The claims at issue in the ’690 patent application cover use of anti-C5 antibodies with an Fc domain.  The claims were drafted in both the “Jepson” and means-plus-function format (claims 8 and 9, respectively):

8. In a method of treating a patient by administering an anti-C5 antibody with an Fc domain, the improvement comprising said Fc domain comprising amino acid substitution M428L/N434S as compared to a human Fc polypeptide, wherein numbering is according to the EU index of Kabat, wherein said anti-C5 antibody with said amino acid substitution has increased in vivo half-life as compared to said antibody without said substitutions.
9. A method of treating a patient by administering an anti-C5 antibody comprising: a) means for binding human C5 protein; and b) an Fc domain comprising amino acid substitution M428L/N434S as compared to a human Fc polypeptide, wherein numbering is according to the EU index of Kabat, wherein said anti-C5 antibody with said amino acid substitution has increased in vivo half-life as compared to said antibody without said substitutions.

The examiner had rejected the claims as unpatentable (a) for failing to comply with the written description requirement, and (b) under the obviousness-type double patenting doctrine.  Xencor appealed the rejection to the Patent Trial and Appeal Board (“PTAB”), after which the examiner withdrew the written description rejection.

Life sciences companies continue to make up a small portion of the companies registering for Unitary Patents. Per the European Patent Office’s statistics portal, as of January 30, 2024 there have been 18,721 registered Unitary Patents. The Uptake Rate is 17.5%. Of this, Medical Technology companies account for 2,266 (or, 11.8%) of the registrations. This is the largest of the 35 technology fields that the portal is tracking. Pharmaceuticals account for 717 (or, 3.7%) of the registrations. Biotechnology accounts for 444 (or, 2.3%) of the registrations.

Notably, Johnson & Johnson has the largest share of registrations at 267. This is followed by Siemens, with 261 registrations. Other life sciences companies cracking the top 25 include: Hoffman-La Roche (82 registrations), Align Technology (46 registrations) and Becton, Dickinson & Company (105 registrations).

In related news, Ireland has also announced that its referendum on whether to ratify the Agreement on a Unified Patent Court (UPCA) will occur in June 2024. If Ireland votes yes, it will become the 18th country to actively join the UPC. All 27 members of the EU are eligible to join the UPC, though only 24 have signed the UPCA. Non-EU countries, such as England, cannot join the UPC. Notably, Poland and Spain have not signed the UPCA.

The post Life Sciences Companies Make Up a Small Portion of the Companies Opting-In to the Unitary Patent; Ireland Announces Referendum Date appeared first on Life Sciences Perspectives.

You have to play the “What If” game when reviewing bank partnership agreements for fintech companies. This game is a pressure-testing exercise, asking yourself as you read through program and platform agreements whether there is adequate contractual coverage if something big happens. Of course, you have to be judicious in doing so, recognizing you may not have leverage on certain points and understanding each party’s desire to negotiate the agreements full speed ahead. 

Here are some questions that you should consider as you go through the agreements: 

• What if the fintech wants to see a change made to the program after launch?
• What if the bank plans to make a material change to the program when everything is going well?
• What if a lending fintech–bank partnership arrangement gets challenged in a lawsuit or regulator action on “true lender” grounds?
• What if there is a regulator inquiry? Is the fintech’s perspective and input considered and worked into the response?
• What if the fintech wants some rights to customer data?
• What if the fintech wants to solicit customers for other products and services?
• What if the bank wants to significantly increase the required balance of the reserve or collateral account?
• What if there is an exclusivity provision that does not permit a second or backup bank?

These are all good ones, but perhaps the most important question is: What if the agreement is terminated or not renewed and the program ends? As the saying goes, “all good things must come to an end,” and the parties have to be prepared for this possibility.

Regulatory Developments

Federal Reserve Announces the Bank Term Funding Program will Cease Making New Loans as Scheduled on March 11
On January 24, the Federal Reserve announced that the BTFP, launched in response to the Silicon Valley Bank and Signature Bank failures of March 2023, will cease making new loans on March 11. While the BTFP will continue making new loans to participant banks until March 11, the interest rate applicable to these new loans will be no lower than the interest rate in effect on reserve balances on the day the loan is made.

Acting Comptroller of the Currency Discusses Bank Mergers 
On January 29, Acting Comptroller of the Currency Michael J. Hsu discussed improving transparency and trust in the bank merger process in remarks at the University of Michigan. In his remarks, Mr. Hsu discussed how developing a view on the overall structure of the U.S. banking system could help ensure that it remains diverse, dynamic, and balanced with the economy, as well as inform bank merger policy and decisions.

In furtherance of that objective, Mr. Hsu announced that the OCC was inviting comment on a proposal to amend its regulations governing business combination applications to eliminate automatic expedited approvals and to clarify the features of merger applications and indicators that are consistent with and inconsistent with approval.

“The banking system supports the economy and the businesses, communities, and individuals that comprise it. This point bears reemphasizing when thinking about what the banking system should look like. Put simply, we don’t exist to serve banks; banks exist to serve us. Therefore, in order to have a view on what the banking system should look like, we need to be clear about what to measure it against.”
‒ Michael Hsu, Acting Comptroller of the Currency

OCC Requests Comments on Proposed Rulemaking and Policy Statement on Bank Mergers 
On January 29, the OCC requested comment on a proposal to update its rules for business combinations involving national banks and federal savings associations. The OCC believes that the proposal will increase transparency about its process when reviewing transactions under the Bank Merger Act (BMA). The proposal includes a policy statement to clarify the OCC’s review of applications under the BMA. The proposed policy statement addresses: (1) general principles for the OCC’s review of applications under the BMA, including indicators for applications that may raise concerns; (2) the OCC’s consideration of financial stability; (3) managerial and financial resources and future prospects; (4) convenience and needs statutory factors under the BMA; and (5) the OCC’s decision making process for extending the comment periods or holding public meetings. Comments from the public are due 60 days from the date of publication in the Federal Register. 

In a recent piece in this series, our colleagues showed that funds set hurdle rates differently depending on the asset class. Funds also use different approaches for calculating hurdle rates.

Funds typically use one of three main approaches to calculate the hurdle: compounding interest rate, internal rate of return (IRR), or percent of amounts drawn or committed.

When all funds are considered together, the compounding interest rate approach is the most popular. An analysis of Goodwin’s Private Funds Terms Database shows that 50% of funds overall use this approach, while 38% use IRR, and 12% use percent of amounts drawn or committed.