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Proper implementation of a drug lifecycle management strategy is critical
to maximizing profits in the biopharmaceutical industry.
Among them, the ownership of subsequent patents of drugs has been approved by drug regulatory agencies is an important part
of life cycle management.
Many pharmaceutical companies do not conduct in-house drug development alone, but instead rely on project collaborations with partners (i.
e.
, open innovation projects).
In open innovation projects, the management of external patents is also particularly important
to establish a company's intellectual property (IP) and extend the product life cycle.
to maximizing profits in the biopharmaceutical industry.
Among them, the ownership of subsequent patents of drugs has been approved by drug regulatory agencies is an important part
of life cycle management.
Many pharmaceutical companies do not conduct in-house drug development alone, but instead rely on project collaborations with partners (i.
e.
, open innovation projects).
In open innovation projects, the management of external patents is also particularly important
to establish a company's intellectual property (IP) and extend the product life cycle.
In recent years, with the passage of domestic biopharmaceutical enterprises through License
The number of IN/OUT open innovative drug project licenses is increasing (according to the PharmaMofang database, a total of 56 innovative drug licenses occurred in Chinese biopharmaceutical companies in the first half of 2022
In/Out transactions), as well as possible acquisition transactions, developing an effective patent management strategy, and managing the lifecycle of how to manage external patents (the original development and issuance of patents to external organizations, not pharmaceutical sponsors) will become common issues
.
Studies have shown that some marketed drug patents appear later in the product life cycle, providing an effective means
to prevent generic or improved drugs from competitors.
After the first approval of a drug, it applies to a patent authority for approval and listing in a drug regulatory agency (such as the FDA Orange Book or NMPA
CDE China Listed Drug Patent Information Registration Platform), which in particular significantly extends the overall term of drug patent protection; Managing such subsequent patents is an important part of
the lifecycle management strategy of innovative pharmaceutical companies.
In fact, a significant number of subsequent patents were initially developed and acquired by external partners, rather than drug sponsors
.
In some therapeutic areas, the use of subsequent patents is more prevalent
than in others.
Pharmaceutical companies need to develop drug lifecycle strategies to effectively manage and use external patents
in open innovation projects.
These strategies include appropriate licensing contract design, post-drug approval, and open innovation
.
Who owns the ups and downs of subsequent patents?
Who owns the ups and downs of subsequent patents?Pharmaceutical companies actively use basic patents (primary patents) and subsequent patents (secondary patents) to protect
the drugs they develop.
In general, the base patent protects the active ingredient of the drug compound, and subsequent patents protect the new formulation (dosage form, dosage, etc.
), method of use, polymorphism, isomer, prodrug, ester, salt form, manufacturing technology related to the mass production of the drug, and other processes
.
Once a patent is granted, the inventor is entitled to a ban on others from using, using, or selling products
from the invention for up to 20 years from the filing date.
It is generally believed that after the drug is marketed, the vast majority of subsequent patents are developed, applied for and obtained
by drug sponsors.
However, the cases of Prilosec (omeprazole) and Lipitor (atorvastatin) in the United States show that this is only a hypothesis
.
The discovery of Prilosec active ingredients and the New Drug Marketing Application (NDA) approved by the US FDA in 1995 were completed
by the Swedish company Astra (now AstraZeneca).
After the drug is approved, Prilosec patents (US) involving manufacturing processes and ingredients
6166213/US 6147103/US
6191148) was submitted to the United States Patent and Trademark Office in 1998 and
1999, respectively.
These subsequent patents were not issued to Astra, but to the American pharmaceutical company Merck
.
This is mainly due to the signing of an agreement between Merck and Astra prior to Prilosec's approval, in which Merck acquired the rights
to manufacture and distribute Astra products in the United States.
Following the approval of Prilosec, Merck saw an opportunity to improve Prilosec's manufacturing process and ingredients, and this collaboration allowed Merck to obtain a subsequent patent
to extend the life cycle of Prilosecs.
Lipitor was developed by Pfizer in collaboration with Warner Lambert, and the drug sponsor is Pfizer
.
The first Lipitor related patent for the protection of the active ingredient atorvastatin (US
4681893) filed in 1986 and filed another patent (US 5273995)
for the protection of isomers in 1991.
Subsequently, a patent was filed in 1994 (US) concerning salt forms and oral formulations
5686104), Lipitor was approved for marketing
in the United States in 1996.
In 1997, Warner Lambert filed with the United States Patent and Trademark Office two Lipitor-related crystal forms (US).
5969156) and patents for new compositions (US 6126971
).
Some researchers analyzed the situation of 158 drugs and their subsequent patents granted in the United States, and the results showed that more than 40% of subsequent patents were issued to external partners and 60% to drug sponsors
after drug approval.
These results suggest that a significant proportion of subsequent patents after drug approval are owned by external partners rather than by drug sponsors
.
Through the comparison of the time from drug approval to patent application for subsequent patents of drug sponsors and partners, the proportion of subsequent patents filed 7 years or more after the approval of their drugs is 7% by both drug sponsors and external partners
.
Of course, the frequency of subsequent patents varies in different therapeutic areas
.
More subsequent patents appear in the areas of anti-infection, antitumor, central nervous system and endocrine therapy, while analgesia/anesthesia and other therapeutic areas appear less
.
In conclusion, external patents play an important role
in the life cycle management strategy of branded pharmaceutical companies.
In addition, pharmaceutical companies need to manage relationships with partners after the drug is marketed for successful lifecycle management
in open innovation projects.
Clever contract design
Clever contract designIn reality, partners who obtain subsequent patents after drug approval are likely to be involved in the drug development process
before drug approval.
In many cases, pharmaceutical companies enter into licensing agreements with their partners prior to the approval of their drugs, and such prior licensing contracts play an important role
in obtaining subsequent patents developed by their partners.
Patent licensing contracts are inherently incomplete and imperfect because it is difficult to specify all possible contingencies, decision-makers are bounded rational, and there is a risk
of lock-in.
In addition, drug licensing contracts sometimes involve multiple organizations, which makes it difficult to specify all contingencies and property rights
.
While contracts are unlikely to address all possible contingencies, or pharmaceutical sponsors overcome bounded rationality, companies can establish safeguards against risk
through proper contract design 。 For example, the inclusion of exclusivity clauses (where the licensor agrees to license the invention to only one licensee), grant clauses (where the licensee agrees to grant back subsequent patents based on the licensor's original patent), non-assertion (an agreement between the licensor and the licensee not to seek patent enforcement for infringement of the other's patent), and unilateral or bilateral non-infringement (the licensor agrees to use the patent for defensive purposes) reduces the risk of lock-up in open innovation projects and helps companies to leverage partners' patents for financial gain
。
Acquisition after drug approval
Acquisition after drug approvalWhile proper contract design can greatly reduce the risk of lock-up, it cannot eliminate the transaction costs
involved in licensing contracts.
Acquisitions following regulatory approval are a means
of addressing the transaction costs associated with a partner's subsequent patents.
For example, Pfizer launched an $82.
4 billion hostile takeover of Warner Lambert to reduce the potential risk of lockage associated with Warner Lambert's patent in Lipitor
.
Although Warner Lambert initially objected to the acquisition, the two companies entered into an amicable merger agreement in which Pfizer was able to acquire the rights
to use Warner Lambert Lipitor's subsequent patents.
Abbott's acquisition of the drug Lupron (leuprorelin acetate microspheres) from Takeda is another example
of a means of addressing the cost of subsequent patent transactions with partners.
Abbott and Takeda jointly developed Lupron based on Takeda's patents, and after the drug was marketed, Abbott (through its spin-off, AbbVie) acquired Lupron from Takeda in the U.
S.
market and acquired the rights
to profit from subsequent patents developed by Takeda.
An open science mindset
An open science mindsetOpen innovation projects involve collaboration with a variety of partners, including pharmaceutical companies, biotechnology companies, universities, research institutions, governments, non-profit organizations, medical device manufacturers, hospitals, and scientists
.
Drug sponsors must understand that managing patents owned by different types of partners requires different skills and strategies
.
While pharmaceutical sponsors can work with industry partners to maximize profits by restricting access to their intellectual property, this closed mindset can negatively impact
working with public sector partners to advance science and innovation.
Senior executives of pharmaceutical companies must recognize the importance of open-mindedness with public sector partners in open innovation projects and build "connectivity" to improve absorptive capacity and, more importantly, lifecycle management skills
.
After drug approval, public sector partners continue to conduct research on approved drugs to better understand drug mechanisms and therapeutic effects, which provides an important opportunity to discover subsequent patentable inventions related to their drugs, thereby extending the product lifecycle
.
For example, Johnson & Johnson, the sponsor of the Topamax drug originally used to treat epilepsy, continues to study the drug's efficacy in collaboration with Tufts Medical Center and found that Topamax is an effective migraine treatment
.
Tufts Medical Center patented different uses of Topamax for treating migraines and headaches, allowing Johnson & Johnson to extend the product's lifecycle
using Tufts' subsequent patents.
Through open innovation projects, pharmaceutical companies have the opportunity to manage subsequent patents from external partners, which in turn affects their product lifecycle
.
Existing data analysis and case studies show that a significant number of subsequent patents involving new drugs come from external partners after drug approval, so pharmaceutical companies should continue to manage relationships
with partners after the drug is on the market.
There are a variety of strategies that pharmaceutical companies can employ to maximize the use of their partners' subsequent patents
.
An important factor that must be considered is that there is a wide variety of partners in open innovation drug projects, and a "one-size-fits-all" approach to different partners and their patents will not be effective
.
