtailed, trial-like proceeding meant to efficiently resolve a challenge to patent validity," the claim construction standard used in these proceedings should be no different than that used in district court.

    Finally, the joint dissent took issue with the panel majority's holding that the Court should apply Chevron deference to Patent Office's promulgated rules.  First, they did not think it was clear that deference was warranted.  The only congressional grant of authority was for procedural regulations, according to the joint dissent, and therefore should not apply to the claim construction standard.  But, assuming for argument sake that claim construction was more procedural in nature, the joint dissent would still not believe that deference would be warranted because the PTO regulation is contrary to congressional intent.  Nevertheless, even under the deferential standard, the joint dissent would have found the BRI standard unreasonable.

    Judge Newman's Dissent

    Judge Newman authored her own dissent to address the concerns expressed by the amicus curiae.  In addition to the appellant and the Office of the Solicitor, briefs were filed in this case by the Pharmaceutical Research and Manufacturers of America (PhRMA), the Intellectual Property Owners Association (IPO), the New York Intellectual Property Law Association (NYIPLA), and a collective of companies (3M, Caterpillar, Eli Lilly, General Electric, Glaxosmithkline, Illinois Tool Works, Johnson & Johnson, Pfizer, Procter & Gamble, and Sanofi US) that reportedly "collectively hold tens of thousands of patents."  In fact, based on this showing, Judge Newman made the sweeping comment that the BRI standard "has no defender other than a majority of the Federal Circuit court."

    Judge Newman noted the collective's concern that the currently used claim construction standard is inconsistent with the AIA and is against sound patent policy.  The resulting environment "is costly to the inventive community and discourages innovation."  Moreover, the application of different standards in these proceedings and in district court results in no estoppel effect and encourages gamesmanship.  Judge Newman also noted the IPO's concern that the BRI standard is upsetting the settled expectations of inventors, patentees, and anyone else that depends on the patent system.  PhRMA highlighted the importance of the patent system for medical advances, where approximately $40-50 billion in investments are made annually.  Finally, the NYIPLA stressed that the claim construction standard is of great importance and should be heard by the Court en banc.

    Judge Newman continued by stressing that all of the amici curiae were in agreement that these new post-issuance adjudicative proceedings are important.  Nevertheless, the legislative purpose is thwarted by the application of a different claim construction standard before the Board.  This was clearly not the legislative intent, and as Judge Newman also pointed out, there is corrective legislation in bills that have already been approved by both the House and Senate committees, although "[p]rompt resolution is reported to be unlikely."  She then provided a list of why the BRI standard is inappropriate:

    • Claim construction should be the same for validity and infringement;
    • Claim amendments in AIA proceedings require permission, and are limited even when permitted;
    • A patentee must now defend a broader construction than it ultimately obtained during prosecution;
    • The AIA procedures are surrogate tribunals for determining validity, and the claim construction standard should therefore be the same;
    • The public notice of patent claims requires the correct claim construction;
    • There is no guidance on what is too broad — therefore predictability is replaced with fuzziness and uncertainty;
    • The PTO tribunals are to review the validity of patents, and it was expected that they would apply the correct law of validity.

    Finally, Judge Newman took issue with the concurrence's comment that BRI has been used by the Patent Office for a hundred years.  In patent interferences, according to Judge Newman, the Office does not apply the "broadest" interpretation of anything.  And, in reissue proceedings, the goal is correctness, not breadth.  Therefore, according to Judge Newman, the deciding "question before this court is not whether to 'eliminate' BRI, but whether to impose it on issued patents, where it has not previously reposed."

  • By Donald Zuhn

    Federal Circuit SealLast month, in Mohsenzadeh v. Lee, the Federal Circuit affirmed the decision by the District Court for the Eastern District of Virginia granting summary judgment to the Director of the U.S. Patent and Trademark Office that the Office had properly calculated the Patent Term Adjustment (PTA) for U.S. Patent Nos. 8,352,362 and 8,401,963.  The instant appeal involves 35 U.S.C. § 154(b)(1)(A), which requires that the Office send a notification under § 132 or a notice of allowance under § 151 to the applicant within fourteen months of the date of filing of an application or the commencement of national stage of an international application.  At issue in the instant appeal was the impact of a delayed restriction requirement, one type of notification under § 132.

    Appellant Hossein Mohsenzadeh filed U.S. Application No. 09/899,905 on July 6, 2001.  More than five years after the '905 application was filed, the Office issued a restriction requirement restricting the claims into four groups.  The group of claims that Mohsenzadeh elected to prosecute issued as U.S. Patent No. 7,742,984, with the Office granting Mohsenzadeh 2,104 days of PTA, of which 1,476 days was due to the Office's delay in issuing the restriction requirement.  Mohsenzadeh filed two divisional applications from the '905 application, each corresponding to a group of claims identified as a separate invention in the restriction requirement issued for the '905 application.  Those applications later issued as the '362 and '963 patents, with the Office granting 0 days of PTA to both patents.

    Mohsenzadeh requested reconsideration of the PTA determinations for the '362 and '963 patents, arguing that both patents were entitled to 1,476 days for the Office's delay in issuing a restriction requirement in the '905 application.  The Office denied the requests, and pursuant to 35 U.S.C. § 154(b)(4)(A), Mohsenzadeh filed an action challenging the denials in the Eastern District of Virginia.  The Office moved for summary judgment, which the District Court granted, finding that § 154 unambiguously requires that PTA apply for delays that occurred during the prosecution of the actual application from which the patent directly issued, and not the application from which it derived priority.  The District Court also found that the Office's interpretation of § 154 was reasonable and entitled to deference.

    On appeal, Mohsenzadeh argued that § 154 was enacted to adjust the terms of all patents impacted by Office delays, and relied on the text of the statute to support that argument.  The relevant part of the statute reads (emphasis added):

    [I]f the issue of an original patent is delayed due to the failure of the Patent and Trademark Office to—
        (i) provide at least one of the notifications under section 132 or a notice of allowance under section 151 not later than 14 months after—
            (I) the date on which an application was filed under section 111(a); or
            (II) the date of commencement of the national stage under section 371 in an international application;
    . . .
    the term of the patent shall be extended 1 day for each day [of delay].

    Mohsenzadeh argued that delays in the issuance of "an original patent" (the '362 and '963 patents) were caused by the delay in providing a notification in "an application" (the '905 application).  The Office responded by arguing that the history of amendment of § 154(b)(1)(A)(i) confirms that Congress was referring to a single application throughout, noting that an earlier draft of the statute omitted (i)(II) and used the definite article, referring to "the application was filed under section 111(a)" (emphasis added).  However, when Congress amended the statute to include (i)(II), the indefinite article was used for both (i)(I) and (ii)(II).

    In affirming the District Court's grant of summary judgment to the Office, the Federal Circuit determined that "[t]he language of the provision of the patent term adjustment statute at issue, 35 U.S.C. § 154(b)(1)(A), clearly shows that Congress intended delay in the prosecution of an application to be restored to a single patent, the patent issuing directly from that application."  According to the Court, support for its determination could be found in the amendment of § 154 to change "the application" to "an application," which "signifies that Congress did not intend for patent term adjustments in continuing applications to be made for delays in parent applications."  As the Federal Circuit explained, "[t]he indefinite article, thus, appears not to allow for reference to a different application than the one ripening into 'an original patent,' but simply to signify Congress' adjustment of the statute to account for the fact that a patent may arise either from a domestic application or an international application."  "Because the plain language of 35 U.S.C. § 154(b)(1)(A) does not provide patent term adjustments in continuing applications based on delays in the prosecution of parent applications," the Federal Circuit affirmed the District Court's grant of summary judgment.

    Mohsenzadeh v. Lee (Fed. Cir. 2015)
    Panel: Circuit Judges Moore, Schall, and Reyna
    Opinion by Circuit Judge Reyna