In Australia, we are often told our US clients get title through the “work made for hire” or the “hired to invent” doctrines under US law. Intervet has failed in its attempt to rely on the latter doctrine in its unsuccessful attempt to patent a “soft chew” medicament for pets. Moshinsky J also accepted Merial’s opposition on grounds of lack of inventive step. This post will deal with the entitlement issue. Lack of inventive step case, based on the 2001 amendments, will be the subject of a later post.

Some background

In 2002, Intervet was part of the Akzo group. Most of its R & D activities were carried out at its plant in Delaware. However, a Ms Cady was based in New Jersey and had responsibility for developing formulations for commercialisation. She did not, however, have a laboratory. She had worked with a Mr Pieloch of Pharma Chemie to develop products before. Ms Cady engaged Pharma Chemie to develop a palatable “soft chew” dosage form for companion animals such as horses and dogs.

A formulation was developed. Intervet made a provisional application in the USA, naming a Mr Huron, Ms Cady and Mr Pieloch as inventors.[1] Like Ms Cady, Mr Huron was an employee of Intervet. When the PCT came to be filed on 13 August 2003, Mr Huron, Mr Pieloch and Ms Cady were named as the inventors.

Intervet’s in-house patent attorney sent a copy of the PCT specification to Mr Pieloch was a request to sign a declaration acknowledging that Intervet owned all the rights. Pharma Chemie and Mr Pieloch rejected the request, asserting through their lawyers:[2]

It is our client’s position that Pharma Chemie invented the soft chew technology as described in the above-referenced patent application in 1992, and continued its work on the technology through the 1990’s and into the new millenium [sic]. All of the work on this technology was completed prior to Pharma Chemie’s entry into the Manufacturing and Supply Agreement with Intervet in 2002. Pharma Chemie also invented the manufacturing procedure described in the patent application cited above, and provided Formax with this information well prior to its entry into the development agreement with Intervet in 2002.

Pharma Chemie is therefore the owner of the technology described in the above-referenced patent application, not Intervet. For this reason, Mr. Pieloch will not agree to sign the Declaration and Power of Attorney for this application. ….

Intervet made various attempts to prosecute the US application without Mr Pieloch’s signature. These did not progress, however, and the application in the USA ultimately lapsed. The Australian application, the subject of Merial’s opposition, was at least a divisional from the original PCT application.

Claim 1 of the patent application was for:

A soft chew formulation for oral administration comprising a pharmaceutical for control of a parasite of Equidae, Canidae, Felidae, Bovidae, Ovidae Capridae, or Suidae organisms in a soft chew formulation, a flavouring component, a starch component, a sugar component, an oil component and an emulsifying agent that acts as a forming agent, wherein the moisture content of the composition is between 5.0 and 7.5 percent wt, the soft chew formulation is formed by knockout and the soft chew formulation is not an extrudate.

Merial has lost its opposition to the application before the Commissioner and appealed to the Court. Both Mr Huron and Ms Cady had left Intervet by this time, and Ms Cady was one of the witnesses for Merial.

Entitlement

Section 15 requires that the grantee of a patent derive its title ultimately from all of the inventors. Although Intervet had identified Mr Pieloch as one of the three inventors, Merial’s opposition succeeded because Intervet could not claim title from Mr Pieloch whom Moshinsky J found was the sole inventor.

Moshinsky J accepted Mr Pieloch’s evidence that he had developed the technology used for Intervet’s product through his company, Pharma Chemie, before Ms Cady engaged Pharma Chemie to develop Intervet’s product. Pharma Chemie had used its own technology to make a “soft chew” which used Intervet’s additive. So, at least as claimed in Intervet’s application, Pharma Chemie was the inventor of the relevant technology.[3] Mr Pieloch was careful to eschew any claim to the specific product which embodied Intervet’s additive, but the claims were very much broader than that.

Intervet argued it was nonetheless entitled to the invention through an assignment in a Manufacturing and Supply Agreement under which Pharma Chemie developed the product. Alternatively, Intervet argued the assignment was implied under the US “hired to invent” doctrine.

Manufacturing and Supply Agreement

Intervet’s main problem with this argument was that it could not produce the agreement. Instead, it relied on evidence of other agreements with Pharma Chemie (after the event and relating to other projects) which did include express assignments and the importance to companies like Intervet of ensuring they had the rights to their products locked down.

Moshinsky J was not persuaded:

a) Mr Pieloch was adamant that Pharma Chemie had already developed the technology the subject of the application before the projects with Intervet and had even applied for a patent over it.

b) In re-examination, Mr Pieloch expressly denied that he had ever signed an assignment in the terms claimed by Intervet over the relevant technology (as opposed to the specific product using Intervet’s additives).

c) In 2003 in correspondence about the PCT application, Pharma Chemie’s lawyers had explicitly denied there was any such term and Intervet had not challenged that denial then or until the present proceedings.

d) If there had been such an express assignment, Intervet would have taken steps to keep it safe and secure and would have asserted it aginst Pharma Chemie when Pharma Chemie’s lawyers denied the assignment as long ago as 2003.

Hired to invent

Intervet next argued that US law implied a term to assign into the agreement by which Pharma Chemie developed the products for Intervet.

As foreign law, whether or not US law would in fact imply such a term was a question of fact to be determined on the evidence. Both Intervet and Merial advanced lawyers’ opinions on this question.

Both parties’ witnesses agreed that, under US law, a court could imply a term requiring an assignment. Intervet’s independent expert’s, a Mr Blackburn’s, evidence was that:

US law generally permits a court to imply a contract term in appropriate circumstances to handle developments and contractual gaps; one application of this principle is the “employed to invent” or “hired to invent” doctrine, which requires or obligates an inventor to assign an invention resulting from the development of a product that it was engaged to perform where the inventor was hired specifically to make the invention; while there is no binding precedent directly on point holding that a non-employee or independent contractor can be employed to invent or hired to invent, the reasoning of Standard Peeks and Dubilier suggest that the substance of the relationship between the parties and how the invention is made is the controlling factor.[4]

Merial’s expert, Mr Kowalski, contended that the case law relied on by Mr Blackburn applied only to the employer-employee relationship and did not extend to agreements with independent contractors.

Moshinsky J accepted that the cases relied on by Intervet dealt only with situations involving the employer-employee relationship, but his Honour was not satisfied that they were necessarily so limited. Moshinsky J had earlier noted that Mr Kowalski was Merial’s lawyer and had been involved in the preparation of Mr Pieloch’s affidavits for Merial. At [48(e)], his Honour considered that Mr Kowalski’s evidence at times appeared to be an exercise in advocacy and therefore generally preferred the evidence of Mr Blackburn where there were differences between them.

Having decided to proceed on the basis “that the “hired to invent” doctrine is capable of application notwithstanding that Pharma Chemie is a corporate entity and independent contractor rather than an employee”, Moshinsky J nonetheless held at [127] that no term to assign should be implied:

…. Mr Blackburn emphasised that what “controls” is the nature of the contractual relationship between the parties and how the invention was made; and that the critical fact is whether the contract specifically required the invention to be made. In the present case, I have found that Pharma Chemie was not engaged by Intervet Inc to develop a soft chew dosage form; it was engaged, rather, to incorporate Intervet Inc’s active ingredients into a formulation, using Pharma Chemie’s soft chew technology (see [89] above). Further, I have found that the Manufacturing and Supply Agreement referred to in Ms Marsh’s letter dated 16 September 2003 related to the development projects referred to in these reasons as the Horse Project and the Dog Project (see [75] above). It appears from the 16 September 2003 letter that the agreement contained (in paragraphs 1.4 and 9.3) express provisions relating to the assignment of intellectual property rights to Intervet Inc subject to prescribed conditions. In light of these express provisions, there is no room to imply a term (in this or any other agreement relating to the Horse Project or the Dog Project) requiring Pharma Chemie to assign to Intervet Inc any invention resulting from the projects. I have also found above that there was no response to the 16 September 2003 letter (see [80] above). If Intervet Inc had had a basis to contend that, contrary to the propositions set out in the letter, it acquired rights to an invention under the Manufacturing and Supply Agreement (or any other agreement) it is likely that it would have responded. This provides further support for the proposition that a term is not to be implied in the Manufacturing and Supply Agreement or any other agreement to the effect that Pharma Chemie was required to assign to Intervet Inc any invention resulting from the projects.

Accordingly, although the “hired to invent” doctrine could apply in principle, it did not apply on the facts.

It is worth contrasting the approach taken by Moshinsky J based on the application of US law to the arrangements between Intervet and Pharma Chemie with that applied in copyright by the Full Court in Enzed Holdings. In Enzed Holdings, the Full Court held that ownership of copyright in an artistic work in Australia fell to be determined according to Australian law. So, even though the artistic work in question was created in New Zealand, it was irrelevant that under New Zealand law ownership vested in the commissioning party not the author.[5] This approach would not have saved Intervet in this case, however, as the reasons Moshinshky J found to reject the “hired to invent” argument should lead to the same conclusion under Australian law.

Merial, Inc. v Intervet International B.V. (No 3) [2017] FCA 21


  1. By the time of the trial, both Mr Huron and Ms Cady worked for competitors of Intervet and gave evidence for Merial.  ?
  2. 16 September 2003 letter from Pharma Chemie’s lawyer to Intervet’s inhouse patent attorney.  ?
  3. Patents Act 1990 s 15.  ?
  4. Referring to Standard Parts Co v Peck, 264 US 52 (1924) and United States v Dubilier Condenser Corp, 289 US 178, 187 (1933).  ?
  5. In contrast to Enzed Holdings, the US 2nd Circuit Court of Appeals applied the law of the place where the work was made to determine entitlement to copyright in the USA in *Itar-Tass v Russian Kurier Inc (1998) 43 IPR 565.  ?