Medical procedure patents

tux surgeon
Patents on surgical methods?

Under Federal law 35 USC 287(C), US physicians and other medical practitioners have a limited immunity to certain types of medical procedure patents.

US patent laws allow patents for inventive methods (such as procedures), devices (such as gadgets), and compositions of matter (such as drugs). But should we allow medical procedure patents to be used against medical practitioners?

What is a medical procedure patent? Some historical examples include 1) a new and improved method of making surgical incisions on patient corneas; 2) the first medical use of ether (first anesthetic); 3) the first use of ultrasound for fetal gender evaluation.

Public policy here is a bit uncertain.  We don’t want our physicians to be afraid to try new procedures.  In fact, we want them to use the best procedures possible. But if we don’t financially reward innovation (through patents), then this could stifle further medical progress.  So in the US, and indeed throughout the world, almost everyone is debating this basic question: should medical procedure patents be allowed, or not?

Over about the last 100 years in the US, the pendulum has swung back and forth between “no” and “yes”. Our present 1997 era law, as described by 35 USC 287(C), is somewhere in the middle.  In what is a bit of a strange compromise, the US generally allows medical procedure patents but doesn’t always let you enforce them!  So unless you are aware of this unusual rule, you might accidentally end up getting a medical patent of little value because the law might not let you enforce it.

The trick to avoiding this unfortunate situation – having a medical procedure patent that lacks value due to restrictions on enforcement, is to consider 35 USC 287(C) and write claims that limit the impact of this strange exception.

The good news, from the standpoint of inventors and startups, is that the enforceability carve-out aspects of this law are quite narrow. Patents for devices and compositions of matter are just fine and can still be enforced. Further, under the patent legal rule of “contributory infringement“, you may also still be able to enforce against manufacturers who are teaching use of their products for your patented medical procedure.

So in practice, US rules regarding medical procedure patents are not all that restrictive. The trick is that if you are trying to patent a new medical procedure, think a lot about what devices or medical supplies might be needed to implement your new procedure.  Claim them, and when you get to writing the medical procedure claims, think about contributory infringement as well.

Non-disclosure agreements (NDA)

Confidential
Confidential information

Non-disclosure agreements (NDA) can help preserve business trade secrets and other confidential information, but don’t expect your attorney to sign one.

Businesses often use non-disclosure agreements with their contractors, employees, product evaluators, and site visitors, as well as with other businesses such as suppliers, customers, potential partners, and the like.  These agreements are often required to establish diligence in preserving trade secrets.  If breached, such agreements may also be used, along with other suitable evidence, in subsequent legal action in state or federal court.

Although in some states, non-disclosure agreements are sometimes used as a backdoor form of a non-compete agreement (e.g. attempting to restrict an ex-employee’s employment elsewhere), this is not a universal practice. California, for example, disallows this sort of thing.

NDA typically include various clauses establishing:

  • Who is disclosing the information, and who is the recipient
  • The boundaries of the confidential information – what is and is not covered
  • Confidentiality obligations
  • When and/or how the agreement ends
  • Other legal provisions (beyond the scope of this blog)

Generally, NDA have carve-outs for publically available information and terminate either when information subsequently becomes available to others through no-fault of the recipient, or after a pre-negotiated number of years.

NDA can be particularly useful when you are working on an invention, but either have not filed a patent application yet, or else are continuing to work on improvements to the invention.  Here, if you want to work with vendors or contractors to produce components of the invention, NDA (and other IP rights agreements) can be important.

Attorneys, including myself, usually refuse to sign NDA.  Why is this?  The reason is that attorneys are already subject to strict state (and federal) attorney-client rules and regulations that require them to keep client (and potential client) secrets. In essence, by agreeing to talk to you, the attorney has already agreed to a standardized, legally enforced, type of attorney-client “NDA”.

Consider what would happen if this were not the case.  Clients would be afraid to even ask an attorney about their particular problems. Attorneys would be signing hundreds of NDA each year, each with different terms. The legal system would grind to a halt.

Professional investors (VC, Angels) usually also refuse to sign NDA.  Here, there is no duty of confidentiality.  However, the finance people control the money, see a lot of ideas they don’t fund, and usually don’t want any constraints on their future investments. This is where it is good to have your patent applications filed in advance.

Patent & trademark annuity fees

hourglass
Time passes, set up reminders for your annuity (maintenance) fees

It is easy to lose patents and trademarks by forgetting to pay their annuity fees. Set up your automatic reminder systems today.

You have just received your US utility patent or trademark, congratulations!  But remember that unless you pay annuity fees (maintenance fees) during certain future time windows, your patent or trademark will expire early.  No, you can’t pay these fees early. You must wait until the time window opens to pay.

Why do we have this system?  IP (Intellectual Property) laws are intended to balance both public and private rights.  The underlying idea is that if the IP is really important to you, then you will keep track of the payment windows.  If it is not important to you (as evidenced by your forgetting to pay), then the public rights part of the policy kicks in. The IP rights get transferred back to the public.

Utility patents (the most common type of patent) will often have about a 17-20 year term (your mileage may vary), with maintenance fees due during specific time windows at 3-4, 7-8, and 11-12 years after issue. There is no requirement that patents actually have to be used to keep them in effect.  So during these time windows, the USPTO will just ask you to affirm that you are authorized to pay, and take your money.

Trademarks have to be renewed during specific time windows at 5-6 and then every 9-10 years (forever) after issue.  Unlike patents, trademarks are a “use it or lose it” type of IP.  The USPTO, in addition to charging fees, also requires proof of actual use in commerce. They will deny renewal if this proof is absent or unconvincing.

The responsibility for ensuring that these annuity fees are paid ultimately rests with the IP owner.  Although some law firms may occasionally send out courtesy reminder notices, such courtesy reminders should not be relied upon.

Instead, consider setting up your own reminder system.  At a minimum, enter the dates into at least one (preferably two) long-term electronic calendars or other automatic reminder (docketing) systems, and keep these systems going.

Additionally, consider engaging a professional annuity service. A number of such annuity services exist. Without making any particular recommendations, some of these annuity services include:  Computer Patent Annuities Global, Computer Packages Inc., Dennemeyer & Company, and Maxval.

Patent claim charts

Patent claim chart, with one row not matching
Patent claim chart, with one row not matching

Think that someone is infringing on your patent?  Worried you are infringing, or want to show a patent reads on prior art?  Analyze with patent claim charts.

The basic idea behind a patent claim chart is to first break a given patent claim down into a series of smaller sections, and then to determine if each smaller section matches a corresponding aspect of a target of interest. This target may be a potentially infringing product or service, another patent, or even a public domain product or service (to try to show that a patent may be invalid).

Patent claim charts usually follow a row and column table format.  One column contains various sections from a claim of interest, spread out over a number of rows.  Another column contains various aspects of a target of interest, also spread out over a number of rows.  Rows containing sections from the claim column are compared with rows containing aspects from the target column.

If can be shown that every row from the claim column exactly matches up to one or more rows from the target column, then this suggests that claim does describe the target. Note, however, that although every claim row must match with a target row, there is usually no reverse requirement that every target row match-up with a claim row.

Sounds simple, but the devil is in the details.  Since patent claim charts are often part of an adversarial process, each side may feel under pressure to “slant” their claim charts in a way that favors their particular position.

Claim charts can be slanted in many ways.  One of the most common ways is to write the chart in a way that skips over important details, often by not breaking the claim down into small enough sections.

Some of the comparisons may not be accurate.  Also, remember that individual claim terms can sometimes be misleading because they may have been defined in the text of the patent application (or during prosecution), in a somewhat unexpected way.

So read and write claim charts with caution and skepticism.  Don’t use sloppy claim charts to initiate any legal action.  Of course, don’t blindly accept claim charts from others without doing your own independent analysis.

Contractor ownership of IP

Agree on IP ownership in advance
Agree on IP ownership in advance

The ownership rules for copyrights, patents, and other IP vary depending on if the IP creator is an employee or an independent contractor.

In today’s world, the distinction between employee and independent contractor is often blurred, but legally, these two forms of working are very different.  As a result, whether you are working as an employee or independent contractor, or hiring employees or independent contractors, it is good to be aware of how these different types of work engagements impact IP ownership rights.

These laws can vary from state to state.  Consider California. Generally, work done by an employee for an employer, at the employer’ request, does belong to the employer. However the IP assignment process is not always automatic (patents, for example, generally need to be assigned to the employer in writing).

One of the reasons why California has a booming high-tech economy is that California labor code sections 2870-2872 mandate (with certain exceptions) that work that does not relate to an employer’s business (and is done with the California employee’s own time and materials) generally belongs to the employee. However, this section of California law may not protect independent contractors.  So if you are an independent contractor, you may want to negotiate this.

US copyright law (writing, art, software, etc.) also distinguishes between employees and contractors. For employees, copyright ownership for works made for the employer typically goes to the employer. However for independent contractors, absent a signed written agreement (such as a work made for hire agreement) that copyright ownership is being transferred, often ownership remains with the independent contractor.  So if you are hiring an independent contractor, absent a written agreement, just because you paid for something doesn’t automatically mean that you own it!

How to distinguish an employee from an independent contractor?  Generally, the difference is the amount of control.  For an independent contractor, whoever is paying can control the work result, but generally not how the work is done.  By contrast, even an employer who gives his employees freedom still has the legal right to specify how the work is done.

Regardless of work arrangement, it is always a good idea to work out the issues of who is going to own what in writing and in advance.  For employees, spell this out with a proprietary information and inventions agreement. For independent contractors, negotiate and sign an agreement on these issues before starting work.  This topic often comes up in due diligence.

Patent demand letters

Frustrated patent troll
Frustrated patent troll

Patent demand letters are stressful.  Before responding or ignoring, evaluate infringement, patent prosecution history, ownership, and litigation history.

Has your startup received a “demand” letter asserting that you are infringing on a patent?  Although real infringement of valid patents does occur, and some of these letters are legitimate, many demand letters are sent in less than 100% good faith. The sender may be betting that the startup will settle quickly to avoid litigation costs, regardless of the actual merits of the situation.

Don’t immediately contact the sender, and don’t ignore the letter either.  Instead, calm down and evaluate the facts, preferably with the help of a patent attorney.  Is there a plausible infringement problem or not?  How to tell the difference?  A few common methods are discussed below.

To start, get: 1) a copy of the issued patents discussed in the demand letter, 2) the USPTO prosecution history of these patents, and 3) information about the allegedly infringing product.  If the letter doesn’t provide actual issued patent numbers, or if the letter only cites patent application numbers, the probability that the letter is bogus becomes higher.

Look at the independent claims for each patent (claim 1 is not always the broadest claim), and see if your allegedly infringing product infringes the entire wording of any independent claim. If so, look at the relevant dependent claims for more detail. If the letter argues contributory infringement, combine your product with the other accused product for this analysis, and check if your marketing literature is promoting this combination.

The patent prosecution history for the patents in question, usually downloadable from the USPTO, can be very relevant. This history will often reference if the patent has been used in litigation before; if the patent has been reevaluated by either reexamination or the Patent Trial and Appeal Board (PTAB); and if the patent applicant had to make significant concessions during the patent prosecution history.

The patent’s USPTO assignment records can be used to better understand the relationship between the sender and the actual patent owner of record. This is often obfuscated. What is this relationship, and is the purported patent owner the real patent owner?

If there is a history of litigation, check it out. Patent litigation usually takes place in Federal Courts.  This is usually available through PACER (Public Access to Court Electronic Records) and a number of other sources. Has the patent owner been filing a lot of lawsuits and then settling before the court reaches a decision, or does the patent owner usually win?

There are many other issues that can be explored as well, but this type of information can help you and your attorney better evaluate what your next steps should be.

Startup IP due diligence

Maat
Maat – Egyptian goddess of truth

Startup investors know that they are mostly investing in just your IP.  So get your IP ownership situation under control before due diligence starts.

What does a startup investor get for his money? Startup companies are really just a bundle of information (usually ideas), people (founders, contractors, consultants), and things (tangible property, cash). A startup’s “things” will usually have minimal value. The people can walk out the door at any minute. So all that an investor may actually get for his money is some sort of ownership option in the information – the startup’s intellectual property (IP).  Prudent startup investors thus often conduct a fair amount of due diligence on this “IP”.

A startup’s IP can be viewed as being a mixture of alleged inventions (e.g. actual or potential patents), alleged copyrights, alleged trademarks, and alleged trade secrets.  At least some of this information may still only exist in the minds of the founders, contractors, and consultants. What is potentially real here, and what is not?

Sophisticated investors also know that according to our IP laws, unless actions are taken to protect the IP, the IP may either still belong to the individual that created it; or it may have become public domain.  Investors also know that startups often don’t fully understand IP law.  Has that intriguing startup already accidentally lost its key IP?  Was it missing essential IP to begin with?  This is why investors want IP due diligence studies.

Some ways that IP can be missing or lost include failure to obtain written IP assignment contracts, inadvertently placing IP into the public domain, and reliance on IP owned by someone else.

Failure to obtain written IP assignment contracts: IP assignment agreements should be obtained from anyone who has materially contributed to the company’s IP. Don’t assume that just because you paid for something, your company owns that IP — you often don’t. Try to do these IP assignments up front, because the longer you wait, the more leverage the other party has. For example, they could make unreasonable demands, or deny assignment altogether.

Inadvertently placing IP in the public domain: For patents, assume that anything you publish before a patent application is filed can be used against you, and be careful to update your patent filings as your technology advances. For trade secrets (i.e. important, not-generally known information which is often not patentable), take active steps to restrict access, require confidentiality agreements, and of course never publish this at all.

Reliance on IP owned by someone else: For patents, consider prior art searches to reduce the chances that you are infringing on other patents. For copyrights, check the status of your software licenses, and that you and your contractors are not copying other work. Avoid using names that might confuse customers from related companies, since this may cause trademark problems. For trade secrets, stay away from inside knowledge (not generally known in your field) that you or your contractors may have obtained from other companies.

Remember that from an IP due diligence perspective, if you can’t prove you did things right, the assumption will probably be that you didn’t.  So keep your documentation on file.

About Silicon Valley and the San Francisco Bay Area

Golden Gate
Golden Gate Bridge, San Francisco

Silicon Valley and the San Francisco Bay Area have a worldwide reputation for innovation. But is there any subjective evidence for this? What do the patent statistics say?

According to the USPTO statistics, at http://www.uspto.gov/web/offices/ac/ido/oeip/taf/cls_cbsa/allcbsa_gd.htm, as of 2013, Silicon Valley “classic”, characterized as San Jose, Sunnyvale, and Santa Clara (Metropolitan Statistical Area 141940), led the field in patents with 12,899 patents granted. By contrast, the remainder of the San Francisco Bay Area minus Silicon Valley, characterized as San Francisco, Oakland, and Fremont (Metropolitan Statistical Area 141860) came in a respectable second at 8,721 patents.

Here the San Jose, Sunnyvale, and Santa Clara area includes other cities such as Campbell, Cupertino, Los Altos, Los Gatos, Milpitas, Monte Sereno, Morgan Hill, Mountain View, Palo Alto, San Jose, Santa Clara, Saratoga, and Sunnyvale.

By contrast, the San Francisco, Oakland, and Fremont area includes other cities such as Belmont, Burlingame, Emeryville, Foster City, Fremont, Menlo Park, Millbrae, Newark, Oakland, Redwood City, San Bruno, San Carlos, San Francisco, San Mateo, South San Francisco, and Union City.

Combining the two, the San Francisco Bay Area as a whole dominates the rest of the country, at an impressive 21,620 patents granted in 2013. By contrast, the next runner-up, the New York-New Jersey area, comes in at 7,886 patents. The Los Angeles area is close behind at 6,271 patents, followed by the Boston area at 5,610 patents. So from a patent perspective, yes the San Francisco Bay area is, in fact, pretty unique.

CLS Bank v. Alice Corporation II: more cutting-edge legal confusion

Confused? So is everyone else!

Legal confusion:  There remains a lot of legal confusion in the US regarding the question, are software inventions patentable? How to answer this question? We could of course look at the letter of the law (e.g. 35 USC 101), which would give us the rather boring answer that software is patentable. But if someone doesn’t want software to be patentable (and a number of large powerful companies do not), that’s not the answer they want.

How else might we get an answer? In ancient Greece we might consult the Oracle at Delphi, or perhaps sacrifice a goat and examine its entrails. However in the modern US, we know that this is silly. As we all know, the modern US way to decide this is to put this question to a small panel of elderly individuals who know nothing about software or patent law. We call this small panel the Supreme Court of the United States (SCOTUS).

To answer questions, the Oracle at Delphi inhaled vapors, fell into a trance, and then spoke in riddles. These were then interpreted by various priests. In much the same way, SCOTUS (hopefully without the aid of vapors) has given us some confusing and inconsistent rulings, such as the CLS Bank v. Alice Corporation decision, that in essence are riddles that must be interpreted by various priests (e.g. lower courts, the USPTO).

So in “Alice”, SCOTUS told us that “abstract ideas” are patent ineligible, and also told us that “In any event, we need not labor to delimit the precise contours of the “abstract ideas” category in this case. It is enough to recognize that there is no meaningful distinction between the concept of risk hedging in Bilski and the concept of intermediated settlement at issue here. Both are squarely within the realm of “abstract ideas” as we have used that term.

So the ruling in essence is the riddle: “abstract ideas are not allowed“, and “abstract ideas are undefined”. This is a pretty good riddle. So the next step is, now that the Oracle (err… SCOTUS) has spoken, how are the various priests (err… the USPTO and lower courts) going to interpret this riddle?

Some good news on this front. On December 16, 2014, the USPTO issued its “2014 Interim Guidance on Patent Subject Matter Eligibility”, available here:

http://www.gpo.gov/fdsys/pkg/FR-2014-12-16/pdf/2014-29414.pdf

Among other things, the USPTO appears to be heading towards the interpretation that when given incoherent rulings, at least try to minimize damage by applying the rulings narrowly. Thus the latest guidance instructs examiners to perform detailed analysis, and look for specific problems such as financial hedging and mitigating settlement risks, rather than generally rejecting everything. The Guidance also advises examiners that even if a patent hits on a “forbidden area” (judicial exemption), so long as the claim does not seek to tie up the judicial exemption so that others cannot practice it, the claim is probably OK.  (Note added 4-26-16 — sadly the USPTO has not followed their own guidance consistently. The official patent examination “MPEP” rules for eligibility are still literally a blank page).

First (inventor) to file

Mark your calendars for March 15, 2013, because on March 16, 2013, the US patent office switches to the new AIA “first-to-file” system.  In fact, mark your calendars for March 14, 2013, because it is quite possible that the USPTO servers may crash on March 15 under the weight of a huge number of last minute electronic patent filings.

The US patent system has traditionally been friendly to individual inventors and smaller startups.  The old system gave inventors some time to work to improve their original concepts before filing.  Inventors were protected because the old system allowed them to prove (using lab notebooks and the like) that they had thought of the invention some time before their patent filing date.  This proof was called “swearing back”.

The rest of the world, by contrast, has been on a stricter “race to the patent office” aka “first-to-file” standard.  Under “first-to-file”, the inventor with the earliest patent office time stamp wins, end of discussion.

Congresses’ 2011 America Invents Act (AIA) changes the US from the old standard to a US version of “first-to-file”.  There are some tricky aspects to this new standard.  It is possible (with evidence, and only for a limited time) to file a USPTO “derivation proceeding” to challenge a non-inventor (i.e. alleged thief) who filed first.  Inventors are also given up to 12 months after publication or sale of their invention to file, without having their own publication or sale used against them, BUT…

If an inventor publishes or otherwise discloses their idea, someone else hears about the idea, makes a few changes and files first, under the new rules this could legally knock out the inventor’s rights to these improvements. Since, in the real world, inventions often come into focus gradually over time as a series of small improvements, you can see the problem.   To add to the fun, the courts haven’t even seen new rule cases like this yet, and it will take years for them to sort things out.

The moral is, under the new rules, if you want decent patent protection for your work, consider filing on initial concept, and filing again on significant improvements.  Resist the temptation to share your still forming ideas with the world.  The old days of protection by “swearing behind” are gone as of March 15, 2013.  What was OK to do last year is not OK to do this year.