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Harvard Case - Gene Patents (A)

"Gene Patents (A)" Harvard business case study is written by Richard G. Hamermesh, David Kiron, Phillip Andrews. It deals with the challenges in the field of Entrepreneurship. The case study is 26 page(s) long and it was first published on : Jun 7, 2011

At Fern Fort University, we recommend that Myriad Genetics pursue a strategic shift towards a more collaborative and open business model by focusing on licensing its gene patents to other companies while simultaneously investing in research and development of new diagnostic and therapeutic products based on its extensive genetic knowledge. This approach will allow Myriad to leverage its existing intellectual property while expanding its market reach and mitigating the risks associated with the ongoing legal challenges to its gene patents.

2. Background

This case study focuses on Myriad Genetics, a company that holds patents on the BRCA1 and BRCA2 genes, which are linked to an increased risk of breast and ovarian cancer. Myriad?s business model was built around providing exclusive access to these genes through its diagnostic testing services, generating significant revenue but also attracting criticism for its pricing and perceived monopolistic practices. The case study unfolds during a period of increasing legal challenges to gene patents, raising questions about the future of Myriad?s business and its approach to innovation.

The main protagonists of the case are:

  • Mark Skolnick: Founder and CEO of Myriad Genetics, a visionary entrepreneur who spearheaded the company?s success in gene testing.
  • Peter Meldrum: Chief Operating Officer of Myriad Genetics, responsible for the company?s operational efficiency and commercialization strategies.
  • The US Patent and Trademark Office (USPTO): The governing body responsible for granting and upholding patents, facing increasing scrutiny regarding its decisions on gene patents.
  • The Association for Molecular Pathology (AMP): A professional organization representing medical professionals who challenged Myriad?s gene patents in court, arguing that they hindered research and innovation.

3. Analysis of the Case Study

This case study presents a complex situation where Myriad Genetics faces significant challenges to its core business model. We can analyze the situation using a framework that considers the following aspects:

  • Legal and Ethical Considerations: The legal challenges to gene patents raise fundamental questions about the ownership of genetic information and its impact on scientific research and healthcare access. Myriad?s exclusive control over the BRCA1 and BRCA2 genes has been criticized for hindering innovation and driving up costs.
  • Competitive Landscape: The gene testing market is evolving rapidly, with new players entering the scene and offering alternative testing methods. Myriad faces competition from companies like 23andMe, which offers broader genetic testing services at lower prices, and from academic institutions that are developing their own diagnostic tools.
  • Business Model Innovation: Myriad?s current business model, based on exclusive control over patented genes, is unsustainable in the long term due to legal challenges and increasing competition. The company needs to adopt a more flexible and collaborative approach to leverage its intellectual property and remain competitive.
  • Strategic Options: Myriad has several options available, including:
    • Defending its patents aggressively: This approach carries significant legal and financial risks, and may further alienate potential partners and customers.
    • Settling with the challengers: This option could lead to a more open market for gene testing but would require Myriad to relinquish some control over its intellectual property.
    • Shifting to a licensing model: This approach allows Myriad to generate revenue from its patents while enabling other companies to develop and commercialize their own diagnostic and therapeutic products.
    • Investing in research and development: This strategy allows Myriad to remain at the forefront of genetic research and develop new products and services that are not subject to patent challenges.

4. Recommendations

Myriad Genetics should pursue a strategic shift towards a more collaborative and open business model by:

  1. Licensing its gene patents to other companies: This will allow Myriad to generate revenue from its intellectual property while fostering innovation in the gene testing market. By licensing its patents, Myriad can encourage other companies to develop new diagnostic and therapeutic products based on its genetic knowledge, expanding the market and creating a more competitive landscape.
  2. Investing in research and development of new diagnostic and therapeutic products: This will allow Myriad to remain at the forefront of genetic research and develop new products and services that are not subject to patent challenges. This strategy will require significant investment in research, but it will also allow Myriad to diversify its revenue streams and create new growth opportunities.
  3. Adopting a more collaborative approach to research and development: This will involve partnering with academic institutions, other companies, and non-profit organizations to accelerate innovation and develop new genetic technologies. Myriad can leverage its expertise and resources to collaborate with other players in the field, creating a more open and collaborative ecosystem for genetic research.

5. Basis of Recommendations

These recommendations are based on the following considerations:

  • Core competencies and consistency with mission: Myriad?s core competency lies in its expertise in genetic research and diagnostics. Licensing its patents and investing in R&D allows the company to leverage its strengths while remaining consistent with its mission of improving human health.
  • External customers and internal clients: This approach benefits both external customers (patients seeking genetic testing) and internal clients (researchers and healthcare professionals) by promoting innovation and access to genetic information.
  • Competitors: This strategy allows Myriad to compete effectively with other companies by fostering a more collaborative and open market, while also creating new opportunities for growth and differentiation.
  • Attractiveness ? quantitative measures: While quantifying the financial impact of this strategy requires further analysis, the potential benefits include:
    • Increased revenue from licensing fees: This will generate significant revenue from its existing intellectual property.
    • Expanded market reach: This will allow Myriad to reach a wider audience by leveraging the capabilities of other companies.
    • Reduced legal risks: This will mitigate the risks associated with ongoing legal challenges to its gene patents.
    • Enhanced reputation: This will improve Myriad?s public image by demonstrating a commitment to collaboration and innovation.

6. Conclusion

By embracing a more collaborative and open business model, Myriad Genetics can navigate the challenges of the evolving gene testing market and secure its future. This approach allows the company to leverage its existing intellectual property while fostering innovation and expanding its market reach. This strategy will require a significant shift in Myriad?s organizational culture and leadership, but it is ultimately the best path forward for the company to remain competitive and continue to contribute to the advancement of genetic research and healthcare.

7. Discussion

Other alternatives not selected include:

  • Defending its patents aggressively: This approach carries significant legal and financial risks and could further alienate potential partners and customers.
  • Settling with the challengers: This option could lead to a more open market for gene testing but would require Myriad to relinquish some control over its intellectual property.

The risks associated with the recommended strategy include:

  • Loss of control over its intellectual property: Licensing its patents could lead to a loss of control over how its technology is used by other companies.
  • Competition from other companies: Other companies may develop new diagnostic and therapeutic products that are more advanced or cost-effective than Myriad?s products.
  • Failure to attract licensees: Myriad may not be able to find companies willing to license its patents, leading to a loss of revenue.

The key assumptions underlying the recommendation include:

  • The legal challenges to gene patents will continue: This assumption is based on the ongoing legal battles and the increasing scrutiny of gene patents.
  • Other companies will be interested in licensing Myriad?s patents: This assumption is based on the potential benefits of using Myriad?s technology and the growing demand for gene testing services.
  • Myriad can successfully invest in research and development: This assumption is based on Myriad?s existing expertise in genetic research and its ability to attract funding for new projects.

8. Next Steps

To implement this strategy, Myriad Genetics should take the following steps:

  • Establish a licensing program: This will involve defining the terms and conditions for licensing its patents, including royalty rates and technology transfer agreements.
  • Identify potential licensees: This will require outreach to companies that are developing or commercializing genetic testing services.
  • Invest in research and development: This will involve allocating resources to develop new diagnostic and therapeutic products based on its genetic knowledge.
  • Build partnerships with other companies and institutions: This will involve collaborating with academic institutions, research organizations, and other companies to accelerate innovation and develop new technologies.
  • Communicate its new strategy to stakeholders: This will involve informing investors, customers, and employees about the company?s shift towards a more collaborative and open business model.

By taking these steps, Myriad Genetics can position itself for long-term success in the evolving gene testing market. This strategy will require a significant shift in the company?s culture and leadership, but it is ultimately the best path forward for Myriad to remain competitive and continue to contribute to the advancement of genetic research and healthcare.

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Case Description

In March 2010, U.S. District Court Judge Robert Sweet overturned 30 years of legal precedent and ruled that unaltered human genes could not be patented. This case reviews patent law and how it relates to our increasing knowledge of the Human Genome. The case issues deal with the potential implications of Judge Sweet's decision for biotechnology entrepreneurs and investors.

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