Why are medical device patents important? New medical devices are both expensive and risky to produce. Without patent protection, few new medical devices would ever reach the market.
The number of filed and granted medical device patents has substantially increased over the last few years, with certain US states (California, Minnesota and Massachusetts) leading the way. Certain countries, in particular Japan and Germany, are also heavily active in this area.
Write carefully: In contrast to some high tech areas, such as computers and software, which often rely on a larger number of lower impact patents, the medical device industry tends to rely on a smaller number of higher impact patents. What this means is that any given medical device patent is more likely than average to be subjected to a high level of competitor scrutiny. Remember also that in the medical device field, both the patent office and the courts may view the “person having ordinary skill in the art” (PHOSITA) as being highly skilled, such as a PhD or MD. Thus care should be given to write accordingly. It is helpful to include a lot of detail and discuss alternative approaches. Research and disclose prior art, and of course try to write claims in a manner that distinguishes over prior art.
Remember Europe: Medical devices are an international market, and often due to slower FDA review times, US firms first introduce new products in Europe. Many US medical device patent applications end up being filed in Europe. Thus European patent rules are often important.
Although there are a few glaring exceptions, US medical device patent eligibility rules generally tend to be expansive. The USPTO typically reviews these patents in its 3700’s art unit. In recent years, this art unit has continued to grant medical device patents according to its historical percentages.
European patent eligibility rules are also generally quite permissive with regard to “gadgets” and in-vitro devices, as well as technical aspects of in-vivo devices. However Europe (See G-II 4.2.1) doesn’t allow “methods of treatment of the [living] human or animal body by surgery or therapy and diagnostic methods practiced on [usually interpreted as “in”] the human or animal body “. Fortunately the Europeans tend to read this exclusion narrowly, so this isn’t actually quite as restrictive as it sounds. However from a claim writing perspective, be careful of method claims with limitations that read on the patient’s body. Try to focus more on the details of how the gadget (device) itself works. Watch out for methods that remove a tissue, treat it, and then return it to the body, as these could run into trouble.
Non-publication requests: Patent non-publication requests can be an important part of your IP strategy. Under US law, patent applications can be filed with patent non-publication requests. When this request is made, the USPTO will hold a patent application secret (i.e. will not publish it) until when and if the patent finally issues. Otherwise, absent this request, the patent office will automatically publish the patent application 18 months after the initial filing date.
When to consider filing a non-publication request: Non-publication requests are particularly appropriate for certain types of software patent applications, such as “business methods” and related software patents. This is because the US patent law for this type of software is presently in an unsettled state, and the international acceptance of this type of patent is also more limited. By filing with a non-publication request, your disclosure remains a trade secret. If the USPTO grants you a patent that is broad enough to be worth disclosing your work; great. If not, then you can continue to elect to keep your work hidden from the public.
When filing a non-publication request may not be appropriate: If you have plans to file outside the US, then by international treaty, you must file for international patents within 12 months of your initial filing date, and also allow your initial application to be published within 18 months. Here you can either not include a non-publication request on initial filing, or alternatively send in another form rescinding your non-publication request.
Other considerations: Unless a specific reason for non-publication can be identified, I generally recommend filing using the default, “publication” mode. This is because published patent applications can be useful. They help provide published prior art to help establish priority over patent filings from competitors. Additionally, published patent applications look impressive to investors, and can help give you more credibility.
Summary:In general, software patents that deal with technical effects, physical parameters, and improving computer function tend to be favored. By contrast, software patents focused on business methods tend to be disfavored.
China: Before April 2017, China restricted software patents to methods that solve technical problems, control internal or external processes according to the laws of nature, and produce technical effects in accordance with the laws of nature. Machine readable medium type claims, and game patents, were not allowed. However these guidelines are now somewhat more expansive. For example, business methods that also have a technical aspect may now also be eligible for patent protection.
Europe: Software patents should have a “technical effect” (e.g. controlling industrial aspects, improvements in computer technology, data pertains to physical properties,). Pure methods directed “only” to doing business and computer programs without “technical effect” are not allowed.
United States: The rules are presently incoherent. Traditionally (before 2014-2015) US policy was permissive. Indeed the present written (i.e. statutory) US legal standard is that all types of software patents are permitted. However the latest judicial rulings and USPTO policies are that at least some software patents may represent “abstract ideas” run on “generic computers” that are not patentable unless there is “something more”. Unfortunately the terms “abstract”, “generic computer” and “something more” are effectively undefined (and thus can vary according to the whims of the judge or patent examiner at hand).
How will US software patent rules evolve in the future? This is a bit like reading tea leaves, but the latest US software patent decisions appear to be trending more towards a Chinese or European-like approach. On average, “Business method” software is increasingly being rejected as being “abstract”. However software that exhibits technical effects, operates on data pertaining to physical properties, or improves computer function is often accepted on the basis that it is not “abstract”, not run on “generic computers” or contains “something more”. Arguably the US, presently lacking coherent rules, may be at least temporarily filling the void by borrowing rules from other countries. The constitutionality of this approach remains to be determined.
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.
Litigation by unfair surprise is out, at least for US patent PTAB cases — for European patent oppositions, not so much.
One thing that I will never forget about my experience with European patent oppositions is that to American eyes, the European process appears to be rather “due process of law” impaired.
For example, although in theory, issues should be argued in advance by written briefs, the European opposition process also allows parties to introduce new issues during the last minute oral arguments.
This allows for litigation by “unfair surprise”, rather than by reasoned arguments. In this sort of setting, I have seen that illogical but last minute “Chewbacca defenses” can work quite well. The clock is ticking, proceedings are going to finish in an hour, and suddenly you have to discuss entirely new and logically irrelevant issues. It is as if you suddenly have to shift gears and focus on if the Star Wars character Chewbacca lives on the planet Endor or not.
In this regard, it is refreshing to see that the Federal Circuit in Dell Inc., v. Acceleron, LLC (March 15, 2016) has confirmed that this sort of litigation by unfair surprise is unacceptable for US PTAB patent reviews. Due process wins — arguments made during oral argument must be restricted to only those arguments previously discussed in writing beforehand.
Prior art searches: Before investing a lot of time, effort, and money in trying to patent a potential new invention, it is always good to spend at least a few hours doing patent searches to see if there is any prior art (earlier patent or non-patent publications) that might cause problems. As a rule of thumb, if you haven’t found any prior art that concerns you at least a bit, then you probably haven’t looked enough yet!
Why do this? Because eventually, skeptical USPTO examiners will be going through your patent application, looking for ways to reject on the basis that the application is either not novel or obvious in view of prior art.
Patent examination is an adversarial process. Patent examiners have, in effect, quotas which require them to initially reject most patent applications. It is a bit of a game, like tennis, where the examiner initially rejects by citing some combination of prior art. The examiner then hits the ball back onto the applicant’s side of the court. The examiner is expecting the applicant to hit the ball back onto the examiner’s side of the court by submitting convincing arguments pointing out where the examiner was wrong. If the applicant can convincingly argue that the examiner is wrong, usually (often after a few additional volleys), the examiner allows the patent, and the applicant wins. But if the applicant cannot argue back convincingly, it is like dropping the ball or hitting the ball back out of bounds. The applicant loses, and that patent application is going nowhere.
The patent examiner typically starts by doing computer searches for prior art using search terms that the examiner thinks will work best. This computer search will come up with unexpected citations, which the examiner may in turn combine in unexpected ways to try to show that the invention is “obvious”. Because of the quota to initially reject almost everything, often these initial rejections are unreasonable. Unreasonable rejections are “good news” in disguise, because the applicant can then rebut these by reasonable arguments. It is the reasonable rejections that are the real “bad news”, because these are harder to argue against. So before putting a lot of time and money into an invention, it is a good idea to do at least some initial checking to see what the examiner (or for that matter, a competitor) might try to use against you later. This is the idea behind a “feasibility study” type prior art search.
Sometimes, particularly when the inventor or inventors are experts, the inventors themselves may decide that they are sufficiently familiar with their field so that the search-time expense/benefit ratio is low, and no additional prior art searches are worthwhile. Here, since the USPTO will do an independent search anyway, the only obligation that the inventors have is to inform USPTO of the most important prior art that they are aware of.
Other times, particularly when the inventor or inventors are working in an area that is new to them, prior art searches have a better search-time expense/benefit ratio. Here many good sources are available over the Internet, including Google, Google patents, Google Scholar, the USPTO patent database, the WIPO patent database, and the like.
Some common mistakes that inventors make is to underestimate the amount of prior art that a patent examiner can use against their invention. Although pretty much everyone understands the problem of prior patent applications by others, this is only part of the prior art problem.
For example, for the US, anything published more than a year ago can be used against your invention, including your own publications. This includes that “cool” YouTube video, that “cool” social media posting, or that research paper/thesis that you may have published last year. Foreign patent offices are even worse in this regard. Patent examiners know that often the inventor’s own worst enemy is the inventor’s own earlier publications. As a result, patent examiners often specifically search for the inventor’s own publications and internet postings to use against them.
Another problem that inventors sometimes have is that they are a bit too emotionally attached to their cool new idea. This problem can result in sub-optimal prior art searches. The inventor may, perhaps subconsciously, avoid search strategies that may kill that shiny new idea.
Here, there are several advantages to having a patent attorney do a quick feasibility prior art search for you. One is that the patent attorney does prior art searches all the time. Another is that the patent attorney, being both less emotionally invested in the idea, and being expert in finding prior art, may have an easier time thinking of thorough search strategies. The third is that often doing the search helps the patent attorney understand variants of your idea better, which can translate into a better patent application.
For example, if something highly relevant comes up (and often something does come up), then the new idea can be better evaluated in the context of this new-found prior art. The scope of the initial idea may be altered or expanded, and a better patent application can result. Worst case, if it becomes clear that the idea has been done before, then time and money can be saved. Alternative ideas can be explored instead.
In conclusion, “feasibility study” type prior art searches are a good way to get at least a rough estimate of the legal feasibility of a new idea. Although the prior art search may uncover what looks at a first glance to be a tough obstacle, often this initial obstacle may encourage further thinking and improvements to the initial idea, resulting in a better patent down the road.
Note that in addition to “feasibility study” type prior art searches, there are other types of patent searches called “freedom to operate” searches or opinions as well. These represent a different and more extensive type of search, and this is a different topic.
What to do about “Alice”? The US Supreme Court’s “Alice” decision has invited us all to a Mad Tea Party. What fun! But, as previously discussed, if you like logical coherency, or even just want to keep from crashing the economy, there are a few problems with this decision.
Attorney Louis Hoffman, writing in ipwatchdog.com, sums up some of these recent”Alice” problems nicely.
Damaging the economy: As Louis points out, some of the most important areas of US technology are based on software, business methods, and biotechnology. The USPTO has recently taken upon itself to reject many patents in this area. However this loss of patent coverage can impede the economy by making investments difficult, and/or by driving inventions underground in the form of trade secrets.
What about actual (written) patent law? Article I, Section 8, Clause 8 of the US Constitution has empowered Congress to: “promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.”
Congress has done so, and has determined under 35 USC 101 that: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”
If you want to know what’s important about this case, it’s right there: the Court’s acknowledgement that the judge-made “exclusionary principle” has the potential to “swallow all of patent law” because “all patents” are at some level based on the very things that can’t be patented under the judge-made doctrine.
Decisions, decisions: So the Alice decision, read too broadly, produces an unconstitutional result. At some point, there will be likely corrective action. However the practical question that some inventors, particularly business method inventors, have to address today is: file a patent and risk an “‘Alice” rejection, or don’t file a patent and be certain that the invention will become public domain?
In my opinion, part of the “Alice” patent problem is that few true impartial (i.e. neutral) judges have really been involved yet.
Both the USPTO and Federal judges have at least a subconscious incentive to get complex patents off of their respective desks with a minimum of time and effort. Why fill your head with complex matters — just say the patent is “abstract”, and the problem is gone. Instant relief! So perhaps there is an inherent conflict of interest built into the legal system in this regard.
So, as the Supreme Court itself warned, Alice will continue to swallow up more and more patent law until it finally reaches an opposing force. Given our legal system, this opposing force may have to be formed by group of middle to large sized companies. Here, any company that doesn’t depend on either advertising, copyrights, or non-innovative technology might be a potential candidate for such a group.
Perhaps some of the presently pending cases will eventually put some boundaries here.
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 Corporationdecision, 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:
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).