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Articles by Luke Shannon
High Court's 'Skinny Label' Case May Tackle Wider Questions
Taft Stettinius & Hollister are most popular: with readers working within the Aerospace & Defence industries In 2024, the U.S. Court of Appeals for the Federal Circuit ruled in Amarin v. Hikma that Amarin had plausibly alleged that Hikma induced infringement of its patents. Now that the U.S. Supreme Court has granted certiorari, we present an update and some practice tips. The fight in Hikma is not really about one omega-3 drug.
Fed. Circ. Skinny Label Ruling Guides On Infringement Claims
ADVERTISEMENT Don't want ads? Subscribe or login now. By Luke Shannon and Roshan Shrestha (July 5, 2024, 11:30 AM EDT) -- The U.S. Court of Appeals for the Federal Circuit's June 25 opinion in Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc. provides the court's latest direction in the application of so-called section viii carveouts under Title 21 of the U.S. Code, Section 355(j)(2)(A)(viii).[1]...
Application modernization: Common problems and respecting the enterprise environment
We all want to do the right thing. We all want the best outcome. Which means, we all need to abide by best practice, right? When it comes to a legacy enterprise environment, this might not always be correct. Sometimes even when a team makes a technically sound decision and moves forward, they can run into problems. This is because the best technology fit might not be determined on technical merit alone. Organizational fit must also be considered.
Application modernization: The importance of an opinionated workflow
In earlier discussions, we highlighted the importance of aligning modernization efforts with business outcomes and corporate strategic alignment. We also explored the challenges associated with modernizing applications in an enterprise environment, including siloed culture and unexpected regulation or policy problems. Considering these factors, it becomes clear that achieving the desired value from modernization requires an approach that takes into account enterprise-specific details.
Application modernization: Promote, observe and process
The very act of modernizing means not only is there an application feedback loop to improve, there will be a similar loop running around infrastructure and security compliance that allows the application to operate in its current state in a production environment. Let’s talk a bit about what this might look like and some challenges to keep in mind when modernizing.
Application modernization: Effectively building and testing changes to existing software
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Considerations when implementing developer portals in regulated enterprise environments
There is a trend in the industry at present around developer experience. At the center of this is the developer portal. This concept is not new. Many enterprise environments have created their own platforms and tools that help streamline the process of getting teams coding faster in environments where everything is not easily accessible. There is also a large movement within the industry to provide frameworks and tools that build developer portals.
Modenization: Strategies for modernizing existing code
So far in this series I have established that the following are all necessary components of the modernization project planning process: code bases that will provide value when modernized to a future state a general strategy on how that code should be changed to achieve the future state a team that can effectively work in that enterprise environment all the information the team needs to start a brief onboarding course so team members are empowered and enabled to work a place to track work...
Strategic Considerations for Generics and Brands in Light of GSK v. Teva
Event Session October 26, 2022 @ 3:00 PM EST 3:00 PM ET Strategic Considerations for Generics and Brands in Light of GSK v. Teva View Session Speakers Under the Hatch-Waxman Act, so-called “Section VIII carveout” also known as a skinny label, are intended to give generic drug companies protection from patent infringement liability as long as the uses the ANDA applicant lists are not covered by the innovator’s patents. GSK v.
Modernization: Preparing the team
So far in this series I have established that the following are all necessary components of the modernization project planning process: code bases that will provide value when modernized to a future state a team that can effectively work in that enterprise environment all the information the team needs to start a brief onboarding course so team members are empowered and enabled to work a place to track work progress that teams outside of the product team can review if they have questions At...
Modernization: Developing your code migration strategy
This article is part of an ongoing series that has already covered quite a bit of ground, including: Determining the desired future state of the application(s) Reviewing challenges surrounding legacy code Making a case for funding the future state Creating an effective team to work on a modernization project in an enterprise environment Assessing a portfolio of applications to determine the application patterns to tackle first to provide the most value When it comes to modernizing an existing...
Modernization: Building a modernization project team
In this article, I discuss a proposal to build a success-primed team to modernize a portfolio of applications. We will take into account our points for alignment from our previous blog post. It’s important to remember this might not be a team that will be long running or one that will become a key part of the enterprise culture. As we discussed in the previous article, there will be a set budget and timeframe to get the work done.
Modernization: Making a business case
In the previous articles we discussed how to assess, from a high level, whether a modernization effort made sense in your enterprise. We also covered the attributes a successful modernization team should have, and some team characteristics that might cause problems. At this point you might be thinking that starting a modernization project is a no-brainer. However, there is still one more bridge you need to cross. Modernization requires funding Every IT operation in an enterprise requires funding.
Modernization: Why is it hard?
Modernizing a portfolio of legacy applications presents some unique challenges in enterprise environments. In my first blog in this series, Modernization: Why is it important?, I recommended considering these two points when deciding whether to embark on a modernization project: What are the benefits of moving the application to a future state versus the effort it takes to modernize it? Can the enterprise operate this future state over time?
Silence is Not Golden - Federal Circuit Invalidates Method of Treatment Patent for Lack of Written Description
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Modernization: Why is it important?
Modernizing an existing codebase—or often a portfolio of them—is a complex technical endeavor. In the enterprise environment, there are challenges beyond the technical that can hinder or halt modernization. Over decades of running technology at scale, enterprises have formed unique footprints of culture, politics and protective security practices that influence all technical outcomes.
Athlete of the Week: Kaeli Romanowski, Western Wayne
Western Wayne senior started her season with 23 points in a close loss to State College, then poured in 31 in a win over Linden Hall kAmkDEC@?8mu2>:=Jik^DEC@?8m $:DE6C[ t>:=J 2 D@A9@>@C6 @? E96 E62>j >@>[ yF=:6j 525[ y@6k^Am kAmkDEC@?8ms:5 J@F D66 E9:D <:?5 @7 DE2CE E@ J@FC D62D@? 4@>:?8nk^DEC@?8m }@E 2E 2==] x <?6H H6 H6C6 8@:?8 E@ 92G6 2 E@F89 DE2CE] x <?6H E96 E62>D H6 H6C6 A=2J:?8 H6C6 >@C6 6IA6C:6?465] xE H2D 2 E62> 677@CE] x H@F=5?’E 92G6 366?
Federal Circuit Affirms Invalidity of Method of Treatment Patent for Lack of Written Description in Hatch-Waxman Case Original
January 21, 2022 McDermott+Consulting Check-Up: January 21, 2022 by: McDermott + Consulting Beltway Buzz, January 21, 2022 by: James J. Plunkett CFPB Bans Payment Processor for Engaging in Fraudulent Practices by: Moorari Shah and A.J. S. Dhaliwal How to Create a Strong LinkedIn Profile Cover Image by: Stefanie M. Marrone Beyond the OSHA ETS and CMS Rule: What’s Up with Biden’s Executive... by: Leigh M. Nason EPA Requests Comment on Draft TSCA Screening Level Approach for... by: Lynn L.
Canadian players shine for Penn State
Canada Day was celebrated Saturday in Happy Valley, even if it was a few months late. kAmu@FC r2?25:2?D AC@G:565 <6J >@>6?ED[ 2?5 3:8 A=2JD[ :? !6?? $E2E6’D ag\_ H:? @G6C #FE86CD]k^Am kAmxE DE2CE65 H:E9 ~EE2H2’D r9C:DE:2? '6:==6FI[ E96 ECF6 7C6D9>2? 324<FA BF2CE6C324< H9@ E9C6H 7@C abd J2C5D 2?5 E9C66 E@F495@H?D :? 9:D 7:CDE 4@==686 82>6]k^Am kAmw6 42>6 :?E@ 2 D4@C6=6DD 82>6 H96? DE2CE6C $62? r=:77@C5[ H9@ H2D 32EE=:?8 E96 7=F[ H2D :?;FC65 H:E9 bicf =67E :?
U of S women's soccer team advances to Sweet 16
SCRANTON — It was a match of near misses for the University of Scranton women’s soccer team. kAm%96 #@J2=D E9C62E6?65 E96 $&}* v6?6D6@ 5676?D6 2== 82>6[ 3FE 4@F=5?’E 3C62< E9C@F89 :? :ED }rpp s:G:D:@? xxx %@FC?2>6?E D64@?5\C@F?5 >2E49FA]k^Am kAm$E6A9 {@HC6J AFE 2? 6?5 E@ E92E]k^Am kAm%96 D6?:@C >:57:6=56C D4@C65 @77 2? 2DD:DE 7C@> r=2:C6 |F=9@==2?5 :? E96 ga?5 >:?FE6 E@ =625 $4C2?E@?
NCAA SOCCER: Scranton blanks Nazareth in first round
SCRANTON — The University of Scranton women’s soccer team has prided itself on having a well-balanced attack all year. kAm~? $2EFC52J[ |2CJ w2886CEJ H2D E96 =2E6DE E@ DE6A FA]k^Am kAm%96 D@A9@>@C6 >:57:6=56C 7C@> v2C56? r:EJ[ }]y] 925 2 8@2= 2?5 2? 2DD:DE 2D E96 #@J2=D 5@>:?2E65 7C@> DE2CE E@ 7:?:D9 :? 2 b\_ G:4E@CJ @G6C }2K2C6E9 r@==686 :? E96 }rpp s:G:D:@? xxx E@FC?2>6?E @A6?6C 2E (6:DD u:6=5]k^Am kAm%96 #@J2=D H:== 9@DE $&}*\v6?6D6@ :?
Athlete of the Week: Caleb Kenyon, North Pocono
Won the boys District 2 Class 3A cross country individual title with a 15:59.6 time in the 5-kilometer race, leading North Pocono to their first district team title since 2001. kAmkDEC@?8mu2>:=Jik^DEC@?8m |@>[ $FD2?j 525[ rFCE:Dj 3C@E96CD %C24J 2?5 s6CC:4<k^Am kAmkDEC@?8mr2? J@F E2<6 >6 E9C@F89 J@FC 766=:?8D @? 86EE:?8 E96 E62> 492>A:@?D9:Ank^DEC@?8m x H2D DFA6C 6I4:E65 23@FE :E] |J E62>’D 92C5 H@C< 7:?2==J A2:5 @77] x H2D 8=25 E92E H6 H6C6 23=6 E@ 8@ E9C@F89 E96 D62D@?
Old Forge's Kelley earns Bassmaster Elite Series berth
Going into the second day of the three-day Bassmaster Northern Open at the Thousand Islands, Old Forge’s Jonathan Kelley knew what he needed to do. kAmw6 925 2 H6:89E 8@2= :? 9:D >:?5 4@>:?8 :?E@ E96 $6AE] `_ 6G6?E[ 2?5 6G6CJ 42E49 3C@F89E 9:> 2 3:E 4=@D6C E@ 364@>:?8 2 q2DD>2DE6C t=:E6 $6C:6D 2?8=6C]k^Am kAm“x <?6H x 925 :E @? E96 H2E6C 2E ``ib_ 2?5 H96?
Athlete of the Week: Karissa Ghigiarelli, Riverside
The Riverside senior has the chance to chase a second state championship after winning her fourth straight District 2 Class 2A singles championship. kAmkDEC@?8mu2>:=Jik^DEC@?8m |@>[ r9C:DEJj 525[ r925j 3C@E96C[ %@?Jk^Am kAmkDEC@?8mpC6 E96C6 2?J 2E9=6E6D J@F 25>:C6nk^DEC@?8m x’G6 2=H2JD 25>:C65 #2726= }252=[ E96 H2J 96 7:89ED E9C@F89 9:D >2E496D 2?5 9:D DEJ=6 @7 A=2J] w6’D D@>6@?6 x C62==J =@@<65 FA E@ 2?5 H2E4965 A=2J]k^Am kAmkDEC@?8ms@ J@F 92G6 2?J 72G@C:E6 DA@CED E62>Dnk^DEC@?8m x?
Athlete of the Week: Vincent DePalma
Ran for 323 yards and three touchdowns and also added a touchdown pass in Carbondale Area’s 52-26 win over Susquehanna on Saturday night. kAmkDEC@?8mu2>:=Jik^DEC@?8m |2C:?@[ 3C@E96Cj y2>:6[ >@E96Cj $E6G6?[ 72E96C]k^Am kAmkDEC@?8mu2G@C:E6 E62>Dik^DEC@?8m %96 W!9:=256=A9:2X t28=6D — E96J’C6 >J E62>]k^Am kAmkDEC@?8mpE9=6E6D J@F 25>:C6ik^DEC@?8m $2BF@? q2C<=6J 2?5 z@36 qCJ2?E]k^Am kAmkDEC@?8m%9C66 A6@A=6 J@F’5 =:<6 E@ 92G6 5:??6C H:E9ik^DEC@?8m s6??:D #@5>2?[ #2J {6H:D 2?5 qC:2?
HS FOOTBALL: Carbondale Area wins up front, drops Holy Cross
DUNMORE — Vinny DePalma’s message was clear following his team’s victory Saturday: it all started up front. kAms6DA:E6 =625:?8 r2C3@?52=6 pC62 W`\`X H:E9 a_a J2C5D CFD9:?8 2?5 E9C66 E@F495@H?D @? `b 42CC:6D :? 2 dc\af H:? @G6C w@=J rC@DD W`\`X[ E96 CF??:?8 324< 4C65:E65 9:D @776?D:G6 =:?6 H:E9 2==@H:?8 9:> E@ 4@>A:=6 E9@D6 ?F>36CD]k^Am kAm“|2<6 DFC6 J@F D9@FE @FE >J 3=@4<:?8[” s6!2=>2 D2:5]k^Am kAm%96 r92C86CD C@56 2 H6==\C@F?565 8C@F?5 2EE24< E@ G:4E@CJ :? 2 {24<2H2??2 u@@E32== r@?76C6?46 s:G:D:@?
Voit homers in rehab game with RailRiders
Returning from his third stint on the injured list of the 2021 season, New York Yankee first baseman Luke Voit made a rehab start for the Scranton/Wilkes-Barre RailRiders on Tuesday. kAm'@:E A=2J65 D6G6? :??:?8D 2E 7:CDE 32D6 2?5 H6?E ` 7@C b H:E9 2 9@>6 CF? :? 9:D 7:CDE 82>6 24E:@? D:?46 8@:?8 5@H? H:E9 =67E <?66 :?7=2>>2E:@? yF=J `e] xE H2D 9:D 7@FCE9 9@>6 CF? :? D6G6? C6923 82>6D H:E9 E96 #2:=#:56CD E9:D D62D@?[ H9:49 E:6D 9:> 7@C `_E9 >@DE @?
Scalable, Cloud-native Data Applications by Example
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Federal Circuit Addresses Obviousness of Polymorphs in Grunenthal GmbH v. Alkem Labs. Ltd., No. 2017-1153 (Fed. Cir. Mar. 28, 2019) | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
Federal Circuit Addresses Obviousness of Polymorphs in Grunenthal GmbH v. Alkem Labs. Ltd., No. 2017-1153 (Fed. Cir. Mar. 28, 2019)
April 03, 2019 EPA Issues New Emergency Response Requirements for Community Water... by: Terese (T.C.) Richmond and Gwendolyn Keyes Fleming PTAB Brings Promise to Pot Patent Protection by: Gene Markin 340B Drug Ceiling Prices Now Available by: Bryan P. Murray and Jennifer Orr Mitchell DOT-Regulated Truck Driver’s Claims Dismissed Because He Could Not... by: Ashley C. Zangara A Summary of Certain Recent Enforcement and Non-Enforcement Actions by: Garrett F. Bishop and J.
Update on Pending Legislation: Three New Bills Have the Potential to Affect Generic Pharmaceutical Companies | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
Update on Pending Legislation: Three New Bills Have the Potential to Affect Generic Pharmaceutical Companies
Tuesday, February 12, 2019 In the first month of the 116th Congress, three bills have been introduced (or re-introduced) that have potential to impact generic pharmaceutical companies. Hatch-Waxman Integrity Act of 2019 On January 30, 2019, Sen. Thom Tillis (R-NC) and Rep.
Supreme Court Confirms the AIA On-Sale Bar Covers Secret Sales—But Invites Controversy over What Is “Otherwise Available to the Public.” | JD Supra
Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.
Spring Cloud Data Flow Set-Up
How to get SCDF set up on PWS In a previous life, I learned an ETL tool called Talend. Talend is an open source tool based on Eclipse. Similar to other tools in its class, ie: Informatica, it was very good at working with batch oriented data. Although Batch processing will never go away, these days there are many valid use cases for relentless streams of data. The data in such streams can often be more interesting as it's happening.
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