![](https://investorshub.advfn.com/uicon/718139.png?cb=1600184674)
Tuesday, June 16, 2020 2:51:00 PM
So as I see it there are three major problems:
(1) Assumption of obviousness based on flawed factual and statistical interpretation of data (Mori Kurabayashi) and flawed extrapolation of incomplete data (Hayashi) to entirely different TG>500mg/dl population (considered by Du and flatly rejected). Just because Amrn didn't produce one of the inventors at trial e.g. Mehar Manku in court or did not/could not expressly point out the statistical flaws in generics/Du's interpretation, does not detract from obvious factual error of analysis which stands on itw own merits)
(2) Shifting of burden of proof of obviousness to Amrn which occurred de facto the minute Du used a weighing system of her own creation, to assess a relative importance basis for the secondary objective indicia, without considering them in totality.
....even panels that have used the “prima facie” and “rebuttal” language generally have made clear that a fact finder must consider all evidence of obviousness and nonobviousness before reaching a determination. For example, in Iron Grip Barbell Co. v. USA Sports, Inc., while the panel did hold that “there is no objective evidence to rebut the strong showing of obviousness based on the prior art,” 392 F.3d 1317, 1325 (Fed.Cir.2004), it also cautioned that, in “determining the question of obviousness, inquiry should always be made into whatever objective evidence of nonobviousness there may be.” Id. at 1323 (quoting Vandenberg v. Dairy Equip. Co., 740 F.2d 1560, 1567 (Fed.Cir.1984))
(3) Failure to consider the secondary indicia SIMULTANEOUSLY with the prima facie evidence of obviousness (prior art etc..). Had Du done this honestly, she might have stopped to question her prima facie obviousness construct in the first place.
In Stratoflex, Inc. v. Aeroquip Corp., we held that a fact finder in district court litigation may not defer examination of the objective considerations until after the fact finder makes an obviousness finding:
It is jurisprudentially inappropriate to disregard any relevant evidence on any issue in any case, patent cases included. Thus evidence rising out of the so-called “secondary considerations” must always when present be considered en route to a determination of obviousness· Indeed, evidence of secondary considerations may often be the most probative and cogent evidence in the record. It may often establish that an invention appearing to have been obvious in light of the prior art was not. It is to be considered as part of all the evidence, not just when the decisionmaker remains in doubt after reviewing the art.
The premature nature of the court's obviousness finding is apparent. Before it reached the objective considerations, the district court stated that the claimed PK profile “would have been obvious to one of skill in the art at the time of the invention” and that “a person of ordinary skill in the art would have been motivated to take a group of known elements to create an extended release version of cyclobenzaprine, and [would have had] a reasonable expectation of success in doing so.” It was not until after the district court found the asserted claims obvious that it proceeded to analyze the objective considerations, or what it called the “secondary considerations.”
Recent AMRN News
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/01/2024 08:54:53 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/01/2024 08:54:46 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/31/2024 11:05:34 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 07/31/2024 11:05:26 AM
- Amarin Reports Second Quarter 2024 Financial Results and Provides Business Update • GlobeNewswire Inc. • 07/31/2024 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/29/2024 09:30:08 PM
- Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Portugal • GlobeNewswire Inc. • 07/17/2024 08:15:00 PM
- Amarin to Report Second Quarter 2024 Financial Results and Host Conference Call on July 31, 2024 • GlobeNewswire Inc. • 07/17/2024 12:00:00 PM
- Amarin Partner EddingPharm Receives Regulatory Approval for VASCEPA® (Icosapent Ethyl) in Mainland China for Cardiovascular Risk Reduction (CVRR) • GlobeNewswire Inc. • 07/08/2024 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/04/2024 11:30:10 AM
- Amarin Board of Directors Announces CEO Transition • GlobeNewswire Inc. • 06/04/2024 11:30:00 AM
- Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Greece and Announces Exclusive Marketing and Commercialization Agreement with Vianex S.A. • GlobeNewswire Inc. • 05/28/2024 12:15:23 PM
- Amarin to Present at H.C. Wainwright 2nd Annual BioConnect Investor Conference • GlobeNewswire Inc. • 05/06/2024 12:00:00 PM
- Amarin Reports First Quarter 2024 Business Update and Financial Results • GlobeNewswire Inc. • 05/01/2024 11:00:00 AM
- Amarin Applauds HealthyWomen’s Citizen’s Petition Urging FDA To Take Further Action On Fenofibrate Prescribing in Patients at Risk of Cardiovascular Event • GlobeNewswire Inc. • 04/24/2024 06:00:01 PM
- Amarin Announces Results of Annual General Meeting of Shareholders • GlobeNewswire Inc. • 04/22/2024 12:00:25 PM
- Amarin to Report First Quarter 2024 Financial Results and Host Conference Call on May 1, 2024 • GlobeNewswire Inc. • 04/15/2024 12:00:00 PM
- Amarin Highlights Key Data Providing Mechanistic Insights into Eicosapentaenoic Acid (EPA) at ACC.24 • GlobeNewswire Inc. • 04/08/2024 12:00:00 PM
- New REDUCE-IT® Analyses Show VASCEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups • PR Newswire (Canada) • 04/08/2024 10:30:00 AM
- New REDUCE-IT® Analyses Show VASCEPA®/VAZKEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups • GlobeNewswire Inc. • 04/06/2024 07:30:00 PM
- Amarin Provides Update on VAZKEPA® (Icosapent Ethyl) Intellectual Property Portfolio in Europe • GlobeNewswire Inc. • 04/03/2024 12:00:00 PM
- Research Evaluating Benefits of VASCEPA®/VAZKEPA® (icosapent ethyl) to be Presented at the American College of Cardiology’s (ACC) Annual Scientific Session & Expo • GlobeNewswire Inc. • 03/25/2024 12:00:00 PM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 03/04/2024 10:30:53 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 03/04/2024 01:00:24 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 02/29/2024 12:06:26 PM
FEATURED POET and Luxshare Tech Expand Product Offerings for Artificial Intelligence Networks • Aug 1, 2024 9:28 AM
Management Discusses Financial Filings of Global Arena Holding Inc., for 10-K 2023 and 10-Q, 1st Quarter 2024 • GAHC • Aug 1, 2024 9:14 AM
VAYK Announces LOI to Acquire $1 Million Home Service Company to Support Airbnb Business • VAYK • Aug 1, 2024 9:00 AM
Duane Forrester Joins INDEXR as SVP of Search • MONI • Jul 31, 2024 11:46 AM
Lingerie Fighting Championships Help Fulfill Death-Bed Promise With First Major Motion Picture • BOTY • Jul 31, 2024 9:00 AM
Kona Gold Beverage Significantly Reduces Debt from Multiple Holders • KGKG • Jul 31, 2024 9:00 AM