Biotechnology law has evolved from a niche specialty into one of the most complex and debated areas of intellectual property, and Dr. Jorge Goldstein has been at the center of that journey. A founding partner of Stern, Kessler, Goldstein & Fox, Jorge has spent more than four decades helping define the legal boundaries of the life sciences while working alongside scientists, startups, and global institutions at the very front edge of discovery. His career path, shaped by mentors who saw the future in biology and patents, offers a rare window into how law and science grew together during the biotechnology revolution.

His new book, Patenting Life: Tales from the Front Lines of Intellectual Property and the New Biology, captures that history through the people, cases, and controversies that shaped modern biotech. From the Chakrabarty decision that opened the door for patenting living inventions, to the Wands case that created the well-known enablement factors, Jorge brings to life the courtroom battles and policy debates that continue to influence how research becomes innovation. He also shares behind-the-scenes stories from his own practice, including the Myriad Genetics dispute over gene patents and the still-unfolding CRISPR battles that pit leading universities and scientists against each other.

We also talk about artificial intelligence as the next great test for intellectual property law. With AI already designing new drugs and synthetic proteins, it raises the question of inventorship as more pressing than ever. The law still recognizes only human inventors. Change will have to come from Congress, and future generations of lawyers will be tasked with rewriting the rules for a world where human and machine creativity overlap. This conversation connects a past, present, and future that underscores how much the definition of “invention” shapes the pace of discovery.

In This Episode:

[01:21 ] Jorge describes how he came from Argentina to study chemistry at RPI, pursued a PhD at Harvard, and was encouraged by mentor Frank Westheimer to study biology.

[02:15 ] Auditing James Watson’s molecular biology course opened his eyes to the future of genetics during the early days of recombinant DNA research.

[03:45 ] He recalls being unaware of groundbreaking advances like monoclonal antibodies while focused on his thesis work.

[04:48 ] Jorge explains why lab research didn’t suit him, realizing his temperament wasn’t suited for years of trial and error and delayed gratification.

[06:32 ] A Harvard Law student introduced him to patent law, and he quickly saw its potential in the emerging field of biotechnology.

[07:20 ] The Chakrabarty Supreme Court decision allowing patents on living organisms solidified his decision to enter biotech IP law.

[08:21 ] Jorge recounts co-founding Stern Kessler Goldstein & Fox with Robert Stern, combining expertise in biology and electronics for a future-focused law firm.

[10:15 ] Early interactions with young biotech companies like Genentech, Amgen, and Genetics Institute showed the demand for lawyers fluent in science.

[11:48 ] He credits Marvin Guthrie of Massachusetts General Hospital with mentoring him on IP strategy and diplomacy in academic-industry partnerships.

[13:31 ] Jorge explains how Guthrie, a founder of AUTM, gave him access to top scientists and Nobel Prize winners, shaping his approach to tech transfer.

[14:51 ] He introduces his book Patenting Life and explains his motivation to document the history of biotech commercialization through human stories.

[17:02 ] A writers’ circle helped him shed legal and scientific jargon, making the book approachable for a broader audience.

[18:22 ] Jorge revisits the Myriad Genetics case over gene patents, explaining why eligibility battles over isolated DNA became so significant.

[21:15 ] He describes the shock when a district court ruled that isolated genes were not patentable, contrary to decades of biotech practice.

[23:48 ] The Federal Circuit reversed that ruling, with Judge Lourie emphasizing covalent bonds, before the Supreme Court ultimately sided against gene patents.

[27:10 ] Jorge reflects on how the Supreme Court’s unanimous decision in Myriad reshaped eligibility standards under Section 101.

[30:45 ] He notes how subsequent cases, including Prometheus and Alice, further unsettled patent law in diagnostics and other industries.

[32:05 ] Jorge turns to In re Wands, explaining how it tested enablement of broad antibody claims and became a landmark case.

[35:10 ] He recalls oral arguments before the Federal Circuit, including Judge Pauline Newman pressing the Patent Office on the impossibility of requiring unlimited deposits.

[39:32 ] The resulting decision established the eight “Wands factors,” which remain central to enablement analysis today.

[41:42 ] Jorge highlights how Wands has been cited thousands of times and even survived scrutiny in the recent Amgen v. Sanofi case.

[44:15 ] He shares a personal story about Jack Wands, who the case was named after and dedicating a chapter of his book to him before his passing in 2023.

[46:01 ] The conversation shifts to the CRISPR patent battle between UC Berkeley/Vienna and the Broad Institute, one of the most high-profile disputes in biotech law.

[49:25 ] Jorge explains the interference process under the former first-to-invent system and why it made the CRISPR case especially complex.

[52:10 ] Statements from Jennifer Doudna expressing scientific uncertainty were used against her in the legal proceedings.

[54:40 ] He outlines how these admissions shaped arguments around conception versus reduction to practice.

[57:16 ] Jorge recalls the year-long wait for the Federal Circuit’s ruling, which ultimately found that doubts expressed by inventors should not determine conception.

[58:38 ] The appeals court sent the case back to the Patent Office with instructions to apply the correct legal test, leaving the battle unresolved.

[1:00:08 ] He turns to emerging concerns about artificial intelligence in biotech innovation, from drug repurposing to protein design.

[1:01:15 ] Jorge notes that current law does not recognize AI as an inventor, creating challenges for patenting AI-driven discoveries.

[1:02:29 ] He argues that Congress should update patent law to allow AI to be recognized as a co-inventor, since control of patent rights is ultimately what matters.

[1:03:15 ] Jorge closes by urging the next generation of lawyers to focus on AI’s impact on inventorship and the need for law to adapt to new models of innovation.

Resources: 

Jorge A. Goldstein

Jorge A. Goldstein - LinkedIn

Jorge A. Goldstein, Ph.D. - Sterne, Kessler, Goldstein & Fox

Patenting Life: Tales from the Front Lines of Intellectual Property and the New Biology