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Fundamentally, having a patent granted in a specific region enables you to enforce your exclusive right to practice the patent claims. The decision on where to patent should therefore be driven by your development and commercialization strategy. Where will your product be manufactured and sold? Where will clinical studies be conducted? Where are your competitors and potential partners active? For biologics and cell &amp; gene therapies in particular, high-priority regions for patent protection are the US (and often Canada), Europe &amp; the UK, China, Japan, and Korea. Additional regions can include Australia, India, Hong Kong, Taiwan, Singapore, and Israel, as well as Mexico, Brazil, and other emerging markets for advanced therapeutics.Patent costs stack up as you extend your patent applications into more regions. It’s important to consider the short-term and long-term costs of filing, prosecution, grant, and maintenance/renewal fees over the lifetime of the patent. Realistic projections of costs and timing, with consideration of regional differences, are critical. For example, maintenance fees are due during patent prosecution in Canada and Europe, whereas these fees are only due after patent grant in other regions, such as the US, Japan, and China.&nbsp;Representative costs for one patent family in the US, Canada, Europe (5MM), China, Japan, and Korea are shown below. Lifetime costs are estimated at $385k USD, with upfront costs of $100k in the first 3 years. Validation fees represent a substantial one-time cost for Europe, as the initial patent application filed at the European patent office (EPO) must be validated under the unitary patent system and/or in individual territories.&nbsp;In the life science space, differences in patent practice between regions must also be considered, as these will impact the type of claims that may be granted and may affect the value of the patent and the time and cost of getting to grant.&nbsp;<h4>In summary: early, proactive alignment of your patent filing strategy with commercial and clinical development is essential to manage costs and file where you need to be.</h4>

Start-up IP Series #3: Global Patent Protection

Put off by the title? “Innovation Culture” can be just a buzzword, offhandedly used to exaggerate a company’s commitment to growth and development. In practice, however, building relationships and emphasizing the value of IP across the organization will strengthen your IP position and ensure opportunities to protect platform and program advances are realized.&nbsp;The following practices can help to foster an effective innovation culture:<h4>Identify IP champions</h4>Support scientists with enthusiasm for invention by including them in IP discussions, even beyond preparing a new filing. They bring a depth of technical understanding, project history, and new ideas and directions to strengthen patent drafts and support robust responses during patent examination. The outcome is higher-quality patents that are well-aligned with ongoing project developments.Integration of the internal or external IP team with business development (BD) is critical for effective communication of portfolio value to investors and partners. Competitor landscaping complements patent searching and diligence, and sharing resources or combining projects can be an efficient way to manage patentability and FTO activities. Further, IP support and collaboration with BD is essential for identifying and evaluating external IP.<h4>Provide recognition</h4>Patent prosecution is a lengthy process for biotechnologies, and initial contributions can be forgotten in the later examination stages. Clear identification and recognition of all contributions, inventive or otherwise, not only provides defining lines for inventorship but also keeps scientific team members engaged in the process and encouraged to continue to innovate. Consider including contributions to new IP as part of employee recognition programs, or providing separate innovation awards. This can further be supported by providing a forum for submitting and discussing new ideas outside of existing projects, and considering IP potential when launching new projects.&nbsp;<h4>Conduct ongoing evaluation</h4>An IP portfolio should effectively protect your R&amp;D strategy, and this requires leadership to be enabled to manage IP assets on an ongoing basis. A clear and well-run invention disclosure process ensures capture of new IP and tracking of ideas and projects. In parallel, periodic review and, if necessary, culling of the overall portfolio frees up resources and time to focus on high-value IP. Evaluating the fit of pending patents with ongoing projects can also reveal opportunities to strengthen existing IP or expand into new filings.&nbsp;<h4>Overall, a focus on intra-company collaboration and alignment of your IP portfolio with an evolving company strategy provides a strong foundation for a meaningful “innovation culture”.&nbsp;</h4>For further support on developing IP best practices and building a strong IP portfolio, reach out to <a target="_blank" rel="noopener noreferrer nofollow" href="mailto:consulting@ied-ip.com">consulting@ied-ip.com</a>.

Start-up IP Series #2: Innovation Culture

Chanelle Case Borden, Ph.D., a postdoctoral fellow in the National Cancer Institute's Experimental Immunology Branch, pipetting DNA samples into a tube for polymerase chain reaction, or PCR, a laboratory technique used to make multiple copies of a segment of DNA.

I specialize in intellectual property services tailored for startups, investors, and early-stage companies. A foundational IP strategy is critical to establishing a competitive position and protecting R&amp;D advances. Leveraging scientific expertise in cell &amp; gene therapies and experience in company creation, I work with you to build your global IP portfolio. Navigate IP diligence and focus on driving innovation with confidence.

Vaccine. Hands of a scientist, under a sterile hood, preparing the carcinoembryonic antigen (CEA) vaccinia used to try to prevent cancer. The scientist is diluting the concentrated vaccinnia virus into a dose level appropriate for administration to a patient. This vaccinnia marks any cancer cells expressing the CEA.

Empowering Biotech Innovation with IP

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Irja is a Canadian patent agent passionate about supporting biotech innovation.They pair deep subject matter expertise in life sciences, including cell &amp; gene therapies and biomaterials, with experience in corporate IP strategy, global patent drafting and prosecution, and early-stage commercialization.Registered Class 1 Patent Agent, College of Patent and Trademark Agents (CPATA)PhD (Chemical &amp; Biomedical Engineering), University of TorontoBSc (Engineering Chemistry), Queen's University

Irja Elliott Donaghue, PhD

Support in drafting and negotiating IP licensing and collaboration agreements tailored to biotech and gene therapy sectors.

Licensing and Collaboration Agreements

Analyze and optimize your patent portfolio to maximize value and align with your business goals in biotechnology and regenerative medicine.

KanderKultur Frutigen Patent Ochsner Konzert

Patent Portfolio Optimization

Evaluate competitors’ IP assets to identify opportunities and threats, helping you stay ahead in the biotech market.

Competitive Analysis identifies and evaluates the business strategies of your competitors, resulting in the analysis of strengths, weaknesses, opportunities and threats (SWOT) for your product relative to the competitors’ in a business ecosystem. Further analysis may provide an insight to your product strategy.

The analysis is often conducted in the early stages of product development. As the dynamics of products in the ecosystem change rapidly, many companies have embraced agile competitive analysis as a part of their product strategy.


Competitive IP Landscape Analysis

Development of a comprehensive IP strategy to protect and enhance your corporate and R&amp;D strategy, including:<ul><li>IP asset identification &amp; evaluation</li><li>Global patent considerations for biotech</li><li>Opportunities for new IP</li><li>Trade secret protections</li></ul>

IP Strategy

IP valuation and assessment of IP risk for current portfolio and new opportunities, including:<ul><li>Portfolio assessment</li><li>Patent and competitor landscaping</li><li>Freedom-to-operate analysis</li><li>Preparation for investor diligence</li><li>External IP evaluation &amp; external innovation support</li></ul>

IP Diligence

One-time or ongoing support to build a strong, cost-efficient patent portfolio to protect R&amp;D breakthroughs, including:<ul><li>Prior art searching</li><li>Drafting of patent applications and prosecution responses</li><li>Strategic global portfolio management</li><li>Budget projections</li></ul>

Patent Portfolio

Tailored Services for Founders, R&D Teams, & Venture Capital

IP assessment is a key part of due diligence by an investor or partner. How can you efficiently prepare before opening the dataroom? What ongoing practices will set up a smooth diligence process?&nbsp;<h4>Prepare the essentials</h4><ul><li>Accurate, clear reporting can avoid undervaluing of IP assets and reduce diligence timelines and expenses.</li><li>Keep a concise, updated summary schedule of registered IP: patents, trademarks, and/or copyrights.&nbsp;</li><li>For deeper diligence, a detailed IP schedule may include patent claims, examination status, and upcoming costs and deadlines, as well as copies of published and granted patents. </li></ul><h4>Communicate portfolio value</h4><ul><li>Prepare to speak to both the subject matter claimed in each piece of IP and its alignment with the company's value proposition.</li><li>Revisit the IP portfolio strategy frequently to maintain focus on key programs and technologies.</li></ul><h4>Provide certainty on ownership</h4><ul><li>Create, enforce, and document company policies on IP ownership and protection.</li><li>Clearly identify in-licensed vs. solely-owned or jointly-owned assets.</li><li>Ensure all assignments from inventors to the company are in place and recorded at applicable patent offices, in addition to assignment provisions in employment contracts.</li><li>Maintain clearly-labeled records of assignments and license agreements to include in dataroom materials at a later diligence stage.</li></ul><h4>Address IP risks</h4><ul><li>Prepare with patent counsel for discussions on freedom-to-operate and mitigation of IP risks through development, commercialization, and launch.</li><li>Document previous searches: maintenance of a record of search strings and tracked competitors/technologies can provide a good starting point.</li></ul><h4>Don’t overlook trade secrets</h4><ul><li>Failing to document and communicate trade secrets could leave a substantial portion of your IP out of an assessment.</li><li>Trade secret and invention disclosure management may mitigate loss of internal knowledge or capabilities following a transaction and provides a clear record of the starting date and originator for any discoveries or projects that could become collaborative.</li><li>Maintain trade secret records to identify protection measures taken and track internal and external access.</li><li>Be prepared to discuss (not disclose!) critical trade secrets and know-how, and their strategic value.&nbsp;</li></ul><h4>In summary: periodic review of your IP portfolio and maintenance of key documents ensures you are ready to quickly dive into diligence and take advantage of any opportunity for partnership.</h4>Reach out today for further guidance and support on preparation for IP due diligence.

Packing 1. Similar to using Booleans to add or subtract space from an object, this HoudiniFX procedures is creating spheres, which then get packed into the confines of another sphere, and meld into the existing materials.