Unified Patent Court Defines ‘Inventive Step’ Standard in Landmark Appeal Rulings
Recent decisions from the Unified Patent Court (UPC) Court of Appeal are establishing crucial precedents for assessing inventive step, a key determinant in patent validity. These rulings, involving high-profile disputes between pharmaceutical giants Amgen and Sanofi, alongside cases involving Edwards Lifesciences, are providing much-needed clarity for patent holders and challengers alike. The implications extend across various industries, impacting the landscape of intellectual property protection in Europe.
Understanding the ‘Inventive Step’ Requirement
The ‘inventive step’ – often referred to as non-obviousness – is a fundamental requirement for patentability. To be patentable, an invention must not be an obvious modification of existing technology to a person skilled in the art. Determining whether an invention meets this standard has historically been a complex and often subjective process. The UPC, designed to streamline patent litigation across Europe, aims to harmonize this assessment.
<p>The recent appeals focused on refining the methodology for evaluating this step. The court is moving towards a more structured approach, emphasizing the identification of the ‘closest prior art’ – the most relevant existing technology – and then assessing whether the invention, in light of that prior art, would have been obvious to a skilled person. This isn’t simply a matter of combining known elements; the court is looking for a demonstrable reason why a skilled person *would* have made that combination.</p>
<h2>Amgen’s Victories: Cholesterol Treatment and Beyond</h2>
<p>Amgen has secured significant wins in two separate appeals. In the dispute with Sanofi, the UPC Court of Appeal clarified the standard for inventive step, reinforcing the need for a robust analysis of the prior art and a clear demonstration of non-obviousness. <a href="https://news.google.com/rss/articles/CBMihgFBVV95cUxQc3A3X3g4ZGZENEhrQ2Vzb1FzOFNHRlBxSGVGU1RBMS1WOHFGVWh2cFZXWFdLVld6M2g3UURDTjRRZjQ1TGlScXpxbFN1b3VCM1VENl9oUkdWbjd3dmVYOW1iWUNBLU5ybDVHdTdrN3hFMWRnZDlDV0dIc0hodmt0SVNPcnhuUQ?oc=5">Pinsent Masons</a> provides detailed coverage of this ruling.</p>
<p>Separately, Amgen and Edwards Lifesciences prevailed in a case concerning inventive step in medical device technology. <a href="https://news.google.com/rss/articles/CBMiowFBVV95cUxPTXNzY3hNeVpWODZEWG1QZjJpci1sbmc1dGFmY1h0eHAtNHFXVHdIcGhkbjNaVWt6eDN2M0hpQ05qYkx0TFpOUEdGZ3NyUE00RGZzeUJvWmhPNlU3V0dVOU1teHdhZk1icVc2YkRMVmtWOG5uN0Q0SWEzWTFqb243UWJKTUVsT0tqOEh3TWo4dUJNcnNrSVFyWWZoMDlUS1l2cDhv?oc=5">IAM Patent</a> reports on this outcome, highlighting the court’s focus on the specific technical challenges overcome by the invention.</p>
<p>The cholesterol dispute, also resolved in Amgen’s favor, further demonstrates the UPC’s willingness to uphold patent rights when a clear inventive step can be established. <a href="https://news.google.com/rss/articles/CBMipAFBVV95cUxNcWJVcVZSYmRHODByaHdLQVd5cHhwdW82bzJGb1RLTjhBRmY4LVJZRnh0cVU3eTNiRWVoYTBhU2U0NlltZDI5Ty1zQ21WZXhRU3FxcGlSSS1kTWxtN184MnRVME0ydjhXNG9YUmNYTERIMHFCSzdINDRoYW5keVB1Qk5IMVRnYXkwcnQtdV9BMXlRMXUxbFRvV2dfVTI2dVVERTg4TQ?oc=5">Life Sciences Intellectual Property Review</a> details the specifics of this case.</p>
<p>Brinkhof and Bardehle represented Amgen in the Sanofi appeal, while JUVE Patent <a href="https://news.google.com/rss/articles/CBMisAFBVV95cUxOT1JMTGpuZWpyRUc1cm5FNEY5X2ZHTnVSQXhfRzBqQWQtd254eGx3em5zdWtnTzg0Y2ZRMS1lOHpqNFBSSW1JUTZwbUZZc3k3OFZXT1NDVFJkWHVYZU1zTzB0eGJGYXE1ZXRIU3hteENOampaQVdtTXVHaUdKdmQ1djBVTW5TQnZpUVN0Z05oYnBzdDEzREYwN2tXenNvOHJKaWlZOS00eE84M3RpemVCbw?oc=5">reported</a> on their successful strategy.</p>
<p>MLex <a href="https://news.google.com/rss/articles/CBMiygFBVV95cUxQRDB6aEU1cTl6SDBmVEZJdWlsVUEtQUs2NDIwU3d6VlRYZjNzMTlKSWVEdXlmVkZyQjR1OGxSd3RqSXIxM3NsaDFJVm91VDFrRE5wZTY1MG9LaWlyR1ItdV9qUmlyelpJRGd6SEJHc0o1SHBLbUtZcG10SHdUOWdnemp2ZTFDNEx2d0dfQ0s0UVRnUHhwanBVMWlvc282Y0JUdHdzcDBfNG5aVG5ScWNGQjBmdTN4MEdXTzUtTmVOVXpYQXVZaE5xLWlB0gFaQVVfeXFMT1VlMmVXRXhWb0gwYlZZbE5ORGZNcWUzd091ZjA0U3p2OGJMaUNid1FVaHVMWktleVNDRVdGU0FkMlFweDZaVlNpZ0h2VC1jcnBUelZIeG05bEpn?oc=5">clarifies</a> how the UPC is applying the inventive step standard in these complex cases.</p>
<p>What impact will these rulings have on the types of inventions that are pursued for patent protection? And how will companies adjust their patent strategies in light of this evolving legal landscape?</p>Frequently Asked Questions About the UPC and Inventive Step
What is the significance of the UPC’s rulings on ‘inventive step’?
These rulings provide crucial guidance on how the UPC will assess inventive step, a key factor in determining patent validity. They establish precedents that will influence future decisions and impact patent litigation strategy across Europe.
How does the UPC define ‘closest prior art’ when assessing inventive step?
The UPC identifies the ‘closest prior art’ as the most relevant existing technology that a skilled person would consider when developing the invention. This forms the basis for evaluating whether the invention is non-obvious.
What role does the ‘person skilled in the art’ play in the inventive step analysis?
The ‘person skilled in the art’ is a hypothetical individual with average knowledge and skills in the relevant technical field. The UPC assesses whether the invention would have been obvious to this hypothetical person.
How do these UPC decisions affect pharmaceutical patent litigation?
The Amgen-Sanofi case, in particular, has significant implications for pharmaceutical patent litigation, as it clarifies the standard for inventive step in the context of complex drug development.
Will these rulings lead to more or fewer patents being granted by the UPC?
It’s likely that the UPC’s stricter approach to inventive step will result in fewer patents being granted, as the threshold for patentability is now more clearly defined and potentially higher.
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