27 October 2015Americas

Animal patents: Blurring the lines

Animal testing is one of the most contentious issues of modern times. On the one hand, the suffering of animals is not worth the speculative attempts to find a cure for diseases. On the other, if such testing can bring about cures for life-threatening diseases, then the pain is worth it.

Biotechnology companies have sought patents covering transgenic animals at agencies including the US Patent and Trademark Office (USPTO) and the European Patent Office (EPO). But such applications—sometimes directed to improved ways of conducting medical research—usually invite challenges from non-profit groups that are ideologically opposed to the patenting of transgenic animals.

It is primarily the job of offices such as the EPO to grant patents based on their legality, but a provision within the European Patent Convention (EPC) blurs the line between morality and legality. Under article 53(a) of the EPC, the EPO cannot grant patents for inventions which would be contrary to ‘ordre public’, or morality. Such a provision places the burden of deciding not only patent eligibility but morality on to EPO examiners.

In July, the EPO revoked a patent covering genetically modified (GM) mice and rats that was applied for by Altor Bioscience. Thirteen organisations ranging from biotech companies such as Regeneron Pharmaceuticals to activist groups including GeneWatch UK and the Jane Goodall Institute opposed the patent on the grounds it lacked an inventive step. The opposition was filed in 2013 when the patent claims also covered chimpanzees and goats. Despite Altor’s amending the claims during the opposition proceedings, the EPO ruled that the patent lacked an inventive step.

While the EPO’s opposition division dealt with the legality of the patent, it is clear that activist groups such as GeneWatch UK and No Patents on Seeds are motivated by concerns that go beyond intellectual property protection. Both organisations have officially declared their opposition to the practice of granting patents for GM animals. In a statement on the No Patents on Seeds website, both groups argue that granting such patents “undermines the provisions in European law” that exclude “essentially biological processes” from being patented.

The examiner’s role

Adrian Tombling, partner at law firm Withers & Rogers, says there is a case to get rid of the ordre public provision. He argues it drags examiners away from their role of assessing the legality of patents to considering public order. Because some patents can attract opposition from activist groups, the EPO’s job of determining the legality of the application becomes much harder, he says.

Tombling is not aware of any attempts to remove the ordre public provision, but he does say that many within the IP community share his view.

“A growing number of people within the profession believe it is unfair to ask patent examiners to make a decision on whether an invention meets the morality requirement,” he says.

He says the morality of GM animal-related inventions is a matter for national courts to decide.

“I believe that people with moral concerns are not concerned about the granting of the patent, but instead about the working of the invention.

“The moral issue is therefore whether the invention can be worked or whether, because of morality issues, it should not be worked. This question should be decided on a national level by the courts that already decided what activities are morally acceptable,” he adds.

"The outcry over the death of Cecil the lion in July is symptomatic of how the welfare of animals is a mainstream issue across the world."

Tombling says that examiners show an “inherent nervousness” when reviewing patents covering transgenic animals. Examiners request an “incredible” amount of data from applicants in order to demonstrate their patentability, he explains. This is not restricted to transgenic animals: applicants for patents covering plant varieties are also subject to the same scrutiny from examiners, he adds. Because of such a “high bar”, many companies are forced to unnecessarily “restrict the breadth” of their applications.

The humanzee

Activists in the US have also used the tactic of opposing patents covering transgenic animals.

Stewart Newman, founder of the Council for Responsible Genetics, took a different approach, however. In 1997, rather than opposing an application, Newman applied for a patent covering the creation of a ‘humanzee’—a hypothetical creature that is part-human, part-chimpanzee—at the USPTO. In applying for the patent, Newman actually aimed to have it rejected.

The USPTO rejected the patent in 2005 on the grounds the applied-for creation was too close to being a human. Newman said rejection was his goal because he aimed ultimately to create a legal precedent that clarified inventions directed to humans are ineligible. On the other hand, if Newman was successful he would have also declared victory, he argued, because if he obtained market exclusivity then he would have deterred other biotechs
from conducting research with chimeras.

Jennifer Toffenetti, partner at law firm McDermott Will & Emery, says the issue of patents related to chimeras has been “put to bed” and there is a clear understanding in US patent law that they cannot be patented.

In 1980, the US Supreme Court issued a ruling in Diamond v Chakrabarty clarifying that artificially engineered organisms can be patented. The court was split 5–4 on the question, but Warren Burger, writing the majority opinion, said scientist Ananda Mohan Chakrabarty’s invention of a genetically engineered bacterium that was able to break down crude oil was “a product of human ingenuity” and worthy of patent protection.

For more than three decades, the question surrounding patents for artificially engineered organisms has been clear. But the speed at which the biotech industry operates means that new advances are constantly challenging laws and court rulings in this area.

The tale of Dolly

In 1996, Dolly the Sheep became probably the most famous sheep in the world after scientists from the Roslin Institute in Edinburgh produced the first cloned animal.

The Roslin Institute, which had obtained a European patent in 1999, suffered a backlash three years later. Greenpeace opposed the patent on the basis that it could be interpreted as covering human cloning. Article 53(a) of the EPC includes a specific provision precluding “processes for cloning human beings” from patentability.

Fast-forward to 2013 and the Patent Trial and Appeal Board (PTAB) in the US had its say on the ‘product-by-process’ claims submitted by the institute. It had filed a patent application covering cloned animals that were the product of a cloning process, for which the institute already had a patent.

A year later the PTAB and the US Court of Appeals for the Federal Circuit both rejected the institute’s application. Citing the Supreme Court’s decision in Association of Molecular Pathology v Myriad Genetics, the federal circuit declared that the application covered a “natural phenomenon” and therefore was not eligible for a patent.

Judge Timothy Dyk, writing the opinion, said: “Here, as in Myriad, the institute did not create or alter any of the genetic information of its claimed clones, nor did [the institute] create or alter the genetic structure of [the] DNA used to make its clones.”

Toffenetti says the federal circuit’s decision was not surprising.

“The court argued that Dolly was no different from any other sheep ... her DNA wasn’t altered. She was a natural normal sheep and there was no genetic change.”

She adds that biotechs in the US face similar obstacles to their European counterparts in obtaining patents for transgenic animals. Mounting opposition can affect whether such patents are granted as, despite ethics not playing a role in the patenting of transgenic animals, Toffenetti says, “the USPTO doesn’t operate in a vacuum”.

However, while the data requirements for all biotech applicants are incredibly high, Toffenetti says she is not familiar with any evidence of ethical concerns by patent examiners “seeping into questions of patentability”.

Animal rights groups in the US have developed a much louder voice and a larger audience over the years, she adds. The outcry over the death of Cecil the lion in July is symptomatic of how the welfare of animals is a mainstream issue across the world.

Biotechs argue that animal testing is a necessary means to an end: curing diseases. And while regulations are in place in both the US and Europe, and many other countries, to ensure the suffering of animals is minimal, there are still many who want to see the practice eliminated.

The rapid development of the biotech industry suggests new, unforeseen questions may arise concerning experimentation with animals and the associated patentability. What role offices such as the EPO and USPTO will play in this continued development remains to be seen.

Tombling’s call to remove the ordre public provision is an appealing suggestion and may be key to keeping the EPO out of moral debates. But as there is no sign that this clause will be removed, separating legal and ethical issues is going to remain a challenge for European examiners.

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