Vanda Pharma v. West-Ward Pharma Int'l: Tips for Life Sciences

Vanda Pharma, Inc., v. West-Ward Pharma Int'l, Ltd., was decided in 2018 and it includes some important tips for those seeking a patent in the life sciences. Despite being an excellent source of review for ANDA and generic patents, it also includes information regarding how to help a life sciences patent pass scrutiny under 35 USC § 101 (i.e., patent subject matter eligibility). For example, below is a list of tips gleaned from the case. Doubtless there are more hidden gems in there, but these are among the most valuable: 

Tips: 

1. A method of treatment is more likely to be patent eligible than a diagnostic method. 
2. A technique that is based purely on relationships within a biological system (e.g., concentrations of a drug within the body) and likely outcomes based on those relationships (e.g., likelihood a dosage concentration would produce harm) is less likely to be patent eligible. 
3. A specific method of application, administration, or treatment using a specific compound at a specific dose to achieve a specific outcome is likely to be patent eligible. 
• Tip number three may hold true even if the specific compound is an already existing drug, as long as there is a new way of using the existing drug (e.g., refined treatment) that produces an unexpected result. For example, a new administration of an existing drug that is safer because it reduces the chances of a negative side effect is likely to be patent eligible. 
4. Naturally occurring traits, characteristics, or parts of a biological system, even if slightly modified, are unlikely to be patent eligible (e.g., DNA or cDNA). 
5. A method or technique that is phrased in a patent claim so broadly that it prevents additional improvements to the drug, its use, or its administration is unlikely to be patent eligible because it "preempts" the field and hinders the progress of science. 
   

Significantly, passing scrutiny under 35 USC § 101 does not mean that the other statutory bars will be passed (e.g., 35 USC §§ 102, 103, and 112). Each of the other statutory bars must be properly addressed for the patent to issue. However, passing § 101 is a significant achievement, especially in the life sciences. 

As previously mentioned, there are additional legal gems within this case, including a few tips on Federal Subject Matter Jurisdiction in cases involving the Hatch-Waxman Act, Paragraph IV certification, and ANDA filings for generic pharmaceuticals. However, hopefully you will find the above-mentioned tips useful in directing your research and your efforts to protect it. 

Boom Payments v. Stripe: 35 USC §101 Lessons

 

On January 13, 2021, the Court of Appeals for the Federal Circuit (CAFC) decided a non-precedential case, Boom Payments, Inc. v. Stripe, Inc. Despite being a non-precedential case, there are a few 35 USC §101 lessons that can be gleaned from the case.

The background is such that Boom Payments owned three patents: U.S. Patents 8,429,084 ("'084 patent”), 9,235,857 ("'857 patent”), and 10,346,840 ("'840 patent”). Boom believed Stripe and Shopify, Inc. (hereinafter "Stripe") to be infringing on the patents and asserted their rights. Generally, the patents are directed towards an e-Commerce solution that allows a purchaser to submit payment information to the online hosting service (e.g., Craigslist) without the transaction being finalized until the purchaser has a chance to examine and accept the goods as satisfactory. In order to finalize the transaction, the purchaser's device generates a unique identifier, which can be transferred to the seller to redeem the identifier for payment.

During its Alice Two-Step Analysis, the district court determined that the patents were directed to computerized escrow (i.e., an abstract idea), and then dismissed Boom's lawsuit under a Rule 12(b)(6) motion. There are problems with dismissing one or more patents that have been challenged under §101 using Rule 12(b)(6) motions (e.g., as discussed in this Patently-O article), which are only briefly be discussed below.

One problem with the case that I would like to discuss in more detail is illustrated by the dicta provided by the CAFC in reaching its determination of invalidity. During the appeal to the CAFC, Boom argued that the claims were not directed to an abstract idea but were directed to a technological improvement of systems for making computerized payments. Alternatively, Stripe argued that the representative claims were routine or conventional and did not include an inventive step. The CAFC agreed with Stripe and in dicta said, "But use of an identification code known only to the buyer and the third party to verify a transaction could be performed just as readily without the use of computers and cannot be said to be a 'technological' solution that improves the functioning of a computer system." This portion of the dicta provided by the CAFC is significant because when processes are able to be performed without the use of computers, then under the Alice Two-Step Analysis, it is a fairly good indicator that the proposed process/invention may be an abstract idea rather than a practical application of an inventive concept. (See, e.g., MPEP §2106.04(a)(2)(III)).

Taking a closer look at the representative claim used by the CAFC and the district court, we can see that the CAFC's reasoning as exemplified by the portion of the dicta above is likely incorrect. For example, the representative claim from the '840 patent is as follows:

1. An Internet-based computer system for confirming that a proposed sale transaction has been consummated, said Internet-based computer system including a payment processor system comprising at least one computer device programmed to:

receive a buyer’s payment information and store said payment information; prior to a sale of an at least one item associated with an online store of a seller to said buyer, receive, at said payment processor system, a request transmitted from a buyer computer device for said buyer to be able to purchase at least one item offered for sale by said online store;

in response to said request, generate a transaction-specific buyer acceptance identifier comprising a combination of human-readable characters;

provide said transaction-specific buyer acceptance identifier to said buyer computer device;

store in computer-accessible memory associated with said payment processor system a record comprising a relationship between said transaction-specific buyer acceptance identifier, a buyer-specific identifier, and a seller-specific identifier;

receive from a seller computer device an identifier of the transaction, an identifier of the buyer, and an identifier of the seller;

compare the identifier of the transaction with the transaction-specific buyer acceptance identifier;

compare the identifier of the buyer with the buyer-specific identifier;

compare the identifier of the seller with the seller-specific identifier; and

if said identifier of the transaction corresponds to the transaction-specific identifier, said identifier of the buyer corresponds to the buyer-specific identifier, and said identifier of the seller corresponds to the seller-specific identifier, charge an account associated with the buyer for an amount associated with the request to purchase at least one item offered for sale by said online store.

Admittedly, most of these steps could likely be performed without the use of a computer. However, as emphasized in bold and underlining, there is a step that includes creating a "...record comprising a relationship...." Relying on claim construction principles, one would have to look to the intrinsic record to determine the meaning of this step and the term "relationship".

In at least one embodiment, the specification describes the relationship as one between a random hash string, to identify the transaction, and both the buyer's cell phone and the seller's cell phone. This type of relationship cannot be done by pen and paper without the use of a computer.

Not knowing how much weight the CAFC placed on this factor, one cannot be sure how much error was actually committed. However, since this point does not seem to have been raised by Boom, one takeaway from this case is that in §101 cases, always emphasize functionality within a claim that cannot be performed using pen and paper. This helps to show that your invention is not merely a mental process and strengthens an argument (if made) that it is an improvement to a computer system.

Another takeaway can be gleaned from a second portion of the CAFC's dicta, where the Court said that the claims in this case were similar to those in Alice, which attempted to claim exchanging financial obligations between two parties using a third-party intermediary to mitigate settlement risk. The takeaway is this, if you're claiming a financial transaction that is in any way similar to the transaction found in Alice, then you'll have to work hard to differentiate your claims from those found in Alice.

The final takeaway is instead of only arguing substantively, one should also argue legal procedure. For example, Stripe attacked the substance of the claims under §101, saying that the claims included ineligible subject matter because the subject matter is merely routine and conventional, and Boom only argued in return that the claims were not routine and were not conventional. Boom should have also argued that the use of a Rule 12(b)(6) motion should be improper in a case where a federal agency (the USPTO) has already determined the patent claims to be valid, meaning that they already passed §101 scrutiny at least once. Therefore, Rule 12(b)(6), which preemptively dismisses the case before factual arguments are heard, should be improper.

HVLPO2, LLC v. Oxygen Frog, LLC: Tips on Expert Testimony

 

HVLPO2, LLC v. Oxygen Frog, LLC was decided in February 2020. Although the case was decided a few years back, it may be profitable to review some of the principles of the Federal Rules of Evidence and Federal Rules of Civil Procedure presented in the case.

As background information, it is important to remember that in legal cases there are different tasks assigned to those involved. For example, the judge is often the trier of law and the jury is often the trier of fact. The trier of law is responsible for understanding and applying the law to the outcome of the case, whereas the trier of fact is responsible for understanding and applying the facts to the outcome of the case. In some cases, an issue that affects the ultimate outcome may be mixed, meaning that it is not solely a legal issue or solely a factual issue but includes both law and fact. In these cases, the jury may decide the issue as long as they are instructed properly as to the legal issues. Generally, obviousness in patent law is seen as a mixed issue of law and fact and the judge together with the different parties are tasked with properly instructing the jury according to the Federal Rules of Evidence and Civil Procedure.

In Oxygen Frog, the jury was asked to determine the obviousness and validity of the patent claims for U.S. Patent Nos. 8,876,941 and 9,372,488. These patents are directed to an oxygen-generating system, which is used to sustain and manage airflow for torch glass artists. At the district court level HVO objected to testimony of Tyler Piebes and filed a motion for a new trial. The district court overruled the objection and denied the motion for a new trial. At issue in the objection and motion was whether or not Mr. Piebes could be treated as an expert.

Federal Rule of Evidence 702 requires that a witness be qualified as an expert to help the trier of fact understand the evidence or to determine a fact in issue. Federal Rule of Civil Procedure 26 requires that each party be informed of the evidence that supports its case, including providing a report of expert witnesses who will be relied upon at trial. Qualifying a witness, under Rule 702, as an expert witness is an involved process that includes multiple steps. Significantly, this process never took place in Oxygen Frog relative to Mr. Piebes. Furthermore, prior to the trial, Oxygen Frog never provided the opposing party with a report that included Mr. Piebes listed as an expert.

The failure to qualify Mr. Piebes as an expert or to provide the report with him listed as an expert meant that Mr. Piebes would have to be consigned to that of a lay witness at trial. Being consigned to the status of a lay witness limited the subject matter about which Mr. Piebes could testify (i.e., he could not testify about the ultimate question of obviousness). Despite being a lay witness, the jury heard the following from Mr. Piebes:

Question from J.A. 704: "Did you think that modifying the Cornette system to support two circuits to be obvious?"

Answer: "Yes, I did."

Question from J.A. 708: "So would you consider it obvious if you have a pressure switch with instructions to wire it to turn on and off two circuits?

Answer: "Yes."

Although the jury was instructed by the district court to limit the testimony of Mr. Piebes, this limitation was insufficient. The limitation was insufficient because the instruction should have been to disregard Mr. Piebes' testimony. The instruction to disregard Mr. Piebes' testimony was never given. Therefore, the CAFC held that a new trial should have been granted and reversed and remanded the case for a new trial.

In dicta, the CAFC stated, "...Mr. Piebes' opinion testimony was directed to the central legal and technical question at trial: whether HVO's asserted patent claims were invalid for obviousness. This testimony from Mr. Piebes is thus in the clear purview of experts and lay witness testimony on such issues does not comply with the Federal Rules of Evidence or Civil Procedure." The takeaways from this case are 1) although the process to qualify an expert can be a bit tedious, it is necessary for those witnesses who will be relied upon as experts; and 2) especially when preparing for patent cases, make sure witness reports are thoroughly reviewed to include all expert witnesses and are provided to the opposing party.