Modern innovation typically occurs one step-improvement at a time. Some clients initially question whether their new application of an existing technology is patentable. Usually, the answer is ‘yes.’ Under U.S. law (and most other jurisdictions), an innovation to an existing technology is patentable so long as at least one claim limitation is novel and non-obvious....… Continue Reading

Pharmaceutical and biotech companies breathed a sigh of relief Monday when the Federal Circuit unanimously ruled in a precedential opinion that the mere sale of manufacturing services to create embodiments of a patented product is not a “commercial sale” of the invention that triggers the on-sale bar of 35 U.S.C. § 102(b) (pre-AIA).[1]  The en banc opinion...… Continue Reading

A large amount of wind, much discussion about the U.S healthcare, and the public getting soaked again – if you were thinking about Washington, DC and the new Congress, you’re 3,000 miles away from the action. This is the week of the annual JP Morgan Healthcare conference in San Francisco, with many thousands of healthcare...… Continue Reading

Following the European Parliament’s vote, the Council has now also agreed to the Brexit with its decision on the conclusion of the withdrawal agreement on behalf of the EU. The EU Parliamentarians sang off the UK members and celebrated that they never have to speak to Nigel Farage again. UK EU civil servants are clearing […]

It has been some time since the MDCG guidance on cybersecurity for medical devices was released (MDCG 2019-16 December 2019), so everybody has probably had the opportunity to get used to the document by now. While the document is by no means ideal or even flawless (congratulations MDCG on a glaring spelling mistake in the […]

I have blogged before about the effects and possibilities of the Corrigendum of December 2019 for class I medical devices. I refer you to that blog for the background to this discussion, which covers the mechanics of timing. The draft corrigendum discussed in that blog was adopted as described.  The new guidance The MDCG has […]

What is this recommendation about? Obviously this recommendation is an attempt of the Commission to manage administative barriers to placing PPE (personal protective equipment) and medical devices on the market that would be needed in the struggle to get the current Covid-19 pandemic under control. In my view you can also see this as a […]

It’s always a risk to put out a theory about legislative oversight after a Sherlock Homes investigation that eliminates all other options as I did in my last blog about the MDR amendment proposal. Recent development seem to confirm that I was right in assuming that not touching the two dates of application of 26 […]

When it rains guidance, it pours. The MDCG just released Guidance on temporary extraordinary measures related to medical devices Notified Body audits during COVID-19 quarantine orders and travel restrictions. The guidance takes immediate effect and is valid for the whole period of duration of the pandemic COVID-19 as declared by the World Health Organisation. It […]

If the worst thing that happens to me during this global pandemic is that I have to buy new pants, I will weep with gratitude.

Here is where masks are currently required, as well as proposals that would dramatically increase face-covering requirements.

Andy Serkis, who plays Gollum in the "Lord of the Rings" films, announced that he will livestream a reading of J.R.R. Tolkien's "The Hobbit" on Friday.

The L.A. Pride parade, which would have marked its 50th year, joins the list of events canceled or postponed because of the coronavirus outbreak.

Newsom said earlier this week that bookstores, florists and others can reopen for curbside pickup Friday, unless barred by tougher local restrictions.

The coronavirus outbreak has forced the cancellation of myriad life events. Santa Clara County won't even let you celebrate in your car now.

As the economy has cratered, mortgage lenders tightened standards for people who are still interested in buying or refinancing a home.

The U.N. triples its fundraising target for fighting the coronavirus, even as President Trump plans to freeze U.S. aid to its principal health agency.

The good news: The state is far better prepared to meet this challenge than it was a decade ago. The bad news: It will need help from the feds, and a lot of it.

San Francisco will allow certain businesses to reopen beginning May 18 as it eases its stay-at-home orders. But officials warn that they will keep track to make coronavirus infections don't spike.

Film critic Justin Chang hosted a live discussion of 'The Avengers,' the first film Times readers chose in the Ultimate Summer Movie Showdown series.

Souplantation's owner says there was no way the restaurants' longtime self-serve model could survive in the era of COVID-19

Analysts say steep jump in unemployment and layoffs caused by the pandemic will be hard to reverse quickly.

The idea that old people are worth something because they contribute significantly to society puts us on a slippery slope.

Nursing facilities account for a large percentage of COVID-19 deaths. Better protection and testing can change that.

Republicans, once confident of keeping their Senate majority in the fall election, now fear Democrats have a fresh advantage as the coronavirus crisis has reshaped campaigns.

The daft showdown over coronavirus masks wouldn't matter if we didn't live in the political tinderbox that is Trump's America.

Trump admits that he's putting Americans at grave risk by encouraging economices to reopen. He should protect us with testing.

Building a wardrobe of fashionable face masks doesn't make me insensitive to the grave consequences of coronavirus.

As nations across the globe try to fight a pandemic, many also stop to mark the close of another conflict: the end of World War II in Europe.

Reopening California begins -- but very slowly, cautiously and under the shadow of a second wave.

With no coronavirus vaccine in sight, employers and building landlords are turning to tech, design and distancing to keep office workers healthy.

The drug helped some coronavirus patients recover faster. But it's hardly everything we'd wished for.

Loyola swimming star Riley Griffis quickly read the reality of life outside the pool: 'The time away has shown it's something I need to function."

It was one of last year's hot tickets: Gustavo Dudamel, Esa-Pekka Salonen and Zubin Mehta, on the same stage at the same time. How to see it for free.

The Ramirezes never thought the coronavirus would get them. They took every precaution, but the virus still found its way into their home. Over the course of days, each member of the 10-person household became infected. Three were hospitalized. And one, the family patriarch, died.

Even as Mayor Eric Garcetti has extended testing to everyone in L.A. County, doing the same for homeless people has proved to be far more challenging.

Parts of California, including Los Angeles County, are allowing some businesses to offer curbside service Friday.

If you factor in a potential undercount of furloughed workers, nearly 1 in 5 working Americans may be in line for unemployment benefits.

The coronavirus outbreak makes finding jobs more difficult for everyone. College seniors face unique career challenges.

City and county trails reopen this weekend. Almost every day, the rules change in the beaches and parks of Southern California. Here's the latest.

The vast majority of California isn't close to meeting Gov. Gavin Newsom's reopening requirements, a Times analysis finds.

The America that condones mass murder of children is allowing the coronavirus to spread.

Amid a plateau in the number of new coronavirus-related deaths in Los Angeles County, officials Friday were easing into an economic recovery plan.

Gov. Gavin Newsom ordered ballots be mailed to the state's 20.6 million voters for the November election while imposing new rules for in-person voting.

Robert De Niro told Stephen Colbert he wants to play New York Gov. Andrew Cuomo in a pandemic movie. And Cuomo approves.

COVID-19 victims in their 20s and 30s make headlines, but does it mean the coronavirus has become more dangerous to younger people? Here's what we know.

The U.S. death toll in the coronavirus outbreak surpasses 77,000 as states continue to ease restrictions and President Trump pushes for faster reopening.