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.

Secondary considerations of nonobviousness

Reset button

Is your examiner repeatedly insisting that your patent application claims are obvious?  One option: “reboot” your examiner by submitting at least one Rule 132 declaration providing “secondary considerations of nonobviousness”.

 Obviousness rejections are needed to prevent trivial patents.  Obviousness is legally determined by considering if the invention would be obvious from the standpoint of an imaginary Person Having Ordinary Skill In The Art (PHOSITA). This is ultimately just legal guesswork, and as previously discussed, such determinations are often unduly influenced by hindsight bias.

There is an alternative mechanism. The patent legal system also allows applicants to rebut obviousness rejections by submitting “objective indicia of nonobviousness”, which we will call “outside evidence”. This outside evidence can include unexpected results, commercial success, long-unsolved needs, failure of others, professional approval, skepticism of experts, and the like.

Although allowed, such outside evidence has a rather second-class status.  You can even see this in the terminology: “secondary considerations of nonobviousness”.  The patent legal system actually prefers its imaginary PHOSITA reasoning over actual real-world evidence! Sounds silly, but remember that they are skeptical because applicants are constantly trying to game the system.

Submission of outside evidence is not done often.  You might think that with the 2007 KSR removal of anti-hindsight rules, it would be more frequently used, but it isn’t. However, in my opinion, it is a useful “in an emergency, break glass” kind of tool.  You use it when you want to try to break the examiner out of a mental “rut”, or even a mental “infinite loop” of obviousness rejections.

When to use it?  Obviousness rejections are routine.  It usually takes at least two office actions to see if the examiner is showing signs of having a non-negotiable “I still think it’s obvious” position.  If this seems to be the case, outside evidence can potentially be used to try to “reboot” the examiner and break out of the loop. This is because according to the USPTO examination rules MPEP 716.01(d)   Weighing Objective Evidence…“When an applicant timely submits [outside] evidence traversing a rejection, the examiner must reconsider the patentability of the claimed invention.”

Outside evidence is submitted as various “Rule 132 declarations”.  Here the identity and the credentials of an outside declarant (someone other than the attorney, and preferably other than the applicant) are presented, the relevant outside facts are given, and the declaration is signed by the declarant. It is important to try to find credible individuals for this and to submit the best evidence available.

Due to USPTO concerns that the outside evidence is unreliable, this is not a sure tactic.  The rules state that there must be a “clear nexus” between the outside evidence and the invention’s claims. The examiner may rebut by arguing that no such clear nexus exists, proposing alternative explanations, and/or looking for other ways to discount the declaration.  Still, if you do have good evidence, why not use it?

Obviousness, hindsight, KSR

Training the human neural network: by Novasdid (CC BY-SA 4.0)

The 2007 KSR v. Teleflex Supreme Court (SCOTUS) decision is why the patent examiner, ignoring hindsight issues, just used your own teaching against you to reject your patent application claims as being “unpatentable” (obvious) under 35 USC 103.  Unfortunately, the US patent “obviousness” rules and regulations still have some “bugs”. 

The patent examiner has just reviewed your patent application, and has sent you a response. What are all these “rejected under 35 USC 103 as being unpatentable over (various citations)” statements? It almost looks like the examiner just copied your claim, interspersed it with various citations matching some of the claim words, and concluded with “therefore it would have been obvious to one of ordinary skill in the art…

This might even look to you like a standard formula that could be used to reject almost anything. Why does the USPTO work this way?

Some background: Without obviousness rejections, your patent could soon be swamped by many other competitor patents that claim the smallest, most trivial changes to your work. To keep the patent system healthy, there needs to be some “shielding”, some sort of “force field” that keeps competitors from getting too close to your work. In the US, the depth of the “shielding” or “force field” is set by trying to legally determine, often years later, what a person having ordinary skill in the art (PHOSITA) would think was obvious.

The big problem is “hindsight bias”. Lots of non-obvious things look obvious in hindsight. Here the legal system is attempting to cope, with varying success, with a very complex underlying problem of pattern recognition. Once you see the solution to a puzzle, it is hard to see anything else.

Prior to 2007, the USPTO used anti-hindsight rules in an attempt to minimize hindsight problems. However, in the 2007 KSR v. Teleflex case, SCOTUS made what, in my opinion, was a key error. Dictionaries define hindsight somewhat incompletely as: “understanding of a situation or event only after it has happened or developed”. SCOTUS ran this incomplete dictionary definition into the ground. They argued that the earlier anti-hindsight rules were too “rigid”, and that “common sense” should be used. They held that hindsight could be avoided by just considering if the invention would be obvious “at the time of the invention”.

This is an almost meaningless statement.  Who would file a patent application if it could be invalidated by later filed patent applications?

In reality, the patent applicant has just shown the examiner the solution to a puzzle, thus “training the examiner’s neural net” to subsequently view this solution as “obvious”.  However, the examiner is told to examine with 100% hindsight bias.  The examiner can also dismiss “hindsight” rebuttals by merely stating that under the newer, post-KSR, USPTO rules (MPEP 2141.01 III): “Content of the prior art is determined at the time the invention was made to avoid hindsight.”

In other words, thanks to the KSR ruling, the present USPTO rules can be paraphrased as Don’t bother us about “hindsight”, we’re not listening, and SCOTUS says that we don’t have to!

Fortunately, there are other ways to rebut obviousness rejections. Examiners often misquote the citations, have gaps in their reasoning, and their proposed combination is often a Frankenstein monster that differs significantly from the claim.  Secondary considerations can also be raised. So things can be done, but this hindsight “bug” (or feature) in US obviousness patent law is annoying.

Conley, Twombly, and Iqbal

Motion to dismiss denied!

Conley, Twombly, and Iqbal are different standards of proof to successfully initiate patent litigation. This varies between the states.  Consider this when incorporating your company.

From the standpoint of patent litigation, “Conley, Twombly, and Iqbal” are attorney speak for how much “meat” a patent infringement complaint must have in order to not get quickly tossed out of court under a motion to dismiss [rule 12(b)(6)]. So if you ever receive a patent infringement complaint, or plan to institute a patent infringement complaint, these names will become important to you.

Historically, it was very difficult for the average person to initiate litigation. In earlier centuries, pleading had to follow strict “code pleading” rules, where even minor defects could cause otherwise good cases to be tossed out of court.  In rebellion to this, in the 1930’s, when the modern Federal Rules for Civil Procedure were first established, the thinking was that everyone should be able to have their day in court. To do this, the standards for the initial pleading were set at a low “short plain statement” level (1957 Conley v. Gibson case).  So it didn’t take much to start a Federal lawsuit. The legal theory here was that deficiencies in the initial filing could be easily corrected by subsequent discovery motions. Justice for the masses – this would be great!

Fast forward to 2007 and the legal situation was actually not so great. The Federal courts were clogged with cases. Discovery motions notoriously chewed up large amounts of time and money, sometimes on the basis of initial pleadings that were a bit “thin”.

In the 2007 Bell Atlantic Corp. v Twombly case, the US Supreme Court (SCOTUS) took it upon itself to raise the standards for pleading.  As rephrased by SCOTUS in the later (2009) Ascroft v. Iqbal case: “…only a complaint that states a plausible claim for relief survives a motion to dismiss… While legal conclusions can provide the framework of a complaint, they must be supported by factual allegations. When there are well-pleaded factual allegations, a court should assume their veracity and then determine whether they plausibly give rise to an entitlement to relief.  Note the term “plausible”. It means “reasonable” or “believable”. This is where the standards get tightened, because the old standard was “possible”.

In practice, the court will initially assume that the complaint facts are correct, but then examine various alternative scenarios to see if there are plausible alternatives that are legally OK. For example, in the original Twombly case, collusion between telecommunications carriers was alleged. Facts showing that different carriers behaved in a similar manner were given, but no evidence of actual collusion was presented.  Here the “plausible” alternative scenario was that each was just independently protecting their own tuff without improper collusion. So the 12(b)(6) motion to dismiss was upheld.

Similarly, prior to Twombly, it did not take much to start a patent infringement lawsuit.  Just fill out a “Form 18” giving the patent number, an assertion of infringement, and a few other minor details and this was good enough.  In theory, after Twombly, standards should now be higher, but…

Ten years later, and due to intervening Federal Circuit rulings that encouraged continued use of “Form 18”, this higher standard is only now slowly trickling down to patent litigation. There are still significant inconsistencies between different states and different Federal District Courts. Before 2017, this didn’t matter as much because for patent infringement, a company could be sued anywhere.  But now, since the 2017 TC Heartland case, a company is usually sued in its state of incorporation.

So at present, we have a new and interesting situation where a company can apparently lower the risk of patent infringement lawsuits by incorporating in a state where the Federal Courts have higher standards.

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.

Selling patents

Selling patents is a bit like selling a house

For selling patents, try to create a family of commercially useful patents that are hard to design around and legally strong.  Know your market!

Although patents are best used to help inventors and startups attract funding and protect their products from copycats, sometimes the barriers to commercialization are just too high. Thus occasionally, alternative patent monetization approaches, such as sales, licensing, or litigation; may be a potential alternative. Here I discuss selling patents in a non-litigation context. Licensing and litigation will be discussed in later articles.

Your patents need to have good commercial potential, or else the game stops right here. The considerations include potential market size, market share, and value added by the patents.  The patents have to be “strong” (e.g. not easily invalidated on the basis of prior art, and not have a lot of loopholes).

To understand selling patents, consider the subject from the standpoint of a potential corporate purchaser. With the exception of “blocking patents” (which are relatively rare), for any given single patent, the corporate technologists will usually say “no problem, we can design around it”, and the corporate legal counsel will usually say, “no problem, we will come up with non-infringement/invalidity arguments”. Given this “no problem” input, if there is only one patent, the corporate decision maker will often decide to “risk it”, and if so, there will be no sale.

By contrast, when the corporate purchaser considers multiple patents, the assurances of the technologists and legal counsel decrease.  Technologist assurances that “we can design around it” become more guarded. Legal counsel, realizing that it may have to challenge multiple patents, will add up the potential costs and risks of multiple potential court cases, and also be less reassuring.  This is why, even for the strongest patents, most patent sales take place in the context of a family of related patents.

Patent valuation, and comparables: Although you may be tempted to put your pinky in your mouth and say “one hundred billion dollars”, market realities should be considered.  Just as there are real estate “comps” (average selling prices of houses in a neighborhood) and real estate valuation schemes, so there are “patent comps” and various techniques to measure patent valuation. Corporate purchasers have to justify their expenses to their upper management or their board of directors.  This justification becomes harder as the patent price moves outside of typical comps and valuation schemes. So it is important to be aware of these comps and valuation schemes, and set your expectations and negotiating strategies accordingly.

Selling methods: There are various methods of selling patents, including direct corporate deals (the traditional method), online auction sales, sales using brokers, and sales to NPE (non-practicing entities – formerly big, lately less active). As in any financial transaction, it is helpful to try to position yourself to negotiate from a position of strength (e.g. have financial means to walk away from bad deals) and to approach the transaction in an informed manner.

Sovereign Immunity, Tribes, & IPR

tribal lands
Tribal lands in the US

A strange way to help immunize US patents from IPR attack has recently emerged – the “sovereign immunity defense”.

IPR attacks: Since the America Invents Act (ACA) went into effect in 2013, a popular way to invalidate patents has been to challenge them in Inter Partes Review (IPR) proceedings. IPR proceedings are a USPTO (Federal) Patent Trial and Appeal Board (PTAB) proceeding where challengers can argue that a given patent is not novel, or is obvious, in view of various published prior art.

Sovereign Immunity: The Eleventh Amendment to the US Constitution reads: “The Judicial power of the United States shall not be construed to extend to any suit in law or equity, commenced or prosecuted against one of the United States by Citizens of another State, or by Citizens or Subjects of any Foreign State.”

Background: The University of Maryland (UMD) owned patent 7,635,386, covering a method of repairing cardiac valves. In May 2017, UMD successfully overcame an IPR challenge by arguing that UMD, as part of the State of Maryland, was therefore immune from the PTAB and IPR under the Eleventh Amendment (Sovereign Immunity).

OK… maybe so. Certainly UMD was able to cite various cases supporting their view. PTAB agreed and dismissed the challenge.

They did what? Allergan PLC, a multinational pharmaceutical company with its own patents to protect, decided to push this concept to the limit.  Allergan sold some of their patents to the St. Regis Mohawk Tribe (located in New York) and then immediately licensed the patents back again. In September 2017 Allergan then argued that since this tribe is also a sovereign government, “the tribe’s” patents also had sovereign immunity to IPR challenges!

Well, points for creativity! I don’t think anyone has ever thought of this angle before. Certainly the tribe was very happy to supplement its Casino business.

We will have to see how this plays out.  In terms of sovereignty, the tribes’ legal status, “domestic dependent nations”, is best described as “it’s complicated”. Has Allergan invented a new form of “patent laundering“? Patent law just took a bizarre turn.

While the courts sort this one out, enjoy the enclosed map of the continental US, showing the larger tribal lands in color. Are these the new frontier in creative patent law strategies?

Beware the “on-sale bar”

Victim of the on-sale bar

A patent is invalid if the invention was sold more than a year before filing (on-sale bar), and the recent “Helsinn v Teva” case shows that the courts can be harsh.  

A patent applicant can accidentally ruin their own patent in various ways.  In the US, one error is to first sell an invention (presumably in the form of a product), and then wait more than a year to file the patent. This error violates the 35 USC 102 on-sale bar of classic (pre-2012) patent law. This error also violates the latest 2012 AIA version of patent law, which phrases this as “on sale, or otherwise available to the public”.

However, the relationship between an “invention” and a “product” isn’t always clear, and it also isn’t always clear if a “sale” has taken place.  If I privately show you a cardboard box and say “I have an invention inside, want to buy it sometime if it works?”, and you say “Maybe”, is this a sale that invalidates a later patent?  In the event of doubt, how will the courts rule?  Will they err on the side of protecting the patent, or invalidating the patent?

In their May 1, 2017 “Helsinn Healthcare via Teva Pharmaceuticals” decision, the Federal Circuit took a harsh and patent unfriendly approach. Indeed, this ruling was so harsh that Lamar Smith, the Congressional sponsor of the 2012 AIA law, stated that the court was ignoring the intent of Congress.

To greatly simplify the Helsinn case: back in 2001, Helsinn was doing FDA clinical trials on the efficacy of various palonosetron drug formulations to reduce nausea during chemotherapy. During these trials, they signed a supply agreement with MGI (another company) stating that if the FDA approved some of Helsinn’s various drug formulations, and if MGI subsequently made purchase orders for these drug formulations, and if Helsinn subsequently accepted these purchase orders, then Helsinn would sell the drug to MGI. In 2003, after the clinical trials were successful, but before FDA approval, and before any actual product changed hands, Helsinn began filing for various patents.

Teva, a competitor, decided to challenge these patents as being invalid due to the “on-sale bar”. But was there really a sale? Was there an invention yet? Was it disclosed to the public? A lower court ruled in favor of Helsinn, but the Federal Circuit reversed.

The Federal Circuit used the Uniform Commercial Code (UCC – a set of laws intended to “save” ambiguous contracts by automatically supplying missing terms) to argue that there was a “sale” despite all the “ifs” and ambiguity. They then argued that the invention was in the (undelivered) product and that the invention existed before clinical proof that it actually worked.  Strangely, they even argued that the AIA “on sale, or otherwise available to the public” language didn’t apply because… this would change past practice. Apparently Congress, (despite good reasons and clear intent) somehow doesn’t have enough authority to make these changes?

The case is presently being appealed, but the moral is: be careful.

Inventorship and co-inventors

Participants: RRZE (CC BY-SA 3.0) license

US patent inventorship criteria are tricky, but “conception” of the invention and “intellectual domination” are more important than reduction to practice.

If multiple people are involved with your invention, one issue that commonly arises is: “who gets listed as inventor or co-inventor, and in what order?”

For academic and scientific papers, there is a common order – the junior person who did most of the work often goes in front, the senior professor or principal investigator who may or may not have done much work goes at the end, and other persons go in the middle as co-authors according to usually unwritten criteria. So long as no one is seriously offended, the co-author list otherwise doesn’t matter too much.

Many inventors begin their careers by writing academic papers, and often make the mistake of thinking that the same rules apply to patents.

However, patents are different.  You probably wouldn’t let a friend put his name on the deed to your house unless you want to give him co-ownership.  Patents are more like property deeds.  In the US, just who is and who isn’t a patent inventor can make a big difference in terms of who ultimately owns the patent.  As a result, patents have their own set of rules as to who is and who isn’t considered an inventor.

So what are the rules for inventorship? The USPTO rules are covered by MPEP 2137.01 INVENTORSHIP.  These rules were worked out through a number of court cases, and are occasionally a bit fuzzy and open to interpretation.  At the risk of oversimplification, the main idea is that the inventor is the person who conceived of the invention, and not necessarily the person (such as a supervisor) who suggested working on the problem, or the person (such as a technician or programmer) who did the hands-on work to reduce the invention to practice (e.g. make a working prototype). In fact, reduction to practice is usually not necessary.

Other considerations, such as the issue of “intellectual domination”, are also important.  An inventor who is “intellectually dominating” an invention may still be able to use suggestions from others without making them co-inventors.

Things can get tricky. Sometimes the supervisor’s suggestion is really the key insight behind an invention,  making the supervisor an inventor. Similarly, sometimes the person reducing the invention to practice ends up solving unexpected problems, and these solutions form a key part of the invention, making the “technician” an inventor.  Here looking at the invention’s claims can help sort things out.  Who was responsible for what?  Note, however, that claims can change during the examination, and sometimes an inventor can end up being added to an invention, or left on the “cutting room floor” as a result.

In any event, the best time to consider these issues is in advance of filing.  It is also important to discuss assignment in advance of filing as well since the usual goal is to have 100% of the invention assigned to the same persons or organizations.

 

Goodbye Texas Eastern District

 

But armadillos love patent trolls!

In the TC Heartland v. Kraft Food case, the Supreme Court ruled that the Eastern District Court of Texas is no longer patent litigation central. Goodbye forum shopping. 

In a strange quirk of patent law, a single judge from Marshall Texas (population 24,000) has been deciding more than 25% of the US patent infringement cases. If you wanted to sue someone for patent infringement and wanted a friendly court, the Eastern District Court of Texas was the place for you.

Put it this way: so much patent litigation happened here that Samsung actually sponsored a local Marshall Texas ice skating rink, just to keep the locals happy.

This is very unusual.  Corporations are typically sued in their state of incorporation or in the primary state where they do business.  However, patent litigation has had its own set of rules.  For nearly a generation, lower courts have interpreted these rules as implying that corporations can be for sued for patent violations nearly anywhere in the US.

It didn’t take long for patent litigation experts to figure out that if this was the rule, then why not sue where the courts are friendliest? This practice is also called “forum shopping”.

The local economy around Marshall Texas had been struggling.  What to do? In what may have been a bit of a “race to the bottom”, the Federal Court and local juries in Marshall Texas became increasingly patent-plaintiff-friendly.  Lots of attorneys with big corporate expense accounts started flying to Marshall.  Good for the local economy, but it starts to look a bit fishy…

In the recent TC Heartland v. Kraft Food decision, the Supreme Court decided that this had to stop.  They ruled that if Congress had intended this sort of thing, Congress would have said so plainly.  They also pointed out that there wasn’t much of a basis for the “file anywhere” interpretation. So goodbye “file anywhere” rule.  And for the most part, goodbye Eastern District Court of Texas.

Going forward, the new hot spots for patent litigation may become Delaware (many corporations are incorporated there), California (high tech industry), and other high-tech areas.