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Beyond the impact that innovation may create for the world, there are real financial consequences that may result from a lack of specialized expertise.
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Here are a few real case scenarios related to patent infringement and inventors' inability to patent their innovations in their fields.
These examples illustrate the significant financial, legal, and strategic consequences that companies can face due to patent infringement or the inability to secure patents for their innovations in chemical engineering and drug delivery.
PCSK9 Inhibitors
Amgen vs. Sanofi and Regeneron
CRISPR/Cas9 Technology
University of California vs. Broad Institute
Sofosbuvir Patent Dispute
Merck vs. Gilead Sciences
Protonix Patent Infringement
Pfizer vs. Teva Pharmaceuticals
In 2014, Amgen filed a lawsuit against Sanofi and Regeneron, accusing them of infringing on patents related to PCSK9 inhibitor drugs, which are used to lower LDL cholesterol.
Amgen argued that their patents covered the methods used to develop these drugs.
In 2019, the Federal Circuit upheld a lower court's ruling that invalidated Amgen's patents for lack of written description and enablement, meaning Amgen could not sufficiently describe how to make and use the invention.
This decision resulted in a significant financial loss for Amgen, as it allowed competitors to market similar drugs without licensing agreements.
In the highly publicized patent battle over CRISPR/Cas9 gene-editing technology, the University of California (UC) and the Broad Institute of MIT and Harvard both claimed rights to the foundational patents.
The dispute centered around whether UC's earlier patent filings covered the use of CRISPR/Cas9 in eukaryotic cells, which the Broad Institute later patented.
In 2017, the U.S. Patent Trial and Appeal Board ruled in favor of the Broad Institute, stating that their patents did not interfere with UC's earlier filings.
This decision meant that UC could not claim exclusive rights over the technology, potentially costing them billions in licensing fees and royalties.
In 2013, Merck filed a lawsuit against Gilead Sciences, claiming that Gilead's hepatitis C drug, Sovaldi (sofosbuvir), infringed on Merck's patents.
In 2016, a jury initially awarded Merck $2.54 billion in damages, one of the largest patent infringement verdicts in history.
However, in 2018, a federal judge overturned the verdict, citing that a former Merck scientist had lied under oath and engaged in unethical conduct during the patent process.
This reversal was a significant financial and reputational loss for Merck.
In 2004, Pfizer sued Teva Pharmaceuticals for infringing on its patent for the acid reflux medication Protonix (pantoprazole).
Teva launched a generic version of Protonix before Pfizer's patent expired, leading to a protracted legal battle.
In 2013, Teva agreed to pay Pfizer $1.6 billion to settle the patent infringement lawsuit.
This case highlights the potential financial impact on companies when their patents are not upheld or are challenged by generic competitors.
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