BIO preview: a meeting of minds

This year’s annual Biotechnology Industry Organization (BIO) International Convention couldn’t start at a better time.

Mere weeks after a rash of big decisions from the US Supreme Court, there will be plenty to discuss at the conference’s IP sessions—not just the ruling on Roslin, which found that mammals made using the cloning method that produced Dolly the sheep are not patentable, but also Nautilus and Limelight which, while concerning tech patents, could also have an impact on the life sciences industry.

More than 15,000 industry professionals are expected to attend the conference, which this year sets up at the heart of the US’s second life sciences cluster, at San Diego’s Convention Center from June 23 to 26.

At noon on Tuesday June 24, the first official day of sessions, Sir Richard Branson will talk to BIO president and chief executive Jim Greenwood about the importance of business collaboration and investing for the future. He will also recall the launch of his Virgin brands, including Virgin Galactic, which is due to create the world’s first ‘space tourists’ by the end of this year.

Former US secretary of state Hillary Rodham Clinton, who headed a task force on healthcare reform during the administration of her husband Bill Clinton and has campaigned for wider access to emergency contraception, has been confirmed to speak at the Wednesday Keynote Luncheon on the following day, also at noon.

IP sessions

Francis Gurry, director general of the World Intellectual Property Organization, will kick off two days of IP-dedicated sessions on Tuesday afternoon, where he will share his views on how the organisation’s activities have an impact on biotechnology.

At 3pm, the heads of the Mexican and Chilean IP offices, Miguel Ángel Margáin and Maximiliano Santa Cruz, will discuss how to protect biotechnology patents in the US and Latin America with former deputy administrator for policy and external affairs at the US Patent and Trademark Office (USPTO), Jasemine Chambers.

They will bring their perspectives on patent filing trends, the challenges associated with patent examination, the patent eligibility of subject matter and recent legislative developments in their respective jurisdictions.

A session at 4:15pm titled ‘Show Me the Data!’ will focus on the admissibility of evidence of post-filing evidence in patent applications in the US, EU, Canadian and Chinese patent offices.

Moderator Ed Haug, managing partner at Frommer Lawrence & Haug LLP, will be joined by Arvie Anderson, assistant general patent counsel at Eli Lilly, Wen Cao, patent attorney at NTD Intellectual Property Attorneys in Shanghai, Ute Kilger, a partner at Boehmert & Boehmert in Munich, and Patrick Kierans, senior partner at Norton Rose Fulbright in Toronto, who spoke to LSIPR about the session.

What are the arguments for and against allowing post-filing evidence?

The international conventions give us the four conditions of patentability: an invention is patentable if it (i) is novel (Article 54 EPC), (ii) involves an inventive step (Article 56 EPC), (iii) is capable of industrial application (Article 57 EPC), and (iv) is not excluded by Article 52(2) and (3) EPC. However, different jurisdictions have taken varying approaches to what an invention is precisely and when it comes about.

For example, in the US, they say it’s an invention when you’ve reduced it to some practical form of expression. So the date of invention is the day you wrote it in your lab book, not necessarily the day you filed for the patent.

On the other hand, Canada would say that the date of invention is the day you proved it worked.

That’s an example of how there’s a fundamental divergence in practice.

With regards to post-filing evidence, different offices handle it differently. In the US, the old law and the America Invents Act (AIA) provide opportunities to file evidence in the USPTO in support of patentability and against the patent by third parties before and after it has been issued.

In Canada, the patentee is not allowed to rely on any post-filing evidence. In Canada the view is that you have an invention only if you’ve demonstrated it. If you haven’t demonstrated it or disclosed data which soundly predict it, then the patent application may be found invalid. The patent office won’t allow you to supplement the application with post-filing evidence.

That is a big difference between Canada and the US—frankly, it’s a big difference between Canada and the rest of the world.

Are there any efforts to harmonise the rules around the world on whether post-filing evidence is admissible?

There have been efforts over the years to harmonise beyond the four conditions of patentability on a deeper level.

There was a patent harmonisation treaty which was being discussed in the 1980s and 1990s, but it just faded away. It was too complicated: there were so many little divergences and, probably, in many other countries, very little political will to make significant changes.

What kind of evidence is admissible after the patent filing? Is it disputed?

It depends what the evidence is for. From a Canadian perspective, if you want to file evidence from clinical trials to support your patent that provides a cure for cancer, you wouldn’t be allowed.  Your patent would be invalid, so it’s a mess.

However, if I were to see a patent application that had been filed by somebody else, and I didn’t think it was new, and I knew of a piece of prior art that shows that invention had been disclosed some time ago, I would be allowed to file that evidence to protest against the patent application.

In that case the patent applicant for the protested application can respond and he may be able to amend his application to get round the prior art.

In Canada, post-filing data confirming the invention works cannot be added to the patent or relied upon to support its validity—that’s the real problem.

Patents and the AIA

On Wednesday morning, lead administrative patent judge of the Patent Trial and Appeal Board Michael Tierney will speak at a session about patent challenges faced by the industry following the implementation of the America Invents Act (AIA).

Fully implemented last March, the AIA switched the US patent system from a ‘first to invent’ to a ‘first inventor to file’ system, eliminating the need for interference proceedings.

Tierney will consider the potential impact of the changes brought by the act, with a look at Fresenius USA v Baxter International.

The AIA discussion continues after lunch in an interactive debate on whether patent litigation reform is needed in the US.

Richard Gervase, a member at Mintz, Levin, Cohn, Ferris, Glovsky and Popeo PC, will oversee the session, in which Brian Barrett, senior director—assistant general patent counsel for Eli Lilly and Company, and Ira Finkelstein, senior patent counsel at Baxter Healthcare Corporation, will speak.

Then, at 3pm, there will be a look at the practical implications of the Supreme Court’s Prometheus and Myriad decisions, including how they are informing the way the USPTO examines and reviews biotechnology patents, in a session titled ‘Patent Eligibility from the Trenches’.

LSIPR caught up with Matthew McFarlane, principal at Robins, Kaplan, Miller & Ciresi LLP in New York, who is due to speak at the session.

What kinds of challenges are innovators in the biotech sector facing in terms of patenting their inventions?

For innovators in biotechnology, governing laws in the US have evolved in the past decade or so to place more pressure on patentees. A significant challenge emerges from the transition to a first to file system, where early disclosure of an invention (or potential invention) is key to obtaining a patent monopoly.

In other fields, such as consumer electronics, it’s more or less clear to an innovator at the time a patent application is filed what the final product or process is (or will be) that warrants the most protection to create future value. For example, my engineers have developed a phone having features X, Y, and Z, and we want to sell that phone and prevent our competitors from doing the same.

Because of the long and uncertain development time that characterises biotechnology-based inventions, the same clarity is not always present. The best or most practical aspect of an innovative biotechnology invention may take years to discover. Providing an adequate written description of the full invention—a statutory requirement—becomes a challenge if that full scope is not appreciated at the time the application is filed.

The scope of patent-eligible subject matter has been narrowed in the Prometheus and Myriad decisions from 2012 and 2013.  As a result of those decisions, the USPTO and courts are still determining the validity of methods involving relationships between pharmaceutical treatment, naturally-occurring gene and  protein sequences, physiological measurements and the risk of contracting disease—approaches vital to advancing personalised medicine.

Two decisions of the US Supreme Court on June 2 also strengthen the defences available to an accused infringer. In Limelight Networks, Inc v Akamai Technologies, Inc, the court required that liability for inducement of infringement of a method claim requires proof of direct infringement—meaning actions attributed to a single entity. This makes proving infringement of complex multi-step processes more difficult. In Nautilus, Inc v Biosig Instruments, Inc, the court struck down the Federal Circuit’s test for indefinite claims, which are likely to make it easier to prove that a claim term is invalid.

Finally, changes in case law over the past several years have limited the availability of remedies for patent infringement in ways that some would argue have decreased the overall value of a patent monopoly. In particular, proving damages has become far more complex, costly and uncertain. And after the Supreme Court’s decision in eBay, the availability of an injunction—once considered to be a routine remedy for patent infringement—has been restricted.

Those are just some of the challenges facing innovators given recent changes to the law.

Are there any irregularities in the USPTO’s guidelines on applying the principles of the Prometheus and Myriad decisions in patent examination?

The observation I can share—from the point of view of a patent litigator reviewing a relatively small number of patent applications now under examination—is that the guidelines have begun to normalise rejections (or, in other words, whether a particular claim will be rejected based on its structure or scope).

In their current form, there are some inconsistencies, and the examiner’s task requires application of a slightly cumbersome, multi-step analysis. But the end result will be a more consistent application of the law as interpreted by the guidelines.

How will the recent decision on Dolly the sheep have an impact on future cases concerned with patenting naturally derived products?

The Roslin case is an interesting one, not because of its reach, but because it illuminates a fundamental issue with the Supreme Court’s recent jurisprudence about patent-eligible subject matter. How is it possible that inventors cannot patent a remarkable new product resulting from years of novel research and the development of new and useful tools for that purpose?

Certainly for parties interested in patenting natural products, or defendants accused of infringing such patents, the existence of fundamental and measurable differences between naturally-occurring and naturally-derived products will be paramount. Time and further litigation will continue to refine those differences that confer patent eligibility from those that do not.

A patent on trial

Day 2 of the sessions will be rounded off with a mock trial at 4:15pm, in which three examiners from the European Patent Office (EPO) will conduct realistic opposition proceedings and, with some participation from the audience, decide the fate of a contested patent.

Donald Zuhn, a partner at McDonnell Boehnen Hulbert & Berghoff LLP in Chicago, will oversee proceedings, while Reuben Jacob, partner at RGC Jenkins & Co in London, Aylsa Williams, partner at D Young & Co LLP in Southampton, UK, and Siobhán Yeats, director of biotechnology at the EPO, will be involved in the debate.

This is just a snapshot of what is happening at BIO this year. With a variety of forums on big issues including orphan drugs and digital health, as well as ‘Super Sessions’, in which leaders in biotech will forecast the state of the industry in 2015, it promises to be an informative and stimulating four days.

LSIPR will be there too—if you spot us, do come and say hello. See you on June 23.