Tech IP counsel wary of overreaching Amgen v Sanofi ruling

Tech IP counsel wary of overreaching Amgen v Sanofi ruling

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In-house tech sources say Amgen v Sanofi has the potential to stifle their prosecution and litigation strategies if SCOTUS’s decision is too broad

  • Insight from Pure Storage, Appian, Atlassian and a tech company

  • Analysis of what a key life sciences court case could mean for tech

  • Discussion on what case could mean for software prosecution and litigation strategy


Tech companies fear that the US Supreme Court’s decision in Amgen v Sanofi could complicate their patent prosecution and litigation strategies.

The US Supreme Court will hear oral arguments in this dispute on March 27. It agreed to take on the case after the Court of Appeals for the Federal Circuit ruled in 2021 that two of biotech firm Amgen’s antibody patents were invalid for a lack of enablement under Section 112 in Title 35 of the US Code.

Amgen has now asked the high court to consider whether patentees must enable those skilled in the art to reach the full scope of claimed embodiments, which are versions of the invention, without undue experimentation.

This case has obviously received attention from life sciences stakeholders, who are divided over what the standard for enablement should be. But in-house counsel in the tech industry say the decision could affect them too.

They say a ruling against Amgen could make it more difficult for companies to be granted sufficiently broad software patents, though much would depend on what the court says in its analysis.

Elizabeth Morris, legal director of intellectual property and product at tech company Pure Storage in California, says software patents can have a lot of variations because there are many different ways to code the same invention.

It could therefore be concerning if SCOTUS determines that applicants must reach the full scope of the claimed embodiments without undue experimentation, or if it finds that claims with too many variations can lack enablement.

“If SCOTUS says a claim leaves too many variations, what is too many?” she questions. “If too many means millions, that’s probably fine. But if it defines too many as closer to hundreds, that could be a problem for the software space. The devil is in the detail.”

Morris says she’d like to see the impact of the ruling limited to the life sciences sector.

“If the decision is broader, I’m concerned about what this could mean for software,” she notes.

Prosecution problems

If the court makes it more difficult for companies to comply with Section 112 requirements, practitioners might have to approach patent prosecution differently, say sources.

Gaurav Asthana, director of IP at software business Atlassian in San Francisco, says his company would probably need to significantly flesh out its specifications.

“It would make it more challenging because you would have to describe in detail how to make and use every embodiment without undue experimentation,” he says.

Regardless of how the court comes down, sources say getting clarity will help their prosecution efforts.

Christopher Geyer, deputy general counsel at cloud computing business Appian in Virginia, says he will pay attention to the decision and adjust his strategy, if necessary.

But he notes that if the threshold for complying with Section 112 is excessively high, innovators will have less incentive to invent because it would be harder to protect their inventions or enforce their rights.

Other way around

Adjusting strategies could be a good practice either way because a decision in Amgen’s favour could create other complications, especially for companies that don’t want their competitors to obtain broad patents.

Daniel Zeilberger, of counsel at Paul Hastings in Washington DC, says Section 112 issues could affect software patents when an innovation potentially applies to two types of data with very different properties.

Companies, for example, could strive to develop a particular algorithm that could be applied to multimedia data, including audio and video, he says.

One open question is whether the first person to come up with such an algorithm – but in a way that only works for one class of data – should be allowed to obtain claims that cover all classes of data.

He declines to comment on whether that would be good or bad. But he says that if Amgen v Sanofi is decided in Amgen’s favour, this situation could arise.

Some sources worry that if the court rules too broadly in Amgen’s favour, it could stifle competition.

Morris at Pure Storage says patent owners that obtain broad claims can encourage investment because they can protect their inventions and move forward to innovate further in their respective fields.

She adds, however, that broad claims could discourage competitors from investing in those areas for fear of infringement. That could benefit whoever’s first to market too much, she says.

“I don’t want SCOTUS to weed Section 112 out completely. If they go too far in either direction, it’s going to be a problem.”

An Amgen victory could also make it more difficult for companies to challenge patents.

Zeilberger says there’s a risk that patentees could disclose less prior art because they wouldn’t need to put forth as much.

Then it would not only be harder to challenge patents for lack of enablement under Section 112, but also more difficult for other businesses to find prior art to invalidate patents, he says.

Not a concern

Although they have concerns about Amgen v Sanofi, tech companies aren’t particularly worried about Section 112 overall.

Morris at Pure Storage says Section 112 concerns surface from time to time. But it’s not something that comes up often. She says she hopes the patent system remains focused on whether technology is new or non-obvious.

“We just have to keep the rest of the stuff in check,” she says.

Asthana at Atlassian agrees that he doesn’t encounter too many Section 112 issues.

“It’s nothing like Section 101 where it has been confusing how to interpret or apply the law post Alice [v CLS Bank],” he notes.

Some sources say there could be benefits if Section 112 requirements were even stricter than they are right now.

The senior IP counsel at a tech company says it could be helpful to require patentees to be more specific about what they’re trying to claim in their initial patents. That could create more certainty down the road about what they did and didn’t know about their inventions at the time they filed, the source adds.

Still, on the whole, it seems this doctrine hasn’t been much of a bugbear for tech firms either way. They’ll just have to hope that SCOTUS keeps it that way.

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