Double Patenting Research Articles

Extent of Drug Patents With Terminal Disclaimers and Obviousness-Type Double Patenting Rejections

This study evaluates the frequency of terminal disclaimers filed by drug patent holders to obviate obviousness-type double patenting rejections associated with drug patent thickets.

Top Ten Biotechnology Patent Cases of 2023: Antibodies Unenabled, Extrinsic Evidence Excluded, and Double Patenting Prohibited

Top Ten Biotechnology Patent Cases of 2023: Antibodies Unenabled, Extrinsic Evidence Excluded, and Double Patenting Prohibited

Looking at Patent Law: Patenting an Electrochemically Mediated Oxidation Reaction on Electrode Arrays–A Case Study

In this installment of the “Looking at Patent Law” series, we present a case study of the prosecution of U.S. Patent No. 7,507,837 directed towards “Process for Performing an Isolated Pd(II)-Mediated Oxidation Reaction” assigned to CombiMatrix Corporation of Mukilteo, Washington. This case was chosen to coincide with the focus of this issue of Interface on the Organic and Biological Electrochemistry (OBE) division of the Electrochemical Society (ECS). Notably, Prof. Kevin Moeller, a co-inventor on the subject patent, is a member-at-large of OBE. The case study begins with a brief synopsis of the background of the invention followed by 1) a discussion of the parent and child patent applications associated with the invention, 2) inventor assignment and power of attorney designations, 3) summary of office actions, 4) summary of applicant response to non-final rejection, and 5) allowance of the patent application. The case study discusses double patenting and the applicant’s response by filling a terminal disclaimer to traverse the rejection. With this case study, we hope to de-mystify the patent prosecution process and better prepare electrochemical and solid-state scientists, engineers and technologists to interact with their patent counsel regarding their inventions.

Patenting Inventions or Inventing Patents? Strategic Use of Continuations at the USPTO

Continuations allow inventors to claim technology developed after the original filing date of a patent, leading to concerns about inadvertent infringement and hold-up. For researchers seeking to study this practice, a key challenge is the difficulty of linking patent applications to potentially infringing technology. We use the link created by disclosure of standard essential patents (SEPs) to analyze the relationship between standard publication -- a key observable milestone in technology development -- and continuation filing. More than half of the SEPs in our data are filed after standard publication. There is a substantial increase in continuation filings immediately after standard publication, and this increase is larger when the initial patent examiner is more lenient. We also find that claims in SEP continuations are more likely to be rejected for double patenting (indicating an effort to change the scope of previous patents), and that keywords in the claims of SEPs linked to the same standard become more similar after standard publication. Overall, these findings suggest widespread use of continuation procedures to opportunistically

Immunex Corp. v. Sandoz Inc. United States Court of Appeals of the Federal Circuit, 2020 964 F.3d 1049

Immunex Corp. v. Sandoz Inc. United States Court of Appeals of the Federal Circuit, 2020 964 F.3d 1049

Patenting Fast and Slow: Examiner Rejections and Applicant Traversals to Non-Prior Art Rejections

It is no secret that some Patent and Trademark Office (PTO) examiners operate more quickly than others. Previous studies have shown that an applicant’s ability to obtain a patent is inexorably linked to the random assignment of a patent examiner. However, not all patent examiners are created equal. Some patent examiners allow patent applications quickly within just one or two Office Actions resulting in only a few months of substantive patent prosecution. In contrast, other patent examiners constantly reject patents applications, which can result in unnecessarily delaying prosecution and years of substantive patent prosecution. This study focuses on how different examiners use prior art rejections to prolong or compact prosecution. This study demonstrates how two different populations of patent examiners (slow vs. fast) can achieve and even exceed their production goals by either an allowance or rejection strategy. The allowance strategy relies on granting a large number of applications with only a few rejections and usually within one or two office actions. The rejection strategy relies on rejecting a large number of applications using a wide variety of different rejection types. Unlike many studies, this is the first paper that evaluates patent quality based on individual examiner characteristics at the patent prosecution level focused on non-prior art rejections. In particular, high volume biotechnology examiners reject applications based mainly on obviousness type double patenting and indefiniteness rejections, while issuing fewer obviousness or anticipation type rejections. In contrast, low volume examiners reject applications based mainly on obviousness rejections. Furthermore, number of pages in the low volume examiners’ office actions are more than three times more than high volume examiners. Thus, low volume examiners are writing longer office actions and rejecting based on a wide variety of statutory authorities, while high volume examiners are writing shorter office actions based mainly on obviousness type double patenting issues. We find that different types of examiners use different strategies to maximize their “counts” in order to keep their production numbers high. Specifically, low volume examiners will generally reject applications creating lengthy prosecution histories while forcing the applicant to narrow claims. In contrast, high volume examiners will usually only make one rejection then allow the case, thus creating a small prosecution history with only small amendments to the claims. This results in a dramatic range of patent prosecution times as well as a large difference in claim scope. Slow examiners take approximately 5.85 years to issue a patent while fast examiner only take approximately 1.64 years. The added four years of prosecution greatly increases direct costs to the inventor (both in PTO and attorney fees) as well as indirect costs such as reduced growth in employment, sales and follow on innovation. Finally, there may be harms to not only the inventor, but to rivals in the form of diminished access to external capital and slower growth of follow on innovation.

Federal circuit addresses impact of the Uruguay Rounds Agreement Act and patent term extension on obviousness-type double patenting

Federal circuit addresses impact of the Uruguay Rounds Agreement Act and patent term extension on obviousness-type double patenting

Patenting Inventions or Inventing Patents? Strategic Use of Continuations at the USPTO

Continuations allow inventors to claim technology developed after the original filing date of a patent, leading to concerns about inadvertent infringement and hold-up. For researchers seeking to study this practice, a key challenge is the difficulty of linking patent applications to potentially infringing technology. We use the link created by disclosure of standard essential patents (SEPs) to analyze the relationship between standard publication -- a key observable milestone in technology development -- and continuation filing. More than half of the SEPs in our data are filed after standard publication. There is a substantial increase in continuation filings immediately after standard publication, and this increase is larger when the initial patent examiner is more lenient. We also find that claims in SEP continuations are more likely to be rejected for double patenting (indicating an effort to change the scope of previous patents), and that keywords in the claims of SEPs linked to the same standard become more similar after standard publication. Overall, these findings suggest widespread use of continuation procedures to opportunistically

Patenting Inventions or Inventing Patents? Strategic Use of Continuations at The USPTO

Continuations allow inventors to claim technology developed after the original filing date of a patent, leading to concerns about inadvertent infringement and hold-up. For researchers seeking to study this practice, a key challenge is the difficulty of linking patent applications to potentially infringing technology. We use the link created by disclosure of standard essential patents (SEPs) to analyze the relationship between standard publication — a key observable milestone in technology development — and continuation filing. More than half of the SEPs in our data are filed after standard publication. There is a substantial increase in continuation filings immediately after standard publication, and this increase is larger when the initial patent examiner is more lenient. We also find that claims in SEP continuations are more likely to be rejected for double patenting (indicating an effort to change the scope of previous patents), and that keywords in the claims of SEPs linked to the same standard become more similar after standard publication. Overall, these findings suggest widespread use of continuation procedures to opportunistically ”invent patents” that are infringed by already-published standards. Institutional subscribers to the NBER working paper series, and residents of developing countries may download this paper without additional charge at www.nber.org.

Double Patenting: Follow-On Pharmaceutical Patents that Suppress Competition

Prices for pharmaceutical products over the last 10 years have skyrocketed, increasing far more rapidly than the general cost of living. This article argues there should be greater competition for the production of follow-on drugs through the strengthening of the double patenting prohibition: preventing extending exclusive rights beyond the original patent term by dressing up part of that invention as a new one. This prohibition against the same party holding two patents covering the same composition announced by the Supreme Court in the 1800’s has been weakened by lower federal courts to (1) only considering the claims and not the rest of the specification in determining if the same invention is being claimed by the inventor in two patents and (2) only applying the prohibition when the earlier patent did not satisfy the technical meaning of “prior art” within §102 of the Patent Act. The rulings weakening the double patenting doctrine have disregarded that the “invention” of a genus patent is not determined only by the claims, but also by the embodiments disclosed in the specification, and under Supreme Court and Federal Circuit precedent it must be presumed that the party with a genus patent has invented the full scope of the genus. These weakening rulings have also disregarded that the double patenting doctrine arises from §101 of the patent statutes, rather than §§102 and 103, which the Federal Circuit models it double patenting test on, often incorrectly concluding there is no double patenting. §§102 and 103 serve different purposes than §101. This article argues that when the same inventor holds a genus patent for a pharmaceutical product, it should be estopped from obtaining a patent on a species within the scope of the genus, whether or not the genus patent constitutes prior art. Applying this strengthened double patenting doctrine would increase competition for the development of follow-on pharmaceutical products.

The Federal Circuit's Ongoing Expansion of Obviousness-Type Double Patenting Creates Patent Prosecution Pitfalls

The Federal Circuit's Ongoing Expansion of Obviousness-Type Double Patenting Creates Patent Prosecution Pitfalls

Recent Federal Circuit rulings strengthen obviousness-type double patenting defense to assertions of patent infringement in pharmaceutical litigations

Recent Federal Circuit rulings strengthen obviousness-type double patenting defense to assertions of patent infringement in pharmaceutical litigations

Introducing new evidence in patent appeals from USPTO

Introducing new evidence in patent appeals from USPTO

Double patenting and internal priority

Double patenting and internal priority

The strategy of enantiomer patents of drugs

Enantiomer patents (ENPTs), constituents of chiral switches, claim single enantiomers of chiral drugs previously claimed as racemates. In this article, the strategy of ENPTs and recent court decisions and trends in case law worldwide are highlighted. ENPTs are challenged frequently (e.g. anticipation, obviousness, double patenting and insufficient disclosure), even though the novelty of enantiomers is not destroyed by the description of racemates. For establishing inventiveness (nonobviousness), the description in ENPTs should include superior pharmacological and/or pharmaceutical properties of enantiomer vis-á-vis racemate, above the expected 2:1 ratio. ENPTs were 'obvious-to-try' (unless taught away) since the mid-1980s. General concern about evergreening by ENPTs is not justified. ENPTs should be evaluated on a case-by-case basis. ENPT litigations are especially susceptible to settlements.

Double Patenting and Process Patents; Apparently, Oxford, U.K., Is Not in California; When Does the Two-Way Test for Obviousness Apply?; Illumina Sues for Infringement of Analytical Technology Patent; Ruling in Favor of Affymetrix Overturned; Abbott Ordered to Pay $1.67 Billion; BASF Sues Pioneer Hi-Bred for Unlawful Use of Technology; DuPont Countersues Monsanto; Beckman, Orchid, and Sequenom Suit Dropped

Double Patenting and Process Patents; Apparently, Oxford, U.K., Is Not in California; When Does the Two-Way Test for Obviousness Apply?; Illumina Sues for Infringement of Analytical Technology Patent; Ruling in Favor of Affymetrix Overturned; Abbott Ordered to Pay $1.67 Billion; BASF Sues Pioneer Hi-Bred for Unlawful Use of Technology; DuPont Countersues Monsanto; Beckman, Orchid, and Sequenom Suit Dropped

Roche Is Not Infringing Carnegie Mellon Patents Disclosing Method of Producing Enzyme; Amgen Wins Permanent Injunction Blocking Sales of Competing Epo Formulation; Co-op Concedes It Is Violating Monsanto Patents; CAFC Agrees Claims for Declaratory Judgment of Noninfringement Should Have Been Dismissed; Patent on Treatment of ALS with Riluzole Not Anticipated; BLR Archives: Pfizer Loses One Patent for Double Patenting But

Roche Is Not Infringing Carnegie Mellon Patents Disclosing Method of Producing Enzyme; Amgen Wins Permanent Injunction Blocking Sales of Competing Epo Formulation; Co-op Concedes It Is Violating Monsanto Patents; CAFC Agrees Claims for Declaratory Judgment of Noninfringement Should Have Been Dismissed; Patent on Treatment of ALS with Riluzole Not Anticipated; <i>BLR</i> Archives: Pfizer Loses One Patent for Double Patenting But

Will Biotechnology Companies Lose Ability to Restrict Production of Their Self-Replicating Products?; Merck Did Reveal Its Process and Is Not Guilty of Fraud; BLR Archives: AstraZeneca Coverage of Cardiovascular Drug Falls for Double Patenting

Will Biotechnology Companies Lose Ability to Restrict Production of Their Self-Replicating Products?; Merck Did Reveal Its Process and Is Not Guilty of Fraud; BLR Archives: AstraZeneca Coverage of Cardiovascular Drug Falls for Double Patenting

In Re Metoprolol Succinate Patent Litigation: Composition Claims Render Later Product Claims Invalid for Obviousness-Type Double Patenting

In Re Metoprolol Succinate Patent Litigation: Composition Claims Render Later Product Claims Invalid for Obviousness-Type Double Patenting

MedImmune Case Gets More Complicated: Supreme Court Gives Company Right to Sue, But PTO Revokes Cabilly II for Double Patenting; Israeli Firm Does Not Own Patent on Rheumatoid Arthritis Treatment; Lilly Keeps Its Anti-Schizophrenia Drug Patent; A Win for Abbott; More Trouble for ImClone; Infringement of Ethanol-Manufacture Patent Found to Be Willful; Stratagene, Third Wave Settle PCR Suits; Short Stories

MedImmune Case Gets More Complicated: Supreme Court Gives Company Right to Sue, But PTO Revokes Cabilly II for Double Patenting; Israeli Firm Does Not Own Patent on Rheumatoid Arthritis Treatment; Lilly Keeps Its Anti-Schizophrenia Drug Patent; A Win for Abbott; More Trouble for ImClone; Infringement of Ethanol-Manufacture Patent Found to Be Willful; Stratagene, Third Wave Settle PCR Suits; Short Stories