1. Stem Cell Patents: An Introduction
2. Global Stem Cell Patent Landscape
3. Stem Cell Patent Challenges at the USPTO and Before the AIA
4. Stem Cell Patent Challenges After the AIA

Stem Cell Patents: An Introduction

Stem cell patents are a controversial protection for the developers of medical processes and procedures related to stem cells. This type of undifferentiated human cell has the potential to treat a range of conditions and diseases. However, patent lawyers, religious groups, and even some scientists are against the idea of assigning ownership to a fundamental human building block.

Despite this controversy, stem cell patents are rarely legally challenged, although this may change after the implementation of new administrative procedures of the United States Patent and Trademark Office (USPTO). The USPTO may begin to hear new types of challenges to stem cell patents and pending patents under the 2012 Leahy-Smith America Invents Act (AIA). Under the Act, challenges may be filed by anyone, regardless of that individual's legal interest in the patent. This is likely to result in more common and aggressive stem cell patent challenges.

Global Stem Cell Patent Landscape

Approximately 10,681 patent applications and granted patents related to stem cells were filed between 1985 and 2005 with the USPTO, the European Patent Office, and the World Intellectual Property Organization (WIPO). Stem-cell-related patent filings by nation are as follows:

  • United States: 21%
  • WIPO: 19%
  • European Patent Office: 14%
  • Australia: 12%
  • Canada: 7%
  • Japan: 7%
  • Germany: 3%
  • China: 2%
  • United Kingdom: 2%
  • Israel: 1%
  • Other (53 additional countries): 12%

Stem Cell Patent Challenges at the USPTO and Before the AIA

As mentioned above, new challenges to stem cell-related patents may arise under the AIA. Patent challenges usually play out in one of two ways. The first is a challenge of the validity of the patent through the federal court system. This takes place when the patent holder has already sued or threatened to sue an accused infringer, creating a substantial controversy that meets the criteria to be heard in federal court. Patents can also be challenged through the USPTO. Before the AIA was passed, certain parties could ask that the USPTO reconsider already-granted patents. The first procedure of this kind — inter partes reexamination — was introduced in 1999 and allowed anyone to contest a patent at any time if new scientific or technical evidence have rendered it invalid. However, the challenge criteria is limited to that specific evidence. The patent holder can respond by changing the claims of its patent to delay or prevent further action. In more than 75 percent of cases, this type of challenge occurs when the involved parties are already in federal court regarding a dispute of that patent. Inter partes reexamination can take an average of three years.

Because of these limits, stem cell patents were rarely challenged before the AIA was passed, although several prominent scientists joined forces with the Foundation for Taxpayer and Consumer Rights to challenge the pioneering embryonic stem cell patents for research by James Thomson of the University of Wisconsin. These patents were aggressively licensed and enforced by the Wisconsin Alumni Research Foundation. Because challenges through the USPTO are slow-moving, in most cases the technology in question would be rendered obsolete by advances in the field before the matter was settled. 

Stem Cell Patent Challenges After the AIA

The passage of the AIA has changed these procedures dramatically. While the federal procedure for challenges remains the same, the AIA has revamped their review system from the slow amendment and response procedure previously used to a trial-style process that expedites the challenge review. More than one party, including those with no legal interest in the patent in question, can join the challenge with permission of the USPTO. Although the filing fee for a patent challenge starts at $27,500, the attorney fees for this process will be about a tenth of the fees for a patent challenge in federal court. USPTO review is now easier to initiate and takes less than 15 months. Since the process has changed, more than 70 percent of patent claims initiated have been invalidated.

In another new aspect of the USPTO procedure known as preissuance submissions, anyone can challenge patent applications that are currently under review. The individual or corporation doing so can submit published literature that can be used to challenge the patent's validity. Fees for this process are just a few hundred dollars.

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