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.

USPTO office actions

USPTO office actions
USPTO office actions

USPTO office actions are used to reject most patent applications by using “done before”, “obvious”, “vague”, or “not patent eligible” type arguments.

Although we all hope that a patent application will sail through the USPTO patent examination process and be allowed “as is”, this usually doesn’t occur.  As a practical matter, examiners work on a quota system. The net effect of this quota or “count” system is that the average successful patent is usually rejected several times before it is allowed.

Typically an examiner will first read the patent claims, and search for various citations (often earlier filed patent applications) that match certain claim key-words.  The examiner will then write a 20-40+ page “office action” document that rejects your various claims for various reasons, and send it to the correspondence contact of record.  The examiner expects you to respond within three months by submitting a written “office action response” that rebuts these various rejections.

The most “popular” USPTO rejections are:

Done before – 35 USC 102: The examiner thinks he has found another single citation that teaches everything in your particular claim. However absent actual copying, no two patents are usually totally alike. This type of rejection can often be rebutted by explaining where the citation is different, or amending the claims to add additional detail that differs from the citation.

Obvious – 35 USC 103:  The examiner (sometimes impermissibly guided by your disclosure) is attempting to reject your claim by combining features from multiple citations. The examiner may often create a Frankenstein concept that may or may not be plausible. Fortunately, there are examination rules here. Often this type of rejection can be rebutted by any of 1) showing that the examiner is misquoting the citations, 2) amending your claims, 3) showing which “103” examination rules were broken.

Vague – 35 USC 112:  This “vagueness” or “indefinite” type rejection is used for different things. Sometimes it is harmless and easily corrected, such as when the claim’s grammar is off. Sometimes it is deadly, such as when your underlying patent application doesn’t teach how your invention works in adequate detail.  This is more likely to happen if the original application lacks specific examples.  Although this can often be rebutted or fixed by changing the claims, sometimes the only way to attempt to fix this is to file a “continuation in part” application that adds the missing detail.

Not eligible – 35 USC 101:  In the old days (i.e. before 2015), this was a rarely used rejection because the 35 USC 101 law was written to be very expansive. However, recent court decisions have made this area quite a swamp, and this is still being sorted out. In the meantime, realize that business methods and financial methods have a higher than average rejection risk.