In the Synergy series, I will be looking at collaborations between IP strategy and other facets that feed into the overall plans, goals and operations of a start-up company. Where does IP fit into the puzzle with these other pieces and how can they work together?
Today’s blog is looking at the interaction between the development of a strong and broad IP portfolio in conjunction with a technical plan for scientific research and data to expand the landscape beyond initial lead identification.
Let’s start with an example – you have synthesized a lead chemical structure that has some activity, in our example, let’s say it is an antibiotic. You are pretty sure that the structure is novel and preliminary tests have shown activity against a handful of bacterial strains and pathogens. How would you go about protecting this compound, its activity spectrum, and variations a competitor could make? How can you protect a decent swath of the landscape?
Can you describe your invention with sufficient breadth?
Patents have written description and enablement requirements. This means that you need to explain within your application how to make and use the compound. For protection of more than just the single structure you have made, you generally need to show representatives of other species, in structure and how to make them. This may demand that you envision variations on the structure and perform additional synthesis for representative structures. Also, for claims related to their activity, you will want to test them. In our example, this would include testing their efficacy on a variety of bacterial strains. You may want to see how they perform against strain mixtures and/or combinations of your compound and other antibiotics that might generate a synergistic effect.
As a small start-up, you may not have the synthetic and microbial testing capabilities to perform all of these assays. So, what are the options? If you have been working with a university, you might perform the work with a university collaborator or in your former lab. However, this scenario may bring along some baggage – namely, shared IP rights, royalty obligations, and loss of control in steering the IP strategy in shaping and filing new patent applications. Another option to consider is working with a contract research organization.
Using a Contract Research Organization to Expand the Reach of Your Patent Protection
A contract research organization (CRO) can provide a well-outfitted laboratory with experienced scientists to perform activities such as chemical synthesis, purification, analysis and activity testing. While this route requires an outlay of cash, it can offer vast advantages. Typically, CROs do not retain any IP rights to the structures, methods and reports or data. In this manner, the start-up retains full rights of the expanded discoveries, which can be attractive for potential investors. The CRO offers key technical expertise and tools that can expand the breadth and depth of the discoveries, often more so than the start-up could do on its own. Additionally, the CRO performs work at the direction of the start-up, so the technical strategy and accompanying patent strategy can be driven by the company (rather than an academic project at a university for comparison).
To investigate this further, I met with Dr. Ron Najafi, the President and CEO of a CRO called Emery Pharma. Ron is a longtime entrepreneur and trained scientist. Before starting Emery Pharma, he founded NovaBay Pharmaceuticals, and was CEO from 2000 to 2015. In late 2007, he took NovaBay public.
With his extensive knowledge and connections in the biotech start-up world, Ron goes by the mantra MTDD when it comes to critical elements of a start-up from an investor perspective: This translates as “Market – Technology-Team -Deal,” four elements that effectively comprise the business plan of a typical start-up. Ron and his team of scientists at Emery Pharma are working with companies to support the Technology prong, by helping start-ups expand the breadth of their discoveries.
Emery has a chemistry lab outfitted for both synthesis and characterization, with NMR and LC-MS/MS analytical capabilities. Emery also offers both a collection of standard methods and development of proprietary methods for sampling of biological materials (blood, serum, urine etc.) as well as analysis of formulated products. The CRO will also perform small batch formulation, impurity analysis and characterization and stability testing.
On the biology side, Emery Pharma has assays in place for antimicrobial susceptibility and sensitivity. Assays also include a checkerboard method to look at combination effects, biofilms testing, and time-kill evaluation. The company also offers assistance with preclinical assays such as cytotoxicity, irritation tests, hemocompatibility and acute systemic toxicity.
And here’s the synergy
In the discussion with Ron Najafi, we realized that we both work on portfolio expansion from different angles that are truly complementary. So, we explored the idea that IP strategy and a CRO, like Emery Pharma, could work in a collaborative manner to provide a start-up with an integrated plan to achieve a strong and broad IP position.
Take the starting gate question: Can I (and should I) patent this? Not all discoveries, even if novel, are patentable. For instance, natural products, on their own, are not patentable in the US. What are the options? Trade secret is one; patenting aspects around the natural product such as methods, formulations, mixtures and variations is another approach.
What is the breadth available for a patent claim? This will depend on what is already out there in the public knowledge, research literature and what others have patented. It will also depend on what you can describe and enable from a patentability standpoint.
A key feature for protecting a broad class of compounds is making and testing a representative number of species. Working from both the IP angle and the technical scientific angle, can create a synergistic strategy.
- Starting first with what is the available landscape for IP protection?
- Where are competitors focused and what have they already covered?
- Where are the opportunities?
Next, layering on the technical strategy:
- What is feasible to synthesize?
- Which structures will make good representative species for characterization and activity testing?
- What are the key structure-function relationships?
- Are there new assays that could be developed? And are these most valuable as trade secrets or protected by a patent?
Before you invest in expanding a particular lead or choosing between leads for which is the most fruitful to pursue, you will also want to know if there is a clear path forward.
Do you have freedom-to-operate (FTO)? In other words, are you working in open space or does some other entity already have this space locked up with patents? And even if some of the landscape is taken, are there some gaps you can use to your advantage? Are the patents covering the landscape strong?
Getting a read on FTO early can help target your limited resources. In this manner, you can broaden the landscape around the most fruitful areas for example, with synthesis and testing of additional compounds, proteins and strains.
In this scenario, the IP and the technical analyses sync together. You now have a plan that can be set in motion that includes the scope of patent applications to be filed, a timeline for generating the technical data to support the patent claims on structure and activity, and you may even have identified proprietary assay development that can be kept as trade secret or patented to give you a further competitive edge.
So, going forward as you move from initial lead generation, think about using your resources in a synergistic manner. Make your R&D and your IP strategy work together to get you to a place of strong and broad protection.
Emery Pharma is a full-service contract research laboratory located in Alameda, CA. The laboratory is FDA registered, DEA licensed and cGMP-GLP compliant. EP specializes in microbiology, cell biology, medicinal chemistry, and bioanalytical services. For more information about Emery Pharma please visit www.emerypharma.com.
Laboratory photographs are provided courtesy of Emery Pharma.
 IngensityTM IP and Emery Pharma are independent businesses, with no agency for profit between them
The content of this blog is for informational purposes only and does not offer legal advice. Circumstances are fact-specific and you should consult an attorney for legal advice concerning your individual issues.