IP portfolios: the five biggest headaches for in-house counsel

1) Different patentability standards

In some countries it’s very difficult, if not impossible, to get claims that include ranges of sequence identity, warns Kamrin MacKnight, chief patent counsel at protein engineering company Codexis.

“We’re stuck with claims that cover only a specific sequence. That makes it much easier for competitors to design around our patents, as all they have to do is change one amino acid,” says MacKnight.

She adds that, in the US, narrow restriction requirements are also problematic, as the company needs to elect specific sequences and usually amino acid (or nucleotide) positions.

“At least we can usually use claims with a decent sequence identity range, but we often have to file many divisionals and/or continuations, in order to get enough protection,” MacKnight concludes.

It’s no surprise to anyone in the patent space, that patentability differs across the major jurisdictions.

In 2013, the US Supreme Court struck a devastating blow to biotech company Myriad—in its Association for Molecular Pathology v Myriad Genetics ruling, the court concluded that isolated human DNA is not patent-eligible under section 101. Protecting diagnostic methods and tools in the US is also problematic, following 2012’s Mayo v Prometheus.

"We often have to file many divisionals and/or continuations, in order to get enough protection." - Kamrin MacKnight, Codexis

It’s a different situation in Europe, where this prohibition doesn’t exist, explains Thomas Malone, IP corporate counsel at industrial biotech company DuPont Industrial Biosciences.

He adds that Asia “tends to be much more restrictive” than Europe or the US in terms of claim breadth allowed.

“This has to be taken into account to some extent in drafting patent applications,” says Malone.

2) Pruning the portfolio

Despite portfolios sometimes ranging into the hundreds or thousands of patents, IP counsel have to keep a close eye on the value of each right.

Pruning the portfolio can be a very difficult task, says MacKnight, particularly because topics seem to come in and out of favour or interest.

“If we abandon a case now, we run the risk that the subject matter will be ‘important’ two, three, four, five or more years down the road,” she adds.

“Biotech companies may have many commercial products, but these change over time,” Malone says.

“It is necessary to go back to applications filed many years ago and reassess their value,” he adds.

Malone warns that it’s not always a simple exercise. People move in and out of the company and the process is further complicated when mergers and acquisitions take place.

“It is not always easy to determine the commercial value of acquired IP,” he concludes.

3) Doing the work of private practice

For MacKnight, the reluctance of non-US associate firms to provide claim amendments and arguments that would help get cases allowed in their country is frustrating. Instead, the firms ask Codexis to provide amendments and arguments.

“I’m registered only in the US and I don’t know the best ways to get patents granted in other countries (except to some extent in the European Patent Office). I need to rely on them to provide the amendments and arguments that will place the cases in a condition for allowance in their country,” she says.

"Other questions to ask: 'does the country in question have a functioning parent system?' and 'what are the costs/annuities?'." - Thomas Malone, DuPont Industrial Biosciences

While MacKnight is more than happy to share what has happened in the US and other countries, she wants her associate firms to step up and be more proactive.

She adds: “I’m finding this to be less of a problem as time goes on and the firms are more accustomed to working with us. But it is time-consuming and a bit annoying to have to do their work for them.”

4) Fighting for your rights on a budget

“Monitoring newly-filed patent applications and issued patents is very time consuming and expensive,” says Malone.

He explains that deciding which patents to oppose, or to ask the US Patent and Trademark Office (USPTO) to institute an inter partes review (IPR) or post-grant review (PGR) for, is very challenging, requiring business and research and development input.

According to the DuPont counsel, the high cost of IPRs and PGRs in the US versus European oppositions is a “self-explanatory” challenge.

At the USPTO, the cost of an IPR request for up to 20 claims comes to $15,500, but the average overall cost reaches between $300,000 and $600,000. Before the European Patent Office, applicants pay €785 ($870) to oppose a patent.

Costs of litigation before the US courts can soar much higher than an IPR, a challenge that inhouse counsel must be aware of.

5) When, and where, to file?

Last, but certainly not least, is the question of where to file your patents, and when.

For Malone, deciding where to file the company’s biotech inventions is a process during which the costs and benefits of filing in various jurisdictions must be weighed up.

Do you file in every country in which the product will be commercialised, or do you file only in countries where manufacturing is likely?

“Other questions to ask are: ‘does the country in question have a functioning patent system?’ and ‘what are the costs/annuities?’,” says Malone.

“As all jurisdictions now operate a first-to-file system, there is a priority to file applications early and get a stake in the ground,” he explains.

“However, early applications do not always have enough data to show enablement/written description. When is there enough data?” he concludes.