Academy

Welcome to the Academy. Here you will find real-world and practical lessons and advice for startups, career development and ecosystem development.

THE ACADEMY—where you can find useful lessons and reference articles that focus on real-world experience and practical application. Business development and entrepreneurial educational content is often vague or written from the point of view of an outsider speaking in generalizations referenced from other specialties. Unfortunately the hurdles faced by health company founders are drastically different from the difficulties faced by retail or digital consumer product stakeholders and the lessons are not particularly transferable.

To provide grounded and practical advice, our articles are written in partnership with regional experts that have successfully navigated the challenges we cover—that are important to you. Each section (organized here and referenced as a collection within a Series) covers a specific topic relevant to healthcare startups with real-world applications and tips from hard-earned experience. The material is then organized into content chapters—which includes the core articles, supporting reference materials and brief case studies as examples of companies that succeeded or failed in each area of interest.

"Let's go learn something new today" quote

SERIES | Founding a Healthcare Startup: Practical and Usable Advice from Successful Experts.

Startup founders come from diverse backgrounds and possess diverse sets of skills—but only rarely have all of the skills they actually need for success. We work with a number of subject matter experts who have launched their own successful businesses to provide practical guidance for health care entrepreneurs.

#INVESTMENT STRATEGIES | #STARTUPS | #PATENTS

Introduction: Elements of Success for Startups

Having a good idea and a driven team are necessary requirements for a successful startup, but far from sufficient.
Success in a competitive environment often hinges on mastering the fundamentals. Make sure you practice your “blocking and tackling.”

Chapter 1: Intellectual Property & Patents

For innovation-based startups, like healthcare, a firm’s intellectual property is its primary asset. Once a company has been founded and before anything else they must establish, define and prepare to defend that asset.

#INTELLECTUALPROPERTY | #STARTUPS | #PATENTS

Intellectual Property & Patents Part 1: Elements of a Robust Patent

Essential elements of a robust patent strategy can safeguard proprietary innovations and drive long-term value.
The most important thing to remember here is that paperwork is your friend. Do NOT skimp on defining your innovation and establishing a clear freedom to operate with patent protection.

Strategic IP management for startups (chess board)

#BIOTECH | #STARTUPS | #PATENTS | #IPSTRATEGIES

Intellectual Property & Patents Part 2: Navigating a Safe Passage

Intellectual Property (IP) is the most valuable asset of information-age companies. Defining and protecting the value of that asset can be as important as creating it.
IP is your most important asset. The investment in time, resources and expertise required for effective IP management should be viewed not as a burden but as an essential component of business strategy.

#RESOURCES

Don’t Panic: Helpful Tips on Filling Out Patent Forms

Patent applications can seem daunting, but getting it right is key to protecting your biotech innovations.
Crafting the specification section and claims requires clarity and detail, ensuring your invention is both understandable and legally sound.

Resources + Supporting Materials

Get ahead of the curve with our curated resources and supporting materials—the secret sauce every life sciences entrepreneur and startup needs (because insider info. tastes better with a side of strategy).

Case Studies

In the 2021 case of Juno Therapeutics, Inc. v. Kite Pharma, Inc., the Federal Circuit invalidated Juno’s patent on chimeric antigen receptor (CAR) T-cell therapy due to insufficient written description:

[Case Study Link: Biotechnology & the Patent Quid Pro Quo: When Is “This” Enough For “That”?]

In the case of Endo Pharmaceuticals Inc. v. Actavis Inc. (2014), Endo held patents on Opana ER, an extended-release formulation of oxymorphone.

[Case Study Link: Patent Eligibility Determinations in Life Sciences Patent Cases]

In the case of The Broad Institute, Inc. v. The Regents of the University of California the dispute centered on the CRISPR-Cas9 gene-editing technology, with both parties claiming priority.

[Case Study Link: Recent Appellate Decision Overturns Revocations of Broad Institute CRISPR-Cas9 Patents]

University of California v. Genentech (1999): The University of California (UC) developed a method for producing human growth hormone and published their findings before filing a patent application.

[Case Study Link: Genentech agreed afterwards to a settlement of $200 million to resolve the dispute.]

Amgen Inc. sued Chugai Pharmaceutical Co. in 1991 in a landmark case for patent law which highlighted how prior publications can serve as prior art potentially invalidating later patents if they lack novelty or are deemed obvious.

[Case Study Link: Amgen, Inc. v. Chugai Pharmaceutical Co. LTD.]

Table—Progressive Stages of Patent Filing: Timeline, Efforts and Costs

The patenting process is a multi-stage journey that involves strategic decision-making, considerable effort, and financial investment. The table below outlines the key stages from the initial filing to the final patent issuance, focusing on the United States Patent and Trademark Office (USPTO) procedures. It can take years and cost hundreds of thousands of dollars.

Chapter 2: Licensing Agreements

Intellectual Property (IP) is a startup’s first and most important asset. Your IP partner is, by definition, your first and most important business relationship. Whether licensing third-party research products or advancing proprietary research in partnership with a large institution, transparent and direct rules of engagement will limit damaging future conflicts and add investor value.

Life sciences: Licensing Agreement part 1—signing forms

#INTELLECTUALPROPERTY | #STARTUPS | #LICENSINGAGREEMENTS | #LIFESCIENCES

Licensing Agreements 1

Introduction: Managing your first partnership is a critical step.
Negotiating an IP licensing agreement with a partner institution is one of the earliest legal responsibilities of healthcare startup founders. If executed poorly, your company could be living with that mistake permanently.

#LIFESCIENCES | #STARTUPS | #INTELLECTUALPROPERTY| #ENTREPRENEURS

Licensing Agreements 2

A guide for startup entrepreneurs in life sciences
Negotiating licensing agreements with hosting academic centers is a complex and crucial process. We provide some examples of the key aspects to address in these agreements.